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Survey: 42% of PCPs not familiar with biologics for asthma
ANAHEIM, CALIF. – Patients with uncontrolled asthma are seen more often by primary care providers (PCPs) than by allergists, but a survey has found that
Bijalben Patel, MD, with the department of internal medicine, University of South Florida, Tampa, said in an interview that in addition to the considerable lack of knowledge of biologics in primary care, she was surprised that 77% of survey participants stated they only referred patients to specialists after two or more exacerbations.
“This is important because these patients are considered to have exacerbation-prone asthma, which should be managed by specialists,” she said.
She said that being “unfamiliar” with biologics meant that the healthcare provider may have heard of biologics but did not know the various types, initiation criteria, or side effects.
The researchers administered a REDCap (Research Electronic Data Capture) survey by email to primary care attending and resident physicians in the departments of internal medicine, family medicine, and pediatrics, and 85 responded. Responses were compared using Chi-square tests.
Patel presented the results of the survey at the annual meeting of the American College of Allergy, Asthma & Immunology.
82% do not order labs
Familiarity did not vary in primary care with number of patients with asthma seen per month, the researchers noted.
“Also, the frequency of PCP referrals to a specialist did not change familiarity with biologics (P = .260) or eligibility criteria (P = .393),” the researchers said.
In addition, they found that 82% of those surveyed do not order labs, and 90% do not use absolute eosinophil count to guide care.
Dr. Patel explained that lab work such as obtaining IgE levels and a complete blood count with a differential and examining the absolute eosinophil count help identify patients who are at high risk for future exacerbation and also treatable phenotypic traits, which can be targeted with biologic therapy.
Angela Duff Hogan, MD, vice chair of the ACAAI Asthma Committee and professor of pediatrics at Eastern Virginia Medical School, Norfolk, said in an interview that she finds the delay on referrals the most concerning finding in the survey results.
“I’m not as concerned they are not obtaining labs,” said Dr. Hogan, who was not part of the study. “The specialist can do that. It’s more concerning they wait so long to refer a patient with poorly controlled asthma. We know that asthma patients treated by an allergist have better asthma control, better quality of life, and reduced health care costs.”
Asthma specialists ‘need better marketing’
Dr. Hogan said that the results show the need for more studies to demonstrate that asthma specialists can improve outcomes and reduce healthcare costs.
“Objective data is more convincing than subjective data,” she noted. “As a specialty, we need to disseminate more information about asthma management, the “new” asthma guidelines, SMART/MART therapy, and the importance of biologicals in asthma. We need better marketing as a specialty in asthma care.”
Dr. Patel said that their goal with the study is to raise awareness about the available asthma biologic therapies, which have been improving care for 2 decades.
“The results of the survey point to the need to improve the communication between primary care physicians and asthma care specialists, including regarding use of biologics,” senior author Juan Carlos Cardet, MD, MPH, also an allergy specialist at USF, added in a press release. “Biologics have become an important tool in the treatment of asthma and other allergic diseases such as atopic dermatitis (eczema), chronic rhinosinusitis with nasal polyps and eosinophilic esophagitis, and can prevent substantial ill results from occurring in patients who are eligible for them.”
The study authors and Dr. Hogan disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
ANAHEIM, CALIF. – Patients with uncontrolled asthma are seen more often by primary care providers (PCPs) than by allergists, but a survey has found that
Bijalben Patel, MD, with the department of internal medicine, University of South Florida, Tampa, said in an interview that in addition to the considerable lack of knowledge of biologics in primary care, she was surprised that 77% of survey participants stated they only referred patients to specialists after two or more exacerbations.
“This is important because these patients are considered to have exacerbation-prone asthma, which should be managed by specialists,” she said.
She said that being “unfamiliar” with biologics meant that the healthcare provider may have heard of biologics but did not know the various types, initiation criteria, or side effects.
The researchers administered a REDCap (Research Electronic Data Capture) survey by email to primary care attending and resident physicians in the departments of internal medicine, family medicine, and pediatrics, and 85 responded. Responses were compared using Chi-square tests.
Patel presented the results of the survey at the annual meeting of the American College of Allergy, Asthma & Immunology.
82% do not order labs
Familiarity did not vary in primary care with number of patients with asthma seen per month, the researchers noted.
“Also, the frequency of PCP referrals to a specialist did not change familiarity with biologics (P = .260) or eligibility criteria (P = .393),” the researchers said.
In addition, they found that 82% of those surveyed do not order labs, and 90% do not use absolute eosinophil count to guide care.
Dr. Patel explained that lab work such as obtaining IgE levels and a complete blood count with a differential and examining the absolute eosinophil count help identify patients who are at high risk for future exacerbation and also treatable phenotypic traits, which can be targeted with biologic therapy.
Angela Duff Hogan, MD, vice chair of the ACAAI Asthma Committee and professor of pediatrics at Eastern Virginia Medical School, Norfolk, said in an interview that she finds the delay on referrals the most concerning finding in the survey results.
“I’m not as concerned they are not obtaining labs,” said Dr. Hogan, who was not part of the study. “The specialist can do that. It’s more concerning they wait so long to refer a patient with poorly controlled asthma. We know that asthma patients treated by an allergist have better asthma control, better quality of life, and reduced health care costs.”
Asthma specialists ‘need better marketing’
Dr. Hogan said that the results show the need for more studies to demonstrate that asthma specialists can improve outcomes and reduce healthcare costs.
“Objective data is more convincing than subjective data,” she noted. “As a specialty, we need to disseminate more information about asthma management, the “new” asthma guidelines, SMART/MART therapy, and the importance of biologicals in asthma. We need better marketing as a specialty in asthma care.”
Dr. Patel said that their goal with the study is to raise awareness about the available asthma biologic therapies, which have been improving care for 2 decades.
“The results of the survey point to the need to improve the communication between primary care physicians and asthma care specialists, including regarding use of biologics,” senior author Juan Carlos Cardet, MD, MPH, also an allergy specialist at USF, added in a press release. “Biologics have become an important tool in the treatment of asthma and other allergic diseases such as atopic dermatitis (eczema), chronic rhinosinusitis with nasal polyps and eosinophilic esophagitis, and can prevent substantial ill results from occurring in patients who are eligible for them.”
The study authors and Dr. Hogan disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
ANAHEIM, CALIF. – Patients with uncontrolled asthma are seen more often by primary care providers (PCPs) than by allergists, but a survey has found that
Bijalben Patel, MD, with the department of internal medicine, University of South Florida, Tampa, said in an interview that in addition to the considerable lack of knowledge of biologics in primary care, she was surprised that 77% of survey participants stated they only referred patients to specialists after two or more exacerbations.
“This is important because these patients are considered to have exacerbation-prone asthma, which should be managed by specialists,” she said.
She said that being “unfamiliar” with biologics meant that the healthcare provider may have heard of biologics but did not know the various types, initiation criteria, or side effects.
The researchers administered a REDCap (Research Electronic Data Capture) survey by email to primary care attending and resident physicians in the departments of internal medicine, family medicine, and pediatrics, and 85 responded. Responses were compared using Chi-square tests.
Patel presented the results of the survey at the annual meeting of the American College of Allergy, Asthma & Immunology.
82% do not order labs
Familiarity did not vary in primary care with number of patients with asthma seen per month, the researchers noted.
“Also, the frequency of PCP referrals to a specialist did not change familiarity with biologics (P = .260) or eligibility criteria (P = .393),” the researchers said.
In addition, they found that 82% of those surveyed do not order labs, and 90% do not use absolute eosinophil count to guide care.
Dr. Patel explained that lab work such as obtaining IgE levels and a complete blood count with a differential and examining the absolute eosinophil count help identify patients who are at high risk for future exacerbation and also treatable phenotypic traits, which can be targeted with biologic therapy.
Angela Duff Hogan, MD, vice chair of the ACAAI Asthma Committee and professor of pediatrics at Eastern Virginia Medical School, Norfolk, said in an interview that she finds the delay on referrals the most concerning finding in the survey results.
“I’m not as concerned they are not obtaining labs,” said Dr. Hogan, who was not part of the study. “The specialist can do that. It’s more concerning they wait so long to refer a patient with poorly controlled asthma. We know that asthma patients treated by an allergist have better asthma control, better quality of life, and reduced health care costs.”
Asthma specialists ‘need better marketing’
Dr. Hogan said that the results show the need for more studies to demonstrate that asthma specialists can improve outcomes and reduce healthcare costs.
“Objective data is more convincing than subjective data,” she noted. “As a specialty, we need to disseminate more information about asthma management, the “new” asthma guidelines, SMART/MART therapy, and the importance of biologicals in asthma. We need better marketing as a specialty in asthma care.”
Dr. Patel said that their goal with the study is to raise awareness about the available asthma biologic therapies, which have been improving care for 2 decades.
“The results of the survey point to the need to improve the communication between primary care physicians and asthma care specialists, including regarding use of biologics,” senior author Juan Carlos Cardet, MD, MPH, also an allergy specialist at USF, added in a press release. “Biologics have become an important tool in the treatment of asthma and other allergic diseases such as atopic dermatitis (eczema), chronic rhinosinusitis with nasal polyps and eosinophilic esophagitis, and can prevent substantial ill results from occurring in patients who are eligible for them.”
The study authors and Dr. Hogan disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
FROM ACAAI 2023
Alpha-gal syndrome: Red meat is ‘just the beginning,’ expert says
ANAHEIM, CALIF. – allergist and immunologist Scott P. Commins, MD, PhD, told attendees at the annual meeting of the American College of Allergy, Asthma, and Immunology (ACAAI) annual meeting.
Dr. Commins, associate chief for allergy and immunology at the University of North Carolina at Chapel Hill, has made alpha-gal, a potentially fatal allergy, which, in the United States is tied to the bite of the Lone Star tick, his primary research focus.
Beyond red meat, “there are some people who are allergic to all things mammal,” he explained. Dairy products from mammals, medical devices made from mammalian products, vaccines and medicines that contain gelatin, and even commercial products such as perfumes and cosmetics may be behind an AGS reaction.
“The derived products from pigs and cows really find their way into a lot of our day-to-day products,” he said. “I try to keep an open mind about these exposures.”
Physicians should also be aware that “this can happen to kids,” said Dr. Commins. “It looks very similar to adults’ [AGS]. They can end up in the emergency department.”
He also had clinical advice about food challenges for AGS. He explained that there’s more alpha-gal in beef than in other red meats (including pork, venison, and lamb) with the exception of pork kidney. Pork kidney, he said, “has the most alpha-gal that we can find in the lab.”
Dr. Commins said he has stopped using beef for AGS food challenges and has switched to pork sausage patties with a high fat content microwaved in the clinic because they have less alpha-gal in general and he views them as safer.
Long delay in symptom onset
AGS symptoms typically take 2-6 hours to appear after eating red meat or being exposed to mammalian products, but Dr. Commins related a story about a patient he sent home who had very mild symptoms (some lower back itching) after he had spent the day at the clinic after a pork sausage food challenge for AGS.
The patient had returned home. Eight hours after the food challenge, his wife sent Dr. Commins a picture of her husband’s back, which was riddled with welts and was itching badly.
“I learned that if you’re going to do these food challenges, if there is a hint of symptoms at the clinic at 6 hours, keep them in the clinic, because it may really take that long to evolve,” Dr. Commins said.
One of the early signs he’s discovered is palmar erythema (redness and swelling of the hands).
Research has shown that AGS has been heavily concentrated in the Southeast, where Lone Star tick populations are clustered, but research has shown that from 2017 to 2022, it moved up the East Coast to the central United States and Upper Midwest.
“We are seeing increasing diagnoses of AGS in places that are not, perhaps, where we first thought this allergy existed,” said Dr. Commins. “Stay aware,” he cautioned.
The allergy is not exclusive to the United States, he noted. In Europe and Australia, for example, AGS is not thought to be tied to the Lone Star tick, which doesn’t inhabit those regions.
“It is a global phenomenon,” Dr. Commins said.
In August, the CDC alerted physicians to emerging cases of alpha-gal allergy after an article in Morbidity and Mortality Weekly Report indicated that health care providers have little knowledge about the allergy. Of the 1,500 health care providers surveyed, 42% had never heard of the syndrome, and another 35% were not confident in diagnosing or managing affected patients.
Matthew Lau, MD, an allergist with Kaiser Permanente in Honolulu who listened to Dr. Commins’ talk, told this news organization, “It’s important to raise awareness in primary care particularly, he said, as “allergists see only a fraction of the [AGS] patients.”
Allergists can help raise awareness
“Allergists have a role to alert the general community” and to drive more referrals, he said. That includes emergency departments, where physicians commonly see anaphylaxis.
Dr. Lau said he expects the incidence of AGS to increase, because global warming will likely lengthen warmer seasons and cause the geographic distribution to change.
Jay Lieberman, MD, a pediatric allergist at Le Bonheur Children’s Hospital in Memphis, Tenn., told this news organization, “There’s still a lot of confusion, and hearing from an expert like Dr. Commins helps tease out the not-obvious things about patients who are having more mild symptoms,” such as from allergy to dairy or medicines or vaccines that contain gelatin.
As a pediatric allergist, Dr. Lieberman said he sees less alpha-gal than his colleagues, but, he said, “On the adult side in Tennessee, it’s rampant.”
Dr. Commins, Dr. Lieberman, and Dr. Lau report no relevant financial relationships.
A version of this article appeared on Medscape.com.
ANAHEIM, CALIF. – allergist and immunologist Scott P. Commins, MD, PhD, told attendees at the annual meeting of the American College of Allergy, Asthma, and Immunology (ACAAI) annual meeting.
Dr. Commins, associate chief for allergy and immunology at the University of North Carolina at Chapel Hill, has made alpha-gal, a potentially fatal allergy, which, in the United States is tied to the bite of the Lone Star tick, his primary research focus.
Beyond red meat, “there are some people who are allergic to all things mammal,” he explained. Dairy products from mammals, medical devices made from mammalian products, vaccines and medicines that contain gelatin, and even commercial products such as perfumes and cosmetics may be behind an AGS reaction.
“The derived products from pigs and cows really find their way into a lot of our day-to-day products,” he said. “I try to keep an open mind about these exposures.”
Physicians should also be aware that “this can happen to kids,” said Dr. Commins. “It looks very similar to adults’ [AGS]. They can end up in the emergency department.”
He also had clinical advice about food challenges for AGS. He explained that there’s more alpha-gal in beef than in other red meats (including pork, venison, and lamb) with the exception of pork kidney. Pork kidney, he said, “has the most alpha-gal that we can find in the lab.”
Dr. Commins said he has stopped using beef for AGS food challenges and has switched to pork sausage patties with a high fat content microwaved in the clinic because they have less alpha-gal in general and he views them as safer.
Long delay in symptom onset
AGS symptoms typically take 2-6 hours to appear after eating red meat or being exposed to mammalian products, but Dr. Commins related a story about a patient he sent home who had very mild symptoms (some lower back itching) after he had spent the day at the clinic after a pork sausage food challenge for AGS.
The patient had returned home. Eight hours after the food challenge, his wife sent Dr. Commins a picture of her husband’s back, which was riddled with welts and was itching badly.
“I learned that if you’re going to do these food challenges, if there is a hint of symptoms at the clinic at 6 hours, keep them in the clinic, because it may really take that long to evolve,” Dr. Commins said.
One of the early signs he’s discovered is palmar erythema (redness and swelling of the hands).
Research has shown that AGS has been heavily concentrated in the Southeast, where Lone Star tick populations are clustered, but research has shown that from 2017 to 2022, it moved up the East Coast to the central United States and Upper Midwest.
“We are seeing increasing diagnoses of AGS in places that are not, perhaps, where we first thought this allergy existed,” said Dr. Commins. “Stay aware,” he cautioned.
The allergy is not exclusive to the United States, he noted. In Europe and Australia, for example, AGS is not thought to be tied to the Lone Star tick, which doesn’t inhabit those regions.
“It is a global phenomenon,” Dr. Commins said.
In August, the CDC alerted physicians to emerging cases of alpha-gal allergy after an article in Morbidity and Mortality Weekly Report indicated that health care providers have little knowledge about the allergy. Of the 1,500 health care providers surveyed, 42% had never heard of the syndrome, and another 35% were not confident in diagnosing or managing affected patients.
Matthew Lau, MD, an allergist with Kaiser Permanente in Honolulu who listened to Dr. Commins’ talk, told this news organization, “It’s important to raise awareness in primary care particularly, he said, as “allergists see only a fraction of the [AGS] patients.”
Allergists can help raise awareness
“Allergists have a role to alert the general community” and to drive more referrals, he said. That includes emergency departments, where physicians commonly see anaphylaxis.
Dr. Lau said he expects the incidence of AGS to increase, because global warming will likely lengthen warmer seasons and cause the geographic distribution to change.
Jay Lieberman, MD, a pediatric allergist at Le Bonheur Children’s Hospital in Memphis, Tenn., told this news organization, “There’s still a lot of confusion, and hearing from an expert like Dr. Commins helps tease out the not-obvious things about patients who are having more mild symptoms,” such as from allergy to dairy or medicines or vaccines that contain gelatin.
As a pediatric allergist, Dr. Lieberman said he sees less alpha-gal than his colleagues, but, he said, “On the adult side in Tennessee, it’s rampant.”
Dr. Commins, Dr. Lieberman, and Dr. Lau report no relevant financial relationships.
A version of this article appeared on Medscape.com.
ANAHEIM, CALIF. – allergist and immunologist Scott P. Commins, MD, PhD, told attendees at the annual meeting of the American College of Allergy, Asthma, and Immunology (ACAAI) annual meeting.
Dr. Commins, associate chief for allergy and immunology at the University of North Carolina at Chapel Hill, has made alpha-gal, a potentially fatal allergy, which, in the United States is tied to the bite of the Lone Star tick, his primary research focus.
Beyond red meat, “there are some people who are allergic to all things mammal,” he explained. Dairy products from mammals, medical devices made from mammalian products, vaccines and medicines that contain gelatin, and even commercial products such as perfumes and cosmetics may be behind an AGS reaction.
“The derived products from pigs and cows really find their way into a lot of our day-to-day products,” he said. “I try to keep an open mind about these exposures.”
Physicians should also be aware that “this can happen to kids,” said Dr. Commins. “It looks very similar to adults’ [AGS]. They can end up in the emergency department.”
He also had clinical advice about food challenges for AGS. He explained that there’s more alpha-gal in beef than in other red meats (including pork, venison, and lamb) with the exception of pork kidney. Pork kidney, he said, “has the most alpha-gal that we can find in the lab.”
Dr. Commins said he has stopped using beef for AGS food challenges and has switched to pork sausage patties with a high fat content microwaved in the clinic because they have less alpha-gal in general and he views them as safer.
Long delay in symptom onset
AGS symptoms typically take 2-6 hours to appear after eating red meat or being exposed to mammalian products, but Dr. Commins related a story about a patient he sent home who had very mild symptoms (some lower back itching) after he had spent the day at the clinic after a pork sausage food challenge for AGS.
The patient had returned home. Eight hours after the food challenge, his wife sent Dr. Commins a picture of her husband’s back, which was riddled with welts and was itching badly.
“I learned that if you’re going to do these food challenges, if there is a hint of symptoms at the clinic at 6 hours, keep them in the clinic, because it may really take that long to evolve,” Dr. Commins said.
One of the early signs he’s discovered is palmar erythema (redness and swelling of the hands).
Research has shown that AGS has been heavily concentrated in the Southeast, where Lone Star tick populations are clustered, but research has shown that from 2017 to 2022, it moved up the East Coast to the central United States and Upper Midwest.
“We are seeing increasing diagnoses of AGS in places that are not, perhaps, where we first thought this allergy existed,” said Dr. Commins. “Stay aware,” he cautioned.
The allergy is not exclusive to the United States, he noted. In Europe and Australia, for example, AGS is not thought to be tied to the Lone Star tick, which doesn’t inhabit those regions.
“It is a global phenomenon,” Dr. Commins said.
In August, the CDC alerted physicians to emerging cases of alpha-gal allergy after an article in Morbidity and Mortality Weekly Report indicated that health care providers have little knowledge about the allergy. Of the 1,500 health care providers surveyed, 42% had never heard of the syndrome, and another 35% were not confident in diagnosing or managing affected patients.
Matthew Lau, MD, an allergist with Kaiser Permanente in Honolulu who listened to Dr. Commins’ talk, told this news organization, “It’s important to raise awareness in primary care particularly, he said, as “allergists see only a fraction of the [AGS] patients.”
Allergists can help raise awareness
“Allergists have a role to alert the general community” and to drive more referrals, he said. That includes emergency departments, where physicians commonly see anaphylaxis.
Dr. Lau said he expects the incidence of AGS to increase, because global warming will likely lengthen warmer seasons and cause the geographic distribution to change.
Jay Lieberman, MD, a pediatric allergist at Le Bonheur Children’s Hospital in Memphis, Tenn., told this news organization, “There’s still a lot of confusion, and hearing from an expert like Dr. Commins helps tease out the not-obvious things about patients who are having more mild symptoms,” such as from allergy to dairy or medicines or vaccines that contain gelatin.
As a pediatric allergist, Dr. Lieberman said he sees less alpha-gal than his colleagues, but, he said, “On the adult side in Tennessee, it’s rampant.”
Dr. Commins, Dr. Lieberman, and Dr. Lau report no relevant financial relationships.
A version of this article appeared on Medscape.com.
Studies address primary care oral health screening and prevention for children
Both were published online in JAMA.
In one report, the United States Preventive Services Task Force (USPSTF) concludes that there is not enough evidence to assess harms versus benefits of routine screening or interventions for oral health conditions, including dental caries, in primary care for asymptomatic children and adolescents aged 5-17 years.
The evidence report on administering fluoride supplements, fluoride gels, sealants and varnish finds evidence that they improve outcomes. The report was done to inform the USPSTF for a new recommendation on primary care screening, dental referral, behavioral counseling, and preventive interventions for oral health in children and adolescents aged 5-17.
Primary care physicians’ role
One problem the USPSTF identified in its report was limited evidence on available clinical screening tools or assessments to identify which children have oral health conditions in the primary care setting.
The USPSTF’s team, led by Michael J. Barry, MD, of Harvard Medical School in Boston, calls for more research to fill in the gaps before it can reassess.
Michael S. Reddy, DMD, DMSc, with University of California San Francisco School of Dentistry, Oral Health Affairs, said in an accompanying editorial that the current lack of data should not keep primary care physicians from considering oral health during routine medical exams or keep dentists from finding ways to collaborate with primary care physicians. “Medical primary care must partner with dentistry,” they wrote.
Until there is enough evidence for a USPSTF reevaluation on the topic, primary care clinicians should ask patients about their oral hygiene routines, whether they have any dental symptoms, and when they last saw a dentist, as well as referring to a dentist as necessary, the editorialists wrote.
That works both ways, the editorialists added. “Equally important, oral health professionals are encouraged to collaborate and be a resource for their primary care colleagues. Prevention is one of the best tools clinicians have, and it is promoted by integrated, whole-person health effort, “ wrote Dr. Reddy and colleagues.
When oral health stays separate from medical care, patients are left vulnerable, and referrals between medical and dental offices should be a stronger two-way system, the editorialists said.
“[N]ot every primary care patient has access to a dentist,” they wrote. “Oral health screening and referral by medical primary care clinicians can help ensure that individuals get to the dental chair to receive needed interventions that can benefit both oral and potentially overall health. Likewise, medical challenges and oral mucosal manifestations of chronic health conditions detected at a dental visit should result in medical referral, allowing prompt evaluation and treatment.”
Evidence that gels, varnish, sealants are effective
In a companion paper, done to inform the USPSTF, Roger Chou, MD, with Pacific Northwest Evidence-based Practice Center, Department of Medical Informatics and Clinical Epidemiology at Oregon Health & Science University in Portland, and colleagues found that when administered by a dental professional or in school settings, fluoride supplements, gels and varnish, and resin-based sealants improved health outcomes.
The findings were based on three systematic reviews (20,684 participants) and 19 randomized clinical trials; three nonrandomized trials; and one observational study (total 15,026 participants.)
With fluoride versus placebo or no intervention, researchers found a decrease from baseline in the number of decayed, missing, or filled permanent teeth (DMFT index) or decayed or filled permanent teeth (DFT index). The average difference was −0.73 [95% confidence interval [CI], −1.30 to −0.19]) at 1.5 to 3 years (six trials; n = 1,395).
Fluoride gels were associated with a DMFT- or DFT-prevented fraction of 0.18 (95% CI, 0.09-0.27) at outcomes closest to 3 years (four trials; n = 1,525).
Researchers found an association between fluoride varnish and a DMFT- or DFT-prevented fraction of 0.44 (95% CI, 0.11-0.76) at 1 to 4.5 years (five trials; n = 3,902). The sealants tested were associated with decreased risk of caries in first molars (odds ratio, 0.21 [95% CI, 0.16-0.28]) at 48-54 months (four trials; n = 440).
They noted that the feasibility of administering preventive measures in primary care is unknown; the effectiveness shown here was based on administration in dental and supervised school settings.
Barriers in primary care settings may include lack of training and equipment (particularly for sealants), uncertain reimbursement and lack of acceptance and uptake.
USPSTF working to close evidence gaps
Wanda Nicholson, MD, MPH, Prevention and Community Health, George Washington Milken Institute of Public Health in Washington, wrote in an accompanying editorial that to speed necessary research to facilitate recommendations, “the USPSTF and its stakeholders need a transparent, easily implementable communication tool that will systematically describe the research necessary to be directly responsive to the evidence gaps.”
The editorialists noted that the USPSTF in trying to update recommendations often has few, if any, high-quality additional studies to consider since its previous recommendation.
To address that, meetings were conducted in November of 2022 involving USPSTF members, Agency for Healthcare Research and Quality (AHRQ) staff, and leadership from the Office of Disease Prevention and the National Institutes of Health. Members formed a working group “to develop a standardized template for communicating research gaps” according to a framework developed by the National Academies of Sciences, Engineering, and Medicine.
Dr. Nicholson and colleagues wrote, “classifying evidence gaps and calling for specific research needs is a prudent, collaborative step in addressing missing evidence,” particularly for underserved populations.
The authors and editorialists declared no relevant conflicts of interest.
Both were published online in JAMA.
In one report, the United States Preventive Services Task Force (USPSTF) concludes that there is not enough evidence to assess harms versus benefits of routine screening or interventions for oral health conditions, including dental caries, in primary care for asymptomatic children and adolescents aged 5-17 years.
The evidence report on administering fluoride supplements, fluoride gels, sealants and varnish finds evidence that they improve outcomes. The report was done to inform the USPSTF for a new recommendation on primary care screening, dental referral, behavioral counseling, and preventive interventions for oral health in children and adolescents aged 5-17.
Primary care physicians’ role
One problem the USPSTF identified in its report was limited evidence on available clinical screening tools or assessments to identify which children have oral health conditions in the primary care setting.
The USPSTF’s team, led by Michael J. Barry, MD, of Harvard Medical School in Boston, calls for more research to fill in the gaps before it can reassess.
Michael S. Reddy, DMD, DMSc, with University of California San Francisco School of Dentistry, Oral Health Affairs, said in an accompanying editorial that the current lack of data should not keep primary care physicians from considering oral health during routine medical exams or keep dentists from finding ways to collaborate with primary care physicians. “Medical primary care must partner with dentistry,” they wrote.
Until there is enough evidence for a USPSTF reevaluation on the topic, primary care clinicians should ask patients about their oral hygiene routines, whether they have any dental symptoms, and when they last saw a dentist, as well as referring to a dentist as necessary, the editorialists wrote.
That works both ways, the editorialists added. “Equally important, oral health professionals are encouraged to collaborate and be a resource for their primary care colleagues. Prevention is one of the best tools clinicians have, and it is promoted by integrated, whole-person health effort, “ wrote Dr. Reddy and colleagues.
When oral health stays separate from medical care, patients are left vulnerable, and referrals between medical and dental offices should be a stronger two-way system, the editorialists said.
“[N]ot every primary care patient has access to a dentist,” they wrote. “Oral health screening and referral by medical primary care clinicians can help ensure that individuals get to the dental chair to receive needed interventions that can benefit both oral and potentially overall health. Likewise, medical challenges and oral mucosal manifestations of chronic health conditions detected at a dental visit should result in medical referral, allowing prompt evaluation and treatment.”
Evidence that gels, varnish, sealants are effective
In a companion paper, done to inform the USPSTF, Roger Chou, MD, with Pacific Northwest Evidence-based Practice Center, Department of Medical Informatics and Clinical Epidemiology at Oregon Health & Science University in Portland, and colleagues found that when administered by a dental professional or in school settings, fluoride supplements, gels and varnish, and resin-based sealants improved health outcomes.
The findings were based on three systematic reviews (20,684 participants) and 19 randomized clinical trials; three nonrandomized trials; and one observational study (total 15,026 participants.)
With fluoride versus placebo or no intervention, researchers found a decrease from baseline in the number of decayed, missing, or filled permanent teeth (DMFT index) or decayed or filled permanent teeth (DFT index). The average difference was −0.73 [95% confidence interval [CI], −1.30 to −0.19]) at 1.5 to 3 years (six trials; n = 1,395).
Fluoride gels were associated with a DMFT- or DFT-prevented fraction of 0.18 (95% CI, 0.09-0.27) at outcomes closest to 3 years (four trials; n = 1,525).
Researchers found an association between fluoride varnish and a DMFT- or DFT-prevented fraction of 0.44 (95% CI, 0.11-0.76) at 1 to 4.5 years (five trials; n = 3,902). The sealants tested were associated with decreased risk of caries in first molars (odds ratio, 0.21 [95% CI, 0.16-0.28]) at 48-54 months (four trials; n = 440).
They noted that the feasibility of administering preventive measures in primary care is unknown; the effectiveness shown here was based on administration in dental and supervised school settings.
Barriers in primary care settings may include lack of training and equipment (particularly for sealants), uncertain reimbursement and lack of acceptance and uptake.
USPSTF working to close evidence gaps
Wanda Nicholson, MD, MPH, Prevention and Community Health, George Washington Milken Institute of Public Health in Washington, wrote in an accompanying editorial that to speed necessary research to facilitate recommendations, “the USPSTF and its stakeholders need a transparent, easily implementable communication tool that will systematically describe the research necessary to be directly responsive to the evidence gaps.”
The editorialists noted that the USPSTF in trying to update recommendations often has few, if any, high-quality additional studies to consider since its previous recommendation.
To address that, meetings were conducted in November of 2022 involving USPSTF members, Agency for Healthcare Research and Quality (AHRQ) staff, and leadership from the Office of Disease Prevention and the National Institutes of Health. Members formed a working group “to develop a standardized template for communicating research gaps” according to a framework developed by the National Academies of Sciences, Engineering, and Medicine.
Dr. Nicholson and colleagues wrote, “classifying evidence gaps and calling for specific research needs is a prudent, collaborative step in addressing missing evidence,” particularly for underserved populations.
The authors and editorialists declared no relevant conflicts of interest.
Both were published online in JAMA.
In one report, the United States Preventive Services Task Force (USPSTF) concludes that there is not enough evidence to assess harms versus benefits of routine screening or interventions for oral health conditions, including dental caries, in primary care for asymptomatic children and adolescents aged 5-17 years.
The evidence report on administering fluoride supplements, fluoride gels, sealants and varnish finds evidence that they improve outcomes. The report was done to inform the USPSTF for a new recommendation on primary care screening, dental referral, behavioral counseling, and preventive interventions for oral health in children and adolescents aged 5-17.
Primary care physicians’ role
One problem the USPSTF identified in its report was limited evidence on available clinical screening tools or assessments to identify which children have oral health conditions in the primary care setting.
The USPSTF’s team, led by Michael J. Barry, MD, of Harvard Medical School in Boston, calls for more research to fill in the gaps before it can reassess.
Michael S. Reddy, DMD, DMSc, with University of California San Francisco School of Dentistry, Oral Health Affairs, said in an accompanying editorial that the current lack of data should not keep primary care physicians from considering oral health during routine medical exams or keep dentists from finding ways to collaborate with primary care physicians. “Medical primary care must partner with dentistry,” they wrote.
Until there is enough evidence for a USPSTF reevaluation on the topic, primary care clinicians should ask patients about their oral hygiene routines, whether they have any dental symptoms, and when they last saw a dentist, as well as referring to a dentist as necessary, the editorialists wrote.
That works both ways, the editorialists added. “Equally important, oral health professionals are encouraged to collaborate and be a resource for their primary care colleagues. Prevention is one of the best tools clinicians have, and it is promoted by integrated, whole-person health effort, “ wrote Dr. Reddy and colleagues.
When oral health stays separate from medical care, patients are left vulnerable, and referrals between medical and dental offices should be a stronger two-way system, the editorialists said.
“[N]ot every primary care patient has access to a dentist,” they wrote. “Oral health screening and referral by medical primary care clinicians can help ensure that individuals get to the dental chair to receive needed interventions that can benefit both oral and potentially overall health. Likewise, medical challenges and oral mucosal manifestations of chronic health conditions detected at a dental visit should result in medical referral, allowing prompt evaluation and treatment.”
Evidence that gels, varnish, sealants are effective
In a companion paper, done to inform the USPSTF, Roger Chou, MD, with Pacific Northwest Evidence-based Practice Center, Department of Medical Informatics and Clinical Epidemiology at Oregon Health & Science University in Portland, and colleagues found that when administered by a dental professional or in school settings, fluoride supplements, gels and varnish, and resin-based sealants improved health outcomes.
The findings were based on three systematic reviews (20,684 participants) and 19 randomized clinical trials; three nonrandomized trials; and one observational study (total 15,026 participants.)
With fluoride versus placebo or no intervention, researchers found a decrease from baseline in the number of decayed, missing, or filled permanent teeth (DMFT index) or decayed or filled permanent teeth (DFT index). The average difference was −0.73 [95% confidence interval [CI], −1.30 to −0.19]) at 1.5 to 3 years (six trials; n = 1,395).
Fluoride gels were associated with a DMFT- or DFT-prevented fraction of 0.18 (95% CI, 0.09-0.27) at outcomes closest to 3 years (four trials; n = 1,525).
Researchers found an association between fluoride varnish and a DMFT- or DFT-prevented fraction of 0.44 (95% CI, 0.11-0.76) at 1 to 4.5 years (five trials; n = 3,902). The sealants tested were associated with decreased risk of caries in first molars (odds ratio, 0.21 [95% CI, 0.16-0.28]) at 48-54 months (four trials; n = 440).
They noted that the feasibility of administering preventive measures in primary care is unknown; the effectiveness shown here was based on administration in dental and supervised school settings.
Barriers in primary care settings may include lack of training and equipment (particularly for sealants), uncertain reimbursement and lack of acceptance and uptake.
USPSTF working to close evidence gaps
Wanda Nicholson, MD, MPH, Prevention and Community Health, George Washington Milken Institute of Public Health in Washington, wrote in an accompanying editorial that to speed necessary research to facilitate recommendations, “the USPSTF and its stakeholders need a transparent, easily implementable communication tool that will systematically describe the research necessary to be directly responsive to the evidence gaps.”
The editorialists noted that the USPSTF in trying to update recommendations often has few, if any, high-quality additional studies to consider since its previous recommendation.
To address that, meetings were conducted in November of 2022 involving USPSTF members, Agency for Healthcare Research and Quality (AHRQ) staff, and leadership from the Office of Disease Prevention and the National Institutes of Health. Members formed a working group “to develop a standardized template for communicating research gaps” according to a framework developed by the National Academies of Sciences, Engineering, and Medicine.
Dr. Nicholson and colleagues wrote, “classifying evidence gaps and calling for specific research needs is a prudent, collaborative step in addressing missing evidence,” particularly for underserved populations.
The authors and editorialists declared no relevant conflicts of interest.
FROM JAMA
Black men are at higher risk of prostate cancer at younger ages, lower PSA levels
Black men are at higher risk of prostate cancer than their White counterparts at younger ages and lower prostate-specific antigen (PSA) levels, a large new study conducted in a Veterans Affairs health care system suggests.
The findings suggest the need for PSA biopsy thresholds that are set with better understanding of patients’ risk factors, said the authors, led by Kyung Min Lee, PhD, with VA Informatics and Computing Infrastructure, at Salt Lake City Health Care System.
The study, which included more than 280,000 veterans, was published online in Cancer.
Risk higher, regardless of PSA level before biopsy
The researchers found that self-identified Black men are more likely than White men to be diagnosed with prostate cancer on their first prostate biopsy after controlling for age, prebiopsy PSA count, statin use, smoking status, and several socioeconomic variables.
Among the highlighted results are that a Black man who had a PSA level of 4.0 ng/mL before biopsy “had the same risk of prostate cancer as a White man with a PSA level 3.4 times higher [13.4 ng/mL].”
The gap was even more evident at younger ages. “Among men aged 60 years or younger, a Black man with a prebiopsy PSA level of 4.0 ng/mL had the same risk of prostate cancer as a White man with PSA level 3.7 times higher,” they wrote.
Researchers also found that Black veterans sought PSA screening and underwent their first diagnostic prostate biopsy at a younger age than did their White counterparts. Logistic regression models were used to predict the likelihood of a prostate cancer diagnosis on the first biopsy for 75,295 Black and 207,658 White male veterans.
U.S. Black men have an 80% higher risk of prostate cancer that White men
Previous research has shown that, in the United States, Black men have an 80% higher risk than White men of developing prostate cancer and are 220% more likely to die from it. Rigorous early screening has been suggested to decrease deaths from prostate cancer in Black men, but because that population group is underrepresented in randomized controlled trials, evidence for this has been lacking, the authors wrote.
Different national screening guidelines reflect the lack of clarity about best protocols. The U.S. Preventive Services Task Force acknowledges the higher risk but doesn’t make specific screening recommendations for Black men or those at higher risk. Conversely, the National Comprehensive Cancer Network “explicitly recommends earlier PSA screening and a shorter retest interval at lower PSA levels for populations at greater than average risk (including Black men). However, it does not otherwise recommend a different screening protocol.”
Social determinants of health may play a role
The reasons for the higher risk in Black men is unclear, the authors said, pointing out that recent studies suggest that “Black men may have higher genetic risk as assessed by polygenic scores.”
The authors wrote that nongenetic causes, such as access to care, mistrust of the health system, and environmental exposures may also be driving the association of Black race or ethnicity with higher risk of prostate cancer.
“Identifying and addressing these risk factors could further reduce racial disparities in prostate cancer outcomes,” they wrote.
The authors acknowledged that they are limited in their ability to account for socioeconomic status individually and used ZIP codes as proxies. Also, veterans generally have more comorbidities and mortality risks, compared with the general population.
The authors declared no relevant conflicts of interest.
Black men are at higher risk of prostate cancer than their White counterparts at younger ages and lower prostate-specific antigen (PSA) levels, a large new study conducted in a Veterans Affairs health care system suggests.
The findings suggest the need for PSA biopsy thresholds that are set with better understanding of patients’ risk factors, said the authors, led by Kyung Min Lee, PhD, with VA Informatics and Computing Infrastructure, at Salt Lake City Health Care System.
The study, which included more than 280,000 veterans, was published online in Cancer.
Risk higher, regardless of PSA level before biopsy
The researchers found that self-identified Black men are more likely than White men to be diagnosed with prostate cancer on their first prostate biopsy after controlling for age, prebiopsy PSA count, statin use, smoking status, and several socioeconomic variables.
Among the highlighted results are that a Black man who had a PSA level of 4.0 ng/mL before biopsy “had the same risk of prostate cancer as a White man with a PSA level 3.4 times higher [13.4 ng/mL].”
The gap was even more evident at younger ages. “Among men aged 60 years or younger, a Black man with a prebiopsy PSA level of 4.0 ng/mL had the same risk of prostate cancer as a White man with PSA level 3.7 times higher,” they wrote.
Researchers also found that Black veterans sought PSA screening and underwent their first diagnostic prostate biopsy at a younger age than did their White counterparts. Logistic regression models were used to predict the likelihood of a prostate cancer diagnosis on the first biopsy for 75,295 Black and 207,658 White male veterans.
U.S. Black men have an 80% higher risk of prostate cancer that White men
Previous research has shown that, in the United States, Black men have an 80% higher risk than White men of developing prostate cancer and are 220% more likely to die from it. Rigorous early screening has been suggested to decrease deaths from prostate cancer in Black men, but because that population group is underrepresented in randomized controlled trials, evidence for this has been lacking, the authors wrote.
Different national screening guidelines reflect the lack of clarity about best protocols. The U.S. Preventive Services Task Force acknowledges the higher risk but doesn’t make specific screening recommendations for Black men or those at higher risk. Conversely, the National Comprehensive Cancer Network “explicitly recommends earlier PSA screening and a shorter retest interval at lower PSA levels for populations at greater than average risk (including Black men). However, it does not otherwise recommend a different screening protocol.”
Social determinants of health may play a role
The reasons for the higher risk in Black men is unclear, the authors said, pointing out that recent studies suggest that “Black men may have higher genetic risk as assessed by polygenic scores.”
The authors wrote that nongenetic causes, such as access to care, mistrust of the health system, and environmental exposures may also be driving the association of Black race or ethnicity with higher risk of prostate cancer.
“Identifying and addressing these risk factors could further reduce racial disparities in prostate cancer outcomes,” they wrote.
The authors acknowledged that they are limited in their ability to account for socioeconomic status individually and used ZIP codes as proxies. Also, veterans generally have more comorbidities and mortality risks, compared with the general population.
The authors declared no relevant conflicts of interest.
Black men are at higher risk of prostate cancer than their White counterparts at younger ages and lower prostate-specific antigen (PSA) levels, a large new study conducted in a Veterans Affairs health care system suggests.
The findings suggest the need for PSA biopsy thresholds that are set with better understanding of patients’ risk factors, said the authors, led by Kyung Min Lee, PhD, with VA Informatics and Computing Infrastructure, at Salt Lake City Health Care System.
The study, which included more than 280,000 veterans, was published online in Cancer.
Risk higher, regardless of PSA level before biopsy
The researchers found that self-identified Black men are more likely than White men to be diagnosed with prostate cancer on their first prostate biopsy after controlling for age, prebiopsy PSA count, statin use, smoking status, and several socioeconomic variables.
Among the highlighted results are that a Black man who had a PSA level of 4.0 ng/mL before biopsy “had the same risk of prostate cancer as a White man with a PSA level 3.4 times higher [13.4 ng/mL].”
The gap was even more evident at younger ages. “Among men aged 60 years or younger, a Black man with a prebiopsy PSA level of 4.0 ng/mL had the same risk of prostate cancer as a White man with PSA level 3.7 times higher,” they wrote.
Researchers also found that Black veterans sought PSA screening and underwent their first diagnostic prostate biopsy at a younger age than did their White counterparts. Logistic regression models were used to predict the likelihood of a prostate cancer diagnosis on the first biopsy for 75,295 Black and 207,658 White male veterans.
U.S. Black men have an 80% higher risk of prostate cancer that White men
Previous research has shown that, in the United States, Black men have an 80% higher risk than White men of developing prostate cancer and are 220% more likely to die from it. Rigorous early screening has been suggested to decrease deaths from prostate cancer in Black men, but because that population group is underrepresented in randomized controlled trials, evidence for this has been lacking, the authors wrote.
Different national screening guidelines reflect the lack of clarity about best protocols. The U.S. Preventive Services Task Force acknowledges the higher risk but doesn’t make specific screening recommendations for Black men or those at higher risk. Conversely, the National Comprehensive Cancer Network “explicitly recommends earlier PSA screening and a shorter retest interval at lower PSA levels for populations at greater than average risk (including Black men). However, it does not otherwise recommend a different screening protocol.”
Social determinants of health may play a role
The reasons for the higher risk in Black men is unclear, the authors said, pointing out that recent studies suggest that “Black men may have higher genetic risk as assessed by polygenic scores.”
The authors wrote that nongenetic causes, such as access to care, mistrust of the health system, and environmental exposures may also be driving the association of Black race or ethnicity with higher risk of prostate cancer.
“Identifying and addressing these risk factors could further reduce racial disparities in prostate cancer outcomes,” they wrote.
The authors acknowledged that they are limited in their ability to account for socioeconomic status individually and used ZIP codes as proxies. Also, veterans generally have more comorbidities and mortality risks, compared with the general population.
The authors declared no relevant conflicts of interest.
FROM CANCER
Testosterone treatment helps correct anemia in men with hypogonadism
, according to a new analysis published online in JAMA Network Open.
The analysis comes from a randomized, placebo-controlled trial that included 5,204 men with hypogonadism at 316 U.S. sites. This study was nested within the Testosterone Replacement Therapy for Assessment of Long-term Vascular Events and Efficacy Response in Hypogonadal Men (TRAVERSE) Study. That study looked at whether TRT had an effect on major cardiovascular events and results were published earlier this year in the New England Journal of Medicine.
Hypogonadism increases with age
Hypogonadism includes specific symptoms in addition to a low testosterone level and has a lower prevalence (about 6%-12% vs. about 25% with low testosterone alone) in men 40-70 years old in the Massachusetts Male Aging Study (MMAS). But it is still common and increases with age, note authors of the current study, led by Karol M. Pencina, PhD, with the Research Program in Men’s Health: Aging and Metabolism, at Brigham and Women’s Hospital and Harvard Medical School, Boston.
Symptoms of hypogonadism include lower libido, erectile dysfunction, fatigue, reduced muscle mass, poor concentration, and disturbed sleep.
No approved treatment
Currently, there is no approved treatment for unexplained anemia during aging and nearly 15% of older men with hypogonadism experience anemia, the authors explain.
The proportion of participants whose anemia was corrected was significantly higher in the TRT group than the placebo group at 6 months (143 of 349 [41.0%] vs. 122 of 360 [27.5%]), 12 months (45.0% vs. 33.9%), 24 months (42.8% vs. 30.9%), 36 months (43.5% vs. 33.2%), and 48 months (44.6% vs. 39.2%); omnibus test P = .002.
A second aim in the study was to determine the effect of TRT on the development of anemia in participants who did not have anemia at enrollment.
In that group, a significantly smaller proportion of participants in the treatment group developed anemia, compared with the placebo group at 6 months (143 of 1,997 [7.2%] vs. 203 of 1,958 [10.4%]), 12 months (7.1% vs. 9.0%), 24 months (10.0% vs. 12.3%), 36 months (10.0% vs. 12.9%), and 48 months (9.0% vs 10.2%); omnibus test P = .02.
The men in the study had an average age of 64.8; 66.7% were White; 30.3% were Black; 2% were other.
Clinical implications
Shabbir M. H. Alibhai, MD, MSc, with the Institute of Health Policy, Management, and Evaluation, Institute of Medical Sciences, department of medicine, University of Toronto, writes in an invited commentary that this is one of the largest trials of TRT and was well-designed and executed. He points out that it had a long follow-up (mean duration on TRT was more than 20 months).
Given the results, he says, “TRT appears to be generally safe in middle-aged and older men with symptomatic hypogonadism, corrected mild anemia in 10%-15% of recipients, and prevented anemia in 2%-3%, with small improvements in energy but no effect on self-reported cognitive function.”
He said that without further details on long-term benefit, “I would not offer TRT primarily to treat asymptomatic normocytic anemia in men with low testosterone levels. It is reasonable to offer TRT to men with symptomatic hypogonadism regardless of hemoglobin level.”
He advises counseling patients that they could see small increases in hemoglobin levels with TRT, with a small boost in energy if they had anemia, but the effect on cognition, well-being, or function is unclear.
He further advised, “Hemoglobin levels should be monitored in men starting TRT (to detect the development of polycythemia), and prostate-specific antigen levels should be normal prior to start of treatment. Of course, a basic workup for causes of anemia, guided by history and basic parameters such as the mean corpuscular volume and blood film, should be performed in all men with anemia regardless of levels.”
The study was funded by a consortium of testosterone manufacturers led by AbbVie. Coauthors Dr. Artz, Dr. Chan, and Dr. Diegel report receiving consulting fees, grants, or employment from several pharmaceutical companies including AbbVie. Dr. Alibhai reports no relevant financial relationships.
, according to a new analysis published online in JAMA Network Open.
The analysis comes from a randomized, placebo-controlled trial that included 5,204 men with hypogonadism at 316 U.S. sites. This study was nested within the Testosterone Replacement Therapy for Assessment of Long-term Vascular Events and Efficacy Response in Hypogonadal Men (TRAVERSE) Study. That study looked at whether TRT had an effect on major cardiovascular events and results were published earlier this year in the New England Journal of Medicine.
Hypogonadism increases with age
Hypogonadism includes specific symptoms in addition to a low testosterone level and has a lower prevalence (about 6%-12% vs. about 25% with low testosterone alone) in men 40-70 years old in the Massachusetts Male Aging Study (MMAS). But it is still common and increases with age, note authors of the current study, led by Karol M. Pencina, PhD, with the Research Program in Men’s Health: Aging and Metabolism, at Brigham and Women’s Hospital and Harvard Medical School, Boston.
Symptoms of hypogonadism include lower libido, erectile dysfunction, fatigue, reduced muscle mass, poor concentration, and disturbed sleep.
No approved treatment
Currently, there is no approved treatment for unexplained anemia during aging and nearly 15% of older men with hypogonadism experience anemia, the authors explain.
The proportion of participants whose anemia was corrected was significantly higher in the TRT group than the placebo group at 6 months (143 of 349 [41.0%] vs. 122 of 360 [27.5%]), 12 months (45.0% vs. 33.9%), 24 months (42.8% vs. 30.9%), 36 months (43.5% vs. 33.2%), and 48 months (44.6% vs. 39.2%); omnibus test P = .002.
A second aim in the study was to determine the effect of TRT on the development of anemia in participants who did not have anemia at enrollment.
In that group, a significantly smaller proportion of participants in the treatment group developed anemia, compared with the placebo group at 6 months (143 of 1,997 [7.2%] vs. 203 of 1,958 [10.4%]), 12 months (7.1% vs. 9.0%), 24 months (10.0% vs. 12.3%), 36 months (10.0% vs. 12.9%), and 48 months (9.0% vs 10.2%); omnibus test P = .02.
The men in the study had an average age of 64.8; 66.7% were White; 30.3% were Black; 2% were other.
Clinical implications
Shabbir M. H. Alibhai, MD, MSc, with the Institute of Health Policy, Management, and Evaluation, Institute of Medical Sciences, department of medicine, University of Toronto, writes in an invited commentary that this is one of the largest trials of TRT and was well-designed and executed. He points out that it had a long follow-up (mean duration on TRT was more than 20 months).
Given the results, he says, “TRT appears to be generally safe in middle-aged and older men with symptomatic hypogonadism, corrected mild anemia in 10%-15% of recipients, and prevented anemia in 2%-3%, with small improvements in energy but no effect on self-reported cognitive function.”
He said that without further details on long-term benefit, “I would not offer TRT primarily to treat asymptomatic normocytic anemia in men with low testosterone levels. It is reasonable to offer TRT to men with symptomatic hypogonadism regardless of hemoglobin level.”
He advises counseling patients that they could see small increases in hemoglobin levels with TRT, with a small boost in energy if they had anemia, but the effect on cognition, well-being, or function is unclear.
He further advised, “Hemoglobin levels should be monitored in men starting TRT (to detect the development of polycythemia), and prostate-specific antigen levels should be normal prior to start of treatment. Of course, a basic workup for causes of anemia, guided by history and basic parameters such as the mean corpuscular volume and blood film, should be performed in all men with anemia regardless of levels.”
The study was funded by a consortium of testosterone manufacturers led by AbbVie. Coauthors Dr. Artz, Dr. Chan, and Dr. Diegel report receiving consulting fees, grants, or employment from several pharmaceutical companies including AbbVie. Dr. Alibhai reports no relevant financial relationships.
, according to a new analysis published online in JAMA Network Open.
The analysis comes from a randomized, placebo-controlled trial that included 5,204 men with hypogonadism at 316 U.S. sites. This study was nested within the Testosterone Replacement Therapy for Assessment of Long-term Vascular Events and Efficacy Response in Hypogonadal Men (TRAVERSE) Study. That study looked at whether TRT had an effect on major cardiovascular events and results were published earlier this year in the New England Journal of Medicine.
Hypogonadism increases with age
Hypogonadism includes specific symptoms in addition to a low testosterone level and has a lower prevalence (about 6%-12% vs. about 25% with low testosterone alone) in men 40-70 years old in the Massachusetts Male Aging Study (MMAS). But it is still common and increases with age, note authors of the current study, led by Karol M. Pencina, PhD, with the Research Program in Men’s Health: Aging and Metabolism, at Brigham and Women’s Hospital and Harvard Medical School, Boston.
Symptoms of hypogonadism include lower libido, erectile dysfunction, fatigue, reduced muscle mass, poor concentration, and disturbed sleep.
No approved treatment
Currently, there is no approved treatment for unexplained anemia during aging and nearly 15% of older men with hypogonadism experience anemia, the authors explain.
The proportion of participants whose anemia was corrected was significantly higher in the TRT group than the placebo group at 6 months (143 of 349 [41.0%] vs. 122 of 360 [27.5%]), 12 months (45.0% vs. 33.9%), 24 months (42.8% vs. 30.9%), 36 months (43.5% vs. 33.2%), and 48 months (44.6% vs. 39.2%); omnibus test P = .002.
A second aim in the study was to determine the effect of TRT on the development of anemia in participants who did not have anemia at enrollment.
In that group, a significantly smaller proportion of participants in the treatment group developed anemia, compared with the placebo group at 6 months (143 of 1,997 [7.2%] vs. 203 of 1,958 [10.4%]), 12 months (7.1% vs. 9.0%), 24 months (10.0% vs. 12.3%), 36 months (10.0% vs. 12.9%), and 48 months (9.0% vs 10.2%); omnibus test P = .02.
The men in the study had an average age of 64.8; 66.7% were White; 30.3% were Black; 2% were other.
Clinical implications
Shabbir M. H. Alibhai, MD, MSc, with the Institute of Health Policy, Management, and Evaluation, Institute of Medical Sciences, department of medicine, University of Toronto, writes in an invited commentary that this is one of the largest trials of TRT and was well-designed and executed. He points out that it had a long follow-up (mean duration on TRT was more than 20 months).
Given the results, he says, “TRT appears to be generally safe in middle-aged and older men with symptomatic hypogonadism, corrected mild anemia in 10%-15% of recipients, and prevented anemia in 2%-3%, with small improvements in energy but no effect on self-reported cognitive function.”
He said that without further details on long-term benefit, “I would not offer TRT primarily to treat asymptomatic normocytic anemia in men with low testosterone levels. It is reasonable to offer TRT to men with symptomatic hypogonadism regardless of hemoglobin level.”
He advises counseling patients that they could see small increases in hemoglobin levels with TRT, with a small boost in energy if they had anemia, but the effect on cognition, well-being, or function is unclear.
He further advised, “Hemoglobin levels should be monitored in men starting TRT (to detect the development of polycythemia), and prostate-specific antigen levels should be normal prior to start of treatment. Of course, a basic workup for causes of anemia, guided by history and basic parameters such as the mean corpuscular volume and blood film, should be performed in all men with anemia regardless of levels.”
The study was funded by a consortium of testosterone manufacturers led by AbbVie. Coauthors Dr. Artz, Dr. Chan, and Dr. Diegel report receiving consulting fees, grants, or employment from several pharmaceutical companies including AbbVie. Dr. Alibhai reports no relevant financial relationships.
FROM JAMA NETWORK OPEN
COVID, no matter the severity, linked with urologic effects in men
SARS-CoV-2 infection is linked in men with increased incidence of urinary retention, urinary tract infection (UTI), and blood in the urine, a new study finds.
Authors of the study, led by Alex Qinyang Liu, of S.H. Ho Urology Centre, at The Chinese University of Hong Kong, highlighted the clinical implications.
“Clinicians should be aware of the significantly higher incidence of LUTS [lower urinary tract symptoms] complications with COVID-19 in this patient group and understand that these urological manifestations can occur regardless of COVID-19 severity,” the authors wrote.
Findings were published online in the Journal of Internal Medicine.
They explained that current literature has included only small case series and observational studies assessing the connection between COVID-19 and male LUTS.
Nearly 18,000 patients in study
Included in this study were all male patients who used the public health care system in Hong Kong who received alpha-blocker monotherapy for LUTS from 2021 to 2022. After propensity score matching, 17,986 patients were included. Half had polymerase chain reaction–confirmed SARS-CoV-2 infection (n = 8,993).
The retrospective study compared urologic outcomes, including male benign prostatic hyperplasia (BPH) complications, and changes in medical treatment in the two groups. They compared male patients with SARS-CoV-2 infection who were taking baseline alpha blocker monotherapy for LUTS with a control group who had no SARS-CoV-2 infection.
They found that, compared with controls, the SARS-CoV-2–infected group had significantly higher incidence of retention of urine (4.55% vs. 0.86%, P < .001), hematuria (1.36% vs. 0.41%, P < .001), clinical UTI (4.31% vs. 1.49%, P < .001), culture-proven bacteriuria (9.02% vs. 1.97%, P < .001), and addition of 5-alpha reductase inhibitors (0.50% vs. 0.02%, P < .001).
Similar side effects even with asymptomatic infection
The researchers pointed out that similar incidence of retention of urine, hematuria, and addition of medication were seen even when patients had asymptomatic infection.
They added that their findings have biological plausibility because the coexpression of the proteins ACE2 and TMPRSS2 in the prostate makes it a target for SARS-CoV-2, which leads to inflammation and may help explain the primary outcomes.
“Given the high infectivity and unprecedented scale of the COVID-19 pandemic, these urological symptoms and complications represent a significant clinical burden that clinicians and urologists should be aware of,” the authors wrote.
The authors noted that the prevalence of BPH and LUTS rises with age and are among the most common urologic conditions affecting older men. “Incidentally, male patients of advanced age are also more significantly affected by COVID-19.”
The authors declare no relevant financial relationships.
SARS-CoV-2 infection is linked in men with increased incidence of urinary retention, urinary tract infection (UTI), and blood in the urine, a new study finds.
Authors of the study, led by Alex Qinyang Liu, of S.H. Ho Urology Centre, at The Chinese University of Hong Kong, highlighted the clinical implications.
“Clinicians should be aware of the significantly higher incidence of LUTS [lower urinary tract symptoms] complications with COVID-19 in this patient group and understand that these urological manifestations can occur regardless of COVID-19 severity,” the authors wrote.
Findings were published online in the Journal of Internal Medicine.
They explained that current literature has included only small case series and observational studies assessing the connection between COVID-19 and male LUTS.
Nearly 18,000 patients in study
Included in this study were all male patients who used the public health care system in Hong Kong who received alpha-blocker monotherapy for LUTS from 2021 to 2022. After propensity score matching, 17,986 patients were included. Half had polymerase chain reaction–confirmed SARS-CoV-2 infection (n = 8,993).
The retrospective study compared urologic outcomes, including male benign prostatic hyperplasia (BPH) complications, and changes in medical treatment in the two groups. They compared male patients with SARS-CoV-2 infection who were taking baseline alpha blocker monotherapy for LUTS with a control group who had no SARS-CoV-2 infection.
They found that, compared with controls, the SARS-CoV-2–infected group had significantly higher incidence of retention of urine (4.55% vs. 0.86%, P < .001), hematuria (1.36% vs. 0.41%, P < .001), clinical UTI (4.31% vs. 1.49%, P < .001), culture-proven bacteriuria (9.02% vs. 1.97%, P < .001), and addition of 5-alpha reductase inhibitors (0.50% vs. 0.02%, P < .001).
Similar side effects even with asymptomatic infection
The researchers pointed out that similar incidence of retention of urine, hematuria, and addition of medication were seen even when patients had asymptomatic infection.
They added that their findings have biological plausibility because the coexpression of the proteins ACE2 and TMPRSS2 in the prostate makes it a target for SARS-CoV-2, which leads to inflammation and may help explain the primary outcomes.
“Given the high infectivity and unprecedented scale of the COVID-19 pandemic, these urological symptoms and complications represent a significant clinical burden that clinicians and urologists should be aware of,” the authors wrote.
The authors noted that the prevalence of BPH and LUTS rises with age and are among the most common urologic conditions affecting older men. “Incidentally, male patients of advanced age are also more significantly affected by COVID-19.”
The authors declare no relevant financial relationships.
SARS-CoV-2 infection is linked in men with increased incidence of urinary retention, urinary tract infection (UTI), and blood in the urine, a new study finds.
Authors of the study, led by Alex Qinyang Liu, of S.H. Ho Urology Centre, at The Chinese University of Hong Kong, highlighted the clinical implications.
“Clinicians should be aware of the significantly higher incidence of LUTS [lower urinary tract symptoms] complications with COVID-19 in this patient group and understand that these urological manifestations can occur regardless of COVID-19 severity,” the authors wrote.
Findings were published online in the Journal of Internal Medicine.
They explained that current literature has included only small case series and observational studies assessing the connection between COVID-19 and male LUTS.
Nearly 18,000 patients in study
Included in this study were all male patients who used the public health care system in Hong Kong who received alpha-blocker monotherapy for LUTS from 2021 to 2022. After propensity score matching, 17,986 patients were included. Half had polymerase chain reaction–confirmed SARS-CoV-2 infection (n = 8,993).
The retrospective study compared urologic outcomes, including male benign prostatic hyperplasia (BPH) complications, and changes in medical treatment in the two groups. They compared male patients with SARS-CoV-2 infection who were taking baseline alpha blocker monotherapy for LUTS with a control group who had no SARS-CoV-2 infection.
They found that, compared with controls, the SARS-CoV-2–infected group had significantly higher incidence of retention of urine (4.55% vs. 0.86%, P < .001), hematuria (1.36% vs. 0.41%, P < .001), clinical UTI (4.31% vs. 1.49%, P < .001), culture-proven bacteriuria (9.02% vs. 1.97%, P < .001), and addition of 5-alpha reductase inhibitors (0.50% vs. 0.02%, P < .001).
Similar side effects even with asymptomatic infection
The researchers pointed out that similar incidence of retention of urine, hematuria, and addition of medication were seen even when patients had asymptomatic infection.
They added that their findings have biological plausibility because the coexpression of the proteins ACE2 and TMPRSS2 in the prostate makes it a target for SARS-CoV-2, which leads to inflammation and may help explain the primary outcomes.
“Given the high infectivity and unprecedented scale of the COVID-19 pandemic, these urological symptoms and complications represent a significant clinical burden that clinicians and urologists should be aware of,” the authors wrote.
The authors noted that the prevalence of BPH and LUTS rises with age and are among the most common urologic conditions affecting older men. “Incidentally, male patients of advanced age are also more significantly affected by COVID-19.”
The authors declare no relevant financial relationships.
FROM THE JOURNAL OF INTERNAL MEDICINE
FDA approves bimekizumab for moderate to severe plaque psoriasis in adults
, the manufacturer announced in a press release.
The indication is for adults who are candidates for systemic therapy or phototherapy.
With this approval, bimekizumab becomes the only interleukin (IL)-17A and IL-17F inhibitor approved for the treatment of these patients. Psoriasis affects more than 7.5 million U.S. adults, according to the National Psoriasis Foundation.
“We have been eagerly awaiting bimekizumab,” Mark Lebwohl, MD, bimekizumab investigator and dean for clinical therapeutics at the Icahn School of Medicine at Mount Sinai, New York City, said in the press release.
Dr. Lebwohl states that bimekizumab “achieved superior levels of skin clearance at week 16 compared to placebo and three existing biologics for psoriasis, with responses being rapid and lasting up to a year. Long-term data have also shown that the majority of patients maintained high levels of clinical response through three years.”
The most common adverse reactions (occurring in at least 1% of patients) are upper respiratory infections, oral candidiasis, headache, tinea infections, gastroenteritis, herpes simplex infections, acne, folliculitis, other Candida infections, fatigue, and injection site reactions, according to the company, UCB.
Available in about 1 month in U.S.
Bimekizumab can be administered by a health care provider or it can be self-injected by a patient after training. It is available as a single-dose prefilled autoinjector and a single-dose prefilled syringe and will be available in the United States in about 1 month.
The recommended dosage of bimekizumab for patients with psoriasis is 320 mg (two subcutaneous injections of 160 mg each) at baseline, then on weeks 4, 8, 12, and 16, then every 8 weeks thereafter. For patients weighing at least 120 kg (about 265 lb), a dosage of 320 mg every 4 weeks after week 16 may be considered, the company states.
Three phase 3 trials
Approval was based on three phase 3 multicenter, randomized, placebo and/or active comparator-controlled trials: bimekizumab versus placebo and ustekinumab (BE VIVID); versus placebo (BE READY); and versus adalimumab (BE SURE).
“All studies met their co-primary endpoints and all ranked secondary endpoints,” the company reports. Secondary endpoints included the Psoriasis Area and Severity Index (PASI) 75 at week 4 and PASI 100 (complete skin clearance) at week 16.
Highlights from the trials include the following results, according to UCB:
- Clear or almost clear skin: More than 8 out of 10 patients achieved a 90% or greater reduction from baseline in the PASI 90 and an Investigator’s Global Assessment score of 0/1 at week 16.
- Complete skin clearance: About 60% of patients achieved PASI 100 at week 16.
- Time to response: More than 70% of patients achieved PASI 75 at week 4 following one 320-mg dose.
Safety information
The safety information includes the statement that bimekizumab may increase the risk for suicidal ideation and behavior, though a causal association has not been established. Prescribers should advise patients, caregivers, and families “to monitor for emergence or worsening of depression, suicidal ideation, or other mood changes,” according to the prescribing information.
Bimekizumab is being studied for other conditions, including hidradenitis suppurativa. In the European Union, it was approved for the treatment of psoriasis in 2021 and for the treatment of psoriatic arthritis and ankylosing spondylitis in June 2023.
Dr. Lebwohl is an investigator for UCB. He has not accepted any consulting payments from UCB.
A version of this article first appeared on Medscape.com.
, the manufacturer announced in a press release.
The indication is for adults who are candidates for systemic therapy or phototherapy.
With this approval, bimekizumab becomes the only interleukin (IL)-17A and IL-17F inhibitor approved for the treatment of these patients. Psoriasis affects more than 7.5 million U.S. adults, according to the National Psoriasis Foundation.
“We have been eagerly awaiting bimekizumab,” Mark Lebwohl, MD, bimekizumab investigator and dean for clinical therapeutics at the Icahn School of Medicine at Mount Sinai, New York City, said in the press release.
Dr. Lebwohl states that bimekizumab “achieved superior levels of skin clearance at week 16 compared to placebo and three existing biologics for psoriasis, with responses being rapid and lasting up to a year. Long-term data have also shown that the majority of patients maintained high levels of clinical response through three years.”
The most common adverse reactions (occurring in at least 1% of patients) are upper respiratory infections, oral candidiasis, headache, tinea infections, gastroenteritis, herpes simplex infections, acne, folliculitis, other Candida infections, fatigue, and injection site reactions, according to the company, UCB.
Available in about 1 month in U.S.
Bimekizumab can be administered by a health care provider or it can be self-injected by a patient after training. It is available as a single-dose prefilled autoinjector and a single-dose prefilled syringe and will be available in the United States in about 1 month.
The recommended dosage of bimekizumab for patients with psoriasis is 320 mg (two subcutaneous injections of 160 mg each) at baseline, then on weeks 4, 8, 12, and 16, then every 8 weeks thereafter. For patients weighing at least 120 kg (about 265 lb), a dosage of 320 mg every 4 weeks after week 16 may be considered, the company states.
Three phase 3 trials
Approval was based on three phase 3 multicenter, randomized, placebo and/or active comparator-controlled trials: bimekizumab versus placebo and ustekinumab (BE VIVID); versus placebo (BE READY); and versus adalimumab (BE SURE).
“All studies met their co-primary endpoints and all ranked secondary endpoints,” the company reports. Secondary endpoints included the Psoriasis Area and Severity Index (PASI) 75 at week 4 and PASI 100 (complete skin clearance) at week 16.
Highlights from the trials include the following results, according to UCB:
- Clear or almost clear skin: More than 8 out of 10 patients achieved a 90% or greater reduction from baseline in the PASI 90 and an Investigator’s Global Assessment score of 0/1 at week 16.
- Complete skin clearance: About 60% of patients achieved PASI 100 at week 16.
- Time to response: More than 70% of patients achieved PASI 75 at week 4 following one 320-mg dose.
Safety information
The safety information includes the statement that bimekizumab may increase the risk for suicidal ideation and behavior, though a causal association has not been established. Prescribers should advise patients, caregivers, and families “to monitor for emergence or worsening of depression, suicidal ideation, or other mood changes,” according to the prescribing information.
Bimekizumab is being studied for other conditions, including hidradenitis suppurativa. In the European Union, it was approved for the treatment of psoriasis in 2021 and for the treatment of psoriatic arthritis and ankylosing spondylitis in June 2023.
Dr. Lebwohl is an investigator for UCB. He has not accepted any consulting payments from UCB.
A version of this article first appeared on Medscape.com.
, the manufacturer announced in a press release.
The indication is for adults who are candidates for systemic therapy or phototherapy.
With this approval, bimekizumab becomes the only interleukin (IL)-17A and IL-17F inhibitor approved for the treatment of these patients. Psoriasis affects more than 7.5 million U.S. adults, according to the National Psoriasis Foundation.
“We have been eagerly awaiting bimekizumab,” Mark Lebwohl, MD, bimekizumab investigator and dean for clinical therapeutics at the Icahn School of Medicine at Mount Sinai, New York City, said in the press release.
Dr. Lebwohl states that bimekizumab “achieved superior levels of skin clearance at week 16 compared to placebo and three existing biologics for psoriasis, with responses being rapid and lasting up to a year. Long-term data have also shown that the majority of patients maintained high levels of clinical response through three years.”
The most common adverse reactions (occurring in at least 1% of patients) are upper respiratory infections, oral candidiasis, headache, tinea infections, gastroenteritis, herpes simplex infections, acne, folliculitis, other Candida infections, fatigue, and injection site reactions, according to the company, UCB.
Available in about 1 month in U.S.
Bimekizumab can be administered by a health care provider or it can be self-injected by a patient after training. It is available as a single-dose prefilled autoinjector and a single-dose prefilled syringe and will be available in the United States in about 1 month.
The recommended dosage of bimekizumab for patients with psoriasis is 320 mg (two subcutaneous injections of 160 mg each) at baseline, then on weeks 4, 8, 12, and 16, then every 8 weeks thereafter. For patients weighing at least 120 kg (about 265 lb), a dosage of 320 mg every 4 weeks after week 16 may be considered, the company states.
Three phase 3 trials
Approval was based on three phase 3 multicenter, randomized, placebo and/or active comparator-controlled trials: bimekizumab versus placebo and ustekinumab (BE VIVID); versus placebo (BE READY); and versus adalimumab (BE SURE).
“All studies met their co-primary endpoints and all ranked secondary endpoints,” the company reports. Secondary endpoints included the Psoriasis Area and Severity Index (PASI) 75 at week 4 and PASI 100 (complete skin clearance) at week 16.
Highlights from the trials include the following results, according to UCB:
- Clear or almost clear skin: More than 8 out of 10 patients achieved a 90% or greater reduction from baseline in the PASI 90 and an Investigator’s Global Assessment score of 0/1 at week 16.
- Complete skin clearance: About 60% of patients achieved PASI 100 at week 16.
- Time to response: More than 70% of patients achieved PASI 75 at week 4 following one 320-mg dose.
Safety information
The safety information includes the statement that bimekizumab may increase the risk for suicidal ideation and behavior, though a causal association has not been established. Prescribers should advise patients, caregivers, and families “to monitor for emergence or worsening of depression, suicidal ideation, or other mood changes,” according to the prescribing information.
Bimekizumab is being studied for other conditions, including hidradenitis suppurativa. In the European Union, it was approved for the treatment of psoriasis in 2021 and for the treatment of psoriatic arthritis and ankylosing spondylitis in June 2023.
Dr. Lebwohl is an investigator for UCB. He has not accepted any consulting payments from UCB.
A version of this article first appeared on Medscape.com.
Biomarkers may help women with RA to decide on medications in pregnancy
Rheumatoid arthritis can’t be cured, but it can significantly improve naturally during pregnancy in 50%-75% of women, prior research has established. It may worsen or stay the same during pregnancy in others.
As of yet, there’s no way to tell which experience a woman with RA will have. RA occurs in 1% of adults globally and is three times more likely to occur in women.
However, a novel study of 19 women with RA suggests that blood biomarkers before pregnancy may predict who will get better or worse during pregnancy. If confirmed with larger studies, the discovery could lead to personalizing medication choices for women with RA who are seeking to become pregnant and change prepregnancy counseling for physicians.
Findings from the research, conducted by first author Matthew Wright, MS, of Children’s Hospital Oakland (Calif.) Research Institute and colleagues were published online in Arthritis Research & Therapy.
A risky choice for women
Currently, the choice is difficult because stopping medications during pregnancy could cause disease flare and continuing could risk possible harm to the baby as some of the medications have toxic side effects.
This is the first study to analyze genetic differences in women with RA who plan to get pregnant, senior author Damini Jawaheer, PhD, research associate professor of medicine in rheumatology at Northwestern University, Chicago, said in an interview.
Identifying women who have the disease and confirming they were planning to get pregnant has been extremely difficult, she noted, especially since the start of their research predated electronic health records (EHRs).
The researchers were able to develop a cohort from work they were already doing with researchers in Denmark, which has a national registry that included both women with RA and women of reproductive age. From there they could contact women about their pregnancy intentions and build the cohort for this study.
Healthy women and women with RA of Danish descent who planned to get pregnant were enrolled and were prospectively followed.
Genetic differences at prepregnancy baseline
Researchers analyzed genetic differences through RNA sequencing before pregnancy from 19 women with RA and 13 healthy women.
Of the 19 women with RA, disease activity improved during pregnancy in 14 and worsened in 5.
Before pregnancy, the researchers found, several neutrophil-related genes were significantly overexpressed in women whose RA later improved during pregnancy. Genes related to B cells were highly expressed among women who worsened. Those elevated B-cell–related gene levels were not seen in the group who improved during pregnancy, Dr. Jawaheer added.
“We don’t understand at this point why that is,” she said.
They also compared the blood samples with women in the control group who did not have RA.
“Comparisons to healthy women revealed that the B-cell signature was specific” to women with worsened RA, the authors wrote. “Thus, at the prepregnancy stage, the two groups of RA women differed significantly from each other in terms of B-cell function.”
Information could help to eliminate fear
Dr. Jawaheer said almost all the women in the cohort who have RA said they were afraid to take medications during pregnancy even if the medications they are taking are considered safe.
“If we could reliably predict who’s going to improve, those women would not have to be scared,” she said. They could stop their medications if they know they’re going to improve naturally.
“Women who are predicted to worsen could then work together with their rheumatologist so that they get treatment to prevent them from getting worse,” Dr. Jawaheer said. “Treatment could be focused on that group only.”
Arthur Kavanaugh, MD, a rheumatologist at University of California San Diego Health and director of the UCSD Center for Innovative Therapy, who was not part of the study, said his patients planning pregnancy struggle with the choices the researchers describe and that investigating potential biomarkers is important.
“Ideally, people would not want to be on anything when they’re pregnant,” he says.
He found the results “intriguing and hypothesis-generating,” but he said the small sample size makes it hard to draw conclusions about the work before it is replicated on a larger scale.
Beth L. Jonas, MD, chief of the division of rheumatology, allergy, and immunology at the University of North Carolina, Chapel Hill, also not a part of the study, said the small study size must be considered, but if the findings are validated in larger studies, the potential is “huge.”
She said doctors used to tell their patients years ago that there’s an excellent chance they will be in remission in pregnancy.
Now, she says, “We’ve tempered our advice to say there’s a good chance you’ll still have disease activity during your pregnancy.”
Rheumatologists would be very interested in a predictive biomarker, she said, as would colleagues in obstetrics/gynecology and maternal-fetal medicine physicians who manage high-risk pregnancies and do prepregnancy counseling.
She said she would also like to see these data followed over multiple pregnancies for each woman, noting that some of her patients have seen RA improve in one pregnancy and worsen in another.
A question she has is, “with a single patient with RA, could you measure this multiple times and get different results?”
Tackling the unanswered questions
Next, the researchers want to conduct the study with a larger sample in the United States and one that is more diverse than the Danish cohort, which included only White patients. Now, Dr. Jawaheer and her team will have the help of EHRs.
A big part of Dr. Jawaheer’s lab’s focus is to find out why many with RA report “never feeling better” during pregnancy – some even experience remission – and why women who improve during pregnancy report that their disease flares 3-6 months after pregnancy, she said.
Her team is also studying what happens biologically when some women worsen in pregnancy.
Those answers “will give us an indication of what could be a potential drug target,” she said.
The authors and Dr. Kavanaugh and Dr. Jonas reported no relevant financial relationships.
Rheumatoid arthritis can’t be cured, but it can significantly improve naturally during pregnancy in 50%-75% of women, prior research has established. It may worsen or stay the same during pregnancy in others.
As of yet, there’s no way to tell which experience a woman with RA will have. RA occurs in 1% of adults globally and is three times more likely to occur in women.
However, a novel study of 19 women with RA suggests that blood biomarkers before pregnancy may predict who will get better or worse during pregnancy. If confirmed with larger studies, the discovery could lead to personalizing medication choices for women with RA who are seeking to become pregnant and change prepregnancy counseling for physicians.
Findings from the research, conducted by first author Matthew Wright, MS, of Children’s Hospital Oakland (Calif.) Research Institute and colleagues were published online in Arthritis Research & Therapy.
A risky choice for women
Currently, the choice is difficult because stopping medications during pregnancy could cause disease flare and continuing could risk possible harm to the baby as some of the medications have toxic side effects.
This is the first study to analyze genetic differences in women with RA who plan to get pregnant, senior author Damini Jawaheer, PhD, research associate professor of medicine in rheumatology at Northwestern University, Chicago, said in an interview.
Identifying women who have the disease and confirming they were planning to get pregnant has been extremely difficult, she noted, especially since the start of their research predated electronic health records (EHRs).
The researchers were able to develop a cohort from work they were already doing with researchers in Denmark, which has a national registry that included both women with RA and women of reproductive age. From there they could contact women about their pregnancy intentions and build the cohort for this study.
Healthy women and women with RA of Danish descent who planned to get pregnant were enrolled and were prospectively followed.
Genetic differences at prepregnancy baseline
Researchers analyzed genetic differences through RNA sequencing before pregnancy from 19 women with RA and 13 healthy women.
Of the 19 women with RA, disease activity improved during pregnancy in 14 and worsened in 5.
Before pregnancy, the researchers found, several neutrophil-related genes were significantly overexpressed in women whose RA later improved during pregnancy. Genes related to B cells were highly expressed among women who worsened. Those elevated B-cell–related gene levels were not seen in the group who improved during pregnancy, Dr. Jawaheer added.
“We don’t understand at this point why that is,” she said.
They also compared the blood samples with women in the control group who did not have RA.
“Comparisons to healthy women revealed that the B-cell signature was specific” to women with worsened RA, the authors wrote. “Thus, at the prepregnancy stage, the two groups of RA women differed significantly from each other in terms of B-cell function.”
Information could help to eliminate fear
Dr. Jawaheer said almost all the women in the cohort who have RA said they were afraid to take medications during pregnancy even if the medications they are taking are considered safe.
“If we could reliably predict who’s going to improve, those women would not have to be scared,” she said. They could stop their medications if they know they’re going to improve naturally.
“Women who are predicted to worsen could then work together with their rheumatologist so that they get treatment to prevent them from getting worse,” Dr. Jawaheer said. “Treatment could be focused on that group only.”
Arthur Kavanaugh, MD, a rheumatologist at University of California San Diego Health and director of the UCSD Center for Innovative Therapy, who was not part of the study, said his patients planning pregnancy struggle with the choices the researchers describe and that investigating potential biomarkers is important.
“Ideally, people would not want to be on anything when they’re pregnant,” he says.
He found the results “intriguing and hypothesis-generating,” but he said the small sample size makes it hard to draw conclusions about the work before it is replicated on a larger scale.
Beth L. Jonas, MD, chief of the division of rheumatology, allergy, and immunology at the University of North Carolina, Chapel Hill, also not a part of the study, said the small study size must be considered, but if the findings are validated in larger studies, the potential is “huge.”
She said doctors used to tell their patients years ago that there’s an excellent chance they will be in remission in pregnancy.
Now, she says, “We’ve tempered our advice to say there’s a good chance you’ll still have disease activity during your pregnancy.”
Rheumatologists would be very interested in a predictive biomarker, she said, as would colleagues in obstetrics/gynecology and maternal-fetal medicine physicians who manage high-risk pregnancies and do prepregnancy counseling.
She said she would also like to see these data followed over multiple pregnancies for each woman, noting that some of her patients have seen RA improve in one pregnancy and worsen in another.
A question she has is, “with a single patient with RA, could you measure this multiple times and get different results?”
Tackling the unanswered questions
Next, the researchers want to conduct the study with a larger sample in the United States and one that is more diverse than the Danish cohort, which included only White patients. Now, Dr. Jawaheer and her team will have the help of EHRs.
A big part of Dr. Jawaheer’s lab’s focus is to find out why many with RA report “never feeling better” during pregnancy – some even experience remission – and why women who improve during pregnancy report that their disease flares 3-6 months after pregnancy, she said.
Her team is also studying what happens biologically when some women worsen in pregnancy.
Those answers “will give us an indication of what could be a potential drug target,” she said.
The authors and Dr. Kavanaugh and Dr. Jonas reported no relevant financial relationships.
Rheumatoid arthritis can’t be cured, but it can significantly improve naturally during pregnancy in 50%-75% of women, prior research has established. It may worsen or stay the same during pregnancy in others.
As of yet, there’s no way to tell which experience a woman with RA will have. RA occurs in 1% of adults globally and is three times more likely to occur in women.
However, a novel study of 19 women with RA suggests that blood biomarkers before pregnancy may predict who will get better or worse during pregnancy. If confirmed with larger studies, the discovery could lead to personalizing medication choices for women with RA who are seeking to become pregnant and change prepregnancy counseling for physicians.
Findings from the research, conducted by first author Matthew Wright, MS, of Children’s Hospital Oakland (Calif.) Research Institute and colleagues were published online in Arthritis Research & Therapy.
A risky choice for women
Currently, the choice is difficult because stopping medications during pregnancy could cause disease flare and continuing could risk possible harm to the baby as some of the medications have toxic side effects.
This is the first study to analyze genetic differences in women with RA who plan to get pregnant, senior author Damini Jawaheer, PhD, research associate professor of medicine in rheumatology at Northwestern University, Chicago, said in an interview.
Identifying women who have the disease and confirming they were planning to get pregnant has been extremely difficult, she noted, especially since the start of their research predated electronic health records (EHRs).
The researchers were able to develop a cohort from work they were already doing with researchers in Denmark, which has a national registry that included both women with RA and women of reproductive age. From there they could contact women about their pregnancy intentions and build the cohort for this study.
Healthy women and women with RA of Danish descent who planned to get pregnant were enrolled and were prospectively followed.
Genetic differences at prepregnancy baseline
Researchers analyzed genetic differences through RNA sequencing before pregnancy from 19 women with RA and 13 healthy women.
Of the 19 women with RA, disease activity improved during pregnancy in 14 and worsened in 5.
Before pregnancy, the researchers found, several neutrophil-related genes were significantly overexpressed in women whose RA later improved during pregnancy. Genes related to B cells were highly expressed among women who worsened. Those elevated B-cell–related gene levels were not seen in the group who improved during pregnancy, Dr. Jawaheer added.
“We don’t understand at this point why that is,” she said.
They also compared the blood samples with women in the control group who did not have RA.
“Comparisons to healthy women revealed that the B-cell signature was specific” to women with worsened RA, the authors wrote. “Thus, at the prepregnancy stage, the two groups of RA women differed significantly from each other in terms of B-cell function.”
Information could help to eliminate fear
Dr. Jawaheer said almost all the women in the cohort who have RA said they were afraid to take medications during pregnancy even if the medications they are taking are considered safe.
“If we could reliably predict who’s going to improve, those women would not have to be scared,” she said. They could stop their medications if they know they’re going to improve naturally.
“Women who are predicted to worsen could then work together with their rheumatologist so that they get treatment to prevent them from getting worse,” Dr. Jawaheer said. “Treatment could be focused on that group only.”
Arthur Kavanaugh, MD, a rheumatologist at University of California San Diego Health and director of the UCSD Center for Innovative Therapy, who was not part of the study, said his patients planning pregnancy struggle with the choices the researchers describe and that investigating potential biomarkers is important.
“Ideally, people would not want to be on anything when they’re pregnant,” he says.
He found the results “intriguing and hypothesis-generating,” but he said the small sample size makes it hard to draw conclusions about the work before it is replicated on a larger scale.
Beth L. Jonas, MD, chief of the division of rheumatology, allergy, and immunology at the University of North Carolina, Chapel Hill, also not a part of the study, said the small study size must be considered, but if the findings are validated in larger studies, the potential is “huge.”
She said doctors used to tell their patients years ago that there’s an excellent chance they will be in remission in pregnancy.
Now, she says, “We’ve tempered our advice to say there’s a good chance you’ll still have disease activity during your pregnancy.”
Rheumatologists would be very interested in a predictive biomarker, she said, as would colleagues in obstetrics/gynecology and maternal-fetal medicine physicians who manage high-risk pregnancies and do prepregnancy counseling.
She said she would also like to see these data followed over multiple pregnancies for each woman, noting that some of her patients have seen RA improve in one pregnancy and worsen in another.
A question she has is, “with a single patient with RA, could you measure this multiple times and get different results?”
Tackling the unanswered questions
Next, the researchers want to conduct the study with a larger sample in the United States and one that is more diverse than the Danish cohort, which included only White patients. Now, Dr. Jawaheer and her team will have the help of EHRs.
A big part of Dr. Jawaheer’s lab’s focus is to find out why many with RA report “never feeling better” during pregnancy – some even experience remission – and why women who improve during pregnancy report that their disease flares 3-6 months after pregnancy, she said.
Her team is also studying what happens biologically when some women worsen in pregnancy.
Those answers “will give us an indication of what could be a potential drug target,” she said.
The authors and Dr. Kavanaugh and Dr. Jonas reported no relevant financial relationships.
FROM ARTHRITIS RESEARCH & THERAPY
Maternal pertussis vax effective for infants in most vulnerable months
Maternal pertussis vaccinations, given during pregnancy, prevent an estimated 65% of pertussis infections in infants, new research indicates.
The study, led by Annette K. Regan, PhD, MPH, a perinatal and pediatric infectious disease epidemiologist at Curtin University, Perth, Australia, was published online in Pediatrics.
Dr. Regan – who is also with the University of San Francisco and the University of California, Los Angeles – and colleagues reviewed data on 279,418 infants born to 252,444 mothers in Australia.
There, about 52% of the women in this study received the Tdap vaccine through a maternal pertussis vaccination program.
Duration of effectiveness in infants was one of the main questions the study sought to answer.
The authors wrote that they assessed vaccine effectiveness through 18 months of age. “We observed significant protection against disease until at least 8 months of age, 2 months longer than reported in previous studies.” From 70% to 90% of all pertussis-attributable hospitalizations and death occur in infancy.
Answering the ‘blunting’ question
This study also set out to clarify an important clinical question regarding a potential “blunting” effect in infants. Previous work had suggested that maternal antibodies from the vaccination could interfere with the effectiveness of infants’ DtaP (the version of Tdap for infants) and other vaccines.
Dr. Regan and colleagues found that, “although we observed slightly lower VE [vaccine effectiveness] point estimates for the third dose of infant pertussis vaccine among maternally vaccinated compared with unvaccinated infants (76.5% vs. 92.9%, P = .002), we did not observe higher rates of pertussis infection (hazard ratio, 0.70; 95% confidence interval, 0.61-3.39).
Best time to give mothers the vaccine
Another clinical debate has centered on when to give the mother the vaccine during pregnancy. The authors concluded: “Our findings support the infant health benefits of recommendations to administer a booster dose of pertussis vaccine near 28 weeks of gestational age.”
That 28-week mark was associated with lower risk of infection in infants through 8 months of age, they wrote.
Positive results in the United States
In an invited commentary, Kathryn M. Edwards, MD, with the division of infectious diseases, department of pediatrics, at Vanderbilt University Medical Center, Nashville, Tenn., highlighted similar positive findings for maternal pertussis vaccination in the United States.
The Centers for Disease Control and Prevention did an ecologic study of infant pertussis cases reported between Jan. 1, 2000, and Dec. 31, 2019. Rates were compared for the years before maternal Tdap vaccinations were recommended against the 7-year period after they were implemented.
That study found that in the period before maternal Tdap vaccination, annual pertussis incidence did not change among infants younger than 2 months and increased slightly in infants 6-12 months.
However, during the period after maternal Tdap vaccination had started (2012-2019), pertussis incidence significantly decreased in infants younger than 2 months and was unchanged in infants 6-12 months.
“As with the Australian data, the U.S. data support the overall benefit of the maternal Tdap program and, as with the Australian data, do not suggest that blunting has led to an increase in cases within the first year of life,” Dr. Edwards wrote.
The CDC notes that pertussis cases are rising and outbreaks are happening across the United States.
“On average, about 1,000 infants are hospitalized and typically between 5 and 15 infants die each year in the United States due to pertussis,” the CDC states.
Uptake low despite positive data
Dr. Edwards noted that, despite positive data supporting maternal vaccination to reduce pertussis, uptake rates are low – between 50% and 60% in Australia, the United Kingdom, and the United States. “Active engagement to increase these rates should be implemented.”
Maternal vaccination might also be implemented soon to protect against other diseases including respiratory syncytial virus and group B streptococcal disease after promising study data, she said.
As with pertussis, the potential “blunting” effect will need to be carefully monitored, she said, “as was done in the carefully conducted study of pertussis reported in this issue of Pediatrics.”
One coauthor has received institutional honoraria for participation in advisory groups for Merck Sharpe & Dohme and Pfizer unrelated to this work. Another coauthor was supported by scholarships provided by the Wesfarmers Centre of Vaccines and Infectious Disease at the Telethon Kids Institute. Dr. Edwards reported receiving grants from the CDC and consulting for Bionet, Dynavax, and IBM. She is a member of the data safety and monitoring board for Sanofi, X-4 Pharma, Seqirus, Moderna, Pfizer, Merck, Roche, Novavax, and Brighton Collaboration.
Maternal pertussis vaccinations, given during pregnancy, prevent an estimated 65% of pertussis infections in infants, new research indicates.
The study, led by Annette K. Regan, PhD, MPH, a perinatal and pediatric infectious disease epidemiologist at Curtin University, Perth, Australia, was published online in Pediatrics.
Dr. Regan – who is also with the University of San Francisco and the University of California, Los Angeles – and colleagues reviewed data on 279,418 infants born to 252,444 mothers in Australia.
There, about 52% of the women in this study received the Tdap vaccine through a maternal pertussis vaccination program.
Duration of effectiveness in infants was one of the main questions the study sought to answer.
The authors wrote that they assessed vaccine effectiveness through 18 months of age. “We observed significant protection against disease until at least 8 months of age, 2 months longer than reported in previous studies.” From 70% to 90% of all pertussis-attributable hospitalizations and death occur in infancy.
Answering the ‘blunting’ question
This study also set out to clarify an important clinical question regarding a potential “blunting” effect in infants. Previous work had suggested that maternal antibodies from the vaccination could interfere with the effectiveness of infants’ DtaP (the version of Tdap for infants) and other vaccines.
Dr. Regan and colleagues found that, “although we observed slightly lower VE [vaccine effectiveness] point estimates for the third dose of infant pertussis vaccine among maternally vaccinated compared with unvaccinated infants (76.5% vs. 92.9%, P = .002), we did not observe higher rates of pertussis infection (hazard ratio, 0.70; 95% confidence interval, 0.61-3.39).
Best time to give mothers the vaccine
Another clinical debate has centered on when to give the mother the vaccine during pregnancy. The authors concluded: “Our findings support the infant health benefits of recommendations to administer a booster dose of pertussis vaccine near 28 weeks of gestational age.”
That 28-week mark was associated with lower risk of infection in infants through 8 months of age, they wrote.
Positive results in the United States
In an invited commentary, Kathryn M. Edwards, MD, with the division of infectious diseases, department of pediatrics, at Vanderbilt University Medical Center, Nashville, Tenn., highlighted similar positive findings for maternal pertussis vaccination in the United States.
The Centers for Disease Control and Prevention did an ecologic study of infant pertussis cases reported between Jan. 1, 2000, and Dec. 31, 2019. Rates were compared for the years before maternal Tdap vaccinations were recommended against the 7-year period after they were implemented.
That study found that in the period before maternal Tdap vaccination, annual pertussis incidence did not change among infants younger than 2 months and increased slightly in infants 6-12 months.
However, during the period after maternal Tdap vaccination had started (2012-2019), pertussis incidence significantly decreased in infants younger than 2 months and was unchanged in infants 6-12 months.
“As with the Australian data, the U.S. data support the overall benefit of the maternal Tdap program and, as with the Australian data, do not suggest that blunting has led to an increase in cases within the first year of life,” Dr. Edwards wrote.
The CDC notes that pertussis cases are rising and outbreaks are happening across the United States.
“On average, about 1,000 infants are hospitalized and typically between 5 and 15 infants die each year in the United States due to pertussis,” the CDC states.
Uptake low despite positive data
Dr. Edwards noted that, despite positive data supporting maternal vaccination to reduce pertussis, uptake rates are low – between 50% and 60% in Australia, the United Kingdom, and the United States. “Active engagement to increase these rates should be implemented.”
Maternal vaccination might also be implemented soon to protect against other diseases including respiratory syncytial virus and group B streptococcal disease after promising study data, she said.
As with pertussis, the potential “blunting” effect will need to be carefully monitored, she said, “as was done in the carefully conducted study of pertussis reported in this issue of Pediatrics.”
One coauthor has received institutional honoraria for participation in advisory groups for Merck Sharpe & Dohme and Pfizer unrelated to this work. Another coauthor was supported by scholarships provided by the Wesfarmers Centre of Vaccines and Infectious Disease at the Telethon Kids Institute. Dr. Edwards reported receiving grants from the CDC and consulting for Bionet, Dynavax, and IBM. She is a member of the data safety and monitoring board for Sanofi, X-4 Pharma, Seqirus, Moderna, Pfizer, Merck, Roche, Novavax, and Brighton Collaboration.
Maternal pertussis vaccinations, given during pregnancy, prevent an estimated 65% of pertussis infections in infants, new research indicates.
The study, led by Annette K. Regan, PhD, MPH, a perinatal and pediatric infectious disease epidemiologist at Curtin University, Perth, Australia, was published online in Pediatrics.
Dr. Regan – who is also with the University of San Francisco and the University of California, Los Angeles – and colleagues reviewed data on 279,418 infants born to 252,444 mothers in Australia.
There, about 52% of the women in this study received the Tdap vaccine through a maternal pertussis vaccination program.
Duration of effectiveness in infants was one of the main questions the study sought to answer.
The authors wrote that they assessed vaccine effectiveness through 18 months of age. “We observed significant protection against disease until at least 8 months of age, 2 months longer than reported in previous studies.” From 70% to 90% of all pertussis-attributable hospitalizations and death occur in infancy.
Answering the ‘blunting’ question
This study also set out to clarify an important clinical question regarding a potential “blunting” effect in infants. Previous work had suggested that maternal antibodies from the vaccination could interfere with the effectiveness of infants’ DtaP (the version of Tdap for infants) and other vaccines.
Dr. Regan and colleagues found that, “although we observed slightly lower VE [vaccine effectiveness] point estimates for the third dose of infant pertussis vaccine among maternally vaccinated compared with unvaccinated infants (76.5% vs. 92.9%, P = .002), we did not observe higher rates of pertussis infection (hazard ratio, 0.70; 95% confidence interval, 0.61-3.39).
Best time to give mothers the vaccine
Another clinical debate has centered on when to give the mother the vaccine during pregnancy. The authors concluded: “Our findings support the infant health benefits of recommendations to administer a booster dose of pertussis vaccine near 28 weeks of gestational age.”
That 28-week mark was associated with lower risk of infection in infants through 8 months of age, they wrote.
Positive results in the United States
In an invited commentary, Kathryn M. Edwards, MD, with the division of infectious diseases, department of pediatrics, at Vanderbilt University Medical Center, Nashville, Tenn., highlighted similar positive findings for maternal pertussis vaccination in the United States.
The Centers for Disease Control and Prevention did an ecologic study of infant pertussis cases reported between Jan. 1, 2000, and Dec. 31, 2019. Rates were compared for the years before maternal Tdap vaccinations were recommended against the 7-year period after they were implemented.
That study found that in the period before maternal Tdap vaccination, annual pertussis incidence did not change among infants younger than 2 months and increased slightly in infants 6-12 months.
However, during the period after maternal Tdap vaccination had started (2012-2019), pertussis incidence significantly decreased in infants younger than 2 months and was unchanged in infants 6-12 months.
“As with the Australian data, the U.S. data support the overall benefit of the maternal Tdap program and, as with the Australian data, do not suggest that blunting has led to an increase in cases within the first year of life,” Dr. Edwards wrote.
The CDC notes that pertussis cases are rising and outbreaks are happening across the United States.
“On average, about 1,000 infants are hospitalized and typically between 5 and 15 infants die each year in the United States due to pertussis,” the CDC states.
Uptake low despite positive data
Dr. Edwards noted that, despite positive data supporting maternal vaccination to reduce pertussis, uptake rates are low – between 50% and 60% in Australia, the United Kingdom, and the United States. “Active engagement to increase these rates should be implemented.”
Maternal vaccination might also be implemented soon to protect against other diseases including respiratory syncytial virus and group B streptococcal disease after promising study data, she said.
As with pertussis, the potential “blunting” effect will need to be carefully monitored, she said, “as was done in the carefully conducted study of pertussis reported in this issue of Pediatrics.”
One coauthor has received institutional honoraria for participation in advisory groups for Merck Sharpe & Dohme and Pfizer unrelated to this work. Another coauthor was supported by scholarships provided by the Wesfarmers Centre of Vaccines and Infectious Disease at the Telethon Kids Institute. Dr. Edwards reported receiving grants from the CDC and consulting for Bionet, Dynavax, and IBM. She is a member of the data safety and monitoring board for Sanofi, X-4 Pharma, Seqirus, Moderna, Pfizer, Merck, Roche, Novavax, and Brighton Collaboration.
FROM PEDIATRICS
Should children know the severity of their disease? AAP weighs in with report
When children have a serious illness, some families choose not to disclose the severity to them, reasoning that knowing the extent of the illness may take away their hope. Deciding whether to tell children or adolescents about the seriousness of their disease is a complex judgment and can pose legal, ethical, and moral challenges for parents and care providers.
Default should be inclusion
The American Academy of Pediatrics (AAP) recommends in a new clinical report that the default should be to include children in conversations about their illness in a developmentally appropriate way, to the extent parents are comfortable.
The report, written by Sara Taub, MD and Robert Macauley, MD, MDiv, both in the department of pediatrics at Oregon Health & Science University in Portland, on behalf of the AAP Committee on Bioethics, was published online and appears in the October issue of Pediatrics.
“Rather than taking away hope, as some may fear, this approach of openness may create a space for children to ask their questions, share their concerns, and set goals that are appropriate to the circumstances,” the authors wrote in a press release.
The report offers strategies based on ethical, historical, legal, and cultural considerations when discussing what to share with a child or adolescent.
Some of the AAP’s other recommendations include the following:
- If the parents request nondisclosure, the first response should be seeking to understand why they prefer that stance. The care team members should also explain their position to parents.
- If there is no consensus on disclosure, establishing what each party believes is the minimum information that should be shared is important.
- Additional resources to navigate disagreement may be helpful, such as hospital ethics committees, mediators and patient advocates.
- Conversations with the family should be documented in the medical record.
Children may know more than you think
Dr. Taub said that even very young children may know more about their disease than adults believe.
“Without disclosure,” she said, “as children hear the conversations around them, they glean partial information and may weave together stories that are more frightening than reality.”
Sometimes families and the care team disagree on disclosure and for that scenario, the report offers guidance in finding middle ground.
For instance, when pediatricians feel ethically obligated to share information when parents oppose sharing, “pediatricians can reframe the discussion from whether information should be shared with the patient to what information will be communicated, how, and by whom,” the authors said in a press release.
Should you tell 15-year-old paraplegia is likely?
The authors give a case example of a 15-year-old whose spinal tumor likely will lead to paraplegia within weeks. Very few treatment options are available.
The parents ask the care team to avoid any discussions with the child about prognosis, reasoning that the news will be crushing and it’s better to deal with it if or when it happens.
The care team, however, feels compelled to find out about specific activities important to the child that may no longer be feasible with paraplegia.
The parents cite the child’s love of soccer and desire to see the Statue of Liberty. With that information and keeping the parents’ wishes in mind, the team reframes the conversation with the child in terms of goals, acknowledging that mobility may be more difficult in the future.
That conversation leads the child and the family to discuss moving up the trip to New York they had planned.
Guidance where there has been little
Timothy Joos, MD, MPH, a pediatrician who practices at a community health center in Seattle, who was not part of the recommendation team, said he was glad to see the AAP issue advice on a complex topic for which there is little practical guidance.
The authors’ case examples were “heart-tugging,” he said, and will help pediatricians work through their own scenarios.
Dr. Joos agreed with the overall premise that the default should be sharing the information.
“One of the foundations of medicine is truthfulness and openness and if we depart from that, we really have to have a good reason,” Dr. Joos said.
He said that since lying to patients should be nonnegotiable for any physician, it may help to talk with the parents first before answering an inquisitive patient’s questions and then have all parties gather for a discussion.
The authors note that AAP’s clinical reports are written by medical experts and reflect the latest evidence. The reports go through several rounds of peer review before they can be approved by the AAP board of directors.
The authors and Dr. Joos report no relevant financial relationships.
When children have a serious illness, some families choose not to disclose the severity to them, reasoning that knowing the extent of the illness may take away their hope. Deciding whether to tell children or adolescents about the seriousness of their disease is a complex judgment and can pose legal, ethical, and moral challenges for parents and care providers.
Default should be inclusion
The American Academy of Pediatrics (AAP) recommends in a new clinical report that the default should be to include children in conversations about their illness in a developmentally appropriate way, to the extent parents are comfortable.
The report, written by Sara Taub, MD and Robert Macauley, MD, MDiv, both in the department of pediatrics at Oregon Health & Science University in Portland, on behalf of the AAP Committee on Bioethics, was published online and appears in the October issue of Pediatrics.
“Rather than taking away hope, as some may fear, this approach of openness may create a space for children to ask their questions, share their concerns, and set goals that are appropriate to the circumstances,” the authors wrote in a press release.
The report offers strategies based on ethical, historical, legal, and cultural considerations when discussing what to share with a child or adolescent.
Some of the AAP’s other recommendations include the following:
- If the parents request nondisclosure, the first response should be seeking to understand why they prefer that stance. The care team members should also explain their position to parents.
- If there is no consensus on disclosure, establishing what each party believes is the minimum information that should be shared is important.
- Additional resources to navigate disagreement may be helpful, such as hospital ethics committees, mediators and patient advocates.
- Conversations with the family should be documented in the medical record.
Children may know more than you think
Dr. Taub said that even very young children may know more about their disease than adults believe.
“Without disclosure,” she said, “as children hear the conversations around them, they glean partial information and may weave together stories that are more frightening than reality.”
Sometimes families and the care team disagree on disclosure and for that scenario, the report offers guidance in finding middle ground.
For instance, when pediatricians feel ethically obligated to share information when parents oppose sharing, “pediatricians can reframe the discussion from whether information should be shared with the patient to what information will be communicated, how, and by whom,” the authors said in a press release.
Should you tell 15-year-old paraplegia is likely?
The authors give a case example of a 15-year-old whose spinal tumor likely will lead to paraplegia within weeks. Very few treatment options are available.
The parents ask the care team to avoid any discussions with the child about prognosis, reasoning that the news will be crushing and it’s better to deal with it if or when it happens.
The care team, however, feels compelled to find out about specific activities important to the child that may no longer be feasible with paraplegia.
The parents cite the child’s love of soccer and desire to see the Statue of Liberty. With that information and keeping the parents’ wishes in mind, the team reframes the conversation with the child in terms of goals, acknowledging that mobility may be more difficult in the future.
That conversation leads the child and the family to discuss moving up the trip to New York they had planned.
Guidance where there has been little
Timothy Joos, MD, MPH, a pediatrician who practices at a community health center in Seattle, who was not part of the recommendation team, said he was glad to see the AAP issue advice on a complex topic for which there is little practical guidance.
The authors’ case examples were “heart-tugging,” he said, and will help pediatricians work through their own scenarios.
Dr. Joos agreed with the overall premise that the default should be sharing the information.
“One of the foundations of medicine is truthfulness and openness and if we depart from that, we really have to have a good reason,” Dr. Joos said.
He said that since lying to patients should be nonnegotiable for any physician, it may help to talk with the parents first before answering an inquisitive patient’s questions and then have all parties gather for a discussion.
The authors note that AAP’s clinical reports are written by medical experts and reflect the latest evidence. The reports go through several rounds of peer review before they can be approved by the AAP board of directors.
The authors and Dr. Joos report no relevant financial relationships.
When children have a serious illness, some families choose not to disclose the severity to them, reasoning that knowing the extent of the illness may take away their hope. Deciding whether to tell children or adolescents about the seriousness of their disease is a complex judgment and can pose legal, ethical, and moral challenges for parents and care providers.
Default should be inclusion
The American Academy of Pediatrics (AAP) recommends in a new clinical report that the default should be to include children in conversations about their illness in a developmentally appropriate way, to the extent parents are comfortable.
The report, written by Sara Taub, MD and Robert Macauley, MD, MDiv, both in the department of pediatrics at Oregon Health & Science University in Portland, on behalf of the AAP Committee on Bioethics, was published online and appears in the October issue of Pediatrics.
“Rather than taking away hope, as some may fear, this approach of openness may create a space for children to ask their questions, share their concerns, and set goals that are appropriate to the circumstances,” the authors wrote in a press release.
The report offers strategies based on ethical, historical, legal, and cultural considerations when discussing what to share with a child or adolescent.
Some of the AAP’s other recommendations include the following:
- If the parents request nondisclosure, the first response should be seeking to understand why they prefer that stance. The care team members should also explain their position to parents.
- If there is no consensus on disclosure, establishing what each party believes is the minimum information that should be shared is important.
- Additional resources to navigate disagreement may be helpful, such as hospital ethics committees, mediators and patient advocates.
- Conversations with the family should be documented in the medical record.
Children may know more than you think
Dr. Taub said that even very young children may know more about their disease than adults believe.
“Without disclosure,” she said, “as children hear the conversations around them, they glean partial information and may weave together stories that are more frightening than reality.”
Sometimes families and the care team disagree on disclosure and for that scenario, the report offers guidance in finding middle ground.
For instance, when pediatricians feel ethically obligated to share information when parents oppose sharing, “pediatricians can reframe the discussion from whether information should be shared with the patient to what information will be communicated, how, and by whom,” the authors said in a press release.
Should you tell 15-year-old paraplegia is likely?
The authors give a case example of a 15-year-old whose spinal tumor likely will lead to paraplegia within weeks. Very few treatment options are available.
The parents ask the care team to avoid any discussions with the child about prognosis, reasoning that the news will be crushing and it’s better to deal with it if or when it happens.
The care team, however, feels compelled to find out about specific activities important to the child that may no longer be feasible with paraplegia.
The parents cite the child’s love of soccer and desire to see the Statue of Liberty. With that information and keeping the parents’ wishes in mind, the team reframes the conversation with the child in terms of goals, acknowledging that mobility may be more difficult in the future.
That conversation leads the child and the family to discuss moving up the trip to New York they had planned.
Guidance where there has been little
Timothy Joos, MD, MPH, a pediatrician who practices at a community health center in Seattle, who was not part of the recommendation team, said he was glad to see the AAP issue advice on a complex topic for which there is little practical guidance.
The authors’ case examples were “heart-tugging,” he said, and will help pediatricians work through their own scenarios.
Dr. Joos agreed with the overall premise that the default should be sharing the information.
“One of the foundations of medicine is truthfulness and openness and if we depart from that, we really have to have a good reason,” Dr. Joos said.
He said that since lying to patients should be nonnegotiable for any physician, it may help to talk with the parents first before answering an inquisitive patient’s questions and then have all parties gather for a discussion.
The authors note that AAP’s clinical reports are written by medical experts and reflect the latest evidence. The reports go through several rounds of peer review before they can be approved by the AAP board of directors.
The authors and Dr. Joos report no relevant financial relationships.
From Pediatrics