Children with sickle cell disease at risk for vision loss

Article Type
Changed
Wed, 11/08/2023 - 12:34

Clinicians must monitor children with sickle cell disease for eye complications as much as they do for adults, a new research review suggests.

Earlier research indicated that older patients were more at risk for eye complications from sickle cell disease, but the new study found that a full third of young people aged 10-25 years with sickle cell disease had retinopathy, including nonproliferative retinopathy (33%) and proliferative retinopathy (6%), which can progress to vision loss.

Two patients experienced retinal detachment, while two suffered retinal artery occlusion. One patient with retinal artery occlusion lost their vision and had a final best-corrected visual acuity of 20/60, according to the researchers, who presented their findings at the annual meeting of the American Academy of Ophthalmology.

“Our data underscores the need for patients – including pediatric patients – with sickle cell disease to get routine ophthalmic screenings along with appropriate systemic and ophthalmic treatment,” Mary Ellen Hoehn, MD, a professor of ophthalmology at the University of Tennessee Health Science Center, Memphis, who led the research, said in a press release.

The review covered records for 652 patients with sickle cell disease aged 10-25 years (median age, 14 years), who underwent eye exams over a 12-year period.

Besides looking at rates of retinopathy, Dr. Hoehn’s group studied which treatments were most effective. They found that hydroxyurea and chronic transfusions best lowered retinopathy rates among all genotypes.

“We hope that people will use this information to better care for patients with sickle cell disease, and that more timely ophthalmic screen exams will be performed so that vision-threatening complications from this disease are prevented,” Dr. Hoehn said.

The authors reported no relevant financial relationships.

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

Publications
Topics
Sections

Clinicians must monitor children with sickle cell disease for eye complications as much as they do for adults, a new research review suggests.

Earlier research indicated that older patients were more at risk for eye complications from sickle cell disease, but the new study found that a full third of young people aged 10-25 years with sickle cell disease had retinopathy, including nonproliferative retinopathy (33%) and proliferative retinopathy (6%), which can progress to vision loss.

Two patients experienced retinal detachment, while two suffered retinal artery occlusion. One patient with retinal artery occlusion lost their vision and had a final best-corrected visual acuity of 20/60, according to the researchers, who presented their findings at the annual meeting of the American Academy of Ophthalmology.

“Our data underscores the need for patients – including pediatric patients – with sickle cell disease to get routine ophthalmic screenings along with appropriate systemic and ophthalmic treatment,” Mary Ellen Hoehn, MD, a professor of ophthalmology at the University of Tennessee Health Science Center, Memphis, who led the research, said in a press release.

The review covered records for 652 patients with sickle cell disease aged 10-25 years (median age, 14 years), who underwent eye exams over a 12-year period.

Besides looking at rates of retinopathy, Dr. Hoehn’s group studied which treatments were most effective. They found that hydroxyurea and chronic transfusions best lowered retinopathy rates among all genotypes.

“We hope that people will use this information to better care for patients with sickle cell disease, and that more timely ophthalmic screen exams will be performed so that vision-threatening complications from this disease are prevented,” Dr. Hoehn said.

The authors reported no relevant financial relationships.

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

Clinicians must monitor children with sickle cell disease for eye complications as much as they do for adults, a new research review suggests.

Earlier research indicated that older patients were more at risk for eye complications from sickle cell disease, but the new study found that a full third of young people aged 10-25 years with sickle cell disease had retinopathy, including nonproliferative retinopathy (33%) and proliferative retinopathy (6%), which can progress to vision loss.

Two patients experienced retinal detachment, while two suffered retinal artery occlusion. One patient with retinal artery occlusion lost their vision and had a final best-corrected visual acuity of 20/60, according to the researchers, who presented their findings at the annual meeting of the American Academy of Ophthalmology.

“Our data underscores the need for patients – including pediatric patients – with sickle cell disease to get routine ophthalmic screenings along with appropriate systemic and ophthalmic treatment,” Mary Ellen Hoehn, MD, a professor of ophthalmology at the University of Tennessee Health Science Center, Memphis, who led the research, said in a press release.

The review covered records for 652 patients with sickle cell disease aged 10-25 years (median age, 14 years), who underwent eye exams over a 12-year period.

Besides looking at rates of retinopathy, Dr. Hoehn’s group studied which treatments were most effective. They found that hydroxyurea and chronic transfusions best lowered retinopathy rates among all genotypes.

“We hope that people will use this information to better care for patients with sickle cell disease, and that more timely ophthalmic screen exams will be performed so that vision-threatening complications from this disease are prevented,” Dr. Hoehn said.

The authors reported no relevant financial relationships.

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

Publications
Publications
Topics
Article Type
Sections
Article Source

FROM AAO 2023

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

Older adults at risk from inappropriate prescribing

Article Type
Changed
Thu, 11/16/2023 - 00:17

Roughly 2% of prescriptions to older patients appear to be inappropriate – but the figure does not appear to differ between physicians and nurse practitioners, according to a study published in Annals of Internal Medicine.

Older adults are “especially vulnerable to adverse drug events from inappropriate prescribing due to comorbidities and aging-related physiological changes,” said Johnny Huynh, MA, doctoral candidate in economics at UCLA and lead author of the study. “Considering the volume of prescriptions for older adults, even a small percentage can translate to a big impact on adverse drug events and spending.”

In recent years, more states have granted prescriptive authority to NPs, while professional medical organizations have opposed the reforms and made claims about differences in quality of care.

The medical community must focus on the prescribing performance of individual clinicians rather than whether an NP has prescriptive authority, said David Studdert, LLB, ScD, MPH, professor of health policy at Stanford (Calif.) University and a co-author of the study.

“Don’t fixate on whether nurse practitioners have prescriptive authority or don’t,” said Mr. Studdert. “Just try to identify those practitioners who need to boost their performance.”

The investigators found that rates of potentially inappropriate prescribing were “virtually identical.” Adjusted rates were 1.66 per 100 prescriptions for NPs versus 1.68 per 100 prescriptions for physicians (adjusted odds ratio, 0.99; 95% confidence interval, 0.97-1.01).

“Older adults often have more than one chronic condition and are prescribed multiple medications to manage these conditions, putting them at risk for adverse events,” said Paula Rochon, MD, MPH, founding director of the Women’s Age Lab and professor in the Division of Geriatric Medicine at Dalla Lana School of Public Health in Toronto. “Furthermore, older women are more likely than men to have multiple medical problems and experience adverse drug events.”

Dr. Rochon led a 2021 research review on polypharmacy and inappropriate prescribing among older adults in both the United States and abroad. She and her team noted that while women are physiologically more susceptible to drug-related harm, rates of inappropriate prescribing also tend to be higher for women, such as in the case of senior U.S. veterans and older adults in Canada

The researchers analyzed data over a 7-year period starting in 2013 from 23,669 primary care NPs and 50,060 physicians who wrote prescriptions for at least 100 patients with Medicare Part D coverage. Data from 29 states, which had all expanded prescriptive authority to NPs, was included. 

Prescriptive quality was defined by the American Geriatrics Society’s Beers Criteria, a list of potentially inappropriate medications (PIMs) for adults ages 65 and over. Mr. Studdert said it’s important to note the nuance in the Beers Criteria.

“It’s not to say that there may not be certain clinical circumstances where it’s appropriate to” prescribe these drugs, Mr. Studdert said,  “But generally, it’s not appropriate.”

Ten medications accounted for 99.5% of the PIMs prescribed, including drugs that were antidepressants, muscle relaxants, hypnotics, antihistamines (generation 1), antispasmodics, sulfonylureas, barbiturates, antineoplastics, thyroid medications, and nonsteroidal anti-inflammatory drugs.

The top three most frequently potentially inappropriately prescribed were antidepressants (0.393 NPs vs. 0.481 PCPs per 100 prescriptions), muscle relaxants (0.372 NPs vs. 0.305 PCPs per 100), and hypnotics (0.364 NPs vs. 0.440 PCPs per 100). Both antidepressants and hypnotics are associated with an increased risk for falls and fractures among older adults, while muscle relaxants have been shown to increase the risk for hospitalization in this population. 

Despite the overall similar PIM rates, NPs were more present in the “tails,” or highest and lowest end of the quality bell curve. The higher variation among NPs means these patients are at a higher risk of receiving a prescription for an inappropriate medication, said David Chan, MD, PhD, associate professor of health policy at Stanford (Calif.) School of Medicine, and a co-author of the study.

Other studies have shown “high-intensity prescribers” were more likely to dispense drugs like benzodiazepines and opioids, which can be harmful to older patients.

According to Dr. Rochon, clinicians should use the Beers Criteria and STOPP/START Criteria to guide decision-making, along with the DRUGS framework, which follows a geriatric medicine approach that advises clinicians to discuss goals of care with their patients and conduct routine reviews of medications. 

Prescribers should also avoid prescribing cascades, which “occur when a drug is prescribed, an adverse event occurs that is misinterpreted as a new medical condition, and a further drug is prescribed to treat that medical condition,” Dr. Rochon said. 

To reduce cascades, “it’s important to document when a medication was started, why it was started, and who started it so that this information is available when evaluating if a medication continues to be needed,” she said. 

The study was funded by grants from Robert Wood Johnson Foundation and National Science Foundation. The authors report no relevant financial relationships.

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

Publications
Topics
Sections

Roughly 2% of prescriptions to older patients appear to be inappropriate – but the figure does not appear to differ between physicians and nurse practitioners, according to a study published in Annals of Internal Medicine.

Older adults are “especially vulnerable to adverse drug events from inappropriate prescribing due to comorbidities and aging-related physiological changes,” said Johnny Huynh, MA, doctoral candidate in economics at UCLA and lead author of the study. “Considering the volume of prescriptions for older adults, even a small percentage can translate to a big impact on adverse drug events and spending.”

In recent years, more states have granted prescriptive authority to NPs, while professional medical organizations have opposed the reforms and made claims about differences in quality of care.

The medical community must focus on the prescribing performance of individual clinicians rather than whether an NP has prescriptive authority, said David Studdert, LLB, ScD, MPH, professor of health policy at Stanford (Calif.) University and a co-author of the study.

“Don’t fixate on whether nurse practitioners have prescriptive authority or don’t,” said Mr. Studdert. “Just try to identify those practitioners who need to boost their performance.”

The investigators found that rates of potentially inappropriate prescribing were “virtually identical.” Adjusted rates were 1.66 per 100 prescriptions for NPs versus 1.68 per 100 prescriptions for physicians (adjusted odds ratio, 0.99; 95% confidence interval, 0.97-1.01).

“Older adults often have more than one chronic condition and are prescribed multiple medications to manage these conditions, putting them at risk for adverse events,” said Paula Rochon, MD, MPH, founding director of the Women’s Age Lab and professor in the Division of Geriatric Medicine at Dalla Lana School of Public Health in Toronto. “Furthermore, older women are more likely than men to have multiple medical problems and experience adverse drug events.”

Dr. Rochon led a 2021 research review on polypharmacy and inappropriate prescribing among older adults in both the United States and abroad. She and her team noted that while women are physiologically more susceptible to drug-related harm, rates of inappropriate prescribing also tend to be higher for women, such as in the case of senior U.S. veterans and older adults in Canada

The researchers analyzed data over a 7-year period starting in 2013 from 23,669 primary care NPs and 50,060 physicians who wrote prescriptions for at least 100 patients with Medicare Part D coverage. Data from 29 states, which had all expanded prescriptive authority to NPs, was included. 

Prescriptive quality was defined by the American Geriatrics Society’s Beers Criteria, a list of potentially inappropriate medications (PIMs) for adults ages 65 and over. Mr. Studdert said it’s important to note the nuance in the Beers Criteria.

“It’s not to say that there may not be certain clinical circumstances where it’s appropriate to” prescribe these drugs, Mr. Studdert said,  “But generally, it’s not appropriate.”

Ten medications accounted for 99.5% of the PIMs prescribed, including drugs that were antidepressants, muscle relaxants, hypnotics, antihistamines (generation 1), antispasmodics, sulfonylureas, barbiturates, antineoplastics, thyroid medications, and nonsteroidal anti-inflammatory drugs.

The top three most frequently potentially inappropriately prescribed were antidepressants (0.393 NPs vs. 0.481 PCPs per 100 prescriptions), muscle relaxants (0.372 NPs vs. 0.305 PCPs per 100), and hypnotics (0.364 NPs vs. 0.440 PCPs per 100). Both antidepressants and hypnotics are associated with an increased risk for falls and fractures among older adults, while muscle relaxants have been shown to increase the risk for hospitalization in this population. 

Despite the overall similar PIM rates, NPs were more present in the “tails,” or highest and lowest end of the quality bell curve. The higher variation among NPs means these patients are at a higher risk of receiving a prescription for an inappropriate medication, said David Chan, MD, PhD, associate professor of health policy at Stanford (Calif.) School of Medicine, and a co-author of the study.

Other studies have shown “high-intensity prescribers” were more likely to dispense drugs like benzodiazepines and opioids, which can be harmful to older patients.

According to Dr. Rochon, clinicians should use the Beers Criteria and STOPP/START Criteria to guide decision-making, along with the DRUGS framework, which follows a geriatric medicine approach that advises clinicians to discuss goals of care with their patients and conduct routine reviews of medications. 

Prescribers should also avoid prescribing cascades, which “occur when a drug is prescribed, an adverse event occurs that is misinterpreted as a new medical condition, and a further drug is prescribed to treat that medical condition,” Dr. Rochon said. 

To reduce cascades, “it’s important to document when a medication was started, why it was started, and who started it so that this information is available when evaluating if a medication continues to be needed,” she said. 

The study was funded by grants from Robert Wood Johnson Foundation and National Science Foundation. The authors report no relevant financial relationships.

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

Roughly 2% of prescriptions to older patients appear to be inappropriate – but the figure does not appear to differ between physicians and nurse practitioners, according to a study published in Annals of Internal Medicine.

Older adults are “especially vulnerable to adverse drug events from inappropriate prescribing due to comorbidities and aging-related physiological changes,” said Johnny Huynh, MA, doctoral candidate in economics at UCLA and lead author of the study. “Considering the volume of prescriptions for older adults, even a small percentage can translate to a big impact on adverse drug events and spending.”

In recent years, more states have granted prescriptive authority to NPs, while professional medical organizations have opposed the reforms and made claims about differences in quality of care.

The medical community must focus on the prescribing performance of individual clinicians rather than whether an NP has prescriptive authority, said David Studdert, LLB, ScD, MPH, professor of health policy at Stanford (Calif.) University and a co-author of the study.

“Don’t fixate on whether nurse practitioners have prescriptive authority or don’t,” said Mr. Studdert. “Just try to identify those practitioners who need to boost their performance.”

The investigators found that rates of potentially inappropriate prescribing were “virtually identical.” Adjusted rates were 1.66 per 100 prescriptions for NPs versus 1.68 per 100 prescriptions for physicians (adjusted odds ratio, 0.99; 95% confidence interval, 0.97-1.01).

“Older adults often have more than one chronic condition and are prescribed multiple medications to manage these conditions, putting them at risk for adverse events,” said Paula Rochon, MD, MPH, founding director of the Women’s Age Lab and professor in the Division of Geriatric Medicine at Dalla Lana School of Public Health in Toronto. “Furthermore, older women are more likely than men to have multiple medical problems and experience adverse drug events.”

Dr. Rochon led a 2021 research review on polypharmacy and inappropriate prescribing among older adults in both the United States and abroad. She and her team noted that while women are physiologically more susceptible to drug-related harm, rates of inappropriate prescribing also tend to be higher for women, such as in the case of senior U.S. veterans and older adults in Canada

The researchers analyzed data over a 7-year period starting in 2013 from 23,669 primary care NPs and 50,060 physicians who wrote prescriptions for at least 100 patients with Medicare Part D coverage. Data from 29 states, which had all expanded prescriptive authority to NPs, was included. 

Prescriptive quality was defined by the American Geriatrics Society’s Beers Criteria, a list of potentially inappropriate medications (PIMs) for adults ages 65 and over. Mr. Studdert said it’s important to note the nuance in the Beers Criteria.

“It’s not to say that there may not be certain clinical circumstances where it’s appropriate to” prescribe these drugs, Mr. Studdert said,  “But generally, it’s not appropriate.”

Ten medications accounted for 99.5% of the PIMs prescribed, including drugs that were antidepressants, muscle relaxants, hypnotics, antihistamines (generation 1), antispasmodics, sulfonylureas, barbiturates, antineoplastics, thyroid medications, and nonsteroidal anti-inflammatory drugs.

The top three most frequently potentially inappropriately prescribed were antidepressants (0.393 NPs vs. 0.481 PCPs per 100 prescriptions), muscle relaxants (0.372 NPs vs. 0.305 PCPs per 100), and hypnotics (0.364 NPs vs. 0.440 PCPs per 100). Both antidepressants and hypnotics are associated with an increased risk for falls and fractures among older adults, while muscle relaxants have been shown to increase the risk for hospitalization in this population. 

Despite the overall similar PIM rates, NPs were more present in the “tails,” or highest and lowest end of the quality bell curve. The higher variation among NPs means these patients are at a higher risk of receiving a prescription for an inappropriate medication, said David Chan, MD, PhD, associate professor of health policy at Stanford (Calif.) School of Medicine, and a co-author of the study.

Other studies have shown “high-intensity prescribers” were more likely to dispense drugs like benzodiazepines and opioids, which can be harmful to older patients.

According to Dr. Rochon, clinicians should use the Beers Criteria and STOPP/START Criteria to guide decision-making, along with the DRUGS framework, which follows a geriatric medicine approach that advises clinicians to discuss goals of care with their patients and conduct routine reviews of medications. 

Prescribers should also avoid prescribing cascades, which “occur when a drug is prescribed, an adverse event occurs that is misinterpreted as a new medical condition, and a further drug is prescribed to treat that medical condition,” Dr. Rochon said. 

To reduce cascades, “it’s important to document when a medication was started, why it was started, and who started it so that this information is available when evaluating if a medication continues to be needed,” she said. 

The study was funded by grants from Robert Wood Johnson Foundation and National Science Foundation. The authors report no relevant financial relationships.

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

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

Here’s how to help Black smokers quit

Article Type
Changed
Wed, 10/25/2023 - 09:30

Black Americans attempt to quit smoking more often than their White counterparts but are less likely to succeed, and they pay the health consequences.

This knowledge has driven Kevin Choi, MD, acting scientific director of the National Institute on Minority Health and Health Disparities in Bethesda, Md., to dedicate his career to studying the patterns and disparities of smoking among these patients.

Dr. Choi wants primary care clinicians to know not just that they have the potential to educate patients on the harms of smoking – most patients already know smoking is unhealthy – but that aiding them will likely necessitate more assertive follow-up.

To do so, “we need to understand the bigger backdrop of racial and sociological stress experienced by the Black population, which stems from both interpersonal and structural racism,” Dr. Choi said.

Not only are Black smokers more likely to try to quit, but they also tend to smoke fewer cigarettes per day than other racial groups. Yet they experience higher rates of smoking-related mortality.
 

The reasons behind the attempts

Multiple factors play into Black smokers’ lower rates of successful quitting attempts than Asian, Hispanic, White, and Native American individuals.

One reason: An estimated 85% of Black smokers smoke highly addictive menthol cigarettes. According to Dr. Choi and other experts, the tobacco industry engages in targeted marketing of menthols by sponsoring community events in predominantly Black neighborhoods and colleges with historically Black populations and by using Black culture in advertising.

“The built environment really drives a change in behavior, and we have seen that chronically in the African American population being overly targeted and now being overly addicted to nicotine,” said Daniel Kortsch, MD, a family medicine physician and chair of the Tobacco Cessation Workgroup at Denver Health.

Menthol cigarettes are more addictive than traditional cigarettes, in part because they provide a less harsh feeling in the respiratory system, owing to anti-tussive, anti-irritant, and cooling properties that act as a cough suppressant and mask irritation and pain.

“You do not feel like you’re smoking that much or that it’s dangerous, and that’s exactly the reason why it’s harder to quit,” said Julia Adamian, MD, section chief of general internal medicine and clinical innovation at NYU Langone Tisch Hospital.

In addition, menthol cigarettes interact with the body in complex ways that make quitting harder, according to a study published in Nicotine & Tobacco Research. Menthol increases the amount of nicotine that the body absorbs and thus increases the risk of dependence on the drug.

According to Dr. Choi, rates of cigar and cigarillo use are higher among Black Americans, compared with other races, and these products are often left out of cessation programs. Smokers, regardless of race, may have a misguided belief that cigars and cigarillos are less harmful than cigarettes.

Research published in 2021 found that Black cigar smokers who were interested in cessation had not been asked by their health care provider if they smoked cigars, and those who were asked reported a lack of support for cessation.

Primary care providers should work to remove any misconceptions a patient has regarding the safety of cigarillos and cigars, Dr. Choi said.

These smokers are also at a disadvantage regarding cessation success because of the neighborhoods they may live in, according to Dr. Choi. Black Americans are more likely to earn less and to live in neighborhoods with lower housing values than other racial groups. Areas with more low-income households tend to have a higher density of tobacco outlets.

“If you’re trying to quit smoking, but you walk by three, four, or five gas stations, convenience stores, and other tobacco outlets with signs that advertise sales, it’s not going to make quitting easy,” Dr. Choi said.
 

 

 

Tailoring treatment to Black smokers

Considering the unique challenges Black patients may face in quitting, clinicians should provide more follow-up and consistent support, according to Dr. Adamian. The higher risk of tobacco-related death among Black smokers means clinicians need to be more aggressive in recommending every treatment possible if one treatment fails.

Pharmacotherapy, nicotine replacement therapy, and counseling are evidence-based options to help patients stop smoking.

Dr. Kortsch considers pharmacotherapy to be the most effective and evidence-based treatment for nicotine addiction. However, Black Americans are less likely than White smokers to try smoking cessation medications, and they express more suspicion about efficacy and potential addiction to the tools.

“African American populations simply do not use pharmacotherapy to the extent that other populations do to help them quit smoking; this is a problem,” Dr. Kortsch said.

Dr. Kortsch recommends the use of varenicline for all patients with nicotine addiction. He recommends varenicline in combination with tobacco replacement products such as lozenges, patches, gums, or inhalers if the patient is a heavy smoker as opposed to someone who has a few cigarettes on the weekends.

If a patient has anxiety or depression, Dr. Adamian advises initiating a pharmacologic treatment such as bupropion or varenicline more quickly, because mood disorders can hinder cessation.

Cessation counseling is another option, but clinicians may need to more thoroughly explain what it entails. According to Dr. Choi, Black patients may be more reluctant to try cessation counseling because of the negative stigma associated with the term “counseling.” But this treatment is not therapy – it involves identifying and coming up with strategies to manage smoking triggers and providing encouragement. Clinicians can eliminate any confusion patients may have between psychological therapy and cessation counseling.

“ ‘Counseling’ tends to have a somewhat negative connotation among racial minority populations, like you go to counseling because you’re crazy,” Dr. Choi said. “That needs to change.”

Clinicians also must clarify how each cessation tool works. For example, some patients may not realize that the nicotine patch isn’t an instant fix for a craving and that hours may pass before the user feels its effects, according to Dr. Choi.
 

Move past the ‘advise’ stage

While recommending to patients various forms of cessation, clinicians should be mindful of the U.S. Preventive Services Task Force’s guidelines for providers who treat patients who smoke. Those guidelines include a five-step process: Ask, Advise, Assess, Assist, and Arrange.

Dr. Choi said most providers stop at the “Advise” stage. In steps one and two, providers ask patients whether they smoke, then advise them to quit. Stage three involves asking whether or not a patient is ready to quit and where they are in their journey.

Clinicians shouldn’t give up when patients say they do not currently plan to quit. Instead, they can use the conversation to create an ongoing dialogue about the patient’s readiness to quit in future visits. Follow-up phone calls or text messages should be made 2-4 weeks after a patient makes an attempt to quit and at the same interval thereafter, Dr. Adamian advised.

“It takes a concerted effort on behalf of all people to be successful, and it is really uncommon for someone to be successful with only one attempt,” Dr. Kortsch said.

In a recent study published in the Journal of the American Medical Association, researchers identified three key factors that influence a Black smoker’s ability to stop smoking in early attempts. These factors have been shown to increase the chances of long-term cessation: fewer cigarettes per day, nonuse of other tobacco products, and lower levels of cotinine (a nicotine metabolite) at baseline.

“Using these predictors of early treatment response could allow providers to anticipate which smokers may benefit from a minimal, low-cost intervention and who may benefit from more intensive treatment,” said Eleanor Leavens, PhD, assistant professor in the department of population health at the University of Kansas School of Medicine, Kansas City, who led the study.

Dr. Leavens’ research also confirmed that early abstinence predicts long-term cessation success. Smokers who were able to forgo cigarettes within 2 weeks of their quit date were almost four times more likely to remain abstinent over the long term.

A quick phone call or message from the clinician or a staff member can help patients achieve early progress, enable changes in approach to quitting, and build a relationship with the patient, Dr. Adamian said.

“Have more empathy for what Black patients are going through,” Dr. Choi said. “Continue to cheer them on and to be a supporter of their smoking cessation journey.”

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

Publications
Topics
Sections

Black Americans attempt to quit smoking more often than their White counterparts but are less likely to succeed, and they pay the health consequences.

This knowledge has driven Kevin Choi, MD, acting scientific director of the National Institute on Minority Health and Health Disparities in Bethesda, Md., to dedicate his career to studying the patterns and disparities of smoking among these patients.

Dr. Choi wants primary care clinicians to know not just that they have the potential to educate patients on the harms of smoking – most patients already know smoking is unhealthy – but that aiding them will likely necessitate more assertive follow-up.

To do so, “we need to understand the bigger backdrop of racial and sociological stress experienced by the Black population, which stems from both interpersonal and structural racism,” Dr. Choi said.

Not only are Black smokers more likely to try to quit, but they also tend to smoke fewer cigarettes per day than other racial groups. Yet they experience higher rates of smoking-related mortality.
 

The reasons behind the attempts

Multiple factors play into Black smokers’ lower rates of successful quitting attempts than Asian, Hispanic, White, and Native American individuals.

One reason: An estimated 85% of Black smokers smoke highly addictive menthol cigarettes. According to Dr. Choi and other experts, the tobacco industry engages in targeted marketing of menthols by sponsoring community events in predominantly Black neighborhoods and colleges with historically Black populations and by using Black culture in advertising.

“The built environment really drives a change in behavior, and we have seen that chronically in the African American population being overly targeted and now being overly addicted to nicotine,” said Daniel Kortsch, MD, a family medicine physician and chair of the Tobacco Cessation Workgroup at Denver Health.

Menthol cigarettes are more addictive than traditional cigarettes, in part because they provide a less harsh feeling in the respiratory system, owing to anti-tussive, anti-irritant, and cooling properties that act as a cough suppressant and mask irritation and pain.

“You do not feel like you’re smoking that much or that it’s dangerous, and that’s exactly the reason why it’s harder to quit,” said Julia Adamian, MD, section chief of general internal medicine and clinical innovation at NYU Langone Tisch Hospital.

In addition, menthol cigarettes interact with the body in complex ways that make quitting harder, according to a study published in Nicotine & Tobacco Research. Menthol increases the amount of nicotine that the body absorbs and thus increases the risk of dependence on the drug.

According to Dr. Choi, rates of cigar and cigarillo use are higher among Black Americans, compared with other races, and these products are often left out of cessation programs. Smokers, regardless of race, may have a misguided belief that cigars and cigarillos are less harmful than cigarettes.

Research published in 2021 found that Black cigar smokers who were interested in cessation had not been asked by their health care provider if they smoked cigars, and those who were asked reported a lack of support for cessation.

Primary care providers should work to remove any misconceptions a patient has regarding the safety of cigarillos and cigars, Dr. Choi said.

These smokers are also at a disadvantage regarding cessation success because of the neighborhoods they may live in, according to Dr. Choi. Black Americans are more likely to earn less and to live in neighborhoods with lower housing values than other racial groups. Areas with more low-income households tend to have a higher density of tobacco outlets.

“If you’re trying to quit smoking, but you walk by three, four, or five gas stations, convenience stores, and other tobacco outlets with signs that advertise sales, it’s not going to make quitting easy,” Dr. Choi said.
 

 

 

Tailoring treatment to Black smokers

Considering the unique challenges Black patients may face in quitting, clinicians should provide more follow-up and consistent support, according to Dr. Adamian. The higher risk of tobacco-related death among Black smokers means clinicians need to be more aggressive in recommending every treatment possible if one treatment fails.

Pharmacotherapy, nicotine replacement therapy, and counseling are evidence-based options to help patients stop smoking.

Dr. Kortsch considers pharmacotherapy to be the most effective and evidence-based treatment for nicotine addiction. However, Black Americans are less likely than White smokers to try smoking cessation medications, and they express more suspicion about efficacy and potential addiction to the tools.

“African American populations simply do not use pharmacotherapy to the extent that other populations do to help them quit smoking; this is a problem,” Dr. Kortsch said.

Dr. Kortsch recommends the use of varenicline for all patients with nicotine addiction. He recommends varenicline in combination with tobacco replacement products such as lozenges, patches, gums, or inhalers if the patient is a heavy smoker as opposed to someone who has a few cigarettes on the weekends.

If a patient has anxiety or depression, Dr. Adamian advises initiating a pharmacologic treatment such as bupropion or varenicline more quickly, because mood disorders can hinder cessation.

Cessation counseling is another option, but clinicians may need to more thoroughly explain what it entails. According to Dr. Choi, Black patients may be more reluctant to try cessation counseling because of the negative stigma associated with the term “counseling.” But this treatment is not therapy – it involves identifying and coming up with strategies to manage smoking triggers and providing encouragement. Clinicians can eliminate any confusion patients may have between psychological therapy and cessation counseling.

“ ‘Counseling’ tends to have a somewhat negative connotation among racial minority populations, like you go to counseling because you’re crazy,” Dr. Choi said. “That needs to change.”

Clinicians also must clarify how each cessation tool works. For example, some patients may not realize that the nicotine patch isn’t an instant fix for a craving and that hours may pass before the user feels its effects, according to Dr. Choi.
 

Move past the ‘advise’ stage

While recommending to patients various forms of cessation, clinicians should be mindful of the U.S. Preventive Services Task Force’s guidelines for providers who treat patients who smoke. Those guidelines include a five-step process: Ask, Advise, Assess, Assist, and Arrange.

Dr. Choi said most providers stop at the “Advise” stage. In steps one and two, providers ask patients whether they smoke, then advise them to quit. Stage three involves asking whether or not a patient is ready to quit and where they are in their journey.

Clinicians shouldn’t give up when patients say they do not currently plan to quit. Instead, they can use the conversation to create an ongoing dialogue about the patient’s readiness to quit in future visits. Follow-up phone calls or text messages should be made 2-4 weeks after a patient makes an attempt to quit and at the same interval thereafter, Dr. Adamian advised.

“It takes a concerted effort on behalf of all people to be successful, and it is really uncommon for someone to be successful with only one attempt,” Dr. Kortsch said.

In a recent study published in the Journal of the American Medical Association, researchers identified three key factors that influence a Black smoker’s ability to stop smoking in early attempts. These factors have been shown to increase the chances of long-term cessation: fewer cigarettes per day, nonuse of other tobacco products, and lower levels of cotinine (a nicotine metabolite) at baseline.

“Using these predictors of early treatment response could allow providers to anticipate which smokers may benefit from a minimal, low-cost intervention and who may benefit from more intensive treatment,” said Eleanor Leavens, PhD, assistant professor in the department of population health at the University of Kansas School of Medicine, Kansas City, who led the study.

Dr. Leavens’ research also confirmed that early abstinence predicts long-term cessation success. Smokers who were able to forgo cigarettes within 2 weeks of their quit date were almost four times more likely to remain abstinent over the long term.

A quick phone call or message from the clinician or a staff member can help patients achieve early progress, enable changes in approach to quitting, and build a relationship with the patient, Dr. Adamian said.

“Have more empathy for what Black patients are going through,” Dr. Choi said. “Continue to cheer them on and to be a supporter of their smoking cessation journey.”

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

Black Americans attempt to quit smoking more often than their White counterparts but are less likely to succeed, and they pay the health consequences.

This knowledge has driven Kevin Choi, MD, acting scientific director of the National Institute on Minority Health and Health Disparities in Bethesda, Md., to dedicate his career to studying the patterns and disparities of smoking among these patients.

Dr. Choi wants primary care clinicians to know not just that they have the potential to educate patients on the harms of smoking – most patients already know smoking is unhealthy – but that aiding them will likely necessitate more assertive follow-up.

To do so, “we need to understand the bigger backdrop of racial and sociological stress experienced by the Black population, which stems from both interpersonal and structural racism,” Dr. Choi said.

Not only are Black smokers more likely to try to quit, but they also tend to smoke fewer cigarettes per day than other racial groups. Yet they experience higher rates of smoking-related mortality.
 

The reasons behind the attempts

Multiple factors play into Black smokers’ lower rates of successful quitting attempts than Asian, Hispanic, White, and Native American individuals.

One reason: An estimated 85% of Black smokers smoke highly addictive menthol cigarettes. According to Dr. Choi and other experts, the tobacco industry engages in targeted marketing of menthols by sponsoring community events in predominantly Black neighborhoods and colleges with historically Black populations and by using Black culture in advertising.

“The built environment really drives a change in behavior, and we have seen that chronically in the African American population being overly targeted and now being overly addicted to nicotine,” said Daniel Kortsch, MD, a family medicine physician and chair of the Tobacco Cessation Workgroup at Denver Health.

Menthol cigarettes are more addictive than traditional cigarettes, in part because they provide a less harsh feeling in the respiratory system, owing to anti-tussive, anti-irritant, and cooling properties that act as a cough suppressant and mask irritation and pain.

“You do not feel like you’re smoking that much or that it’s dangerous, and that’s exactly the reason why it’s harder to quit,” said Julia Adamian, MD, section chief of general internal medicine and clinical innovation at NYU Langone Tisch Hospital.

In addition, menthol cigarettes interact with the body in complex ways that make quitting harder, according to a study published in Nicotine & Tobacco Research. Menthol increases the amount of nicotine that the body absorbs and thus increases the risk of dependence on the drug.

According to Dr. Choi, rates of cigar and cigarillo use are higher among Black Americans, compared with other races, and these products are often left out of cessation programs. Smokers, regardless of race, may have a misguided belief that cigars and cigarillos are less harmful than cigarettes.

Research published in 2021 found that Black cigar smokers who were interested in cessation had not been asked by their health care provider if they smoked cigars, and those who were asked reported a lack of support for cessation.

Primary care providers should work to remove any misconceptions a patient has regarding the safety of cigarillos and cigars, Dr. Choi said.

These smokers are also at a disadvantage regarding cessation success because of the neighborhoods they may live in, according to Dr. Choi. Black Americans are more likely to earn less and to live in neighborhoods with lower housing values than other racial groups. Areas with more low-income households tend to have a higher density of tobacco outlets.

“If you’re trying to quit smoking, but you walk by three, four, or five gas stations, convenience stores, and other tobacco outlets with signs that advertise sales, it’s not going to make quitting easy,” Dr. Choi said.
 

 

 

Tailoring treatment to Black smokers

Considering the unique challenges Black patients may face in quitting, clinicians should provide more follow-up and consistent support, according to Dr. Adamian. The higher risk of tobacco-related death among Black smokers means clinicians need to be more aggressive in recommending every treatment possible if one treatment fails.

Pharmacotherapy, nicotine replacement therapy, and counseling are evidence-based options to help patients stop smoking.

Dr. Kortsch considers pharmacotherapy to be the most effective and evidence-based treatment for nicotine addiction. However, Black Americans are less likely than White smokers to try smoking cessation medications, and they express more suspicion about efficacy and potential addiction to the tools.

“African American populations simply do not use pharmacotherapy to the extent that other populations do to help them quit smoking; this is a problem,” Dr. Kortsch said.

Dr. Kortsch recommends the use of varenicline for all patients with nicotine addiction. He recommends varenicline in combination with tobacco replacement products such as lozenges, patches, gums, or inhalers if the patient is a heavy smoker as opposed to someone who has a few cigarettes on the weekends.

If a patient has anxiety or depression, Dr. Adamian advises initiating a pharmacologic treatment such as bupropion or varenicline more quickly, because mood disorders can hinder cessation.

Cessation counseling is another option, but clinicians may need to more thoroughly explain what it entails. According to Dr. Choi, Black patients may be more reluctant to try cessation counseling because of the negative stigma associated with the term “counseling.” But this treatment is not therapy – it involves identifying and coming up with strategies to manage smoking triggers and providing encouragement. Clinicians can eliminate any confusion patients may have between psychological therapy and cessation counseling.

“ ‘Counseling’ tends to have a somewhat negative connotation among racial minority populations, like you go to counseling because you’re crazy,” Dr. Choi said. “That needs to change.”

Clinicians also must clarify how each cessation tool works. For example, some patients may not realize that the nicotine patch isn’t an instant fix for a craving and that hours may pass before the user feels its effects, according to Dr. Choi.
 

Move past the ‘advise’ stage

While recommending to patients various forms of cessation, clinicians should be mindful of the U.S. Preventive Services Task Force’s guidelines for providers who treat patients who smoke. Those guidelines include a five-step process: Ask, Advise, Assess, Assist, and Arrange.

Dr. Choi said most providers stop at the “Advise” stage. In steps one and two, providers ask patients whether they smoke, then advise them to quit. Stage three involves asking whether or not a patient is ready to quit and where they are in their journey.

Clinicians shouldn’t give up when patients say they do not currently plan to quit. Instead, they can use the conversation to create an ongoing dialogue about the patient’s readiness to quit in future visits. Follow-up phone calls or text messages should be made 2-4 weeks after a patient makes an attempt to quit and at the same interval thereafter, Dr. Adamian advised.

“It takes a concerted effort on behalf of all people to be successful, and it is really uncommon for someone to be successful with only one attempt,” Dr. Kortsch said.

In a recent study published in the Journal of the American Medical Association, researchers identified three key factors that influence a Black smoker’s ability to stop smoking in early attempts. These factors have been shown to increase the chances of long-term cessation: fewer cigarettes per day, nonuse of other tobacco products, and lower levels of cotinine (a nicotine metabolite) at baseline.

“Using these predictors of early treatment response could allow providers to anticipate which smokers may benefit from a minimal, low-cost intervention and who may benefit from more intensive treatment,” said Eleanor Leavens, PhD, assistant professor in the department of population health at the University of Kansas School of Medicine, Kansas City, who led the study.

Dr. Leavens’ research also confirmed that early abstinence predicts long-term cessation success. Smokers who were able to forgo cigarettes within 2 weeks of their quit date were almost four times more likely to remain abstinent over the long term.

A quick phone call or message from the clinician or a staff member can help patients achieve early progress, enable changes in approach to quitting, and build a relationship with the patient, Dr. Adamian said.

“Have more empathy for what Black patients are going through,” Dr. Choi said. “Continue to cheer them on and to be a supporter of their smoking cessation journey.”

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

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

Vaccination status doesn’t impact infectivity timeline in kids

Article Type
Changed
Tue, 10/24/2023 - 16:18

 

TOPLINE:

Half of kids with COVID-19 become noninfectious 3 days after testing positive, whether they were vaccinated or not, according to a new study. The findings indicate that return-to-school policies for infected children may not need to differ on the basis of vaccine or booster status.

METHODOLOGY:

  • The study looked at 76 children, both vaccinated and unvaccinated, aged 7-18 years who had tested positive for COVID-19. 
  • Researchers performed nasal swabs every other day for 10 days, sending the swab to a lab to be tested for cytopathic effect (CPE), or cell death, an indicator of infectivity.
  • They took pictures of the lab cultures to look for signs of CPE starting at 6 days after the test, which corresponds to the 2nd day after testing positive.
  • If CPE characteristics were present in at least 30% of images, children were considered infectious.

TAKEAWAY:

  • By day 3, half of study participants were noninfectious, independent of whether they had been vaccinated.
  • By day 5, less than 25% of children were infectious, regardless of vaccination status.
  • Among vaccinated children, the duration of infectivity was similar for children who received a booster and for those who had not.
  • The authors state that these results are consistent with those of a study in adults with the Omicron variant, which found no association between vaccination status and infectivity duration.

IN PRACTICE:

“Our findings suggest that current policies requiring isolation for 5 days after a positive test might be appropriate, as the majority of children were not infectious by day 5. Additionally, return-to-school policies may not need to discriminate by vaccine or booster status,” the authors wrote. 

SOURCE:

The study was led by Neeraj Sood, PhD, of the University of Southern California in Los Angeles, and was published in JAMA Pediatrics.

LIMITATIONS:

The sample size was small, and the authors identified the potential for nonresponse bias. The research did not include data from children who didn’t receive a test. CPE is the standard for estimating infectivity, but it can still carry inaccuracies.

DISCLOSURES:

The authors report no disclosures. The study was funded by RF Catalytic Capital.

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

Publications
Topics
Sections

 

TOPLINE:

Half of kids with COVID-19 become noninfectious 3 days after testing positive, whether they were vaccinated or not, according to a new study. The findings indicate that return-to-school policies for infected children may not need to differ on the basis of vaccine or booster status.

METHODOLOGY:

  • The study looked at 76 children, both vaccinated and unvaccinated, aged 7-18 years who had tested positive for COVID-19. 
  • Researchers performed nasal swabs every other day for 10 days, sending the swab to a lab to be tested for cytopathic effect (CPE), or cell death, an indicator of infectivity.
  • They took pictures of the lab cultures to look for signs of CPE starting at 6 days after the test, which corresponds to the 2nd day after testing positive.
  • If CPE characteristics were present in at least 30% of images, children were considered infectious.

TAKEAWAY:

  • By day 3, half of study participants were noninfectious, independent of whether they had been vaccinated.
  • By day 5, less than 25% of children were infectious, regardless of vaccination status.
  • Among vaccinated children, the duration of infectivity was similar for children who received a booster and for those who had not.
  • The authors state that these results are consistent with those of a study in adults with the Omicron variant, which found no association between vaccination status and infectivity duration.

IN PRACTICE:

“Our findings suggest that current policies requiring isolation for 5 days after a positive test might be appropriate, as the majority of children were not infectious by day 5. Additionally, return-to-school policies may not need to discriminate by vaccine or booster status,” the authors wrote. 

SOURCE:

The study was led by Neeraj Sood, PhD, of the University of Southern California in Los Angeles, and was published in JAMA Pediatrics.

LIMITATIONS:

The sample size was small, and the authors identified the potential for nonresponse bias. The research did not include data from children who didn’t receive a test. CPE is the standard for estimating infectivity, but it can still carry inaccuracies.

DISCLOSURES:

The authors report no disclosures. The study was funded by RF Catalytic Capital.

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

 

TOPLINE:

Half of kids with COVID-19 become noninfectious 3 days after testing positive, whether they were vaccinated or not, according to a new study. The findings indicate that return-to-school policies for infected children may not need to differ on the basis of vaccine or booster status.

METHODOLOGY:

  • The study looked at 76 children, both vaccinated and unvaccinated, aged 7-18 years who had tested positive for COVID-19. 
  • Researchers performed nasal swabs every other day for 10 days, sending the swab to a lab to be tested for cytopathic effect (CPE), or cell death, an indicator of infectivity.
  • They took pictures of the lab cultures to look for signs of CPE starting at 6 days after the test, which corresponds to the 2nd day after testing positive.
  • If CPE characteristics were present in at least 30% of images, children were considered infectious.

TAKEAWAY:

  • By day 3, half of study participants were noninfectious, independent of whether they had been vaccinated.
  • By day 5, less than 25% of children were infectious, regardless of vaccination status.
  • Among vaccinated children, the duration of infectivity was similar for children who received a booster and for those who had not.
  • The authors state that these results are consistent with those of a study in adults with the Omicron variant, which found no association between vaccination status and infectivity duration.

IN PRACTICE:

“Our findings suggest that current policies requiring isolation for 5 days after a positive test might be appropriate, as the majority of children were not infectious by day 5. Additionally, return-to-school policies may not need to discriminate by vaccine or booster status,” the authors wrote. 

SOURCE:

The study was led by Neeraj Sood, PhD, of the University of Southern California in Los Angeles, and was published in JAMA Pediatrics.

LIMITATIONS:

The sample size was small, and the authors identified the potential for nonresponse bias. The research did not include data from children who didn’t receive a test. CPE is the standard for estimating infectivity, but it can still carry inaccuracies.

DISCLOSURES:

The authors report no disclosures. The study was funded by RF Catalytic Capital.

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

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

This is how you get patients back for follow-up cancer testing

Article Type
Changed
Wed, 10/11/2023 - 11:06

Screening for cancer is only half the battle: Patients often fail to complete recommended follow-up and additional testing after an abnormal result, leaving them at risk, according to authors of a new study published in the Journal of the American Medical Association.

Results from the clustered, randomized clinical trial indicate that systems-based interventions, such as automating reminders in electronic health records (EHRs), outreach in the form of phone calls or letters, and assistance with barriers to health care, such as housing insecurity, can increase the number of patients who complete appropriate diagnostic follow-up after an abnormal result.

Patients who received an EHR reminder, outreach call or letter, and additional calls to screen for and assist with nine barriers to health care – housing insecurity, food insecurity, paying for basic utilities, family caregiving, legal issues, transportation, financial compensation for treatment, education, and employment – completed follow-up within 120 days of study enrollment at a rate of 31.4%. The follow-up rate was 31% for those who received only an EHR reminder and outreach, 22.7% for those who received only an EHR reminder, and 22.9% for those who received usual care.

“The benefits of cancer screening won’t be fully realized without systems to ensure timely follow-up of abnormal results,” said Anna Tosteson, ScD, director of the Dartmouth Institute for Health Policy and Clinical Practice in Lebanon, N.H., a coauthor of the study.

Current payment incentives and quality-of-care indicators focus on getting people in for screening but should also address completion of screening – meaning timely and appropriate follow-up of results that could be indicative of cancer, Dr. Tosteson said.

“There’s a disconnect if you have screening rates that are high but once people have an abnormal result, which is potentially one step closer to a cancer diagnosis, there are no systems in place to help clinicians track them,” said study coauthor Jennifer Haas, MD, director of the Center for Primary Care Research at Massachusetts General Hospital in Boston.

In a 2016 study, researchers found that follow-up rates after abnormal cancer screenings varied widely. While 95.6% of patients with abnormal breast cancer screenings underwent timely follow-up testing, only 68.1% of patients with colorectal abnormalities and 44.8% of patients with cervical abnormalities did so.

Researchers for the new study used guideline recommendations and specialist input to create automated EHR algorithms that determined a follow-up period and diagnostic test.

They put the algorithm into practice with 11,980 patients who were part of 44 primary care practices within three health networks between August 2020 and December 2021. All patients had received abnormal test results for colorectal, breast, cervical, or lung cancer in varying risk categories.

All patients received usual care from their providers, which consisted of a “hodgepodge of whatever their clinic usually does,” Dr. Haas said. Without standards and systems in place for follow-up, the burden of testing and tracking patients with abnormal results typically falls on the primary care provider.

The researchers intervened only when patients were overdue for completion of follow-up. They then staggered the interventions sequentially.

All study participants received an automated, algorithm-triggered EHR reminder for follow-up in their patient portal along with routine health maintenance reminders. To view the reminder, patients had to log into their portal. Participants in the outreach and outreach and navigation groups also received a phone call, an EHR message, or a physical letter 2 weeks after receiving an EHR notification if they hadn’t completed follow-up. Research assistants performed the outreach after having been prompted by the algorithm.

After another 4 weeks, those in the EHR, outreach, and navigation group received a call from a patient navigator who helped them address nine barriers to health care, chiefly by providing them with referrals to free resources.

Among patients who received navigation, outcomes were not significantly better than among those who received EHR and outreach, indicating social determinants of health did not significantly affect the population studied or that the modest approach to navigation and the resources provided were insufficient, Dr. Haas said.

The complexity of an automated platform that encompasses many types of cancers, test results, and other data elements could prove difficult to apply in settings with less infrastructure, said Steven Atlas, MD, MPH, director of the Practice-Based Research and Quality Improvement Network in the division of general internal medicine at Mass General.

“I think there’s a role for the federal government to take on these initiatives,” Dr. Atlas said. Government intervention could help create “national IT systems to create standards for creating code for what an abnormal result is and how it should be followed,” he said.

While interventions improved patient follow-up, the overall rates were still low.

“What concerns me is that despite the various interventions implemented to encourage and support patients to return for follow-up testing, over 60% of patients still did not return for the recommended testing,” said Joann G. Elmore, MD, MPH, professor of medicine at the University of California, Los Angeles. Dr. Elmore was not involved with the study.

The research took place during the COVID-19 pandemic, which may have reduced follow-up, the study authors wrote. Still, given that previous research has shown that follow-up tends to be low, the rates highlight “the need to understand factors associated with not completing follow-up that go beyond reminder effort,” they wrote. These include a need for patient education about the meaning of test results and what follow-up procedures involve.

The study was supported by the National Cancer Institute and the American Cancer Society. The authors have disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

Publications
Topics
Sections

Screening for cancer is only half the battle: Patients often fail to complete recommended follow-up and additional testing after an abnormal result, leaving them at risk, according to authors of a new study published in the Journal of the American Medical Association.

Results from the clustered, randomized clinical trial indicate that systems-based interventions, such as automating reminders in electronic health records (EHRs), outreach in the form of phone calls or letters, and assistance with barriers to health care, such as housing insecurity, can increase the number of patients who complete appropriate diagnostic follow-up after an abnormal result.

Patients who received an EHR reminder, outreach call or letter, and additional calls to screen for and assist with nine barriers to health care – housing insecurity, food insecurity, paying for basic utilities, family caregiving, legal issues, transportation, financial compensation for treatment, education, and employment – completed follow-up within 120 days of study enrollment at a rate of 31.4%. The follow-up rate was 31% for those who received only an EHR reminder and outreach, 22.7% for those who received only an EHR reminder, and 22.9% for those who received usual care.

“The benefits of cancer screening won’t be fully realized without systems to ensure timely follow-up of abnormal results,” said Anna Tosteson, ScD, director of the Dartmouth Institute for Health Policy and Clinical Practice in Lebanon, N.H., a coauthor of the study.

Current payment incentives and quality-of-care indicators focus on getting people in for screening but should also address completion of screening – meaning timely and appropriate follow-up of results that could be indicative of cancer, Dr. Tosteson said.

“There’s a disconnect if you have screening rates that are high but once people have an abnormal result, which is potentially one step closer to a cancer diagnosis, there are no systems in place to help clinicians track them,” said study coauthor Jennifer Haas, MD, director of the Center for Primary Care Research at Massachusetts General Hospital in Boston.

In a 2016 study, researchers found that follow-up rates after abnormal cancer screenings varied widely. While 95.6% of patients with abnormal breast cancer screenings underwent timely follow-up testing, only 68.1% of patients with colorectal abnormalities and 44.8% of patients with cervical abnormalities did so.

Researchers for the new study used guideline recommendations and specialist input to create automated EHR algorithms that determined a follow-up period and diagnostic test.

They put the algorithm into practice with 11,980 patients who were part of 44 primary care practices within three health networks between August 2020 and December 2021. All patients had received abnormal test results for colorectal, breast, cervical, or lung cancer in varying risk categories.

All patients received usual care from their providers, which consisted of a “hodgepodge of whatever their clinic usually does,” Dr. Haas said. Without standards and systems in place for follow-up, the burden of testing and tracking patients with abnormal results typically falls on the primary care provider.

The researchers intervened only when patients were overdue for completion of follow-up. They then staggered the interventions sequentially.

All study participants received an automated, algorithm-triggered EHR reminder for follow-up in their patient portal along with routine health maintenance reminders. To view the reminder, patients had to log into their portal. Participants in the outreach and outreach and navigation groups also received a phone call, an EHR message, or a physical letter 2 weeks after receiving an EHR notification if they hadn’t completed follow-up. Research assistants performed the outreach after having been prompted by the algorithm.

After another 4 weeks, those in the EHR, outreach, and navigation group received a call from a patient navigator who helped them address nine barriers to health care, chiefly by providing them with referrals to free resources.

Among patients who received navigation, outcomes were not significantly better than among those who received EHR and outreach, indicating social determinants of health did not significantly affect the population studied or that the modest approach to navigation and the resources provided were insufficient, Dr. Haas said.

The complexity of an automated platform that encompasses many types of cancers, test results, and other data elements could prove difficult to apply in settings with less infrastructure, said Steven Atlas, MD, MPH, director of the Practice-Based Research and Quality Improvement Network in the division of general internal medicine at Mass General.

“I think there’s a role for the federal government to take on these initiatives,” Dr. Atlas said. Government intervention could help create “national IT systems to create standards for creating code for what an abnormal result is and how it should be followed,” he said.

While interventions improved patient follow-up, the overall rates were still low.

“What concerns me is that despite the various interventions implemented to encourage and support patients to return for follow-up testing, over 60% of patients still did not return for the recommended testing,” said Joann G. Elmore, MD, MPH, professor of medicine at the University of California, Los Angeles. Dr. Elmore was not involved with the study.

The research took place during the COVID-19 pandemic, which may have reduced follow-up, the study authors wrote. Still, given that previous research has shown that follow-up tends to be low, the rates highlight “the need to understand factors associated with not completing follow-up that go beyond reminder effort,” they wrote. These include a need for patient education about the meaning of test results and what follow-up procedures involve.

The study was supported by the National Cancer Institute and the American Cancer Society. The authors have disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

Screening for cancer is only half the battle: Patients often fail to complete recommended follow-up and additional testing after an abnormal result, leaving them at risk, according to authors of a new study published in the Journal of the American Medical Association.

Results from the clustered, randomized clinical trial indicate that systems-based interventions, such as automating reminders in electronic health records (EHRs), outreach in the form of phone calls or letters, and assistance with barriers to health care, such as housing insecurity, can increase the number of patients who complete appropriate diagnostic follow-up after an abnormal result.

Patients who received an EHR reminder, outreach call or letter, and additional calls to screen for and assist with nine barriers to health care – housing insecurity, food insecurity, paying for basic utilities, family caregiving, legal issues, transportation, financial compensation for treatment, education, and employment – completed follow-up within 120 days of study enrollment at a rate of 31.4%. The follow-up rate was 31% for those who received only an EHR reminder and outreach, 22.7% for those who received only an EHR reminder, and 22.9% for those who received usual care.

“The benefits of cancer screening won’t be fully realized without systems to ensure timely follow-up of abnormal results,” said Anna Tosteson, ScD, director of the Dartmouth Institute for Health Policy and Clinical Practice in Lebanon, N.H., a coauthor of the study.

Current payment incentives and quality-of-care indicators focus on getting people in for screening but should also address completion of screening – meaning timely and appropriate follow-up of results that could be indicative of cancer, Dr. Tosteson said.

“There’s a disconnect if you have screening rates that are high but once people have an abnormal result, which is potentially one step closer to a cancer diagnosis, there are no systems in place to help clinicians track them,” said study coauthor Jennifer Haas, MD, director of the Center for Primary Care Research at Massachusetts General Hospital in Boston.

In a 2016 study, researchers found that follow-up rates after abnormal cancer screenings varied widely. While 95.6% of patients with abnormal breast cancer screenings underwent timely follow-up testing, only 68.1% of patients with colorectal abnormalities and 44.8% of patients with cervical abnormalities did so.

Researchers for the new study used guideline recommendations and specialist input to create automated EHR algorithms that determined a follow-up period and diagnostic test.

They put the algorithm into practice with 11,980 patients who were part of 44 primary care practices within three health networks between August 2020 and December 2021. All patients had received abnormal test results for colorectal, breast, cervical, or lung cancer in varying risk categories.

All patients received usual care from their providers, which consisted of a “hodgepodge of whatever their clinic usually does,” Dr. Haas said. Without standards and systems in place for follow-up, the burden of testing and tracking patients with abnormal results typically falls on the primary care provider.

The researchers intervened only when patients were overdue for completion of follow-up. They then staggered the interventions sequentially.

All study participants received an automated, algorithm-triggered EHR reminder for follow-up in their patient portal along with routine health maintenance reminders. To view the reminder, patients had to log into their portal. Participants in the outreach and outreach and navigation groups also received a phone call, an EHR message, or a physical letter 2 weeks after receiving an EHR notification if they hadn’t completed follow-up. Research assistants performed the outreach after having been prompted by the algorithm.

After another 4 weeks, those in the EHR, outreach, and navigation group received a call from a patient navigator who helped them address nine barriers to health care, chiefly by providing them with referrals to free resources.

Among patients who received navigation, outcomes were not significantly better than among those who received EHR and outreach, indicating social determinants of health did not significantly affect the population studied or that the modest approach to navigation and the resources provided were insufficient, Dr. Haas said.

The complexity of an automated platform that encompasses many types of cancers, test results, and other data elements could prove difficult to apply in settings with less infrastructure, said Steven Atlas, MD, MPH, director of the Practice-Based Research and Quality Improvement Network in the division of general internal medicine at Mass General.

“I think there’s a role for the federal government to take on these initiatives,” Dr. Atlas said. Government intervention could help create “national IT systems to create standards for creating code for what an abnormal result is and how it should be followed,” he said.

While interventions improved patient follow-up, the overall rates were still low.

“What concerns me is that despite the various interventions implemented to encourage and support patients to return for follow-up testing, over 60% of patients still did not return for the recommended testing,” said Joann G. Elmore, MD, MPH, professor of medicine at the University of California, Los Angeles. Dr. Elmore was not involved with the study.

The research took place during the COVID-19 pandemic, which may have reduced follow-up, the study authors wrote. Still, given that previous research has shown that follow-up tends to be low, the rates highlight “the need to understand factors associated with not completing follow-up that go beyond reminder effort,” they wrote. These include a need for patient education about the meaning of test results and what follow-up procedures involve.

The study was supported by the National Cancer Institute and the American Cancer Society. The authors have disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

Publications
Publications
Topics
Article Type
Sections
Article Source

FROM JAMA

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

False-positive Pap smear may indicate genitourinary syndrome

Article Type
Changed
Thu, 10/05/2023 - 15:19

 

TOPLINE:

A Pap smear result indicating cervical dysplasia may actually be an early signal of genitourinary syndrome (vaginal atrophy) and can be treated effectively with local estrogen, according to a poster presented at The Menopause Society 2023 annual meeting.

METHODOLOGY:

  • Starting in 2010, researchers in Florida and Antigua saw an increase in the number of perimenopausal women with no history of cervical abnormalities and low risk for sexually transmitted infections (STIs) presenting with abnormal Pap smears at their clinics.
  • They studied 1,500 women aged 30-70 from several clinics. The women had low risk for STIs, a maximum of two sexual partners, and the presence of cervical dysplasia over a period of 12 years.

TAKEAWAY:

  • Nearly all (96.7%) of the women who received local estrogen treatment had a normal Pap smear following therapy.
  • A high number of patients who initially presented with cervical dysplasia underwent interventions such as colposcopies, biopsies, LEEP excisions, cryotherapy, cone biopsies, and hysterectomies because of cervical atrophy.
  • The researchers concluded that local estrogen treatment could save patients money spent on treatments for cervical atrophy.
  • Some women who underwent cone biopsies and hysterectomies and did not receive local estrogen still had vaginal dysplasia.

IN PRACTICE:

“In this study, we report an early sign of genitourinary syndrome of menopause: false positive cervical dysplasia caused by cervicovaginal atrophy resulting from decreased estrogen levels during perimenopause,” say the investigators. “We also demonstrate how the use of local estrogen therapy can prevent a significant number of interventions and procedures, resulting in significant cost savings. This is particularly relevant as the number of Pap smears conducted in this population represents 50%-60% of all Pap smears performed on women.”

SOURCE:

The data were presented at The Menopause Society 2023 annual meeting. The study was led by Alberto Dominguez-Bali, MD, from the Miami Center for Obstetrics, Gynecology and Human Sexuality.

LIMITATIONS:

The study authors report no limitations.

DISCLOSURES:

The authors report no relevant financial relationships.

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

Meeting/Event
Publications
Topics
Sections
Meeting/Event
Meeting/Event

 

TOPLINE:

A Pap smear result indicating cervical dysplasia may actually be an early signal of genitourinary syndrome (vaginal atrophy) and can be treated effectively with local estrogen, according to a poster presented at The Menopause Society 2023 annual meeting.

METHODOLOGY:

  • Starting in 2010, researchers in Florida and Antigua saw an increase in the number of perimenopausal women with no history of cervical abnormalities and low risk for sexually transmitted infections (STIs) presenting with abnormal Pap smears at their clinics.
  • They studied 1,500 women aged 30-70 from several clinics. The women had low risk for STIs, a maximum of two sexual partners, and the presence of cervical dysplasia over a period of 12 years.

TAKEAWAY:

  • Nearly all (96.7%) of the women who received local estrogen treatment had a normal Pap smear following therapy.
  • A high number of patients who initially presented with cervical dysplasia underwent interventions such as colposcopies, biopsies, LEEP excisions, cryotherapy, cone biopsies, and hysterectomies because of cervical atrophy.
  • The researchers concluded that local estrogen treatment could save patients money spent on treatments for cervical atrophy.
  • Some women who underwent cone biopsies and hysterectomies and did not receive local estrogen still had vaginal dysplasia.

IN PRACTICE:

“In this study, we report an early sign of genitourinary syndrome of menopause: false positive cervical dysplasia caused by cervicovaginal atrophy resulting from decreased estrogen levels during perimenopause,” say the investigators. “We also demonstrate how the use of local estrogen therapy can prevent a significant number of interventions and procedures, resulting in significant cost savings. This is particularly relevant as the number of Pap smears conducted in this population represents 50%-60% of all Pap smears performed on women.”

SOURCE:

The data were presented at The Menopause Society 2023 annual meeting. The study was led by Alberto Dominguez-Bali, MD, from the Miami Center for Obstetrics, Gynecology and Human Sexuality.

LIMITATIONS:

The study authors report no limitations.

DISCLOSURES:

The authors report no relevant financial relationships.

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

 

TOPLINE:

A Pap smear result indicating cervical dysplasia may actually be an early signal of genitourinary syndrome (vaginal atrophy) and can be treated effectively with local estrogen, according to a poster presented at The Menopause Society 2023 annual meeting.

METHODOLOGY:

  • Starting in 2010, researchers in Florida and Antigua saw an increase in the number of perimenopausal women with no history of cervical abnormalities and low risk for sexually transmitted infections (STIs) presenting with abnormal Pap smears at their clinics.
  • They studied 1,500 women aged 30-70 from several clinics. The women had low risk for STIs, a maximum of two sexual partners, and the presence of cervical dysplasia over a period of 12 years.

TAKEAWAY:

  • Nearly all (96.7%) of the women who received local estrogen treatment had a normal Pap smear following therapy.
  • A high number of patients who initially presented with cervical dysplasia underwent interventions such as colposcopies, biopsies, LEEP excisions, cryotherapy, cone biopsies, and hysterectomies because of cervical atrophy.
  • The researchers concluded that local estrogen treatment could save patients money spent on treatments for cervical atrophy.
  • Some women who underwent cone biopsies and hysterectomies and did not receive local estrogen still had vaginal dysplasia.

IN PRACTICE:

“In this study, we report an early sign of genitourinary syndrome of menopause: false positive cervical dysplasia caused by cervicovaginal atrophy resulting from decreased estrogen levels during perimenopause,” say the investigators. “We also demonstrate how the use of local estrogen therapy can prevent a significant number of interventions and procedures, resulting in significant cost savings. This is particularly relevant as the number of Pap smears conducted in this population represents 50%-60% of all Pap smears performed on women.”

SOURCE:

The data were presented at The Menopause Society 2023 annual meeting. The study was led by Alberto Dominguez-Bali, MD, from the Miami Center for Obstetrics, Gynecology and Human Sexuality.

LIMITATIONS:

The study authors report no limitations.

DISCLOSURES:

The authors report no relevant financial relationships.

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

Publications
Publications
Topics
Article Type
Sections
Article Source

FROM THE MENOPAUSE SOCIETY ANNUAL MEETING

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

This symptom signals UTI in 83% of cases

Article Type
Changed
Tue, 10/03/2023 - 13:48

 

TOPLINE:

Dyspareunia is a major indicator of urinary tract infections, being present in 83% of cases. The symptom is especially accurate at identifying UTIs in nonmenopausal women, researchers have found.


METHODOLOGY:

  • Dyspareunia is a common symptom of UTIs, especially in premenopausal women, but is rarely inquired about during patient evaluations, according to researchers from Florida Atlantic University. 
  • In 2010, the researchers found that among 3,000 of their female Latinx patients aged 17-72 years in South Florida, 80% of those with UTIs reported experiencing pain during sexual intercourse. 
  • Since then, they have studied an additional 2,500 patients from the same population.

TAKEAWAY:

  • Among all 5,500 patients, 83% of those who had UTIs experienced dyspareunia.
  • Eighty percent of women of reproductive age with dyspareunia had an undiagnosed UTI.
  • During the perimenopausal and postmenopausal years, dyspareunia was more often associated with genitourinary syndrome than UTIs.
  • Ninety-four percent of women with UTI-associated dyspareunia responded positively to antibiotics.

IN PRACTICE:

“We have found that this symptom is extremely important as part of the symptomatology of UTI [and is] frequently found along with the classical symptoms,” the researchers reported. “Why has something so clear, so frequently present, never been described? The answer is simple: Physicians and patients do not talk about sex, despite dyspareunia being more a clinical symptom than a sexual one. Medical schools and residency programs in all areas, especially in obstetrics and gynecology, urology, and psychiatry, have been neglecting the education of physicians-in-training in this important aspect of human health. In conclusion, this is [proof] of how medicine has sometimes been influenced by religion, culture, and social norms far away from science.”

SOURCE:

The data were presented at the 2023 meeting of the Menopause Society. The study was led by Alberto Dominguez-Bali, MD, from Florida Atlantic University, Boca Raton, Fla.

LIMITATIONS:

The study authors reported no limitations.

DISCLOSURES:

The authors reported no relevant financial relationships.

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

Meeting/Event
Publications
Topics
Sections
Meeting/Event
Meeting/Event

 

TOPLINE:

Dyspareunia is a major indicator of urinary tract infections, being present in 83% of cases. The symptom is especially accurate at identifying UTIs in nonmenopausal women, researchers have found.


METHODOLOGY:

  • Dyspareunia is a common symptom of UTIs, especially in premenopausal women, but is rarely inquired about during patient evaluations, according to researchers from Florida Atlantic University. 
  • In 2010, the researchers found that among 3,000 of their female Latinx patients aged 17-72 years in South Florida, 80% of those with UTIs reported experiencing pain during sexual intercourse. 
  • Since then, they have studied an additional 2,500 patients from the same population.

TAKEAWAY:

  • Among all 5,500 patients, 83% of those who had UTIs experienced dyspareunia.
  • Eighty percent of women of reproductive age with dyspareunia had an undiagnosed UTI.
  • During the perimenopausal and postmenopausal years, dyspareunia was more often associated with genitourinary syndrome than UTIs.
  • Ninety-four percent of women with UTI-associated dyspareunia responded positively to antibiotics.

IN PRACTICE:

“We have found that this symptom is extremely important as part of the symptomatology of UTI [and is] frequently found along with the classical symptoms,” the researchers reported. “Why has something so clear, so frequently present, never been described? The answer is simple: Physicians and patients do not talk about sex, despite dyspareunia being more a clinical symptom than a sexual one. Medical schools and residency programs in all areas, especially in obstetrics and gynecology, urology, and psychiatry, have been neglecting the education of physicians-in-training in this important aspect of human health. In conclusion, this is [proof] of how medicine has sometimes been influenced by religion, culture, and social norms far away from science.”

SOURCE:

The data were presented at the 2023 meeting of the Menopause Society. The study was led by Alberto Dominguez-Bali, MD, from Florida Atlantic University, Boca Raton, Fla.

LIMITATIONS:

The study authors reported no limitations.

DISCLOSURES:

The authors reported no relevant financial relationships.

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

 

TOPLINE:

Dyspareunia is a major indicator of urinary tract infections, being present in 83% of cases. The symptom is especially accurate at identifying UTIs in nonmenopausal women, researchers have found.


METHODOLOGY:

  • Dyspareunia is a common symptom of UTIs, especially in premenopausal women, but is rarely inquired about during patient evaluations, according to researchers from Florida Atlantic University. 
  • In 2010, the researchers found that among 3,000 of their female Latinx patients aged 17-72 years in South Florida, 80% of those with UTIs reported experiencing pain during sexual intercourse. 
  • Since then, they have studied an additional 2,500 patients from the same population.

TAKEAWAY:

  • Among all 5,500 patients, 83% of those who had UTIs experienced dyspareunia.
  • Eighty percent of women of reproductive age with dyspareunia had an undiagnosed UTI.
  • During the perimenopausal and postmenopausal years, dyspareunia was more often associated with genitourinary syndrome than UTIs.
  • Ninety-four percent of women with UTI-associated dyspareunia responded positively to antibiotics.

IN PRACTICE:

“We have found that this symptom is extremely important as part of the symptomatology of UTI [and is] frequently found along with the classical symptoms,” the researchers reported. “Why has something so clear, so frequently present, never been described? The answer is simple: Physicians and patients do not talk about sex, despite dyspareunia being more a clinical symptom than a sexual one. Medical schools and residency programs in all areas, especially in obstetrics and gynecology, urology, and psychiatry, have been neglecting the education of physicians-in-training in this important aspect of human health. In conclusion, this is [proof] of how medicine has sometimes been influenced by religion, culture, and social norms far away from science.”

SOURCE:

The data were presented at the 2023 meeting of the Menopause Society. The study was led by Alberto Dominguez-Bali, MD, from Florida Atlantic University, Boca Raton, Fla.

LIMITATIONS:

The study authors reported no limitations.

DISCLOSURES:

The authors reported no relevant financial relationships.

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

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

FDA panel deems phenylephrine ineffective

Article Type
Changed
Wed, 09/13/2023 - 13:38

America’s most popular oral nasal decongestant, phenylephrine, was deemed ineffective by a Food and Drug Administration panel in a unanimous vote on Sept. 12.

The Nonprescription Drug Advisory Committee discussed the efficacy and pharmacokinetic data for phenylephrine. The committee’s next move is to determine if the drug’s status as Generally Recognized as Safe and Effective should be revoked. This would mean manufacturers would have to come up with new formulations, or products containing the drug would be removed from store shelves. NDAC did not disclose a timeline for assessing GRASE status.

FDA icon
   

The vote that formally declared phenylephrine ineffective was in line with a review of pharmacology and clinical data presented by the FDA on Sept. 11, which found that the oral bioavailability of the drug is less than 1%, compared with 38%, a number often cited in the literature and based on outdated technology.

A mechanism potentially responsible for inefficacy may be the half-life of phenylephrine.

“The half-life of the parent phenylephrine is much shorter than that of total phenylephrine, suggesting that the duration of action for active parent phenylephrine is far shorter than the monographed dosing interval of every 4 hours and is therefore open to question,” the review states.

The side effects of phenylephrine include headaches, insomnia, and nervousness. At higher doses, it can increase blood pressure. 

The review also found that original studies used to support the efficacy of phenylephrine were inconclusive at best and contained potential methodological, statistical, and data integrity issues.

Pseudoephedrine is the only other nonprescription oral nasal decongestant on the retail market but is only available behind the counter due to its use as a potential narcotic. 

Manufacturers have used phenylephrine instead of pseudoephedrine in many products due to this limitation. 

Revoking the GRASE status of phenylephrine would leave patients without an over-the-counter option. 

According to the FDA review, 242 million packages or bottles of phenylephrine products were sold in 2022, resulting in $1.76 billion in sales. A little over 50 million packages of pseudoephedrine were sold that same year, resulting in $542 million in sales.

“I think there’s a huge potential for consumer concern,” Diane B. Ginsburg, PhD, MS, RPh, the pharmacy practice division associate dean for Healthcare Partnerships at The University of Texas at Austin, said during the panel.

She said patients may be confused and concerned about the panel vote, especially those who feel they have benefitted from phenylephrine products. In the event of GRASE removal, she advised reassuring patients that phenylephrine is being pulled from shelves due to inefficacy rather than immediate health risks.

“The real positive here to me is the opportunity from an educational perspective to show consumers the fact that there are a lot more ways to treat” conditions that present with the symptom of congestion, such as rhinitis.

According to the FDA review, “most consumers may simply need instruction on the alternatives, including how to obtain ‘behind-the-counter’ pseudoephedrine or to use alternative treatments, including intranasal decongestants (including intranasal phenylephrine), intranasal steroids, intranasal antihistamines, or intranasal saline products.” 

Despite these complications, “there are a number of potential benefits that would be derived by changing the GRASE status of oral phenylephrine.”

These include avoiding unnecessary costs of taking an ineffective drug, potential allergic reactions and side effects, and the risks of patients taking a higher dosage.

A version of this article appeared on Medscape.com.

Publications
Topics
Sections

America’s most popular oral nasal decongestant, phenylephrine, was deemed ineffective by a Food and Drug Administration panel in a unanimous vote on Sept. 12.

The Nonprescription Drug Advisory Committee discussed the efficacy and pharmacokinetic data for phenylephrine. The committee’s next move is to determine if the drug’s status as Generally Recognized as Safe and Effective should be revoked. This would mean manufacturers would have to come up with new formulations, or products containing the drug would be removed from store shelves. NDAC did not disclose a timeline for assessing GRASE status.

FDA icon
   

The vote that formally declared phenylephrine ineffective was in line with a review of pharmacology and clinical data presented by the FDA on Sept. 11, which found that the oral bioavailability of the drug is less than 1%, compared with 38%, a number often cited in the literature and based on outdated technology.

A mechanism potentially responsible for inefficacy may be the half-life of phenylephrine.

“The half-life of the parent phenylephrine is much shorter than that of total phenylephrine, suggesting that the duration of action for active parent phenylephrine is far shorter than the monographed dosing interval of every 4 hours and is therefore open to question,” the review states.

The side effects of phenylephrine include headaches, insomnia, and nervousness. At higher doses, it can increase blood pressure. 

The review also found that original studies used to support the efficacy of phenylephrine were inconclusive at best and contained potential methodological, statistical, and data integrity issues.

Pseudoephedrine is the only other nonprescription oral nasal decongestant on the retail market but is only available behind the counter due to its use as a potential narcotic. 

Manufacturers have used phenylephrine instead of pseudoephedrine in many products due to this limitation. 

Revoking the GRASE status of phenylephrine would leave patients without an over-the-counter option. 

According to the FDA review, 242 million packages or bottles of phenylephrine products were sold in 2022, resulting in $1.76 billion in sales. A little over 50 million packages of pseudoephedrine were sold that same year, resulting in $542 million in sales.

“I think there’s a huge potential for consumer concern,” Diane B. Ginsburg, PhD, MS, RPh, the pharmacy practice division associate dean for Healthcare Partnerships at The University of Texas at Austin, said during the panel.

She said patients may be confused and concerned about the panel vote, especially those who feel they have benefitted from phenylephrine products. In the event of GRASE removal, she advised reassuring patients that phenylephrine is being pulled from shelves due to inefficacy rather than immediate health risks.

“The real positive here to me is the opportunity from an educational perspective to show consumers the fact that there are a lot more ways to treat” conditions that present with the symptom of congestion, such as rhinitis.

According to the FDA review, “most consumers may simply need instruction on the alternatives, including how to obtain ‘behind-the-counter’ pseudoephedrine or to use alternative treatments, including intranasal decongestants (including intranasal phenylephrine), intranasal steroids, intranasal antihistamines, or intranasal saline products.” 

Despite these complications, “there are a number of potential benefits that would be derived by changing the GRASE status of oral phenylephrine.”

These include avoiding unnecessary costs of taking an ineffective drug, potential allergic reactions and side effects, and the risks of patients taking a higher dosage.

A version of this article appeared on Medscape.com.

America’s most popular oral nasal decongestant, phenylephrine, was deemed ineffective by a Food and Drug Administration panel in a unanimous vote on Sept. 12.

The Nonprescription Drug Advisory Committee discussed the efficacy and pharmacokinetic data for phenylephrine. The committee’s next move is to determine if the drug’s status as Generally Recognized as Safe and Effective should be revoked. This would mean manufacturers would have to come up with new formulations, or products containing the drug would be removed from store shelves. NDAC did not disclose a timeline for assessing GRASE status.

FDA icon
   

The vote that formally declared phenylephrine ineffective was in line with a review of pharmacology and clinical data presented by the FDA on Sept. 11, which found that the oral bioavailability of the drug is less than 1%, compared with 38%, a number often cited in the literature and based on outdated technology.

A mechanism potentially responsible for inefficacy may be the half-life of phenylephrine.

“The half-life of the parent phenylephrine is much shorter than that of total phenylephrine, suggesting that the duration of action for active parent phenylephrine is far shorter than the monographed dosing interval of every 4 hours and is therefore open to question,” the review states.

The side effects of phenylephrine include headaches, insomnia, and nervousness. At higher doses, it can increase blood pressure. 

The review also found that original studies used to support the efficacy of phenylephrine were inconclusive at best and contained potential methodological, statistical, and data integrity issues.

Pseudoephedrine is the only other nonprescription oral nasal decongestant on the retail market but is only available behind the counter due to its use as a potential narcotic. 

Manufacturers have used phenylephrine instead of pseudoephedrine in many products due to this limitation. 

Revoking the GRASE status of phenylephrine would leave patients without an over-the-counter option. 

According to the FDA review, 242 million packages or bottles of phenylephrine products were sold in 2022, resulting in $1.76 billion in sales. A little over 50 million packages of pseudoephedrine were sold that same year, resulting in $542 million in sales.

“I think there’s a huge potential for consumer concern,” Diane B. Ginsburg, PhD, MS, RPh, the pharmacy practice division associate dean for Healthcare Partnerships at The University of Texas at Austin, said during the panel.

She said patients may be confused and concerned about the panel vote, especially those who feel they have benefitted from phenylephrine products. In the event of GRASE removal, she advised reassuring patients that phenylephrine is being pulled from shelves due to inefficacy rather than immediate health risks.

“The real positive here to me is the opportunity from an educational perspective to show consumers the fact that there are a lot more ways to treat” conditions that present with the symptom of congestion, such as rhinitis.

According to the FDA review, “most consumers may simply need instruction on the alternatives, including how to obtain ‘behind-the-counter’ pseudoephedrine or to use alternative treatments, including intranasal decongestants (including intranasal phenylephrine), intranasal steroids, intranasal antihistamines, or intranasal saline products.” 

Despite these complications, “there are a number of potential benefits that would be derived by changing the GRASE status of oral phenylephrine.”

These include avoiding unnecessary costs of taking an ineffective drug, potential allergic reactions and side effects, and the risks of patients taking a higher dosage.

A version of this article appeared on Medscape.com.

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

Medical treatment for appendicitis effective long-term

Article Type
Changed
Fri, 08/11/2023 - 10:12

 

TOPLINE:

Most patients who receive antibiotics rather than surgical treatment for appendicitis have successful long-term outcomes, but some may require surgery up to 20 years later.

METHODOLOGY:

  • Follow-up on 292 patients involved in two randomized controlled trials conducted in the 1990s by the Swedish National Patient Registry
  • Both trials divided patients into two groups: those who underwent appendectomy and those who received antibiotic treatment for appendicitis.
  • Researchers looked at rates of recurrent appendicitis that required surgery later in life.

TAKEAWAY:

  • 29% of patients in the nonoperative group who were discharged successfully during the initial study eventually underwent surgery.
  • Some patients who initially received antibiotics required surgery up to 20 years later.
  • 9.5% of patients who didn’t undergo surgery went to a surgical outpatient clinic for abdominal pain, compared with 0.01% of those who had surgery.

IN PRACTICE:

“More than half of the patients treated nonoperatively did not experience recurrence and avoided surgery over approximately 2 decades. There is no evidence for long-term risks of nonoperative management other than that of recurrence of appendicitis,” the authors report.

SOURCE:

Simon Eaton, PhD, of UCL Great Ormond Street Institute of Child Health in London, was the corresponding author of the study, published online in JAMA Surgery. The study was funded by the NIHR Biomedical Research Centre at Great Ormond Street Hospital and the Swedish Research Council.

LIMITATIONS:

The data were retrospective, so the researchers could not track how patients’ circumstances and characteristics changed over time. Most patients were male, and the researchers lacked histopathology results for patients for whom nonsurgical treatment succeeded initially but who later required appendectomy. They also relied on diagnostic standards used in the 1990s, when the initial studies were performed; these were less sophisticated and accurate than recent standards.

DISCLOSURES:

Coauthor Jan Svensson, MD, PhD, reported receiving grants from the Lovisa Foundation during the conduct of the study. No other disclosures were reported.

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

Publications
Topics
Sections

 

TOPLINE:

Most patients who receive antibiotics rather than surgical treatment for appendicitis have successful long-term outcomes, but some may require surgery up to 20 years later.

METHODOLOGY:

  • Follow-up on 292 patients involved in two randomized controlled trials conducted in the 1990s by the Swedish National Patient Registry
  • Both trials divided patients into two groups: those who underwent appendectomy and those who received antibiotic treatment for appendicitis.
  • Researchers looked at rates of recurrent appendicitis that required surgery later in life.

TAKEAWAY:

  • 29% of patients in the nonoperative group who were discharged successfully during the initial study eventually underwent surgery.
  • Some patients who initially received antibiotics required surgery up to 20 years later.
  • 9.5% of patients who didn’t undergo surgery went to a surgical outpatient clinic for abdominal pain, compared with 0.01% of those who had surgery.

IN PRACTICE:

“More than half of the patients treated nonoperatively did not experience recurrence and avoided surgery over approximately 2 decades. There is no evidence for long-term risks of nonoperative management other than that of recurrence of appendicitis,” the authors report.

SOURCE:

Simon Eaton, PhD, of UCL Great Ormond Street Institute of Child Health in London, was the corresponding author of the study, published online in JAMA Surgery. The study was funded by the NIHR Biomedical Research Centre at Great Ormond Street Hospital and the Swedish Research Council.

LIMITATIONS:

The data were retrospective, so the researchers could not track how patients’ circumstances and characteristics changed over time. Most patients were male, and the researchers lacked histopathology results for patients for whom nonsurgical treatment succeeded initially but who later required appendectomy. They also relied on diagnostic standards used in the 1990s, when the initial studies were performed; these were less sophisticated and accurate than recent standards.

DISCLOSURES:

Coauthor Jan Svensson, MD, PhD, reported receiving grants from the Lovisa Foundation during the conduct of the study. No other disclosures were reported.

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

 

TOPLINE:

Most patients who receive antibiotics rather than surgical treatment for appendicitis have successful long-term outcomes, but some may require surgery up to 20 years later.

METHODOLOGY:

  • Follow-up on 292 patients involved in two randomized controlled trials conducted in the 1990s by the Swedish National Patient Registry
  • Both trials divided patients into two groups: those who underwent appendectomy and those who received antibiotic treatment for appendicitis.
  • Researchers looked at rates of recurrent appendicitis that required surgery later in life.

TAKEAWAY:

  • 29% of patients in the nonoperative group who were discharged successfully during the initial study eventually underwent surgery.
  • Some patients who initially received antibiotics required surgery up to 20 years later.
  • 9.5% of patients who didn’t undergo surgery went to a surgical outpatient clinic for abdominal pain, compared with 0.01% of those who had surgery.

IN PRACTICE:

“More than half of the patients treated nonoperatively did not experience recurrence and avoided surgery over approximately 2 decades. There is no evidence for long-term risks of nonoperative management other than that of recurrence of appendicitis,” the authors report.

SOURCE:

Simon Eaton, PhD, of UCL Great Ormond Street Institute of Child Health in London, was the corresponding author of the study, published online in JAMA Surgery. The study was funded by the NIHR Biomedical Research Centre at Great Ormond Street Hospital and the Swedish Research Council.

LIMITATIONS:

The data were retrospective, so the researchers could not track how patients’ circumstances and characteristics changed over time. Most patients were male, and the researchers lacked histopathology results for patients for whom nonsurgical treatment succeeded initially but who later required appendectomy. They also relied on diagnostic standards used in the 1990s, when the initial studies were performed; these were less sophisticated and accurate than recent standards.

DISCLOSURES:

Coauthor Jan Svensson, MD, PhD, reported receiving grants from the Lovisa Foundation during the conduct of the study. No other disclosures were reported.

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

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

Folic acid supplementation for birth defects reaffirmed

Article Type
Changed
Wed, 08/02/2023 - 12:46

Taking folic acid supplements before conception and in the first trimester of pregnancy continues to be a major line of defense against neural tube defects.

In a statement published in JAMA, the U.S. Preventive Services Task Force recommended that all people planning on becoming pregnant or who could become pregnant take a daily supplement of 0.4-0.8 mg (400-800 mcg) of folic acid to prevent neural tube defects. 

The task force also found that folic acid is not associated with maternal cancer or autism, which were the concerns of some researchers. The current findings regarding potential harm align with earlier evidence examining possible risks.

The recommendation also aligns with previous recommendations from the USPSTF and is supported by 12 more recent observational studies. Neural tube defects occur in an estimated 3,000 pregnancies per year.

Folic acid deficiency is common due to diet, impaired folate metabolism, and poor nutrient uptake as a result of medications or bariatric surgery. 

“As much as we’ve been trying to get the word out there, we still need to get it out there even more,” Wanda Nicholson, MD, MPH, MBA, vice chair of the USPSTF, told this news organization. “It’s so simple and straightforward and can be so impactful for the health of the baby.”

Neural tube formation occurs 26-28 days after fertilization. Folic acid supplementation is essential for all people who may become pregnant, considering half of the pregnancies in the United States are unplanned, according to the USPSTF.

“In many cases, neural tube formation has already occurred, or not occurred appropriately, before someone realizes that they’re pregnant,” Dr. Nicholson said. “That’s why it’s so important to start taking folic acid one month prior to conception if you’re planning on becoming pregnant, and if you’re capable of being pregnant but not planning pregnancy, yes, we’re advocating that you also proceed with folic acid supplementation.”

Primary care physicians play a key role in patient education and ensuring that all patients receive adequate folic acid, according to Spencer McClelland, MD, an obstetrician-gynecologist at Denver Health, who was not involved in the statement. Dr. McClelland advised that clinicians recommend patients who are or could get pregnant take a multivitamin, because most brands will contain the recommended dosage of folic acid.

“There’s some confusion about folic acid,” he said. “Many patients know that they should be on a prenatal vitamin, but most don’t know that the reason we’re recommending a prenatal vitamin is almost entirely because of the value of folic acid, and everything else in the prenatal vitamin is kind of icing on the cake.”

For patients trying to get pregnant, the risk for neural tube defects “is one of many examples of the importance of preconception counseling,” Dr. McClelland said.

Dr. Nicholson noted that the recommended 0.4-0.8 mg of folic acid per day is for patients without heightened deficiency due to medications or bariatric surgery. At-risk patients should receive counseling from their physician to determine the correct amount to take.

The authors report no conflicts of interest, financial or otherwise.

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

Publications
Topics
Sections

Taking folic acid supplements before conception and in the first trimester of pregnancy continues to be a major line of defense against neural tube defects.

In a statement published in JAMA, the U.S. Preventive Services Task Force recommended that all people planning on becoming pregnant or who could become pregnant take a daily supplement of 0.4-0.8 mg (400-800 mcg) of folic acid to prevent neural tube defects. 

The task force also found that folic acid is not associated with maternal cancer or autism, which were the concerns of some researchers. The current findings regarding potential harm align with earlier evidence examining possible risks.

The recommendation also aligns with previous recommendations from the USPSTF and is supported by 12 more recent observational studies. Neural tube defects occur in an estimated 3,000 pregnancies per year.

Folic acid deficiency is common due to diet, impaired folate metabolism, and poor nutrient uptake as a result of medications or bariatric surgery. 

“As much as we’ve been trying to get the word out there, we still need to get it out there even more,” Wanda Nicholson, MD, MPH, MBA, vice chair of the USPSTF, told this news organization. “It’s so simple and straightforward and can be so impactful for the health of the baby.”

Neural tube formation occurs 26-28 days after fertilization. Folic acid supplementation is essential for all people who may become pregnant, considering half of the pregnancies in the United States are unplanned, according to the USPSTF.

“In many cases, neural tube formation has already occurred, or not occurred appropriately, before someone realizes that they’re pregnant,” Dr. Nicholson said. “That’s why it’s so important to start taking folic acid one month prior to conception if you’re planning on becoming pregnant, and if you’re capable of being pregnant but not planning pregnancy, yes, we’re advocating that you also proceed with folic acid supplementation.”

Primary care physicians play a key role in patient education and ensuring that all patients receive adequate folic acid, according to Spencer McClelland, MD, an obstetrician-gynecologist at Denver Health, who was not involved in the statement. Dr. McClelland advised that clinicians recommend patients who are or could get pregnant take a multivitamin, because most brands will contain the recommended dosage of folic acid.

“There’s some confusion about folic acid,” he said. “Many patients know that they should be on a prenatal vitamin, but most don’t know that the reason we’re recommending a prenatal vitamin is almost entirely because of the value of folic acid, and everything else in the prenatal vitamin is kind of icing on the cake.”

For patients trying to get pregnant, the risk for neural tube defects “is one of many examples of the importance of preconception counseling,” Dr. McClelland said.

Dr. Nicholson noted that the recommended 0.4-0.8 mg of folic acid per day is for patients without heightened deficiency due to medications or bariatric surgery. At-risk patients should receive counseling from their physician to determine the correct amount to take.

The authors report no conflicts of interest, financial or otherwise.

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

Taking folic acid supplements before conception and in the first trimester of pregnancy continues to be a major line of defense against neural tube defects.

In a statement published in JAMA, the U.S. Preventive Services Task Force recommended that all people planning on becoming pregnant or who could become pregnant take a daily supplement of 0.4-0.8 mg (400-800 mcg) of folic acid to prevent neural tube defects. 

The task force also found that folic acid is not associated with maternal cancer or autism, which were the concerns of some researchers. The current findings regarding potential harm align with earlier evidence examining possible risks.

The recommendation also aligns with previous recommendations from the USPSTF and is supported by 12 more recent observational studies. Neural tube defects occur in an estimated 3,000 pregnancies per year.

Folic acid deficiency is common due to diet, impaired folate metabolism, and poor nutrient uptake as a result of medications or bariatric surgery. 

“As much as we’ve been trying to get the word out there, we still need to get it out there even more,” Wanda Nicholson, MD, MPH, MBA, vice chair of the USPSTF, told this news organization. “It’s so simple and straightforward and can be so impactful for the health of the baby.”

Neural tube formation occurs 26-28 days after fertilization. Folic acid supplementation is essential for all people who may become pregnant, considering half of the pregnancies in the United States are unplanned, according to the USPSTF.

“In many cases, neural tube formation has already occurred, or not occurred appropriately, before someone realizes that they’re pregnant,” Dr. Nicholson said. “That’s why it’s so important to start taking folic acid one month prior to conception if you’re planning on becoming pregnant, and if you’re capable of being pregnant but not planning pregnancy, yes, we’re advocating that you also proceed with folic acid supplementation.”

Primary care physicians play a key role in patient education and ensuring that all patients receive adequate folic acid, according to Spencer McClelland, MD, an obstetrician-gynecologist at Denver Health, who was not involved in the statement. Dr. McClelland advised that clinicians recommend patients who are or could get pregnant take a multivitamin, because most brands will contain the recommended dosage of folic acid.

“There’s some confusion about folic acid,” he said. “Many patients know that they should be on a prenatal vitamin, but most don’t know that the reason we’re recommending a prenatal vitamin is almost entirely because of the value of folic acid, and everything else in the prenatal vitamin is kind of icing on the cake.”

For patients trying to get pregnant, the risk for neural tube defects “is one of many examples of the importance of preconception counseling,” Dr. McClelland said.

Dr. Nicholson noted that the recommended 0.4-0.8 mg of folic acid per day is for patients without heightened deficiency due to medications or bariatric surgery. At-risk patients should receive counseling from their physician to determine the correct amount to take.

The authors report no conflicts of interest, financial or otherwise.

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

Publications
Publications
Topics
Article Type
Sections
Article Source

FROM JAMA

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