User login
Does Tailored Acupuncture Relieve Chronic Neck Pain?
TOPLINE:
Patients with chronic neck pain who received acupuncture experienced an alleviation of their symptoms, but not at clinically meaningful levels, compared with those who received sham treatment.
METHODOLOGY:
- A 24-week randomized trial was conducted at four clinical centers in China over a 2-year period starting in 2018.
- A total of 659 patients with chronic neck pain were randomly assigned to one of the four groups: Higher sensitive acupoints (mean age, 38.63 years; 70.41% women; n = 169), lower sensitive acupoints (mean age, 40.21 years; 74.4% women; n = 168), sham acupuncture (mean age, 40.16 years; 75.29% women; n = 170), and a waiting list (mean age, 38.63 years; 69.89% women; n = 176).
- Participants in the acupuncture groups had 10 sessions over 4 weeks and were followed up for 20 weeks. Those in the waiting list group received no treatment.
- The primary outcome was the change in neck pain at 4 weeks, measured on a 0-100 scale. A change of 10 points was considered clinically significant.
- The secondary outcomes were neck pain and movement, quality of life, and use of pain medication over 24 weeks.
TAKEAWAY:
- Acupuncture targeted at higher sensitive points led to a pain score reduction of 12.16 (95% CI, −14.45 to −9.87), while lower sensitive points reduced it by 10.19 (95% CI, −12.43 to −7.95).
- Sham acupuncture reduced the score by 6.11 (95% CI, −8.31 to −3.91), and no treatment reduced it by 2.24 (95% CI, −4.10 to −0.38).
- The higher and lower sensitive acupoint groups showed no clinically significant net differences in pain reduction and secondary outcomes compared with the sham and waiting list groups.
- Differences in reductions in pain between groups all decreased by week 24.
IN PRACTICE:
“The clinical importance of this improvement is unclear. Our results suggest that the selection of pressure pain, sensory-based objective acupoints could be considered as a treatment of CNP [chronic neck pain],” the authors wrote.
SOURCE:
This study, led by Ling Zhao, PhD, of Acupuncture and Tuina School at Chengdu University of Traditional Chinese Medicine in Chengdu, China, was published online in the Annals of Internal Medicine.
LIMITATIONS:
Blinding was not done in the waiting list group. Individuals in the higher and lower sensitive acupoint groups experienced a specific sensation after needle manipulation, which could have influenced the analysis. Additionally, the participants were middle-aged adults with moderate pain, which limited the generalizability to older individuals or those with severe pain.
DISCLOSURES:
The study was supported by grants from the National Natural Science Foundation of China, Central Guidance on Local Science and Technology Development Fund of Sichuan Province, among others. The authors declared no conflicts of interest outside the submitted work.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
Patients with chronic neck pain who received acupuncture experienced an alleviation of their symptoms, but not at clinically meaningful levels, compared with those who received sham treatment.
METHODOLOGY:
- A 24-week randomized trial was conducted at four clinical centers in China over a 2-year period starting in 2018.
- A total of 659 patients with chronic neck pain were randomly assigned to one of the four groups: Higher sensitive acupoints (mean age, 38.63 years; 70.41% women; n = 169), lower sensitive acupoints (mean age, 40.21 years; 74.4% women; n = 168), sham acupuncture (mean age, 40.16 years; 75.29% women; n = 170), and a waiting list (mean age, 38.63 years; 69.89% women; n = 176).
- Participants in the acupuncture groups had 10 sessions over 4 weeks and were followed up for 20 weeks. Those in the waiting list group received no treatment.
- The primary outcome was the change in neck pain at 4 weeks, measured on a 0-100 scale. A change of 10 points was considered clinically significant.
- The secondary outcomes were neck pain and movement, quality of life, and use of pain medication over 24 weeks.
TAKEAWAY:
- Acupuncture targeted at higher sensitive points led to a pain score reduction of 12.16 (95% CI, −14.45 to −9.87), while lower sensitive points reduced it by 10.19 (95% CI, −12.43 to −7.95).
- Sham acupuncture reduced the score by 6.11 (95% CI, −8.31 to −3.91), and no treatment reduced it by 2.24 (95% CI, −4.10 to −0.38).
- The higher and lower sensitive acupoint groups showed no clinically significant net differences in pain reduction and secondary outcomes compared with the sham and waiting list groups.
- Differences in reductions in pain between groups all decreased by week 24.
IN PRACTICE:
“The clinical importance of this improvement is unclear. Our results suggest that the selection of pressure pain, sensory-based objective acupoints could be considered as a treatment of CNP [chronic neck pain],” the authors wrote.
SOURCE:
This study, led by Ling Zhao, PhD, of Acupuncture and Tuina School at Chengdu University of Traditional Chinese Medicine in Chengdu, China, was published online in the Annals of Internal Medicine.
LIMITATIONS:
Blinding was not done in the waiting list group. Individuals in the higher and lower sensitive acupoint groups experienced a specific sensation after needle manipulation, which could have influenced the analysis. Additionally, the participants were middle-aged adults with moderate pain, which limited the generalizability to older individuals or those with severe pain.
DISCLOSURES:
The study was supported by grants from the National Natural Science Foundation of China, Central Guidance on Local Science and Technology Development Fund of Sichuan Province, among others. The authors declared no conflicts of interest outside the submitted work.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
Patients with chronic neck pain who received acupuncture experienced an alleviation of their symptoms, but not at clinically meaningful levels, compared with those who received sham treatment.
METHODOLOGY:
- A 24-week randomized trial was conducted at four clinical centers in China over a 2-year period starting in 2018.
- A total of 659 patients with chronic neck pain were randomly assigned to one of the four groups: Higher sensitive acupoints (mean age, 38.63 years; 70.41% women; n = 169), lower sensitive acupoints (mean age, 40.21 years; 74.4% women; n = 168), sham acupuncture (mean age, 40.16 years; 75.29% women; n = 170), and a waiting list (mean age, 38.63 years; 69.89% women; n = 176).
- Participants in the acupuncture groups had 10 sessions over 4 weeks and were followed up for 20 weeks. Those in the waiting list group received no treatment.
- The primary outcome was the change in neck pain at 4 weeks, measured on a 0-100 scale. A change of 10 points was considered clinically significant.
- The secondary outcomes were neck pain and movement, quality of life, and use of pain medication over 24 weeks.
TAKEAWAY:
- Acupuncture targeted at higher sensitive points led to a pain score reduction of 12.16 (95% CI, −14.45 to −9.87), while lower sensitive points reduced it by 10.19 (95% CI, −12.43 to −7.95).
- Sham acupuncture reduced the score by 6.11 (95% CI, −8.31 to −3.91), and no treatment reduced it by 2.24 (95% CI, −4.10 to −0.38).
- The higher and lower sensitive acupoint groups showed no clinically significant net differences in pain reduction and secondary outcomes compared with the sham and waiting list groups.
- Differences in reductions in pain between groups all decreased by week 24.
IN PRACTICE:
“The clinical importance of this improvement is unclear. Our results suggest that the selection of pressure pain, sensory-based objective acupoints could be considered as a treatment of CNP [chronic neck pain],” the authors wrote.
SOURCE:
This study, led by Ling Zhao, PhD, of Acupuncture and Tuina School at Chengdu University of Traditional Chinese Medicine in Chengdu, China, was published online in the Annals of Internal Medicine.
LIMITATIONS:
Blinding was not done in the waiting list group. Individuals in the higher and lower sensitive acupoint groups experienced a specific sensation after needle manipulation, which could have influenced the analysis. Additionally, the participants were middle-aged adults with moderate pain, which limited the generalizability to older individuals or those with severe pain.
DISCLOSURES:
The study was supported by grants from the National Natural Science Foundation of China, Central Guidance on Local Science and Technology Development Fund of Sichuan Province, among others. The authors declared no conflicts of interest outside the submitted work.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
Quitting Smoking Boosts Life Expectancy at Any Age
TOPLINE:
Quitting smoking at any age increases life expectancy, with the most significant increases observed in younger individuals. But people who quit over age 65 can extend life expectancy.
METHODOLOGY:
- Researchers analyzed the detrimental effects of smoking and the positive impacts of cessation on life expectancy in individuals aged 35-75 years.
- Age-specific death rates by smoking status were calculated using the relative risks for all-cause mortality derived from the Cancer Prevention Study II data, 2018 National Health Interview Survey smoking prevalence data, and 2018 all-cause mortality rates.
- Life tables were constructed to obtain information on the life expectancies of people who never smoked, those who currently smoked, and those who previously smoked but quit at various ages.
- Estimates of years lost due to smoking and years gained by quitting smoking were calculated for people starting at age 35 and over 10-year increments.
TAKEAWAY:
- Compared with people who never smoked, those who smoked at ages 35, 45, 55, 65, and 75 years and continued smoking throughout their lives would lose 9.1, 8.3, 7.3, 5.9, and 4.4 years, respectively.
- People who quit smoking at ages 35, 45, 55, 65, and 75 years would have life expectancies that are shorter by 1.2, 2.7, 3.9, 4.2, and 3.7 years, respectively, than those of same-age individuals who never smoked.
- Individuals who quit smoking at ages 35, 45, 55, 65, and 75 years would experience an additional 8.0, 5.6, 3.4, 1.7, and 0.7 years of life expectancy compared with those who continued smoking.
- People who quit at ages 65 and 75 years would have a 23.4% and 14.2% chance of gaining at least 1 additional year of life.
IN PRACTICE:
“This cessation benefit is not limited to young- and middle-aged adults who smoke; this study demonstrates its applicability to seniors as well. These findings may be valuable for clinicians seeking scientific evidence to motivate their patients who smoke to quit,” the authors wrote.
SOURCE:
The study was led by Thuy T.T. Le, PhD, from the Department of Health Management and Policy at the University of Michigan School of Public Health in Ann Arbor and published online in the American Journal of Preventive Medicine.
LIMITATIONS:
The study’s estimates were according to data from 2018 and may not reflect current trends. The estimates also did not account for variability in smoking intensity among individuals.
DISCLOSURES:
The study was supported by grants from the National Cancer Institute of the US National Institutes of Health and the US Food and Drug Administration Center for Tobacco Products. The authors declared that they had no conflicts of interest.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
A version of this article first appeared on Medscape.com.
TOPLINE:
Quitting smoking at any age increases life expectancy, with the most significant increases observed in younger individuals. But people who quit over age 65 can extend life expectancy.
METHODOLOGY:
- Researchers analyzed the detrimental effects of smoking and the positive impacts of cessation on life expectancy in individuals aged 35-75 years.
- Age-specific death rates by smoking status were calculated using the relative risks for all-cause mortality derived from the Cancer Prevention Study II data, 2018 National Health Interview Survey smoking prevalence data, and 2018 all-cause mortality rates.
- Life tables were constructed to obtain information on the life expectancies of people who never smoked, those who currently smoked, and those who previously smoked but quit at various ages.
- Estimates of years lost due to smoking and years gained by quitting smoking were calculated for people starting at age 35 and over 10-year increments.
TAKEAWAY:
- Compared with people who never smoked, those who smoked at ages 35, 45, 55, 65, and 75 years and continued smoking throughout their lives would lose 9.1, 8.3, 7.3, 5.9, and 4.4 years, respectively.
- People who quit smoking at ages 35, 45, 55, 65, and 75 years would have life expectancies that are shorter by 1.2, 2.7, 3.9, 4.2, and 3.7 years, respectively, than those of same-age individuals who never smoked.
- Individuals who quit smoking at ages 35, 45, 55, 65, and 75 years would experience an additional 8.0, 5.6, 3.4, 1.7, and 0.7 years of life expectancy compared with those who continued smoking.
- People who quit at ages 65 and 75 years would have a 23.4% and 14.2% chance of gaining at least 1 additional year of life.
IN PRACTICE:
“This cessation benefit is not limited to young- and middle-aged adults who smoke; this study demonstrates its applicability to seniors as well. These findings may be valuable for clinicians seeking scientific evidence to motivate their patients who smoke to quit,” the authors wrote.
SOURCE:
The study was led by Thuy T.T. Le, PhD, from the Department of Health Management and Policy at the University of Michigan School of Public Health in Ann Arbor and published online in the American Journal of Preventive Medicine.
LIMITATIONS:
The study’s estimates were according to data from 2018 and may not reflect current trends. The estimates also did not account for variability in smoking intensity among individuals.
DISCLOSURES:
The study was supported by grants from the National Cancer Institute of the US National Institutes of Health and the US Food and Drug Administration Center for Tobacco Products. The authors declared that they had no conflicts of interest.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
A version of this article first appeared on Medscape.com.
TOPLINE:
Quitting smoking at any age increases life expectancy, with the most significant increases observed in younger individuals. But people who quit over age 65 can extend life expectancy.
METHODOLOGY:
- Researchers analyzed the detrimental effects of smoking and the positive impacts of cessation on life expectancy in individuals aged 35-75 years.
- Age-specific death rates by smoking status were calculated using the relative risks for all-cause mortality derived from the Cancer Prevention Study II data, 2018 National Health Interview Survey smoking prevalence data, and 2018 all-cause mortality rates.
- Life tables were constructed to obtain information on the life expectancies of people who never smoked, those who currently smoked, and those who previously smoked but quit at various ages.
- Estimates of years lost due to smoking and years gained by quitting smoking were calculated for people starting at age 35 and over 10-year increments.
TAKEAWAY:
- Compared with people who never smoked, those who smoked at ages 35, 45, 55, 65, and 75 years and continued smoking throughout their lives would lose 9.1, 8.3, 7.3, 5.9, and 4.4 years, respectively.
- People who quit smoking at ages 35, 45, 55, 65, and 75 years would have life expectancies that are shorter by 1.2, 2.7, 3.9, 4.2, and 3.7 years, respectively, than those of same-age individuals who never smoked.
- Individuals who quit smoking at ages 35, 45, 55, 65, and 75 years would experience an additional 8.0, 5.6, 3.4, 1.7, and 0.7 years of life expectancy compared with those who continued smoking.
- People who quit at ages 65 and 75 years would have a 23.4% and 14.2% chance of gaining at least 1 additional year of life.
IN PRACTICE:
“This cessation benefit is not limited to young- and middle-aged adults who smoke; this study demonstrates its applicability to seniors as well. These findings may be valuable for clinicians seeking scientific evidence to motivate their patients who smoke to quit,” the authors wrote.
SOURCE:
The study was led by Thuy T.T. Le, PhD, from the Department of Health Management and Policy at the University of Michigan School of Public Health in Ann Arbor and published online in the American Journal of Preventive Medicine.
LIMITATIONS:
The study’s estimates were according to data from 2018 and may not reflect current trends. The estimates also did not account for variability in smoking intensity among individuals.
DISCLOSURES:
The study was supported by grants from the National Cancer Institute of the US National Institutes of Health and the US Food and Drug Administration Center for Tobacco Products. The authors declared that they had no conflicts of interest.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
A version of this article first appeared on Medscape.com.
Reducing Unnecessary Antibiotics for Conjunctivitis
TOPLINE:
More than two thirds of children with conjunctivitis received antibiotics within a day of their initial ambulatory care visit; however,
METHODOLOGY:
- Researchers evaluated the frequency of topical antibiotic treatment and its association with subsequent health care use among commercially insured children with acute infectious conjunctivitis in the United States.
- This cohort study analyzed data from the 2021 MarketScan Commercial Claims and Encounters Database, including 44,793 children with conjunctivitis (median age, 5 years; 47% girls) and ambulatory care encounters.
- The primary exposure was a topical antibiotic prescription dispensed within 1 day of an ambulatory care visit, with outcomes assessed 2-14 days after the visit.
- The primary outcomes were ambulatory care revisits for conjunctivitis and same-day dispensation of a new topical antibiotic, and secondary outcomes included emergency department revisits and hospitalizations.
TAKEAWAY:
- Topical antibiotics were dispensed within a day of an ambulatory care visit in 69% of the cases; however, they were less frequently dispensed following visits to eye clinics (34%), for children aged 6-11 years (66%), and for those with viral conjunctivitis (28%).
- Ambulatory care revisits for conjunctivitis within 2 weeks occurred in only 3.2% of children who had received antibiotics (adjusted odds ratio [aOR], 1.11; 95% CI, 0.99-1.25).
- Similarly, revisits with same-day dispensation of a new antibiotic were also rare (1.4%), with no significant association between antibiotic treatment and revisits (aOR, 1.10; 95% CI, 0.92-1.33).
- Hospitalizations for conjunctivitis occurred in 0.03% of cases, and emergency department revisits occurred in 0.12%, with no differences between children who received antibiotics and those who did not.
IN PRACTICE:
“Given that antibiotics may not be associated with improved outcomes or change in subsequent health care use and are associated with adverse effects and antibiotic resistance, efforts to reduce overtreatment of acute infectious conjunctivitis are warranted,” the authors wrote.
SOURCE:
The study was led by Daniel J. Shapiro, MD, MPH, of the Department of Emergency Medicine at the University of California, San Francisco, and published online on June 27, 2024, in JAMA Ophthalmology.
LIMITATIONS:
The major limitations of the study included the inability to distinguish scheduled visits from unscheduled revisits, incomplete clinical data such as rare complications of conjunctivitis, and the inability to confirm the accuracy of the coded diagnosis of infectious conjunctivitis, especially in children who did not receive a thorough eye examination.
DISCLOSURES:
This study did not declare receiving funding from any sources. One author reported receiving grants from several sources outside the submitted work.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
More than two thirds of children with conjunctivitis received antibiotics within a day of their initial ambulatory care visit; however,
METHODOLOGY:
- Researchers evaluated the frequency of topical antibiotic treatment and its association with subsequent health care use among commercially insured children with acute infectious conjunctivitis in the United States.
- This cohort study analyzed data from the 2021 MarketScan Commercial Claims and Encounters Database, including 44,793 children with conjunctivitis (median age, 5 years; 47% girls) and ambulatory care encounters.
- The primary exposure was a topical antibiotic prescription dispensed within 1 day of an ambulatory care visit, with outcomes assessed 2-14 days after the visit.
- The primary outcomes were ambulatory care revisits for conjunctivitis and same-day dispensation of a new topical antibiotic, and secondary outcomes included emergency department revisits and hospitalizations.
TAKEAWAY:
- Topical antibiotics were dispensed within a day of an ambulatory care visit in 69% of the cases; however, they were less frequently dispensed following visits to eye clinics (34%), for children aged 6-11 years (66%), and for those with viral conjunctivitis (28%).
- Ambulatory care revisits for conjunctivitis within 2 weeks occurred in only 3.2% of children who had received antibiotics (adjusted odds ratio [aOR], 1.11; 95% CI, 0.99-1.25).
- Similarly, revisits with same-day dispensation of a new antibiotic were also rare (1.4%), with no significant association between antibiotic treatment and revisits (aOR, 1.10; 95% CI, 0.92-1.33).
- Hospitalizations for conjunctivitis occurred in 0.03% of cases, and emergency department revisits occurred in 0.12%, with no differences between children who received antibiotics and those who did not.
IN PRACTICE:
“Given that antibiotics may not be associated with improved outcomes or change in subsequent health care use and are associated with adverse effects and antibiotic resistance, efforts to reduce overtreatment of acute infectious conjunctivitis are warranted,” the authors wrote.
SOURCE:
The study was led by Daniel J. Shapiro, MD, MPH, of the Department of Emergency Medicine at the University of California, San Francisco, and published online on June 27, 2024, in JAMA Ophthalmology.
LIMITATIONS:
The major limitations of the study included the inability to distinguish scheduled visits from unscheduled revisits, incomplete clinical data such as rare complications of conjunctivitis, and the inability to confirm the accuracy of the coded diagnosis of infectious conjunctivitis, especially in children who did not receive a thorough eye examination.
DISCLOSURES:
This study did not declare receiving funding from any sources. One author reported receiving grants from several sources outside the submitted work.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
More than two thirds of children with conjunctivitis received antibiotics within a day of their initial ambulatory care visit; however,
METHODOLOGY:
- Researchers evaluated the frequency of topical antibiotic treatment and its association with subsequent health care use among commercially insured children with acute infectious conjunctivitis in the United States.
- This cohort study analyzed data from the 2021 MarketScan Commercial Claims and Encounters Database, including 44,793 children with conjunctivitis (median age, 5 years; 47% girls) and ambulatory care encounters.
- The primary exposure was a topical antibiotic prescription dispensed within 1 day of an ambulatory care visit, with outcomes assessed 2-14 days after the visit.
- The primary outcomes were ambulatory care revisits for conjunctivitis and same-day dispensation of a new topical antibiotic, and secondary outcomes included emergency department revisits and hospitalizations.
TAKEAWAY:
- Topical antibiotics were dispensed within a day of an ambulatory care visit in 69% of the cases; however, they were less frequently dispensed following visits to eye clinics (34%), for children aged 6-11 years (66%), and for those with viral conjunctivitis (28%).
- Ambulatory care revisits for conjunctivitis within 2 weeks occurred in only 3.2% of children who had received antibiotics (adjusted odds ratio [aOR], 1.11; 95% CI, 0.99-1.25).
- Similarly, revisits with same-day dispensation of a new antibiotic were also rare (1.4%), with no significant association between antibiotic treatment and revisits (aOR, 1.10; 95% CI, 0.92-1.33).
- Hospitalizations for conjunctivitis occurred in 0.03% of cases, and emergency department revisits occurred in 0.12%, with no differences between children who received antibiotics and those who did not.
IN PRACTICE:
“Given that antibiotics may not be associated with improved outcomes or change in subsequent health care use and are associated with adverse effects and antibiotic resistance, efforts to reduce overtreatment of acute infectious conjunctivitis are warranted,” the authors wrote.
SOURCE:
The study was led by Daniel J. Shapiro, MD, MPH, of the Department of Emergency Medicine at the University of California, San Francisco, and published online on June 27, 2024, in JAMA Ophthalmology.
LIMITATIONS:
The major limitations of the study included the inability to distinguish scheduled visits from unscheduled revisits, incomplete clinical data such as rare complications of conjunctivitis, and the inability to confirm the accuracy of the coded diagnosis of infectious conjunctivitis, especially in children who did not receive a thorough eye examination.
DISCLOSURES:
This study did not declare receiving funding from any sources. One author reported receiving grants from several sources outside the submitted work.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
Is Measuring How Many Times Patients Get Screened for Depression Really a Reflection of Good Clinical Care?
Every time a patient visits Jason Connelly, MD, they must fill out a depression screening, thanks to a 2017 rule which mandates such assessments.
Providing a screening and, if needed, a follow-up plan means a patient may gain access to medication or cognitive-behavioral therapy that will improve their lives. But Dr. Connelly, a family medicine physician at Novant Health West Rowan Family Medicine in Cleveland, North Carolina, said the screening measure — and others like it that insurers and quality groups use to assess clinician performance — does not allow for enough flexibility.
For instance, he must follow-up with patients every 4 months, regardless of the severity of their depression.
“A lot of times when these are written for the purpose of measures, they don’t take into consideration the reality of clinical medicine,” Dr. Connelly, who is also a clinical physician executive with Novant, said. “There certainly needs to be room for the ability to specify the level of depression such that if it is mild, well, maybe that follow-up is at 6 months or 12 months or at patient discretion.”
A recent report from the American College of Physicians (ACP) supported Dr. Connelly’s view. The body looked at eight quality measures in primary care for patients with major depressive disorder (MDD) and found only one — a risk assessment for suicide — to be clinically meaningful and based on evidence.
The ACP panel said nearly all of the performance measures “lacked current clinical evidence, did not consider patient preferences, were not tested appropriately, or were outside a physician’s control.”
The group called for improvements in such assessments “to accurately assess the quality of clinical care” for patients with major depression.
Necessary Evil or Burdensome Time Suck?
The Centers for Medicare & Medicaid Services scores clinicians and health systems on the percentage of their patients who receive a screening during a visit; if the screening is positive, clinicians must document a follow-up plan using special manual entry codes.
Physicians say the process of meeting government standards for invalid measures can create unnecessary visits and physician paperwork, shrink monetary bonuses, and may not portray an accurate portrait of what best practice looks like in primary care for mental health. But many also said the program overall brings value to patients and provides a picture of how well they are practicing but only when measures are clinically relevant.
Standards ACP Used for Validating Depression Measurement
A committee with ACP used a modified appropriateness method from RAND and UCLA.
They weighed if a metric was evidence-based, methodologically sound, and clinically meaningful.
They rated each measure using a 9-point scale, including appropriate care, feasibility or applicability, and measure specifications.
A total of 11 committee members voted anonymously if each metric was a valid way of measuring individual clinicians, at the practice/system level, and health plan.
“There’s been such a flood of performance measurements that we can get sidetracked, diverted, and spend resources and effort on measurements that don’t improve care,” said Nick Fitterman, MD, chair of the ACP’s Performance Measurement Committee.
Primary care clinicians can choose from more than 60 metrics for 2024. Many involve caring for patients with mental illness or screening for those who could be underdiagnosed. Programs that certify health systems as providing quality care use the measures, in addition to the Merit-Based Incentive Payment System. Health systems choose six measures of quality to tie to their reimbursement — along with assessments of costs and use of technology.
In turn, Medicare adjusts its reimbursement based on how well a clinician’s numbers turn out and if they improved over time.
“You don’t get the benefit of the upside if you don’t meet the measure, so your payment is neutral and that can be significant from a broader system lens,” Dr. Connelly said. “Then you start to have to make decisions on what services do we then have to limit because we no longer have the financial capability.”
The implications for health systems and patient care are the reason ACP and clinicians are calling for some measures to be amended. Dr. Fitterman said his organization plans to work with CMS.
Implementing Measurement
At Bassett Health in New York, the health system uses the depression and follow-up plan measure to qualify for certification from the Health Resources and Services Administration as a patient-centered medical home, which the company uses in part to market itself to patients.
Amy Grace, MD, an attending physician in internal and family medicine at Bassett Health in Little Falls, New York, said if a patient refuses to take a depression screening, she will not meet the measure for that visit. But providing a screening is not always clinically appropriate, and some patients do not need a follow-up plan.
“If someone has just had a death in the family, they might answer the questions in a way that would be consistent with depression, but they’re experiencing grief as opposed to clinical depression,” Dr. Grace said.
Suggestions From ACP for Improvement in MDD Metrics
- Create and implement criteria for patients who do not need a follow-up plan based on clinician judgment.
- Add methods for clinicians to measure and indicate severity of MDD.
- Enable use of a wider array of evidence-based tools and screenings to screen for MDD.
- Allow clinicians to document changes in treatment plan.
Bassett is building into the electronic health record a button that documents the screening was not conducted and that it was not appropriate to administer that day. Of course, building these in-house options entails utilizing resources that smaller systems or independent groups of clinicians may lack.
Eric Wei, MD, senior vice president and chief quality officer at NYC Health + Hospitals in New York City, said the ACP report underscores that many measures, even beyond depression, must be improved.
“With burnout and cognitive overload of our providers, on top of the medicine and just trying to come to the right diagnosis and providing the right treatment and the best care experience, you have to remember all these quality metrics and make sure you put all these things in certain places in the electronic health record,” Dr. Wei said.
Still, Dr. Wei said that the annual rate of depression screening across 400,000 patients in his system is 91%. He and his team spent 6 years working to improve uptake among clinicians, and now, they have moved on to increasing rates of administration of the suicide assessment.
Each clinician uses a dashboard to track their individual metric performance, according to Ted Long, MD, senior vice president for ambulatory care and population health at NYC Health + Hospitals. Dr. Long said he is proud of the improvements he and his colleagues have made in catching undiagnosed depression and in other disease states.
At his primary care practice in the Bronx, nearly 9 out of 10 patients with hypertension have their condition under control, he said. How does he know? Measurement tracking.
“Knowing that when a new patient is in front of me with high blood pressure, that there’s a 9 out of 10 chance that after seeing me because of my clinic, not just because of me, I’m going to be able to keep them healthy by controlling their blood pressure, that’s very meaningful to me,” Dr. Long said. “I think that’s the other side: It enables me as a doctor to know that I’m delivering the highest quality of care to my patients.”
Takeaways for Depression Screening and Follow-Up in Clinical Settings
Just because a patient scores positive for the depression screener, a clinician should dig deeper before making a diagnosis.
Patients have the right to refuse a screener and their wishes should be respected.
Providing a screener may not be appropriate at every visit, such as for a patient with a sprained ankle or a potential respiratory infection where time is limited.
Clinicians can clarify within the measure that the patient did not have mental capacity on that visit to fill out the screener.
A version of this article appeared on Medscape.com.
Every time a patient visits Jason Connelly, MD, they must fill out a depression screening, thanks to a 2017 rule which mandates such assessments.
Providing a screening and, if needed, a follow-up plan means a patient may gain access to medication or cognitive-behavioral therapy that will improve their lives. But Dr. Connelly, a family medicine physician at Novant Health West Rowan Family Medicine in Cleveland, North Carolina, said the screening measure — and others like it that insurers and quality groups use to assess clinician performance — does not allow for enough flexibility.
For instance, he must follow-up with patients every 4 months, regardless of the severity of their depression.
“A lot of times when these are written for the purpose of measures, they don’t take into consideration the reality of clinical medicine,” Dr. Connelly, who is also a clinical physician executive with Novant, said. “There certainly needs to be room for the ability to specify the level of depression such that if it is mild, well, maybe that follow-up is at 6 months or 12 months or at patient discretion.”
A recent report from the American College of Physicians (ACP) supported Dr. Connelly’s view. The body looked at eight quality measures in primary care for patients with major depressive disorder (MDD) and found only one — a risk assessment for suicide — to be clinically meaningful and based on evidence.
The ACP panel said nearly all of the performance measures “lacked current clinical evidence, did not consider patient preferences, were not tested appropriately, or were outside a physician’s control.”
The group called for improvements in such assessments “to accurately assess the quality of clinical care” for patients with major depression.
Necessary Evil or Burdensome Time Suck?
The Centers for Medicare & Medicaid Services scores clinicians and health systems on the percentage of their patients who receive a screening during a visit; if the screening is positive, clinicians must document a follow-up plan using special manual entry codes.
Physicians say the process of meeting government standards for invalid measures can create unnecessary visits and physician paperwork, shrink monetary bonuses, and may not portray an accurate portrait of what best practice looks like in primary care for mental health. But many also said the program overall brings value to patients and provides a picture of how well they are practicing but only when measures are clinically relevant.
Standards ACP Used for Validating Depression Measurement
A committee with ACP used a modified appropriateness method from RAND and UCLA.
They weighed if a metric was evidence-based, methodologically sound, and clinically meaningful.
They rated each measure using a 9-point scale, including appropriate care, feasibility or applicability, and measure specifications.
A total of 11 committee members voted anonymously if each metric was a valid way of measuring individual clinicians, at the practice/system level, and health plan.
“There’s been such a flood of performance measurements that we can get sidetracked, diverted, and spend resources and effort on measurements that don’t improve care,” said Nick Fitterman, MD, chair of the ACP’s Performance Measurement Committee.
Primary care clinicians can choose from more than 60 metrics for 2024. Many involve caring for patients with mental illness or screening for those who could be underdiagnosed. Programs that certify health systems as providing quality care use the measures, in addition to the Merit-Based Incentive Payment System. Health systems choose six measures of quality to tie to their reimbursement — along with assessments of costs and use of technology.
In turn, Medicare adjusts its reimbursement based on how well a clinician’s numbers turn out and if they improved over time.
“You don’t get the benefit of the upside if you don’t meet the measure, so your payment is neutral and that can be significant from a broader system lens,” Dr. Connelly said. “Then you start to have to make decisions on what services do we then have to limit because we no longer have the financial capability.”
The implications for health systems and patient care are the reason ACP and clinicians are calling for some measures to be amended. Dr. Fitterman said his organization plans to work with CMS.
Implementing Measurement
At Bassett Health in New York, the health system uses the depression and follow-up plan measure to qualify for certification from the Health Resources and Services Administration as a patient-centered medical home, which the company uses in part to market itself to patients.
Amy Grace, MD, an attending physician in internal and family medicine at Bassett Health in Little Falls, New York, said if a patient refuses to take a depression screening, she will not meet the measure for that visit. But providing a screening is not always clinically appropriate, and some patients do not need a follow-up plan.
“If someone has just had a death in the family, they might answer the questions in a way that would be consistent with depression, but they’re experiencing grief as opposed to clinical depression,” Dr. Grace said.
Suggestions From ACP for Improvement in MDD Metrics
- Create and implement criteria for patients who do not need a follow-up plan based on clinician judgment.
- Add methods for clinicians to measure and indicate severity of MDD.
- Enable use of a wider array of evidence-based tools and screenings to screen for MDD.
- Allow clinicians to document changes in treatment plan.
Bassett is building into the electronic health record a button that documents the screening was not conducted and that it was not appropriate to administer that day. Of course, building these in-house options entails utilizing resources that smaller systems or independent groups of clinicians may lack.
Eric Wei, MD, senior vice president and chief quality officer at NYC Health + Hospitals in New York City, said the ACP report underscores that many measures, even beyond depression, must be improved.
“With burnout and cognitive overload of our providers, on top of the medicine and just trying to come to the right diagnosis and providing the right treatment and the best care experience, you have to remember all these quality metrics and make sure you put all these things in certain places in the electronic health record,” Dr. Wei said.
Still, Dr. Wei said that the annual rate of depression screening across 400,000 patients in his system is 91%. He and his team spent 6 years working to improve uptake among clinicians, and now, they have moved on to increasing rates of administration of the suicide assessment.
Each clinician uses a dashboard to track their individual metric performance, according to Ted Long, MD, senior vice president for ambulatory care and population health at NYC Health + Hospitals. Dr. Long said he is proud of the improvements he and his colleagues have made in catching undiagnosed depression and in other disease states.
At his primary care practice in the Bronx, nearly 9 out of 10 patients with hypertension have their condition under control, he said. How does he know? Measurement tracking.
“Knowing that when a new patient is in front of me with high blood pressure, that there’s a 9 out of 10 chance that after seeing me because of my clinic, not just because of me, I’m going to be able to keep them healthy by controlling their blood pressure, that’s very meaningful to me,” Dr. Long said. “I think that’s the other side: It enables me as a doctor to know that I’m delivering the highest quality of care to my patients.”
Takeaways for Depression Screening and Follow-Up in Clinical Settings
Just because a patient scores positive for the depression screener, a clinician should dig deeper before making a diagnosis.
Patients have the right to refuse a screener and their wishes should be respected.
Providing a screener may not be appropriate at every visit, such as for a patient with a sprained ankle or a potential respiratory infection where time is limited.
Clinicians can clarify within the measure that the patient did not have mental capacity on that visit to fill out the screener.
A version of this article appeared on Medscape.com.
Every time a patient visits Jason Connelly, MD, they must fill out a depression screening, thanks to a 2017 rule which mandates such assessments.
Providing a screening and, if needed, a follow-up plan means a patient may gain access to medication or cognitive-behavioral therapy that will improve their lives. But Dr. Connelly, a family medicine physician at Novant Health West Rowan Family Medicine in Cleveland, North Carolina, said the screening measure — and others like it that insurers and quality groups use to assess clinician performance — does not allow for enough flexibility.
For instance, he must follow-up with patients every 4 months, regardless of the severity of their depression.
“A lot of times when these are written for the purpose of measures, they don’t take into consideration the reality of clinical medicine,” Dr. Connelly, who is also a clinical physician executive with Novant, said. “There certainly needs to be room for the ability to specify the level of depression such that if it is mild, well, maybe that follow-up is at 6 months or 12 months or at patient discretion.”
A recent report from the American College of Physicians (ACP) supported Dr. Connelly’s view. The body looked at eight quality measures in primary care for patients with major depressive disorder (MDD) and found only one — a risk assessment for suicide — to be clinically meaningful and based on evidence.
The ACP panel said nearly all of the performance measures “lacked current clinical evidence, did not consider patient preferences, were not tested appropriately, or were outside a physician’s control.”
The group called for improvements in such assessments “to accurately assess the quality of clinical care” for patients with major depression.
Necessary Evil or Burdensome Time Suck?
The Centers for Medicare & Medicaid Services scores clinicians and health systems on the percentage of their patients who receive a screening during a visit; if the screening is positive, clinicians must document a follow-up plan using special manual entry codes.
Physicians say the process of meeting government standards for invalid measures can create unnecessary visits and physician paperwork, shrink monetary bonuses, and may not portray an accurate portrait of what best practice looks like in primary care for mental health. But many also said the program overall brings value to patients and provides a picture of how well they are practicing but only when measures are clinically relevant.
Standards ACP Used for Validating Depression Measurement
A committee with ACP used a modified appropriateness method from RAND and UCLA.
They weighed if a metric was evidence-based, methodologically sound, and clinically meaningful.
They rated each measure using a 9-point scale, including appropriate care, feasibility or applicability, and measure specifications.
A total of 11 committee members voted anonymously if each metric was a valid way of measuring individual clinicians, at the practice/system level, and health plan.
“There’s been such a flood of performance measurements that we can get sidetracked, diverted, and spend resources and effort on measurements that don’t improve care,” said Nick Fitterman, MD, chair of the ACP’s Performance Measurement Committee.
Primary care clinicians can choose from more than 60 metrics for 2024. Many involve caring for patients with mental illness or screening for those who could be underdiagnosed. Programs that certify health systems as providing quality care use the measures, in addition to the Merit-Based Incentive Payment System. Health systems choose six measures of quality to tie to their reimbursement — along with assessments of costs and use of technology.
In turn, Medicare adjusts its reimbursement based on how well a clinician’s numbers turn out and if they improved over time.
“You don’t get the benefit of the upside if you don’t meet the measure, so your payment is neutral and that can be significant from a broader system lens,” Dr. Connelly said. “Then you start to have to make decisions on what services do we then have to limit because we no longer have the financial capability.”
The implications for health systems and patient care are the reason ACP and clinicians are calling for some measures to be amended. Dr. Fitterman said his organization plans to work with CMS.
Implementing Measurement
At Bassett Health in New York, the health system uses the depression and follow-up plan measure to qualify for certification from the Health Resources and Services Administration as a patient-centered medical home, which the company uses in part to market itself to patients.
Amy Grace, MD, an attending physician in internal and family medicine at Bassett Health in Little Falls, New York, said if a patient refuses to take a depression screening, she will not meet the measure for that visit. But providing a screening is not always clinically appropriate, and some patients do not need a follow-up plan.
“If someone has just had a death in the family, they might answer the questions in a way that would be consistent with depression, but they’re experiencing grief as opposed to clinical depression,” Dr. Grace said.
Suggestions From ACP for Improvement in MDD Metrics
- Create and implement criteria for patients who do not need a follow-up plan based on clinician judgment.
- Add methods for clinicians to measure and indicate severity of MDD.
- Enable use of a wider array of evidence-based tools and screenings to screen for MDD.
- Allow clinicians to document changes in treatment plan.
Bassett is building into the electronic health record a button that documents the screening was not conducted and that it was not appropriate to administer that day. Of course, building these in-house options entails utilizing resources that smaller systems or independent groups of clinicians may lack.
Eric Wei, MD, senior vice president and chief quality officer at NYC Health + Hospitals in New York City, said the ACP report underscores that many measures, even beyond depression, must be improved.
“With burnout and cognitive overload of our providers, on top of the medicine and just trying to come to the right diagnosis and providing the right treatment and the best care experience, you have to remember all these quality metrics and make sure you put all these things in certain places in the electronic health record,” Dr. Wei said.
Still, Dr. Wei said that the annual rate of depression screening across 400,000 patients in his system is 91%. He and his team spent 6 years working to improve uptake among clinicians, and now, they have moved on to increasing rates of administration of the suicide assessment.
Each clinician uses a dashboard to track their individual metric performance, according to Ted Long, MD, senior vice president for ambulatory care and population health at NYC Health + Hospitals. Dr. Long said he is proud of the improvements he and his colleagues have made in catching undiagnosed depression and in other disease states.
At his primary care practice in the Bronx, nearly 9 out of 10 patients with hypertension have their condition under control, he said. How does he know? Measurement tracking.
“Knowing that when a new patient is in front of me with high blood pressure, that there’s a 9 out of 10 chance that after seeing me because of my clinic, not just because of me, I’m going to be able to keep them healthy by controlling their blood pressure, that’s very meaningful to me,” Dr. Long said. “I think that’s the other side: It enables me as a doctor to know that I’m delivering the highest quality of care to my patients.”
Takeaways for Depression Screening and Follow-Up in Clinical Settings
Just because a patient scores positive for the depression screener, a clinician should dig deeper before making a diagnosis.
Patients have the right to refuse a screener and their wishes should be respected.
Providing a screener may not be appropriate at every visit, such as for a patient with a sprained ankle or a potential respiratory infection where time is limited.
Clinicians can clarify within the measure that the patient did not have mental capacity on that visit to fill out the screener.
A version of this article appeared on Medscape.com.
High school students using less tobacco, vape products, CDC report shows
TOPLINE:
entice teens and keep them vaping.
which have been shown to bothMETHODOLOGY:
- The MMRW report from the U.S. Centers for Disease Control and Prevention presents data from an annual survey of U.S. middle and high school students of their use of tobacco products, including vapes.
- The survey is a cross-sectional, school-based, self-administered web-based questionnaire that uses a stratified, three-stage cluster sampling procedure to generate a nationally representative sample based off the responses of 22,069 students in 2023.
- The overall response rate was 30.5%.
- “Ever use” was defined as using a product once or twice previously, and “current use” was defined as use in the past 30 days.
- The survey queried students on their use of e-cigarettes, traditional cigarettes, cigars, smokeless tobacco, nicotine pouches, hookahs, pipe tobacco, and other oral nicotine products.
TAKEAWAY:
- The use of tobacco products by high school students decreased by 540,000 people from 2022 to 2023 (2.51 million vs. 1.97 million students).
- From 2022 to 2023, current e-cigarette use among high school students declined from 14.1% to 10.0%.
- Among middle and high school students, e-cigarettes were the most used nicotine product in 2023 (7.7%; 2.13 million), followed by cigarettes (1.6%), cigars (1.6%), nicotine pouches (1.5%), smokeless tobacco (1.2%), other oral nicotine products (1.2%), hookahs (1.1%), heated tobacco products (1.0%), and pipe tobacco (0.5%).
- Among students reporting current e-cigarette use, 89.4% said that they used flavored products, and 25.2% said they used an e-cigarette daily. The most commonly reported brands were Elf Bar, Esco Bar, Vuse, JUUL, and Mr. Fog. Fruit (63.4%) and candy (35%) were the most commonly reported flavors.
IN PRACTICE:
“Sustained efforts to prevent initiation of tobacco product use among young persons and strategies to help young tobacco users quit are critical to reducing U.S. youth tobacco product use,” the report states.
SOURCE:
The report was produced by the CDC and published in the Morbidity and Mortality Weekly Report for Nov. 3, 2023.
LIMITATIONS:
Data were obtained by students self-reporting their tobacco use, which can result in social desirability and recall biases, the report states. In addition, the responses were from students enrolled in school settings and may not be representative of teens who are in detention centers, alternative schools, have dropped out of school or are homeschooled. The response rate for the 2023 survey was also lower than in the previous year (30.5% in 2023 vs. 45.2% in 2022), increasing the potential for higher standard errors and reducing the power to detect significant differences.
DISCLOSURES:
No potential conflicts of interest were disclosed.
A version of this article first appeared on Medscape.com.
TOPLINE:
entice teens and keep them vaping.
which have been shown to bothMETHODOLOGY:
- The MMRW report from the U.S. Centers for Disease Control and Prevention presents data from an annual survey of U.S. middle and high school students of their use of tobacco products, including vapes.
- The survey is a cross-sectional, school-based, self-administered web-based questionnaire that uses a stratified, three-stage cluster sampling procedure to generate a nationally representative sample based off the responses of 22,069 students in 2023.
- The overall response rate was 30.5%.
- “Ever use” was defined as using a product once or twice previously, and “current use” was defined as use in the past 30 days.
- The survey queried students on their use of e-cigarettes, traditional cigarettes, cigars, smokeless tobacco, nicotine pouches, hookahs, pipe tobacco, and other oral nicotine products.
TAKEAWAY:
- The use of tobacco products by high school students decreased by 540,000 people from 2022 to 2023 (2.51 million vs. 1.97 million students).
- From 2022 to 2023, current e-cigarette use among high school students declined from 14.1% to 10.0%.
- Among middle and high school students, e-cigarettes were the most used nicotine product in 2023 (7.7%; 2.13 million), followed by cigarettes (1.6%), cigars (1.6%), nicotine pouches (1.5%), smokeless tobacco (1.2%), other oral nicotine products (1.2%), hookahs (1.1%), heated tobacco products (1.0%), and pipe tobacco (0.5%).
- Among students reporting current e-cigarette use, 89.4% said that they used flavored products, and 25.2% said they used an e-cigarette daily. The most commonly reported brands were Elf Bar, Esco Bar, Vuse, JUUL, and Mr. Fog. Fruit (63.4%) and candy (35%) were the most commonly reported flavors.
IN PRACTICE:
“Sustained efforts to prevent initiation of tobacco product use among young persons and strategies to help young tobacco users quit are critical to reducing U.S. youth tobacco product use,” the report states.
SOURCE:
The report was produced by the CDC and published in the Morbidity and Mortality Weekly Report for Nov. 3, 2023.
LIMITATIONS:
Data were obtained by students self-reporting their tobacco use, which can result in social desirability and recall biases, the report states. In addition, the responses were from students enrolled in school settings and may not be representative of teens who are in detention centers, alternative schools, have dropped out of school or are homeschooled. The response rate for the 2023 survey was also lower than in the previous year (30.5% in 2023 vs. 45.2% in 2022), increasing the potential for higher standard errors and reducing the power to detect significant differences.
DISCLOSURES:
No potential conflicts of interest were disclosed.
A version of this article first appeared on Medscape.com.
TOPLINE:
entice teens and keep them vaping.
which have been shown to bothMETHODOLOGY:
- The MMRW report from the U.S. Centers for Disease Control and Prevention presents data from an annual survey of U.S. middle and high school students of their use of tobacco products, including vapes.
- The survey is a cross-sectional, school-based, self-administered web-based questionnaire that uses a stratified, three-stage cluster sampling procedure to generate a nationally representative sample based off the responses of 22,069 students in 2023.
- The overall response rate was 30.5%.
- “Ever use” was defined as using a product once or twice previously, and “current use” was defined as use in the past 30 days.
- The survey queried students on their use of e-cigarettes, traditional cigarettes, cigars, smokeless tobacco, nicotine pouches, hookahs, pipe tobacco, and other oral nicotine products.
TAKEAWAY:
- The use of tobacco products by high school students decreased by 540,000 people from 2022 to 2023 (2.51 million vs. 1.97 million students).
- From 2022 to 2023, current e-cigarette use among high school students declined from 14.1% to 10.0%.
- Among middle and high school students, e-cigarettes were the most used nicotine product in 2023 (7.7%; 2.13 million), followed by cigarettes (1.6%), cigars (1.6%), nicotine pouches (1.5%), smokeless tobacco (1.2%), other oral nicotine products (1.2%), hookahs (1.1%), heated tobacco products (1.0%), and pipe tobacco (0.5%).
- Among students reporting current e-cigarette use, 89.4% said that they used flavored products, and 25.2% said they used an e-cigarette daily. The most commonly reported brands were Elf Bar, Esco Bar, Vuse, JUUL, and Mr. Fog. Fruit (63.4%) and candy (35%) were the most commonly reported flavors.
IN PRACTICE:
“Sustained efforts to prevent initiation of tobacco product use among young persons and strategies to help young tobacco users quit are critical to reducing U.S. youth tobacco product use,” the report states.
SOURCE:
The report was produced by the CDC and published in the Morbidity and Mortality Weekly Report for Nov. 3, 2023.
LIMITATIONS:
Data were obtained by students self-reporting their tobacco use, which can result in social desirability and recall biases, the report states. In addition, the responses were from students enrolled in school settings and may not be representative of teens who are in detention centers, alternative schools, have dropped out of school or are homeschooled. The response rate for the 2023 survey was also lower than in the previous year (30.5% in 2023 vs. 45.2% in 2022), increasing the potential for higher standard errors and reducing the power to detect significant differences.
DISCLOSURES:
No potential conflicts of interest were disclosed.
A version of this article first appeared on Medscape.com.
FDA approves RSV monoclonal antibody for all infants
The monoclonal antibody Beyfortus (nirsevimab-alip), which already is approved for use in Europe and Canada, is indicated for newborns and infants born during or entering their first RSV season, and for children up to 24 months of age who are vulnerable to severe RSV through their second RSV season.
As many as 80,000 children under age 5 years are hospitalized with an RSV infection annually in the United States. Most cases are mild, but infants under 6 months, those born prematurely, and children with weakened immune systems or neuromuscular disorders are at an increased risk for severe illness, according to the Centers for Disease Control and Prevention.
The highly contagious virus is also a concern for immunocompromised adults and older people with underlying health conditions, who are at increased risk for severe disease.
Sanofi and AstraZeneca, which jointly developed the injectable agent, said in a press release that the companies plan to make it available by the fall of 2023. The long-acting antibody is given as a single intramuscular injection.
Beyfortus was approved in part based on data from the phase 3 MELODY trial, which found the shot reduced the incidence of medically attended lower respiratory tract infections associated with RSV by 74.9% versus placebo (95% confidence interval, 50.6-87.3; P < .001).
The phase 2/3 MEDLEY trial, conducted between July 2019 and May 2021, compared Beyfortus with palivizumab, another RSV antibody injection with more limited indications. The trial included more than 900 preterm infants less than 35 weeks’ gestational age and infants with congenital heart disease. Results were similar to the phase 3 MELODY trial, according to the manufacturers.
“Today’s approval marks an unprecedented moment for protecting infant health in the United States, following an RSV season that took a record toll on infants, their families, and the U.S. health care system,” said Thomas Triomphe, executive vice president for vaccines at Sanofi, in a press release about the FDA decision. “Beyfortus is the only monoclonal antibody approved for passive immunization to provide safe and effective protection for all infants during their first RSV season.”
A version of this article first appeared on Medscape.com.
The monoclonal antibody Beyfortus (nirsevimab-alip), which already is approved for use in Europe and Canada, is indicated for newborns and infants born during or entering their first RSV season, and for children up to 24 months of age who are vulnerable to severe RSV through their second RSV season.
As many as 80,000 children under age 5 years are hospitalized with an RSV infection annually in the United States. Most cases are mild, but infants under 6 months, those born prematurely, and children with weakened immune systems or neuromuscular disorders are at an increased risk for severe illness, according to the Centers for Disease Control and Prevention.
The highly contagious virus is also a concern for immunocompromised adults and older people with underlying health conditions, who are at increased risk for severe disease.
Sanofi and AstraZeneca, which jointly developed the injectable agent, said in a press release that the companies plan to make it available by the fall of 2023. The long-acting antibody is given as a single intramuscular injection.
Beyfortus was approved in part based on data from the phase 3 MELODY trial, which found the shot reduced the incidence of medically attended lower respiratory tract infections associated with RSV by 74.9% versus placebo (95% confidence interval, 50.6-87.3; P < .001).
The phase 2/3 MEDLEY trial, conducted between July 2019 and May 2021, compared Beyfortus with palivizumab, another RSV antibody injection with more limited indications. The trial included more than 900 preterm infants less than 35 weeks’ gestational age and infants with congenital heart disease. Results were similar to the phase 3 MELODY trial, according to the manufacturers.
“Today’s approval marks an unprecedented moment for protecting infant health in the United States, following an RSV season that took a record toll on infants, their families, and the U.S. health care system,” said Thomas Triomphe, executive vice president for vaccines at Sanofi, in a press release about the FDA decision. “Beyfortus is the only monoclonal antibody approved for passive immunization to provide safe and effective protection for all infants during their first RSV season.”
A version of this article first appeared on Medscape.com.
The monoclonal antibody Beyfortus (nirsevimab-alip), which already is approved for use in Europe and Canada, is indicated for newborns and infants born during or entering their first RSV season, and for children up to 24 months of age who are vulnerable to severe RSV through their second RSV season.
As many as 80,000 children under age 5 years are hospitalized with an RSV infection annually in the United States. Most cases are mild, but infants under 6 months, those born prematurely, and children with weakened immune systems or neuromuscular disorders are at an increased risk for severe illness, according to the Centers for Disease Control and Prevention.
The highly contagious virus is also a concern for immunocompromised adults and older people with underlying health conditions, who are at increased risk for severe disease.
Sanofi and AstraZeneca, which jointly developed the injectable agent, said in a press release that the companies plan to make it available by the fall of 2023. The long-acting antibody is given as a single intramuscular injection.
Beyfortus was approved in part based on data from the phase 3 MELODY trial, which found the shot reduced the incidence of medically attended lower respiratory tract infections associated with RSV by 74.9% versus placebo (95% confidence interval, 50.6-87.3; P < .001).
The phase 2/3 MEDLEY trial, conducted between July 2019 and May 2021, compared Beyfortus with palivizumab, another RSV antibody injection with more limited indications. The trial included more than 900 preterm infants less than 35 weeks’ gestational age and infants with congenital heart disease. Results were similar to the phase 3 MELODY trial, according to the manufacturers.
“Today’s approval marks an unprecedented moment for protecting infant health in the United States, following an RSV season that took a record toll on infants, their families, and the U.S. health care system,” said Thomas Triomphe, executive vice president for vaccines at Sanofi, in a press release about the FDA decision. “Beyfortus is the only monoclonal antibody approved for passive immunization to provide safe and effective protection for all infants during their first RSV season.”
A version of this article first appeared on Medscape.com.
‘Deprescribing’: Should some older adults shed their meds?
Joanne Lynn, MD, has lost track of the number of times in her 40 years as a geriatrician she’s seen a new patient come to her office carrying a bucket full of prescription medications – many of which they don’t need.
Dr. Lynn, who is on the faculty of George Washington University,Washington, recalled one woman who unwittingly was taking two blood pressure medications with different names.
“The risks included all the side effects overdosing carries,” Dr. Lynn said, ranging from blurred vision and crankiness to organ failure and even death.
For doctors with patients who don’t know they’re taking too much of a medication, “you wonder whether the drug is causing the health problems, and it’s a symptom of the wrong medication,” rather than a symptom of an undiagnosed illness, she said.
Patients often assume their health providers check for drug interactions or assess if a medication is no longer needed, and will catch extra prescriptions. That could be a risky assumption. Some doctors may prescribe yet another prescription to manage the side effects of an unnecessary drug, instead of doing a medication review and potentially “deprescribing” or discontinuing, a treatment that’s no longer needed.
About 57% of people age 65 years or older take five or more medications regularly – a concept known as polypharmacy, a study published in 2020 in the Journal of the American Geriatrics Society shows. While doctors prescribe drugs to help patients manage various ailments, as a list of medications grows, so do potential complications.
An older adult might forget to tell their doctor what they’re taking, or maybe they don’t even know what they’re taking or why, Dr. Lynn said.
“In some cases, a doctor just added a drug to treat something, not realizing they were already taking something else for it,” she said. “Of course, the situation of whether these patients can even afford all these drugs matters a lot, too.”
Some older adults may pick and choose which medications to take based on cost, not knowing which prescriptions are necessary, Dr. Lynn said.
Finding the ‘right balance’
Indeed, if given the option, up to 80% of older adults ages 50-80 would be open to stopping one or more of their prescribed medications, according to a 2023 poll by researchers at the University of Michigan, Ann Arbor.
“A lot of drugs that people take might have been appropriate at one point, but might have outlived their usefulness for that individual,” said Michael Steinman, MD, a professor of medicine and a geriatrician at the University of California, San Francisco, and coprincipal investigator of the U.S. Deprescribing Research Network, a doctor group focused on improving medication use for older adults.
“Having fewer medications can actually be beneficial,” he said. “You can take too many medications; you can take too few. The optimal thing is finding what is the right balance for you.”
Defining how many medications is too many depends on each person, which is why caregivers and older adults can ask their doctor for a review of medications that have multiplied over time.
By reevaluating their medications, older adults can actually lower their chances of potentially harmful side effects, and avoid the spiral of being prescribed even more medications, said Sarah Vordenberg, PharmD, MPH, a clinical associate professor at the University of Michigan’s College of Pharmacy, Ann Arbor.
“It’s not really the number of medications, it’s [about] are they inappropriate or unnecessary medications for a patient,” she said.
Patients and caregivers can ask for an honest conversation with their doctor. The University of Michigan poll found that more than 90% of older adults who took prescription medications expected their health care provider to review their medicines during a regular visit.
But doctors often need prompting from patients to start a review.
“The clinical inertia, or maintaining the status quo, unfortunately is a lot of times easier than having time-intensive conversations,” Dr. Vordenberg said.
Ask questions
Sara Merwin spent many years helping manage her parents’ medical appointments and health as they transitioned from living independently in Colorado to a retirement community and finally a nursing home. Ms. Merwin, coauthor of “The Informed Patient,” said her father was taking a long list of medications, and she often asked his primary care doctor for a medication review.
“I felt that my father at his age and his frailty didn’t need as many meds as he was on,” said Ms. Merwin, who lives in Long Island, N.Y. “So we went over his meds, and I asked, ‘Does he really need to be on this?’ ‘Does he really need to be on that?’ ”
She questioned one medication in particular, a statin to lower his cholesterol and risk of a heart attack.
“I thought possibly the statin was causing some myalgia, some muscle aches in his legs, which is why I advocated for coming off it,” she said.
The primary care doctor discontinued the anticholesterol drug.
Local pharmacies can also serve as a starting point for older adults and caregivers, where a pharmacist can give them more information on whether a particular combination of the medications taken may be harmful. In states that allow for pharmacists to prescribe some medications, pharmacists may be able to consolidate some of the medications or advise that a patient stop taking one or more, Dr. Vordenberg said.
“All pharmacists have the training to do a comprehensive medication review,” she said. “All pharmacists have the ability to follow up with the patient to find out how the deprescribing is going.”
Ms. Merwin’s parents received their prescriptions from a “small mom-and-pop pharmacy, where they were on a first-name basis with the pharmacist who really looked out for them. So they had that expertise available to them,” she said.
With information in hand on potentially unnecessary medications, the work of shedding medications should be done along with health care providers, some of whom prescribed the medications in the first place.
Many older adults live in geographically isolated areas without pharmacies, or receive prescriptions from mail-order pharmacies. In this case, Medicare plans offer free medication reviews with a doctor or pharmacist – known as a medication therapy management program – and provide recommendations for taking each drug.
Ms. Merwin’s father died in early 2020. She sometimes questions whether he should have stayed on the statin for longer, or if the doctor agreed too quickly without doing more research. But overall, she doesn’t regret raising the question with his health care providers, and she advises other caregivers and older adults to pay attention to medication lists.
“It’s dangerous to be passive when it comes to one’s health care now,” Ms. Merwin said. “That’s a difficult message for older adults to hear because they have grown up with the primacy of the doctor and the authority of the doctor, as opposed to it being a collaborative relationship.”
A version of this article first appeared on WebMD.com.
Joanne Lynn, MD, has lost track of the number of times in her 40 years as a geriatrician she’s seen a new patient come to her office carrying a bucket full of prescription medications – many of which they don’t need.
Dr. Lynn, who is on the faculty of George Washington University,Washington, recalled one woman who unwittingly was taking two blood pressure medications with different names.
“The risks included all the side effects overdosing carries,” Dr. Lynn said, ranging from blurred vision and crankiness to organ failure and even death.
For doctors with patients who don’t know they’re taking too much of a medication, “you wonder whether the drug is causing the health problems, and it’s a symptom of the wrong medication,” rather than a symptom of an undiagnosed illness, she said.
Patients often assume their health providers check for drug interactions or assess if a medication is no longer needed, and will catch extra prescriptions. That could be a risky assumption. Some doctors may prescribe yet another prescription to manage the side effects of an unnecessary drug, instead of doing a medication review and potentially “deprescribing” or discontinuing, a treatment that’s no longer needed.
About 57% of people age 65 years or older take five or more medications regularly – a concept known as polypharmacy, a study published in 2020 in the Journal of the American Geriatrics Society shows. While doctors prescribe drugs to help patients manage various ailments, as a list of medications grows, so do potential complications.
An older adult might forget to tell their doctor what they’re taking, or maybe they don’t even know what they’re taking or why, Dr. Lynn said.
“In some cases, a doctor just added a drug to treat something, not realizing they were already taking something else for it,” she said. “Of course, the situation of whether these patients can even afford all these drugs matters a lot, too.”
Some older adults may pick and choose which medications to take based on cost, not knowing which prescriptions are necessary, Dr. Lynn said.
Finding the ‘right balance’
Indeed, if given the option, up to 80% of older adults ages 50-80 would be open to stopping one or more of their prescribed medications, according to a 2023 poll by researchers at the University of Michigan, Ann Arbor.
“A lot of drugs that people take might have been appropriate at one point, but might have outlived their usefulness for that individual,” said Michael Steinman, MD, a professor of medicine and a geriatrician at the University of California, San Francisco, and coprincipal investigator of the U.S. Deprescribing Research Network, a doctor group focused on improving medication use for older adults.
“Having fewer medications can actually be beneficial,” he said. “You can take too many medications; you can take too few. The optimal thing is finding what is the right balance for you.”
Defining how many medications is too many depends on each person, which is why caregivers and older adults can ask their doctor for a review of medications that have multiplied over time.
By reevaluating their medications, older adults can actually lower their chances of potentially harmful side effects, and avoid the spiral of being prescribed even more medications, said Sarah Vordenberg, PharmD, MPH, a clinical associate professor at the University of Michigan’s College of Pharmacy, Ann Arbor.
“It’s not really the number of medications, it’s [about] are they inappropriate or unnecessary medications for a patient,” she said.
Patients and caregivers can ask for an honest conversation with their doctor. The University of Michigan poll found that more than 90% of older adults who took prescription medications expected their health care provider to review their medicines during a regular visit.
But doctors often need prompting from patients to start a review.
“The clinical inertia, or maintaining the status quo, unfortunately is a lot of times easier than having time-intensive conversations,” Dr. Vordenberg said.
Ask questions
Sara Merwin spent many years helping manage her parents’ medical appointments and health as they transitioned from living independently in Colorado to a retirement community and finally a nursing home. Ms. Merwin, coauthor of “The Informed Patient,” said her father was taking a long list of medications, and she often asked his primary care doctor for a medication review.
“I felt that my father at his age and his frailty didn’t need as many meds as he was on,” said Ms. Merwin, who lives in Long Island, N.Y. “So we went over his meds, and I asked, ‘Does he really need to be on this?’ ‘Does he really need to be on that?’ ”
She questioned one medication in particular, a statin to lower his cholesterol and risk of a heart attack.
“I thought possibly the statin was causing some myalgia, some muscle aches in his legs, which is why I advocated for coming off it,” she said.
The primary care doctor discontinued the anticholesterol drug.
Local pharmacies can also serve as a starting point for older adults and caregivers, where a pharmacist can give them more information on whether a particular combination of the medications taken may be harmful. In states that allow for pharmacists to prescribe some medications, pharmacists may be able to consolidate some of the medications or advise that a patient stop taking one or more, Dr. Vordenberg said.
“All pharmacists have the training to do a comprehensive medication review,” she said. “All pharmacists have the ability to follow up with the patient to find out how the deprescribing is going.”
Ms. Merwin’s parents received their prescriptions from a “small mom-and-pop pharmacy, where they were on a first-name basis with the pharmacist who really looked out for them. So they had that expertise available to them,” she said.
With information in hand on potentially unnecessary medications, the work of shedding medications should be done along with health care providers, some of whom prescribed the medications in the first place.
Many older adults live in geographically isolated areas without pharmacies, or receive prescriptions from mail-order pharmacies. In this case, Medicare plans offer free medication reviews with a doctor or pharmacist – known as a medication therapy management program – and provide recommendations for taking each drug.
Ms. Merwin’s father died in early 2020. She sometimes questions whether he should have stayed on the statin for longer, or if the doctor agreed too quickly without doing more research. But overall, she doesn’t regret raising the question with his health care providers, and she advises other caregivers and older adults to pay attention to medication lists.
“It’s dangerous to be passive when it comes to one’s health care now,” Ms. Merwin said. “That’s a difficult message for older adults to hear because they have grown up with the primacy of the doctor and the authority of the doctor, as opposed to it being a collaborative relationship.”
A version of this article first appeared on WebMD.com.
Joanne Lynn, MD, has lost track of the number of times in her 40 years as a geriatrician she’s seen a new patient come to her office carrying a bucket full of prescription medications – many of which they don’t need.
Dr. Lynn, who is on the faculty of George Washington University,Washington, recalled one woman who unwittingly was taking two blood pressure medications with different names.
“The risks included all the side effects overdosing carries,” Dr. Lynn said, ranging from blurred vision and crankiness to organ failure and even death.
For doctors with patients who don’t know they’re taking too much of a medication, “you wonder whether the drug is causing the health problems, and it’s a symptom of the wrong medication,” rather than a symptom of an undiagnosed illness, she said.
Patients often assume their health providers check for drug interactions or assess if a medication is no longer needed, and will catch extra prescriptions. That could be a risky assumption. Some doctors may prescribe yet another prescription to manage the side effects of an unnecessary drug, instead of doing a medication review and potentially “deprescribing” or discontinuing, a treatment that’s no longer needed.
About 57% of people age 65 years or older take five or more medications regularly – a concept known as polypharmacy, a study published in 2020 in the Journal of the American Geriatrics Society shows. While doctors prescribe drugs to help patients manage various ailments, as a list of medications grows, so do potential complications.
An older adult might forget to tell their doctor what they’re taking, or maybe they don’t even know what they’re taking or why, Dr. Lynn said.
“In some cases, a doctor just added a drug to treat something, not realizing they were already taking something else for it,” she said. “Of course, the situation of whether these patients can even afford all these drugs matters a lot, too.”
Some older adults may pick and choose which medications to take based on cost, not knowing which prescriptions are necessary, Dr. Lynn said.
Finding the ‘right balance’
Indeed, if given the option, up to 80% of older adults ages 50-80 would be open to stopping one or more of their prescribed medications, according to a 2023 poll by researchers at the University of Michigan, Ann Arbor.
“A lot of drugs that people take might have been appropriate at one point, but might have outlived their usefulness for that individual,” said Michael Steinman, MD, a professor of medicine and a geriatrician at the University of California, San Francisco, and coprincipal investigator of the U.S. Deprescribing Research Network, a doctor group focused on improving medication use for older adults.
“Having fewer medications can actually be beneficial,” he said. “You can take too many medications; you can take too few. The optimal thing is finding what is the right balance for you.”
Defining how many medications is too many depends on each person, which is why caregivers and older adults can ask their doctor for a review of medications that have multiplied over time.
By reevaluating their medications, older adults can actually lower their chances of potentially harmful side effects, and avoid the spiral of being prescribed even more medications, said Sarah Vordenberg, PharmD, MPH, a clinical associate professor at the University of Michigan’s College of Pharmacy, Ann Arbor.
“It’s not really the number of medications, it’s [about] are they inappropriate or unnecessary medications for a patient,” she said.
Patients and caregivers can ask for an honest conversation with their doctor. The University of Michigan poll found that more than 90% of older adults who took prescription medications expected their health care provider to review their medicines during a regular visit.
But doctors often need prompting from patients to start a review.
“The clinical inertia, or maintaining the status quo, unfortunately is a lot of times easier than having time-intensive conversations,” Dr. Vordenberg said.
Ask questions
Sara Merwin spent many years helping manage her parents’ medical appointments and health as they transitioned from living independently in Colorado to a retirement community and finally a nursing home. Ms. Merwin, coauthor of “The Informed Patient,” said her father was taking a long list of medications, and she often asked his primary care doctor for a medication review.
“I felt that my father at his age and his frailty didn’t need as many meds as he was on,” said Ms. Merwin, who lives in Long Island, N.Y. “So we went over his meds, and I asked, ‘Does he really need to be on this?’ ‘Does he really need to be on that?’ ”
She questioned one medication in particular, a statin to lower his cholesterol and risk of a heart attack.
“I thought possibly the statin was causing some myalgia, some muscle aches in his legs, which is why I advocated for coming off it,” she said.
The primary care doctor discontinued the anticholesterol drug.
Local pharmacies can also serve as a starting point for older adults and caregivers, where a pharmacist can give them more information on whether a particular combination of the medications taken may be harmful. In states that allow for pharmacists to prescribe some medications, pharmacists may be able to consolidate some of the medications or advise that a patient stop taking one or more, Dr. Vordenberg said.
“All pharmacists have the training to do a comprehensive medication review,” she said. “All pharmacists have the ability to follow up with the patient to find out how the deprescribing is going.”
Ms. Merwin’s parents received their prescriptions from a “small mom-and-pop pharmacy, where they were on a first-name basis with the pharmacist who really looked out for them. So they had that expertise available to them,” she said.
With information in hand on potentially unnecessary medications, the work of shedding medications should be done along with health care providers, some of whom prescribed the medications in the first place.
Many older adults live in geographically isolated areas without pharmacies, or receive prescriptions from mail-order pharmacies. In this case, Medicare plans offer free medication reviews with a doctor or pharmacist – known as a medication therapy management program – and provide recommendations for taking each drug.
Ms. Merwin’s father died in early 2020. She sometimes questions whether he should have stayed on the statin for longer, or if the doctor agreed too quickly without doing more research. But overall, she doesn’t regret raising the question with his health care providers, and she advises other caregivers and older adults to pay attention to medication lists.
“It’s dangerous to be passive when it comes to one’s health care now,” Ms. Merwin said. “That’s a difficult message for older adults to hear because they have grown up with the primacy of the doctor and the authority of the doctor, as opposed to it being a collaborative relationship.”
A version of this article first appeared on WebMD.com.
Forgotten but not gone: EVALI epidemic continues
Rashelle Bernal vaped and ended up in an induced coma for a week. She was one of almost 3,000 people who were hospitalized during 2019 and early 2020 with severe lung damage from vaping and became part of what is now known as the epidemic of e-cigarette, or vaping, product use–associated lung injury (EVALI).
For many, the EVALI epidemic is a distant, pre-COVID memory.
But the vaping-related injuries are still happening. And for Ms. Bernal, the aftermath is her reality. Her pulmonologist from that time described the harm from the vape ingredients as an oil spill in her lungs. Eventually, the toxins would probably clear. But she will likely wrestle with the injuries for a very long time.
More than 3 years later, she frequently finds herself in the emergency department.
“If I get sick, if there’s anything that irritates my lungs – it could be something as simple as pollen in the air – it will cause me to get like a bacterial infection or other issues, and I can’t breathe,” Ms. Ms. Bernal, now 30, said in a recent interview. “I get really winded, to the point where I’ll walk up the stairs and I feel like I just ran a mile.”
In 2019 and 2020, a media firestorm erupted as hospitals notified the public of outbreaks of vaping-related lung injuries. News headlines reported e-cigarettes were killing teens from Texas to the Bronx. Investigators at the U.S. Centers for Disease Control and Prevention tracked most of the cases to vitamin E acetate, an additive in illicit cannabis vaping products intended to promote the metabolism of tetrahydrocannabinol (THC). The agency stopped tracking EVALI in February 2020.
But 2 months later, in April 2020, the agency’s National Center for Health Statistics implemented a diagnostic code, U07.0, for health care professionals in the United States to diagnose EVALI for the first time. The code is also used for lung damage related to use of electronic cigarettes and “dabbing” – a method of inhaling cannabis. Damage could include inflammation of the lungs, pulmonary hemorrhage, and eosinophilic pneumonia.
The incidence of these diagnoses appears to have risen sharply since 2020. In the last three months of 2020, a total of 11,300 medical claims included the U07.0 code. That figure rose to 22,000 in 2021 and hit 31,600 in 2022, according to data compiled for and provided to Medscape by Komodo Health, a health care technology company that holds a database of more than 330 million U.S. patients from Medicare, Medicaid, and commercial insurers’ medical, pharmacy, and laboratory claims.
Harm from vaping, including EVALI, has continued.
said Usha Periyanayagam, MD, MPH, head of clinic product and real-world evidence for Komodo and a former emergency medicine physician.
Where it started
Devika Rao, MD, a pediatric pulmonology specialist at UT Southwestern Medical Center, Dallas, has cared for most of her EVALI patients in the hospital, with the most recent case in early 2023. But in January, for the first time, she saw an EVALI patient in an outpatient clinic. The person had not been admitted to the hospital – like most were pre-pandemic. And like most who were seen during the pandemic, this patient had milder symptoms, not requiring intubation or take-home oxygen.
In 2019 and the beginning of 2020, many EVALI patients who were eventually hospitalized first sought help at urgent care centers or with primary care doctors and were presumed to have pneumonia or gastroenteritis and sent home.
“But they got worse, and they would present to our emergency room; their chest X-rays and CT scans showed extensive lung disease,” Dr. Rao said, adding that the damage was striking among patients all under age 18. “They were short of breath. Their oxygen levels were low. They had diminished lung function. And they had a lot of GI issues like abdominal pain and weight loss from nausea and vomiting.”
“These overwhelming inflammatory reactions that we see with EVALI,” said Karen M. Wilson, MD, MPH, a pediatric hospitalist at the University of Rochester (N.Y.) Medical Center and a tobacco use researcher. “You might find some microvascular changes with normal inhaling of smoke or aerosol, but you’re not going to find macro changes like we see with the EVALI.”
In late 2019, images of the CT scans of patients with EVALI were published, grabbing the attention of Arun Kannappan, MD, an assistant professor of pulmonary sciences and critical care at the University of Colorado Anschutz School of Medicine, Aurora. Dr. Kannappan knew a patient with such severe lung damage could develop acute respiratory distress syndrome, which means a patient would be put on a ventilator because their inflamed lungs could not oxygenate blood.
“That confers within somewhere between 30% to 50% chance of dying; it made all of the pulmonary specialists really turn their heads to make sure that we keep a lookout for it,” said Dr. Kannappan.
CT scans of lungs proved to be a critical diagnostic tool for doctors. Most of the images from patients showed acute inflammation and diffuse lung damage. Ehab Ali, MD, a critical care and pulmonary disease medicine specialist in Louisville, Ky., said the damage was often spread across both lungs in many areas and appeared opaque and hazy, known as “ground glass.” COVID-19, meanwhile, appeared differently in lung scans, often with damage that was more isolated.
But many diseases carry a “ground glass” appearance, with many potential causes, like infections, cigarette smoke, or an autoimmune condition.
“Before you even talk to the patient, you can immediately put it in your mind that ‘I’m going to ask this patient if they vape,’ when I see the distribution of ground glass appearance,” Dr. Ali said.
Dr. Ali said other factors, like the age of the patient – about three-quarters of EVALI patients are under age 34, according to the CDC – would spur him to ask about vaping. But because so many patients were young, discerning vape usage wasn’t always easy.
“When you’re talking to teenagers, if you ask them upon admission, with the parents in the room, they’re going say ‘no,’ ” said Rachel Boykan, MD, a pediatric hospitalist at Stony Brook (N.Y.) Children’s. She added that her hospital is still seeing cases.
Dr. Rao said it often takes two to three people asking a patient about any vape usage before they confess.
Ms. Bernal, who was 27 at the time of her hospital admission for EVALI, said she bought vapes with THC at a retail shop in California. She’d been a traditional marijuana smoker, using the leaf product, but switched when someone told her it was healthier to vape THC than inhale smoke from burned marijuana leaves into her lungs. “I thought this was safe.”
Dr. Rao and her colleagues recently published a study of 41 teenage patients with EVALI who were seen at Children’s Medical Center Dallas between December 2018 and July 2021. All but one reported using e-cigarettes containing THC, and the CDC in its most recent report from February 2020 said about 80% of patients had used vapes containing THC.
The CDC also found that vitamin E acetate, an oily substance that allows THC to travel from the lungs to the brain quickly and an ingredient used in the food and cosmetics industries, was found in many of the lungs of EVALI patients, though not all.
The aftermath
The outcomes of the thousands of patients who had EVALI – and those who may still be developing it – are largely untracked.
Bonnie Halpern-Felsher, PhD, director at the Stanford (Calif.) Reach Lab that bears her name and a researcher on tobacco in youth, said she and many of her colleagues are frustrated that the CDC is not continuing to collect data on EVALI.
“I know a lot of colleagues who’ve said that they’re still seeing EVALI, but because of COVID-19 they stopped collecting the data. And that’s been very frustrating because it’s hard to say whether the kinds of lung issues you’re having are related to e-cigarettes, generally, or EVALI,” Dr. Halpern-Felsher said.
Researchers and doctors affiliated with the American Thoracic Society published a report with solutions on how to better track EVALI. They recommended that a national case registry and biorepository be created.
Doctors also worry that many cases were missed. Dr. Boykan said that while protocol dictated nurses and other clinicians ask about a history of vaping – a key part of EVALI diagnosis – many did not. Dr. Ali, the Louisville critical care physician, said EVALI symptoms of nausea, cough, and fever are associated with viral infections.
“I’m sure that some of these cases might be discharged from the emergency room as a virus,” Dr. Ali said. “Most of the time patients would get prescribed steroids for viral infections, which may help EVALI patients even though it’s never been studied.”
Dr. Rao also said the treatment regimen at Children’s MC Dallas, which included high doses of intravenous steroids, seemed to help. But the best management approach for treatment, or long-term follow up care, has not been studied.
The report in the Annals of the American Thoracic Society said prospective studies are showing that a significant portion of patients with EVALI experience prolonged respiratory issues and cognitive and mood impairment. Dr. Rao said a common thread for many of her EVALI patients has been significant stress in their lives with school or family, which led them to vape in an attempt to reduce stress.
That was certainly the case for Ms. Bernal before her hospital admission. She had recently moved across the country for her husband’s job, was trying to buy a house, and had spent months in a hotel with three children. She vaped to cope.
But she said her mental and cognitive health has worsened. Back in Louisville, she saw a neurologist, who told her that her brain had shrunk, she said. She hasn’t found a new neurologist in Portland, Ore., where her family moved a year after the EVALI episode.
But she often finds herself overwhelmed and overstimulated with tasks that she said she never had problems with before. She tears up while talking about the newfound limitations. She struggled to find a primary care physician who could medically manage her mental health and a counselor who can understand what she’s been through with EVALI.
But, “a lot of doctors aren’t educated in it, and they don’t know how to respond or they don’t know what to do,” Ms. Bernal said. “And that makes me feel like, I guess, what I had wasn’t important.”
Ms. Bernal does have a new pulmonologist and is going in for a round of pulmonary tests soon because she often finds herself unable to breathe while completing simple tasks. She is tired of rushing to the ER. She wants answers, or some kind of treatment to help her feel normal again.
“I feel like this is my fault,” Ms. Bernal said. “Had I not smoked, I would be fine, and that’s hard to live with. Every day. Telling yourself, ‘It’s your fault.’ It’s been how many years now? And I still haven’t found peace yet. I don’t know if ever will.”
A version of this article first appeared on Medscape.com.
Rashelle Bernal vaped and ended up in an induced coma for a week. She was one of almost 3,000 people who were hospitalized during 2019 and early 2020 with severe lung damage from vaping and became part of what is now known as the epidemic of e-cigarette, or vaping, product use–associated lung injury (EVALI).
For many, the EVALI epidemic is a distant, pre-COVID memory.
But the vaping-related injuries are still happening. And for Ms. Bernal, the aftermath is her reality. Her pulmonologist from that time described the harm from the vape ingredients as an oil spill in her lungs. Eventually, the toxins would probably clear. But she will likely wrestle with the injuries for a very long time.
More than 3 years later, she frequently finds herself in the emergency department.
“If I get sick, if there’s anything that irritates my lungs – it could be something as simple as pollen in the air – it will cause me to get like a bacterial infection or other issues, and I can’t breathe,” Ms. Ms. Bernal, now 30, said in a recent interview. “I get really winded, to the point where I’ll walk up the stairs and I feel like I just ran a mile.”
In 2019 and 2020, a media firestorm erupted as hospitals notified the public of outbreaks of vaping-related lung injuries. News headlines reported e-cigarettes were killing teens from Texas to the Bronx. Investigators at the U.S. Centers for Disease Control and Prevention tracked most of the cases to vitamin E acetate, an additive in illicit cannabis vaping products intended to promote the metabolism of tetrahydrocannabinol (THC). The agency stopped tracking EVALI in February 2020.
But 2 months later, in April 2020, the agency’s National Center for Health Statistics implemented a diagnostic code, U07.0, for health care professionals in the United States to diagnose EVALI for the first time. The code is also used for lung damage related to use of electronic cigarettes and “dabbing” – a method of inhaling cannabis. Damage could include inflammation of the lungs, pulmonary hemorrhage, and eosinophilic pneumonia.
The incidence of these diagnoses appears to have risen sharply since 2020. In the last three months of 2020, a total of 11,300 medical claims included the U07.0 code. That figure rose to 22,000 in 2021 and hit 31,600 in 2022, according to data compiled for and provided to Medscape by Komodo Health, a health care technology company that holds a database of more than 330 million U.S. patients from Medicare, Medicaid, and commercial insurers’ medical, pharmacy, and laboratory claims.
Harm from vaping, including EVALI, has continued.
said Usha Periyanayagam, MD, MPH, head of clinic product and real-world evidence for Komodo and a former emergency medicine physician.
Where it started
Devika Rao, MD, a pediatric pulmonology specialist at UT Southwestern Medical Center, Dallas, has cared for most of her EVALI patients in the hospital, with the most recent case in early 2023. But in January, for the first time, she saw an EVALI patient in an outpatient clinic. The person had not been admitted to the hospital – like most were pre-pandemic. And like most who were seen during the pandemic, this patient had milder symptoms, not requiring intubation or take-home oxygen.
In 2019 and the beginning of 2020, many EVALI patients who were eventually hospitalized first sought help at urgent care centers or with primary care doctors and were presumed to have pneumonia or gastroenteritis and sent home.
“But they got worse, and they would present to our emergency room; their chest X-rays and CT scans showed extensive lung disease,” Dr. Rao said, adding that the damage was striking among patients all under age 18. “They were short of breath. Their oxygen levels were low. They had diminished lung function. And they had a lot of GI issues like abdominal pain and weight loss from nausea and vomiting.”
“These overwhelming inflammatory reactions that we see with EVALI,” said Karen M. Wilson, MD, MPH, a pediatric hospitalist at the University of Rochester (N.Y.) Medical Center and a tobacco use researcher. “You might find some microvascular changes with normal inhaling of smoke or aerosol, but you’re not going to find macro changes like we see with the EVALI.”
In late 2019, images of the CT scans of patients with EVALI were published, grabbing the attention of Arun Kannappan, MD, an assistant professor of pulmonary sciences and critical care at the University of Colorado Anschutz School of Medicine, Aurora. Dr. Kannappan knew a patient with such severe lung damage could develop acute respiratory distress syndrome, which means a patient would be put on a ventilator because their inflamed lungs could not oxygenate blood.
“That confers within somewhere between 30% to 50% chance of dying; it made all of the pulmonary specialists really turn their heads to make sure that we keep a lookout for it,” said Dr. Kannappan.
CT scans of lungs proved to be a critical diagnostic tool for doctors. Most of the images from patients showed acute inflammation and diffuse lung damage. Ehab Ali, MD, a critical care and pulmonary disease medicine specialist in Louisville, Ky., said the damage was often spread across both lungs in many areas and appeared opaque and hazy, known as “ground glass.” COVID-19, meanwhile, appeared differently in lung scans, often with damage that was more isolated.
But many diseases carry a “ground glass” appearance, with many potential causes, like infections, cigarette smoke, or an autoimmune condition.
“Before you even talk to the patient, you can immediately put it in your mind that ‘I’m going to ask this patient if they vape,’ when I see the distribution of ground glass appearance,” Dr. Ali said.
Dr. Ali said other factors, like the age of the patient – about three-quarters of EVALI patients are under age 34, according to the CDC – would spur him to ask about vaping. But because so many patients were young, discerning vape usage wasn’t always easy.
“When you’re talking to teenagers, if you ask them upon admission, with the parents in the room, they’re going say ‘no,’ ” said Rachel Boykan, MD, a pediatric hospitalist at Stony Brook (N.Y.) Children’s. She added that her hospital is still seeing cases.
Dr. Rao said it often takes two to three people asking a patient about any vape usage before they confess.
Ms. Bernal, who was 27 at the time of her hospital admission for EVALI, said she bought vapes with THC at a retail shop in California. She’d been a traditional marijuana smoker, using the leaf product, but switched when someone told her it was healthier to vape THC than inhale smoke from burned marijuana leaves into her lungs. “I thought this was safe.”
Dr. Rao and her colleagues recently published a study of 41 teenage patients with EVALI who were seen at Children’s Medical Center Dallas between December 2018 and July 2021. All but one reported using e-cigarettes containing THC, and the CDC in its most recent report from February 2020 said about 80% of patients had used vapes containing THC.
The CDC also found that vitamin E acetate, an oily substance that allows THC to travel from the lungs to the brain quickly and an ingredient used in the food and cosmetics industries, was found in many of the lungs of EVALI patients, though not all.
The aftermath
The outcomes of the thousands of patients who had EVALI – and those who may still be developing it – are largely untracked.
Bonnie Halpern-Felsher, PhD, director at the Stanford (Calif.) Reach Lab that bears her name and a researcher on tobacco in youth, said she and many of her colleagues are frustrated that the CDC is not continuing to collect data on EVALI.
“I know a lot of colleagues who’ve said that they’re still seeing EVALI, but because of COVID-19 they stopped collecting the data. And that’s been very frustrating because it’s hard to say whether the kinds of lung issues you’re having are related to e-cigarettes, generally, or EVALI,” Dr. Halpern-Felsher said.
Researchers and doctors affiliated with the American Thoracic Society published a report with solutions on how to better track EVALI. They recommended that a national case registry and biorepository be created.
Doctors also worry that many cases were missed. Dr. Boykan said that while protocol dictated nurses and other clinicians ask about a history of vaping – a key part of EVALI diagnosis – many did not. Dr. Ali, the Louisville critical care physician, said EVALI symptoms of nausea, cough, and fever are associated with viral infections.
“I’m sure that some of these cases might be discharged from the emergency room as a virus,” Dr. Ali said. “Most of the time patients would get prescribed steroids for viral infections, which may help EVALI patients even though it’s never been studied.”
Dr. Rao also said the treatment regimen at Children’s MC Dallas, which included high doses of intravenous steroids, seemed to help. But the best management approach for treatment, or long-term follow up care, has not been studied.
The report in the Annals of the American Thoracic Society said prospective studies are showing that a significant portion of patients with EVALI experience prolonged respiratory issues and cognitive and mood impairment. Dr. Rao said a common thread for many of her EVALI patients has been significant stress in their lives with school or family, which led them to vape in an attempt to reduce stress.
That was certainly the case for Ms. Bernal before her hospital admission. She had recently moved across the country for her husband’s job, was trying to buy a house, and had spent months in a hotel with three children. She vaped to cope.
But she said her mental and cognitive health has worsened. Back in Louisville, she saw a neurologist, who told her that her brain had shrunk, she said. She hasn’t found a new neurologist in Portland, Ore., where her family moved a year after the EVALI episode.
But she often finds herself overwhelmed and overstimulated with tasks that she said she never had problems with before. She tears up while talking about the newfound limitations. She struggled to find a primary care physician who could medically manage her mental health and a counselor who can understand what she’s been through with EVALI.
But, “a lot of doctors aren’t educated in it, and they don’t know how to respond or they don’t know what to do,” Ms. Bernal said. “And that makes me feel like, I guess, what I had wasn’t important.”
Ms. Bernal does have a new pulmonologist and is going in for a round of pulmonary tests soon because she often finds herself unable to breathe while completing simple tasks. She is tired of rushing to the ER. She wants answers, or some kind of treatment to help her feel normal again.
“I feel like this is my fault,” Ms. Bernal said. “Had I not smoked, I would be fine, and that’s hard to live with. Every day. Telling yourself, ‘It’s your fault.’ It’s been how many years now? And I still haven’t found peace yet. I don’t know if ever will.”
A version of this article first appeared on Medscape.com.
Rashelle Bernal vaped and ended up in an induced coma for a week. She was one of almost 3,000 people who were hospitalized during 2019 and early 2020 with severe lung damage from vaping and became part of what is now known as the epidemic of e-cigarette, or vaping, product use–associated lung injury (EVALI).
For many, the EVALI epidemic is a distant, pre-COVID memory.
But the vaping-related injuries are still happening. And for Ms. Bernal, the aftermath is her reality. Her pulmonologist from that time described the harm from the vape ingredients as an oil spill in her lungs. Eventually, the toxins would probably clear. But she will likely wrestle with the injuries for a very long time.
More than 3 years later, she frequently finds herself in the emergency department.
“If I get sick, if there’s anything that irritates my lungs – it could be something as simple as pollen in the air – it will cause me to get like a bacterial infection or other issues, and I can’t breathe,” Ms. Ms. Bernal, now 30, said in a recent interview. “I get really winded, to the point where I’ll walk up the stairs and I feel like I just ran a mile.”
In 2019 and 2020, a media firestorm erupted as hospitals notified the public of outbreaks of vaping-related lung injuries. News headlines reported e-cigarettes were killing teens from Texas to the Bronx. Investigators at the U.S. Centers for Disease Control and Prevention tracked most of the cases to vitamin E acetate, an additive in illicit cannabis vaping products intended to promote the metabolism of tetrahydrocannabinol (THC). The agency stopped tracking EVALI in February 2020.
But 2 months later, in April 2020, the agency’s National Center for Health Statistics implemented a diagnostic code, U07.0, for health care professionals in the United States to diagnose EVALI for the first time. The code is also used for lung damage related to use of electronic cigarettes and “dabbing” – a method of inhaling cannabis. Damage could include inflammation of the lungs, pulmonary hemorrhage, and eosinophilic pneumonia.
The incidence of these diagnoses appears to have risen sharply since 2020. In the last three months of 2020, a total of 11,300 medical claims included the U07.0 code. That figure rose to 22,000 in 2021 and hit 31,600 in 2022, according to data compiled for and provided to Medscape by Komodo Health, a health care technology company that holds a database of more than 330 million U.S. patients from Medicare, Medicaid, and commercial insurers’ medical, pharmacy, and laboratory claims.
Harm from vaping, including EVALI, has continued.
said Usha Periyanayagam, MD, MPH, head of clinic product and real-world evidence for Komodo and a former emergency medicine physician.
Where it started
Devika Rao, MD, a pediatric pulmonology specialist at UT Southwestern Medical Center, Dallas, has cared for most of her EVALI patients in the hospital, with the most recent case in early 2023. But in January, for the first time, she saw an EVALI patient in an outpatient clinic. The person had not been admitted to the hospital – like most were pre-pandemic. And like most who were seen during the pandemic, this patient had milder symptoms, not requiring intubation or take-home oxygen.
In 2019 and the beginning of 2020, many EVALI patients who were eventually hospitalized first sought help at urgent care centers or with primary care doctors and were presumed to have pneumonia or gastroenteritis and sent home.
“But they got worse, and they would present to our emergency room; their chest X-rays and CT scans showed extensive lung disease,” Dr. Rao said, adding that the damage was striking among patients all under age 18. “They were short of breath. Their oxygen levels were low. They had diminished lung function. And they had a lot of GI issues like abdominal pain and weight loss from nausea and vomiting.”
“These overwhelming inflammatory reactions that we see with EVALI,” said Karen M. Wilson, MD, MPH, a pediatric hospitalist at the University of Rochester (N.Y.) Medical Center and a tobacco use researcher. “You might find some microvascular changes with normal inhaling of smoke or aerosol, but you’re not going to find macro changes like we see with the EVALI.”
In late 2019, images of the CT scans of patients with EVALI were published, grabbing the attention of Arun Kannappan, MD, an assistant professor of pulmonary sciences and critical care at the University of Colorado Anschutz School of Medicine, Aurora. Dr. Kannappan knew a patient with such severe lung damage could develop acute respiratory distress syndrome, which means a patient would be put on a ventilator because their inflamed lungs could not oxygenate blood.
“That confers within somewhere between 30% to 50% chance of dying; it made all of the pulmonary specialists really turn their heads to make sure that we keep a lookout for it,” said Dr. Kannappan.
CT scans of lungs proved to be a critical diagnostic tool for doctors. Most of the images from patients showed acute inflammation and diffuse lung damage. Ehab Ali, MD, a critical care and pulmonary disease medicine specialist in Louisville, Ky., said the damage was often spread across both lungs in many areas and appeared opaque and hazy, known as “ground glass.” COVID-19, meanwhile, appeared differently in lung scans, often with damage that was more isolated.
But many diseases carry a “ground glass” appearance, with many potential causes, like infections, cigarette smoke, or an autoimmune condition.
“Before you even talk to the patient, you can immediately put it in your mind that ‘I’m going to ask this patient if they vape,’ when I see the distribution of ground glass appearance,” Dr. Ali said.
Dr. Ali said other factors, like the age of the patient – about three-quarters of EVALI patients are under age 34, according to the CDC – would spur him to ask about vaping. But because so many patients were young, discerning vape usage wasn’t always easy.
“When you’re talking to teenagers, if you ask them upon admission, with the parents in the room, they’re going say ‘no,’ ” said Rachel Boykan, MD, a pediatric hospitalist at Stony Brook (N.Y.) Children’s. She added that her hospital is still seeing cases.
Dr. Rao said it often takes two to three people asking a patient about any vape usage before they confess.
Ms. Bernal, who was 27 at the time of her hospital admission for EVALI, said she bought vapes with THC at a retail shop in California. She’d been a traditional marijuana smoker, using the leaf product, but switched when someone told her it was healthier to vape THC than inhale smoke from burned marijuana leaves into her lungs. “I thought this was safe.”
Dr. Rao and her colleagues recently published a study of 41 teenage patients with EVALI who were seen at Children’s Medical Center Dallas between December 2018 and July 2021. All but one reported using e-cigarettes containing THC, and the CDC in its most recent report from February 2020 said about 80% of patients had used vapes containing THC.
The CDC also found that vitamin E acetate, an oily substance that allows THC to travel from the lungs to the brain quickly and an ingredient used in the food and cosmetics industries, was found in many of the lungs of EVALI patients, though not all.
The aftermath
The outcomes of the thousands of patients who had EVALI – and those who may still be developing it – are largely untracked.
Bonnie Halpern-Felsher, PhD, director at the Stanford (Calif.) Reach Lab that bears her name and a researcher on tobacco in youth, said she and many of her colleagues are frustrated that the CDC is not continuing to collect data on EVALI.
“I know a lot of colleagues who’ve said that they’re still seeing EVALI, but because of COVID-19 they stopped collecting the data. And that’s been very frustrating because it’s hard to say whether the kinds of lung issues you’re having are related to e-cigarettes, generally, or EVALI,” Dr. Halpern-Felsher said.
Researchers and doctors affiliated with the American Thoracic Society published a report with solutions on how to better track EVALI. They recommended that a national case registry and biorepository be created.
Doctors also worry that many cases were missed. Dr. Boykan said that while protocol dictated nurses and other clinicians ask about a history of vaping – a key part of EVALI diagnosis – many did not. Dr. Ali, the Louisville critical care physician, said EVALI symptoms of nausea, cough, and fever are associated with viral infections.
“I’m sure that some of these cases might be discharged from the emergency room as a virus,” Dr. Ali said. “Most of the time patients would get prescribed steroids for viral infections, which may help EVALI patients even though it’s never been studied.”
Dr. Rao also said the treatment regimen at Children’s MC Dallas, which included high doses of intravenous steroids, seemed to help. But the best management approach for treatment, or long-term follow up care, has not been studied.
The report in the Annals of the American Thoracic Society said prospective studies are showing that a significant portion of patients with EVALI experience prolonged respiratory issues and cognitive and mood impairment. Dr. Rao said a common thread for many of her EVALI patients has been significant stress in their lives with school or family, which led them to vape in an attempt to reduce stress.
That was certainly the case for Ms. Bernal before her hospital admission. She had recently moved across the country for her husband’s job, was trying to buy a house, and had spent months in a hotel with three children. She vaped to cope.
But she said her mental and cognitive health has worsened. Back in Louisville, she saw a neurologist, who told her that her brain had shrunk, she said. She hasn’t found a new neurologist in Portland, Ore., where her family moved a year after the EVALI episode.
But she often finds herself overwhelmed and overstimulated with tasks that she said she never had problems with before. She tears up while talking about the newfound limitations. She struggled to find a primary care physician who could medically manage her mental health and a counselor who can understand what she’s been through with EVALI.
But, “a lot of doctors aren’t educated in it, and they don’t know how to respond or they don’t know what to do,” Ms. Bernal said. “And that makes me feel like, I guess, what I had wasn’t important.”
Ms. Bernal does have a new pulmonologist and is going in for a round of pulmonary tests soon because she often finds herself unable to breathe while completing simple tasks. She is tired of rushing to the ER. She wants answers, or some kind of treatment to help her feel normal again.
“I feel like this is my fault,” Ms. Bernal said. “Had I not smoked, I would be fine, and that’s hard to live with. Every day. Telling yourself, ‘It’s your fault.’ It’s been how many years now? And I still haven’t found peace yet. I don’t know if ever will.”
A version of this article first appeared on Medscape.com.
FDA: Newborns protected by whooping cough vaccine
The Food and Drug Administration has approved a whooping cough vaccine that protects newborns under 2 months of age.
“Infants younger than 2 months of age are too young to be protected by the childhood pertussis vaccine series,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in a press release. “This is the first vaccine approved specifically for use during pregnancy to prevent a disease in young infants whose mothers are vaccinated during pregnancy.”
Pertussis is a highly contagious respiratory tract infection caused by the bacterium Bordetella pertussis. Most cases that result in hospitalizations and death are among infants within 2 months of birth.
The FDA said its decision was based on data from observational studies, which included 108 cases of pertussis in infants younger than 2 months old. According to data evaluated by the agency, the vaccine was 78% effective in preventing whooping cough.
Boostrix is administered as a single 0.5-mL dose.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration has approved a whooping cough vaccine that protects newborns under 2 months of age.
“Infants younger than 2 months of age are too young to be protected by the childhood pertussis vaccine series,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in a press release. “This is the first vaccine approved specifically for use during pregnancy to prevent a disease in young infants whose mothers are vaccinated during pregnancy.”
Pertussis is a highly contagious respiratory tract infection caused by the bacterium Bordetella pertussis. Most cases that result in hospitalizations and death are among infants within 2 months of birth.
The FDA said its decision was based on data from observational studies, which included 108 cases of pertussis in infants younger than 2 months old. According to data evaluated by the agency, the vaccine was 78% effective in preventing whooping cough.
Boostrix is administered as a single 0.5-mL dose.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration has approved a whooping cough vaccine that protects newborns under 2 months of age.
“Infants younger than 2 months of age are too young to be protected by the childhood pertussis vaccine series,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in a press release. “This is the first vaccine approved specifically for use during pregnancy to prevent a disease in young infants whose mothers are vaccinated during pregnancy.”
Pertussis is a highly contagious respiratory tract infection caused by the bacterium Bordetella pertussis. Most cases that result in hospitalizations and death are among infants within 2 months of birth.
The FDA said its decision was based on data from observational studies, which included 108 cases of pertussis in infants younger than 2 months old. According to data evaluated by the agency, the vaccine was 78% effective in preventing whooping cough.
Boostrix is administered as a single 0.5-mL dose.
A version of this article first appeared on Medscape.com.
Reduced-lactose infant formula related to higher risk of obesity later
Doctors may want to advise parents against giving their infants lactose-reduced infant formula unless absolutely necessary, because doing so may be setting babies up for an increased risk of obesity in toddlerhood, new research shows.
Infants who drink infant formula instead of breast milk already carry an increased risk of obesity. But the new study, published in The American Journal of Clinical Nutrition, found a difference in types of formula and obesity outcomes for children.
Babies under 1 year who received lactose-reduced formula made partially of corn syrup solids were at a 10% greater risk (risk ratio, 1.10; 95% confidence interval, 1.02, 1.20; P = .02) of being obese by age 2 than infants who received regular cow’s milk formula.
“This is even another reason to not use a low-lactose formula,” said Mark R. Corkins, MD, division chief of pediatric gastroenterology, hepatology, and nutrition at the University of Tennessee Health Science Center, Memphis, who was not involved in the study. “Parents think if babies are fussy, or they spit up, they have lactose intolerance, but if you look at the actual numbers, lactose intolerance in infants is rare.”
Actual lactose intolerance in infancy is the result of a newborn receiving the same mutated gene from both parents, called congenital lactase deficiency, said Dr. Corkins.
“The reason the low-lactose formulas are even on the market is because parents want them, and they think their kid is lactose intolerant, but they are not,” Dr. Corkins said.
Researchers from the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) in southern California and the University of Southern California, Los Angeles, analyzed data from over 15,000 infants in southern California enrolled in WIC.
Records from infants born between Sept. 2012 and March 2016 were separated into two groups: infants that had stopped breastfeeding by month 3 and had started reduced-lactose formula and infants who received all other forms of formula. Over 80% of infants in both groups were Hispanic.
Infants who received the reduced-lactose formula with corn syrup solids were at an 8% increased risk of obesity by age 3 (RR = 1.08; 95% CI, 1.02, 1.15; P = .01), compared with children who received regular cow’s milk formula, and a 7% increased risk by age 4 (RR = 1.07; 95% CI; 1.01, 1.14; P = .01).
Tara Williams, MD, pediatrician and breastfeeding specialist associated with the Florida Chapter of American Academy of Pediatrics, said the findings should make pediatricians, parents, and others pause and consider what infant formulas contain.
She explained that babies who receive formula have higher obesity risk than babies who are breastfed overall. But research into the effects of different types of formula is relatively new. She said there may be a few reasons for the association between reduced-lactose, corn syrup solid formula and a higher risk of obesity.
“The addition of the corn syrup really starts to potentially teach that child to like sweet things,” Dr. Williams said, which in turn can lead to less healthy eating habits in childhood and adulthood.
Or, it may be that parents who tend to give their children lactose-reduced formula are less likely to be tolerant of fussy babies and end up feeding their babies more, Dr. Williams hypothesized.
In addition, emerging research shows corn syrup may act differently from other sugars in the gut microbiome and as it is metabolized in the liver, leading to weight gain.
Although parents make individual choices for what kind of formula to feed their infants, states play a large role in these choices. In 2018, 45% of babies in the United States were eligible for WIC, which is funded through the federal government but administered by states. State WIC programs request bids from formula manufacturers, and products chosen are then redeemed at retailers by parents.
“Now that we’re starting to see a signal that perhaps some formulas will have a potentially added risk of obesity for participants, states may say that when we’re helping mothers select among the formulas, we need to be very explicit about this additional risk,” said Christopher Anderson, PhD, MSPH, associate research scientist at the southern California Public Health Foundation Enterprises WIC and lead author of the study.
Dr. Williams said more research to do similar analyses in other populations is needed to draw cause and effect conclusions, while Dr. Corkins said he’d like to see more research into the amount of formula eaten and health connections to types of formula.
“We know as soon as you sign up for a baby registry at Target, you’re getting formula samples in the mail. You’re very aggressively marketed to; it’s a $55 billion industry,” Dr. Williams said. “And their goal is to sell their product – not to promote the health of infants. “This research certainly will cause us to pause and consider what we are feeding our infants in the United States and how we allow companies to market their products.”
Dr. Goran receives book royalties from Penguin Random House and is a scientific consultant for Yumi Foods and Else Nutrition. All other authors disclosed no conflicts of interest. Dr. Corkins reports working at a clinic that’s the site of a Takeda pharmaceutical research study. Dr. Williams reports no relevant financial relationships.
Doctors may want to advise parents against giving their infants lactose-reduced infant formula unless absolutely necessary, because doing so may be setting babies up for an increased risk of obesity in toddlerhood, new research shows.
Infants who drink infant formula instead of breast milk already carry an increased risk of obesity. But the new study, published in The American Journal of Clinical Nutrition, found a difference in types of formula and obesity outcomes for children.
Babies under 1 year who received lactose-reduced formula made partially of corn syrup solids were at a 10% greater risk (risk ratio, 1.10; 95% confidence interval, 1.02, 1.20; P = .02) of being obese by age 2 than infants who received regular cow’s milk formula.
“This is even another reason to not use a low-lactose formula,” said Mark R. Corkins, MD, division chief of pediatric gastroenterology, hepatology, and nutrition at the University of Tennessee Health Science Center, Memphis, who was not involved in the study. “Parents think if babies are fussy, or they spit up, they have lactose intolerance, but if you look at the actual numbers, lactose intolerance in infants is rare.”
Actual lactose intolerance in infancy is the result of a newborn receiving the same mutated gene from both parents, called congenital lactase deficiency, said Dr. Corkins.
“The reason the low-lactose formulas are even on the market is because parents want them, and they think their kid is lactose intolerant, but they are not,” Dr. Corkins said.
Researchers from the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) in southern California and the University of Southern California, Los Angeles, analyzed data from over 15,000 infants in southern California enrolled in WIC.
Records from infants born between Sept. 2012 and March 2016 were separated into two groups: infants that had stopped breastfeeding by month 3 and had started reduced-lactose formula and infants who received all other forms of formula. Over 80% of infants in both groups were Hispanic.
Infants who received the reduced-lactose formula with corn syrup solids were at an 8% increased risk of obesity by age 3 (RR = 1.08; 95% CI, 1.02, 1.15; P = .01), compared with children who received regular cow’s milk formula, and a 7% increased risk by age 4 (RR = 1.07; 95% CI; 1.01, 1.14; P = .01).
Tara Williams, MD, pediatrician and breastfeeding specialist associated with the Florida Chapter of American Academy of Pediatrics, said the findings should make pediatricians, parents, and others pause and consider what infant formulas contain.
She explained that babies who receive formula have higher obesity risk than babies who are breastfed overall. But research into the effects of different types of formula is relatively new. She said there may be a few reasons for the association between reduced-lactose, corn syrup solid formula and a higher risk of obesity.
“The addition of the corn syrup really starts to potentially teach that child to like sweet things,” Dr. Williams said, which in turn can lead to less healthy eating habits in childhood and adulthood.
Or, it may be that parents who tend to give their children lactose-reduced formula are less likely to be tolerant of fussy babies and end up feeding their babies more, Dr. Williams hypothesized.
In addition, emerging research shows corn syrup may act differently from other sugars in the gut microbiome and as it is metabolized in the liver, leading to weight gain.
Although parents make individual choices for what kind of formula to feed their infants, states play a large role in these choices. In 2018, 45% of babies in the United States were eligible for WIC, which is funded through the federal government but administered by states. State WIC programs request bids from formula manufacturers, and products chosen are then redeemed at retailers by parents.
“Now that we’re starting to see a signal that perhaps some formulas will have a potentially added risk of obesity for participants, states may say that when we’re helping mothers select among the formulas, we need to be very explicit about this additional risk,” said Christopher Anderson, PhD, MSPH, associate research scientist at the southern California Public Health Foundation Enterprises WIC and lead author of the study.
Dr. Williams said more research to do similar analyses in other populations is needed to draw cause and effect conclusions, while Dr. Corkins said he’d like to see more research into the amount of formula eaten and health connections to types of formula.
“We know as soon as you sign up for a baby registry at Target, you’re getting formula samples in the mail. You’re very aggressively marketed to; it’s a $55 billion industry,” Dr. Williams said. “And their goal is to sell their product – not to promote the health of infants. “This research certainly will cause us to pause and consider what we are feeding our infants in the United States and how we allow companies to market their products.”
Dr. Goran receives book royalties from Penguin Random House and is a scientific consultant for Yumi Foods and Else Nutrition. All other authors disclosed no conflicts of interest. Dr. Corkins reports working at a clinic that’s the site of a Takeda pharmaceutical research study. Dr. Williams reports no relevant financial relationships.
Doctors may want to advise parents against giving their infants lactose-reduced infant formula unless absolutely necessary, because doing so may be setting babies up for an increased risk of obesity in toddlerhood, new research shows.
Infants who drink infant formula instead of breast milk already carry an increased risk of obesity. But the new study, published in The American Journal of Clinical Nutrition, found a difference in types of formula and obesity outcomes for children.
Babies under 1 year who received lactose-reduced formula made partially of corn syrup solids were at a 10% greater risk (risk ratio, 1.10; 95% confidence interval, 1.02, 1.20; P = .02) of being obese by age 2 than infants who received regular cow’s milk formula.
“This is even another reason to not use a low-lactose formula,” said Mark R. Corkins, MD, division chief of pediatric gastroenterology, hepatology, and nutrition at the University of Tennessee Health Science Center, Memphis, who was not involved in the study. “Parents think if babies are fussy, or they spit up, they have lactose intolerance, but if you look at the actual numbers, lactose intolerance in infants is rare.”
Actual lactose intolerance in infancy is the result of a newborn receiving the same mutated gene from both parents, called congenital lactase deficiency, said Dr. Corkins.
“The reason the low-lactose formulas are even on the market is because parents want them, and they think their kid is lactose intolerant, but they are not,” Dr. Corkins said.
Researchers from the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) in southern California and the University of Southern California, Los Angeles, analyzed data from over 15,000 infants in southern California enrolled in WIC.
Records from infants born between Sept. 2012 and March 2016 were separated into two groups: infants that had stopped breastfeeding by month 3 and had started reduced-lactose formula and infants who received all other forms of formula. Over 80% of infants in both groups were Hispanic.
Infants who received the reduced-lactose formula with corn syrup solids were at an 8% increased risk of obesity by age 3 (RR = 1.08; 95% CI, 1.02, 1.15; P = .01), compared with children who received regular cow’s milk formula, and a 7% increased risk by age 4 (RR = 1.07; 95% CI; 1.01, 1.14; P = .01).
Tara Williams, MD, pediatrician and breastfeeding specialist associated with the Florida Chapter of American Academy of Pediatrics, said the findings should make pediatricians, parents, and others pause and consider what infant formulas contain.
She explained that babies who receive formula have higher obesity risk than babies who are breastfed overall. But research into the effects of different types of formula is relatively new. She said there may be a few reasons for the association between reduced-lactose, corn syrup solid formula and a higher risk of obesity.
“The addition of the corn syrup really starts to potentially teach that child to like sweet things,” Dr. Williams said, which in turn can lead to less healthy eating habits in childhood and adulthood.
Or, it may be that parents who tend to give their children lactose-reduced formula are less likely to be tolerant of fussy babies and end up feeding their babies more, Dr. Williams hypothesized.
In addition, emerging research shows corn syrup may act differently from other sugars in the gut microbiome and as it is metabolized in the liver, leading to weight gain.
Although parents make individual choices for what kind of formula to feed their infants, states play a large role in these choices. In 2018, 45% of babies in the United States were eligible for WIC, which is funded through the federal government but administered by states. State WIC programs request bids from formula manufacturers, and products chosen are then redeemed at retailers by parents.
“Now that we’re starting to see a signal that perhaps some formulas will have a potentially added risk of obesity for participants, states may say that when we’re helping mothers select among the formulas, we need to be very explicit about this additional risk,” said Christopher Anderson, PhD, MSPH, associate research scientist at the southern California Public Health Foundation Enterprises WIC and lead author of the study.
Dr. Williams said more research to do similar analyses in other populations is needed to draw cause and effect conclusions, while Dr. Corkins said he’d like to see more research into the amount of formula eaten and health connections to types of formula.
“We know as soon as you sign up for a baby registry at Target, you’re getting formula samples in the mail. You’re very aggressively marketed to; it’s a $55 billion industry,” Dr. Williams said. “And their goal is to sell their product – not to promote the health of infants. “This research certainly will cause us to pause and consider what we are feeding our infants in the United States and how we allow companies to market their products.”
Dr. Goran receives book royalties from Penguin Random House and is a scientific consultant for Yumi Foods and Else Nutrition. All other authors disclosed no conflicts of interest. Dr. Corkins reports working at a clinic that’s the site of a Takeda pharmaceutical research study. Dr. Williams reports no relevant financial relationships.
FROM AMERICAN JOURNAL OF CLINICAL NUTRITION