Be wary of “for eczema” advertising claims contained on the labels of popular skin moisturizers.

Results from a study presented during the virtual annual meeting of the Society for Pediatric Dermatology found that 93% of the top 30–selling skin products for eczema contained at least one common allergen.

“Prescription medications are important for managing eczema flares, but a lot of the work in treating eczema is preventative, done by consistently moisturizing the skin at home with drug store products,” co-first study author Catherine L. Ludwig, said in an interview. “Allergic contact dermatitis occurs more commonly in people with eczema. A previous study was done in characterizing the allergenic potential of drug store moisturizers and found that 88% of moisturizers contain at least one common allergen. Many moisturizers are marketed specifically to eczema, but the allergen content of these products are unknown.”

For the current study, Ms. Ludwig, a medical student at the University of Illinois at Chicago and co-first author Alyssa M. Thompson, a medical student at the University of Arizona, Tucson, and their colleagues compiled a list of the top 30 moisturizers “for eczema” sold by Amazon, Target, and Walmart. For each moisturizer they recorded common ingredients and marketing claims related to benefits for atopic dermatitis, including eczema relief, sensitive/gentle skin, hypoallergenic, anti-itch, anti-inflammatory, clinically proven, oatmeal, dermatologist recommended/approved, organic, fragrance-free, for baby, or National Eczema Association approved. To establish allergenic potential, the researchers used MATLAB to compare ingredient lists to compounds listed as common allergens in the American Contact Dermatitis Society’s Contact Allergen Management Program database (ACDS CAMP). Next, they used the Mann-Whitney U test to evaluate differences in allergen count between products with and without specific marketing claims.

Ms. Ludwig and her associates found that 28 of 30 products analyzed (93%) contained at least one allergen, with an overall average allergen count of 3.60. The three most prevalent allergens were cetyl alcohol (70%), phenoxyethanol (50%), and aloe (33%). “Anti-inflammatory” moisturizers had the greatest average number of allergens (4.00), followed by “anti-itch” (3.71) and “oatmeal” (3.71). Only products claiming to be “hypoallergenic” had significantly lower allergenic ingredient count (an average of 2.45) than those without the claim (P = .011).

“It was validating to see that eczema moisturizer products marketed as ‘hypoallergenic’ truly do have fewer allergenic ingredients than moisturizers without the claim,” Ms. Ludwig said. “However, it was surprising to see that even products marketed to eczema patients, who have a higher prevalence of allergic contact dermatitis, contain an average of 3.6 common allergens. As dermatology providers, we can relay to patients and parents that relying solely on ‘for eczema’ claims is not advisable. Clinicians should acquaint themselves with the top allergens (cetyl alcohol, phenoxyethanol, and aloe) and keep these ingredients, as well as affordability and patient preferences, in mind when making product recommendations.”

The study’s senior author, Vivian Y. Shi, MD, is a stock shareholder of Learn Health and has served as an advisory board member and/or investigator, and/or received research funding from AbbVie, Burt’s Bees, GpSkin, LEO Pharma, Eli Lilly, Menlo Therapeutics, Novartis, Pfizer, Regeneron, Sanofi Genzyme, Skin Actives Scientific, and SUN Pharma, and the Foundation for Atopic Dermatitis, Global Parents for Eczema Research, and the National Eczema Association. The other study authors reported having no financial disclosures.
 

dbrunk@mdedge.com

Be wary of “for eczema” advertising claims contained on the labels of popular skin moisturizers.

Results from a study presented during the virtual annual meeting of the Society for Pediatric Dermatology found that 93% of the top 30–selling skin products for eczema contained at least one common allergen.

“Prescription medications are important for managing eczema flares, but a lot of the work in treating eczema is preventative, done by consistently moisturizing the skin at home with drug store products,” co-first study author Catherine L. Ludwig, said in an interview. “Allergic contact dermatitis occurs more commonly in people with eczema. A previous study was done in characterizing the allergenic potential of drug store moisturizers and found that 88% of moisturizers contain at least one common allergen. Many moisturizers are marketed specifically to eczema, but the allergen content of these products are unknown.”

For the current study, Ms. Ludwig, a medical student at the University of Illinois at Chicago and co-first author Alyssa M. Thompson, a medical student at the University of Arizona, Tucson, and their colleagues compiled a list of the top 30 moisturizers “for eczema” sold by Amazon, Target, and Walmart. For each moisturizer they recorded common ingredients and marketing claims related to benefits for atopic dermatitis, including eczema relief, sensitive/gentle skin, hypoallergenic, anti-itch, anti-inflammatory, clinically proven, oatmeal, dermatologist recommended/approved, organic, fragrance-free, for baby, or National Eczema Association approved. To establish allergenic potential, the researchers used MATLAB to compare ingredient lists to compounds listed as common allergens in the American Contact Dermatitis Society’s Contact Allergen Management Program database (ACDS CAMP). Next, they used the Mann-Whitney U test to evaluate differences in allergen count between products with and without specific marketing claims.

Ms. Ludwig and her associates found that 28 of 30 products analyzed (93%) contained at least one allergen, with an overall average allergen count of 3.60. The three most prevalent allergens were cetyl alcohol (70%), phenoxyethanol (50%), and aloe (33%). “Anti-inflammatory” moisturizers had the greatest average number of allergens (4.00), followed by “anti-itch” (3.71) and “oatmeal” (3.71). Only products claiming to be “hypoallergenic” had significantly lower allergenic ingredient count (an average of 2.45) than those without the claim (P = .011).

“It was validating to see that eczema moisturizer products marketed as ‘hypoallergenic’ truly do have fewer allergenic ingredients than moisturizers without the claim,” Ms. Ludwig said. “However, it was surprising to see that even products marketed to eczema patients, who have a higher prevalence of allergic contact dermatitis, contain an average of 3.6 common allergens. As dermatology providers, we can relay to patients and parents that relying solely on ‘for eczema’ claims is not advisable. Clinicians should acquaint themselves with the top allergens (cetyl alcohol, phenoxyethanol, and aloe) and keep these ingredients, as well as affordability and patient preferences, in mind when making product recommendations.”

The study’s senior author, Vivian Y. Shi, MD, is a stock shareholder of Learn Health and has served as an advisory board member and/or investigator, and/or received research funding from AbbVie, Burt’s Bees, GpSkin, LEO Pharma, Eli Lilly, Menlo Therapeutics, Novartis, Pfizer, Regeneron, Sanofi Genzyme, Skin Actives Scientific, and SUN Pharma, and the Foundation for Atopic Dermatitis, Global Parents for Eczema Research, and the National Eczema Association. The other study authors reported having no financial disclosures.
 

dbrunk@mdedge.com

Be wary of “for eczema” advertising claims contained on the labels of popular skin moisturizers.

Results from a study presented during the virtual annual meeting of the Society for Pediatric Dermatology found that 93% of the top 30–selling skin products for eczema contained at least one common allergen.

“Prescription medications are important for managing eczema flares, but a lot of the work in treating eczema is preventative, done by consistently moisturizing the skin at home with drug store products,” co-first study author Catherine L. Ludwig, said in an interview. “Allergic contact dermatitis occurs more commonly in people with eczema. A previous study was done in characterizing the allergenic potential of drug store moisturizers and found that 88% of moisturizers contain at least one common allergen. Many moisturizers are marketed specifically to eczema, but the allergen content of these products are unknown.”

For the current study, Ms. Ludwig, a medical student at the University of Illinois at Chicago and co-first author Alyssa M. Thompson, a medical student at the University of Arizona, Tucson, and their colleagues compiled a list of the top 30 moisturizers “for eczema” sold by Amazon, Target, and Walmart. For each moisturizer they recorded common ingredients and marketing claims related to benefits for atopic dermatitis, including eczema relief, sensitive/gentle skin, hypoallergenic, anti-itch, anti-inflammatory, clinically proven, oatmeal, dermatologist recommended/approved, organic, fragrance-free, for baby, or National Eczema Association approved. To establish allergenic potential, the researchers used MATLAB to compare ingredient lists to compounds listed as common allergens in the American Contact Dermatitis Society’s Contact Allergen Management Program database (ACDS CAMP). Next, they used the Mann-Whitney U test to evaluate differences in allergen count between products with and without specific marketing claims.

Ms. Ludwig and her associates found that 28 of 30 products analyzed (93%) contained at least one allergen, with an overall average allergen count of 3.60. The three most prevalent allergens were cetyl alcohol (70%), phenoxyethanol (50%), and aloe (33%). “Anti-inflammatory” moisturizers had the greatest average number of allergens (4.00), followed by “anti-itch” (3.71) and “oatmeal” (3.71). Only products claiming to be “hypoallergenic” had significantly lower allergenic ingredient count (an average of 2.45) than those without the claim (P = .011).

“It was validating to see that eczema moisturizer products marketed as ‘hypoallergenic’ truly do have fewer allergenic ingredients than moisturizers without the claim,” Ms. Ludwig said. “However, it was surprising to see that even products marketed to eczema patients, who have a higher prevalence of allergic contact dermatitis, contain an average of 3.6 common allergens. As dermatology providers, we can relay to patients and parents that relying solely on ‘for eczema’ claims is not advisable. Clinicians should acquaint themselves with the top allergens (cetyl alcohol, phenoxyethanol, and aloe) and keep these ingredients, as well as affordability and patient preferences, in mind when making product recommendations.”

The study’s senior author, Vivian Y. Shi, MD, is a stock shareholder of Learn Health and has served as an advisory board member and/or investigator, and/or received research funding from AbbVie, Burt’s Bees, GpSkin, LEO Pharma, Eli Lilly, Menlo Therapeutics, Novartis, Pfizer, Regeneron, Sanofi Genzyme, Skin Actives Scientific, and SUN Pharma, and the Foundation for Atopic Dermatitis, Global Parents for Eczema Research, and the National Eczema Association. The other study authors reported having no financial disclosures.
 

dbrunk@mdedge.com

Less rapid eye movement (REM) sleep is associated with an increased risk for death in middle-aged and older adults, new research suggests.

Investigators at the University of California, San Diego, found that, over a 12-year period, each 5% reduction in REM sleep was associated with a 13% increase in mortality rate. However, the investigators noted that this is only an association and does not indicate cause and effect.

“Determining causality can be difficult,” study investigator Sonia Ancoli-Israel, PhD, professor emeritus of psychiatry at the University of California, San Diego, said in an interview.

“It is therefore important that physicians and the public understand that our findings suggest an increased risk, but that does not mean that reduced REM will always result in shorter survival. With all the self-monitoring sleep gadgets available to the public, I would caution against any panic if one notices reduced REM. But mentioning it to a physician may be a clue to examine what else might be going on with that patient that could more easily be targeted,” Dr. Ancoli-Israel added.

The research was published online July 6 in JAMA Neurology.
 

Negative consequences

Approximately 50-70 million Americans have problems with sleep. Such problems have a multitude of consequences for health, including cardiovascular disease; metabolic, psychiatric, and cognitive disorders; lower quality of life; and increased mortality.

The investigators noted that the aspects of sleep that may be driving this association remain unclear. Because decreased REM sleep has been associated with poor mental and physical health outcomes, the researchers hypothesized that decreased REM sleep may be associated with an increased risk for death.

To test this hypothesis, they conducted a multicenter, population-based, cross-sectional investigation using data from independent cohorts – the Outcomes of Sleep Disorders in Older Men (MrOS) Sleep Study and the Wisconsin Sleep Cohort (WSC). The MrOS cohort included 2,675 men (mean age, 76.3 years) who were recruited from December 2003 to March 2005 at six U.S. centers and were followed for a median of 12.1 years. The WSC cohort included 1,386 individuals (54.3% men; mean age, 51.5 years) and had a median follow-up of 20.8 years. Data from this study were used to replicate the findings from the MrOS study.

Primary outcome measures included all-cause and cause-specific mortality, which were confirmed using death certificates.

Participants in both cohorts underwent polysomnography and evaluation with the Epworth Sleepiness Scale. For MrOS participants, investigators calculated the total number of minutes per night spent in REM sleep and the corresponding percentage of total sleep time.
 

Less sleep, more death

Self-report sleep measures in MrOS participants were collected using the Pittsburgh Sleep Quality Index and the Functional Outcomes of Sleep Questionnaire

The investigators contacted participants in MrOS every 4 months to determine vital status. Cause of death was categorized by the ICD-9 as cardiovascular, cancer, and other. In WSC, the researchers identified deaths by matching participants’ social security numbers with national and state registries. The cause of death was categorized in the same manner as in the MrOS cohort.

Approximately half (53%) of the MrOS cohort died during follow-up. For each mortality category, the highest percentage of deaths occurred among those in the lowest quartile percentage of REM sleep. Adjusted analyses revealed that the MrOS participants had a 13% higher mortality rate for every 5% reduction in REM sleep (hazard ratio, 1.13; 95% confidence interval, 1.08-1.19). These findings were similar for cardiovascular and other causes of death but were not significant for cancer-related mortality. For all mortality categories, the mortality rate was higher for participants who had less than 15% REM sleep per night in comparison with individuals who had 15% or more.

The findings were similar in the WSC cohort despite its younger age, the inclusion of women, and longer follow-up (HR, 1.13; 95% CI, 1.08-1.19). Compared with MrOS participants, WSC participants were more likely to be obese and to use more antidepressants or sedatives. Overall, the mean percentage of REM sleep was 19.2%. Participants in the lowest quartile of REM sleep generally were older, had higher rates of antidepressant use, hypertension, heart attack, and transient ischemic attack, as well as engaging in less physical activity.
 

Ask about sleep

When the data were stratified by sex, the association between decreased REM sleep and mortality was significant for women but not for men.

“Obtaining a sleep study, representative of the patient’s usual sleep, that shows reduced REM time should alert the neurologist to look for reasons for low REM,” the study’s coinvestigator, Susan Redline, MD, MPH, Peter C. Farrell Professor of Sleep Medicine at Harvard Medical School in Boston, said in an interview.

Dr. Redline added that measures to promote sleep health, such as encouraging regular, sufficient nightly sleep; offering guidance on avoiding alcohol before bedtime and on other healthy sleep practices; and treating sleep disorders may be beneficial.

Low REM time, especially interpreted with other relevant clinical information, may alert the neurologist that a patient may have risk factors for poorer health, she added.

Sleep studies are expensive and are in high demand, so “the most realistic approach is for the neurologist to be asking each and every patient about their sleep,” said Ancoli-Israel.

“By asking a few more questions in every intake, the neurologist is more likely to determine if there are any occult sleep disorders that need to be addressed. By improving sleep in general, one is more likely to also improve any REM abnormalities,” she said.
 

Disease indicator?

In an accompanying editorial, Michael S. Jaffee, MD, vice chair of neurology at the University of Florida in Gainesville, and colleagues noted that the study raises the question of whether REM sleep “could serve as a biomarker for general health.”

“Since the known roles of REM sleep do not easily suggest a causal link with mortality ... it seems more likely that REM sleep reduction is either a crude marker of health or specific disease states that decrease REM sleep may play an important role in contributing to mortality,” they wrote.

Neurologists should remember that certain medications affect sleep architecture, the editorialists advised. They note that serotonin reuptake inhibitors, selective serotonin and norepinephrine reuptake inhibitors, and tricyclic antidepressants reduce REM sleep, and that gabapentin, prazosin, and bupropion, on the other hand, increase REM sleep. However, data regarding whether these medications have an effect on mortality are insufficient.

The editorialists wrote that the study findings are a “welcome addition to the literature and demonstrate definitively that the association between sleep and mortality extends beyond the simple measure of total sleep time.”

Funding for the MrOS and WSC studies was provided by the National Institutes of Health and the National Institute on Aging. Dr. Ancoli-Israel consults for Eisai and Merck on matters unrelated to the study. Dr. Redline has received grants and personal fees from Jazz Pharmaceuticals, consulting fees from Respicardia, and personal fees from Eisai unrelated to the study. Dr. Jaffee served on a data and safety monitoring board for Helius Medical Technologies and consulted for the National Collegiate Athletic Association and the Department of Defense.

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

Less rapid eye movement (REM) sleep is associated with an increased risk for death in middle-aged and older adults, new research suggests.

Investigators at the University of California, San Diego, found that, over a 12-year period, each 5% reduction in REM sleep was associated with a 13% increase in mortality rate. However, the investigators noted that this is only an association and does not indicate cause and effect.

“Determining causality can be difficult,” study investigator Sonia Ancoli-Israel, PhD, professor emeritus of psychiatry at the University of California, San Diego, said in an interview.

“It is therefore important that physicians and the public understand that our findings suggest an increased risk, but that does not mean that reduced REM will always result in shorter survival. With all the self-monitoring sleep gadgets available to the public, I would caution against any panic if one notices reduced REM. But mentioning it to a physician may be a clue to examine what else might be going on with that patient that could more easily be targeted,” Dr. Ancoli-Israel added.

The research was published online July 6 in JAMA Neurology.
 

Negative consequences

Approximately 50-70 million Americans have problems with sleep. Such problems have a multitude of consequences for health, including cardiovascular disease; metabolic, psychiatric, and cognitive disorders; lower quality of life; and increased mortality.

The investigators noted that the aspects of sleep that may be driving this association remain unclear. Because decreased REM sleep has been associated with poor mental and physical health outcomes, the researchers hypothesized that decreased REM sleep may be associated with an increased risk for death.

To test this hypothesis, they conducted a multicenter, population-based, cross-sectional investigation using data from independent cohorts – the Outcomes of Sleep Disorders in Older Men (MrOS) Sleep Study and the Wisconsin Sleep Cohort (WSC). The MrOS cohort included 2,675 men (mean age, 76.3 years) who were recruited from December 2003 to March 2005 at six U.S. centers and were followed for a median of 12.1 years. The WSC cohort included 1,386 individuals (54.3% men; mean age, 51.5 years) and had a median follow-up of 20.8 years. Data from this study were used to replicate the findings from the MrOS study.

Primary outcome measures included all-cause and cause-specific mortality, which were confirmed using death certificates.

Participants in both cohorts underwent polysomnography and evaluation with the Epworth Sleepiness Scale. For MrOS participants, investigators calculated the total number of minutes per night spent in REM sleep and the corresponding percentage of total sleep time.
 

Less sleep, more death

Self-report sleep measures in MrOS participants were collected using the Pittsburgh Sleep Quality Index and the Functional Outcomes of Sleep Questionnaire

The investigators contacted participants in MrOS every 4 months to determine vital status. Cause of death was categorized by the ICD-9 as cardiovascular, cancer, and other. In WSC, the researchers identified deaths by matching participants’ social security numbers with national and state registries. The cause of death was categorized in the same manner as in the MrOS cohort.

Approximately half (53%) of the MrOS cohort died during follow-up. For each mortality category, the highest percentage of deaths occurred among those in the lowest quartile percentage of REM sleep. Adjusted analyses revealed that the MrOS participants had a 13% higher mortality rate for every 5% reduction in REM sleep (hazard ratio, 1.13; 95% confidence interval, 1.08-1.19). These findings were similar for cardiovascular and other causes of death but were not significant for cancer-related mortality. For all mortality categories, the mortality rate was higher for participants who had less than 15% REM sleep per night in comparison with individuals who had 15% or more.

The findings were similar in the WSC cohort despite its younger age, the inclusion of women, and longer follow-up (HR, 1.13; 95% CI, 1.08-1.19). Compared with MrOS participants, WSC participants were more likely to be obese and to use more antidepressants or sedatives. Overall, the mean percentage of REM sleep was 19.2%. Participants in the lowest quartile of REM sleep generally were older, had higher rates of antidepressant use, hypertension, heart attack, and transient ischemic attack, as well as engaging in less physical activity.
 

Ask about sleep

When the data were stratified by sex, the association between decreased REM sleep and mortality was significant for women but not for men.

“Obtaining a sleep study, representative of the patient’s usual sleep, that shows reduced REM time should alert the neurologist to look for reasons for low REM,” the study’s coinvestigator, Susan Redline, MD, MPH, Peter C. Farrell Professor of Sleep Medicine at Harvard Medical School in Boston, said in an interview.

Dr. Redline added that measures to promote sleep health, such as encouraging regular, sufficient nightly sleep; offering guidance on avoiding alcohol before bedtime and on other healthy sleep practices; and treating sleep disorders may be beneficial.

Low REM time, especially interpreted with other relevant clinical information, may alert the neurologist that a patient may have risk factors for poorer health, she added.

Sleep studies are expensive and are in high demand, so “the most realistic approach is for the neurologist to be asking each and every patient about their sleep,” said Ancoli-Israel.

“By asking a few more questions in every intake, the neurologist is more likely to determine if there are any occult sleep disorders that need to be addressed. By improving sleep in general, one is more likely to also improve any REM abnormalities,” she said.
 

Disease indicator?

In an accompanying editorial, Michael S. Jaffee, MD, vice chair of neurology at the University of Florida in Gainesville, and colleagues noted that the study raises the question of whether REM sleep “could serve as a biomarker for general health.”

“Since the known roles of REM sleep do not easily suggest a causal link with mortality ... it seems more likely that REM sleep reduction is either a crude marker of health or specific disease states that decrease REM sleep may play an important role in contributing to mortality,” they wrote.

Neurologists should remember that certain medications affect sleep architecture, the editorialists advised. They note that serotonin reuptake inhibitors, selective serotonin and norepinephrine reuptake inhibitors, and tricyclic antidepressants reduce REM sleep, and that gabapentin, prazosin, and bupropion, on the other hand, increase REM sleep. However, data regarding whether these medications have an effect on mortality are insufficient.

The editorialists wrote that the study findings are a “welcome addition to the literature and demonstrate definitively that the association between sleep and mortality extends beyond the simple measure of total sleep time.”

Funding for the MrOS and WSC studies was provided by the National Institutes of Health and the National Institute on Aging. Dr. Ancoli-Israel consults for Eisai and Merck on matters unrelated to the study. Dr. Redline has received grants and personal fees from Jazz Pharmaceuticals, consulting fees from Respicardia, and personal fees from Eisai unrelated to the study. Dr. Jaffee served on a data and safety monitoring board for Helius Medical Technologies and consulted for the National Collegiate Athletic Association and the Department of Defense.

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

Less rapid eye movement (REM) sleep is associated with an increased risk for death in middle-aged and older adults, new research suggests.

Investigators at the University of California, San Diego, found that, over a 12-year period, each 5% reduction in REM sleep was associated with a 13% increase in mortality rate. However, the investigators noted that this is only an association and does not indicate cause and effect.

“Determining causality can be difficult,” study investigator Sonia Ancoli-Israel, PhD, professor emeritus of psychiatry at the University of California, San Diego, said in an interview.

“It is therefore important that physicians and the public understand that our findings suggest an increased risk, but that does not mean that reduced REM will always result in shorter survival. With all the self-monitoring sleep gadgets available to the public, I would caution against any panic if one notices reduced REM. But mentioning it to a physician may be a clue to examine what else might be going on with that patient that could more easily be targeted,” Dr. Ancoli-Israel added.

The research was published online July 6 in JAMA Neurology.
 

Negative consequences

Approximately 50-70 million Americans have problems with sleep. Such problems have a multitude of consequences for health, including cardiovascular disease; metabolic, psychiatric, and cognitive disorders; lower quality of life; and increased mortality.

The investigators noted that the aspects of sleep that may be driving this association remain unclear. Because decreased REM sleep has been associated with poor mental and physical health outcomes, the researchers hypothesized that decreased REM sleep may be associated with an increased risk for death.

To test this hypothesis, they conducted a multicenter, population-based, cross-sectional investigation using data from independent cohorts – the Outcomes of Sleep Disorders in Older Men (MrOS) Sleep Study and the Wisconsin Sleep Cohort (WSC). The MrOS cohort included 2,675 men (mean age, 76.3 years) who were recruited from December 2003 to March 2005 at six U.S. centers and were followed for a median of 12.1 years. The WSC cohort included 1,386 individuals (54.3% men; mean age, 51.5 years) and had a median follow-up of 20.8 years. Data from this study were used to replicate the findings from the MrOS study.

Primary outcome measures included all-cause and cause-specific mortality, which were confirmed using death certificates.

Participants in both cohorts underwent polysomnography and evaluation with the Epworth Sleepiness Scale. For MrOS participants, investigators calculated the total number of minutes per night spent in REM sleep and the corresponding percentage of total sleep time.
 

Less sleep, more death

Self-report sleep measures in MrOS participants were collected using the Pittsburgh Sleep Quality Index and the Functional Outcomes of Sleep Questionnaire

The investigators contacted participants in MrOS every 4 months to determine vital status. Cause of death was categorized by the ICD-9 as cardiovascular, cancer, and other. In WSC, the researchers identified deaths by matching participants’ social security numbers with national and state registries. The cause of death was categorized in the same manner as in the MrOS cohort.

Approximately half (53%) of the MrOS cohort died during follow-up. For each mortality category, the highest percentage of deaths occurred among those in the lowest quartile percentage of REM sleep. Adjusted analyses revealed that the MrOS participants had a 13% higher mortality rate for every 5% reduction in REM sleep (hazard ratio, 1.13; 95% confidence interval, 1.08-1.19). These findings were similar for cardiovascular and other causes of death but were not significant for cancer-related mortality. For all mortality categories, the mortality rate was higher for participants who had less than 15% REM sleep per night in comparison with individuals who had 15% or more.

The findings were similar in the WSC cohort despite its younger age, the inclusion of women, and longer follow-up (HR, 1.13; 95% CI, 1.08-1.19). Compared with MrOS participants, WSC participants were more likely to be obese and to use more antidepressants or sedatives. Overall, the mean percentage of REM sleep was 19.2%. Participants in the lowest quartile of REM sleep generally were older, had higher rates of antidepressant use, hypertension, heart attack, and transient ischemic attack, as well as engaging in less physical activity.
 

Ask about sleep

When the data were stratified by sex, the association between decreased REM sleep and mortality was significant for women but not for men.

“Obtaining a sleep study, representative of the patient’s usual sleep, that shows reduced REM time should alert the neurologist to look for reasons for low REM,” the study’s coinvestigator, Susan Redline, MD, MPH, Peter C. Farrell Professor of Sleep Medicine at Harvard Medical School in Boston, said in an interview.

Dr. Redline added that measures to promote sleep health, such as encouraging regular, sufficient nightly sleep; offering guidance on avoiding alcohol before bedtime and on other healthy sleep practices; and treating sleep disorders may be beneficial.

Low REM time, especially interpreted with other relevant clinical information, may alert the neurologist that a patient may have risk factors for poorer health, she added.

Sleep studies are expensive and are in high demand, so “the most realistic approach is for the neurologist to be asking each and every patient about their sleep,” said Ancoli-Israel.

“By asking a few more questions in every intake, the neurologist is more likely to determine if there are any occult sleep disorders that need to be addressed. By improving sleep in general, one is more likely to also improve any REM abnormalities,” she said.
 

Disease indicator?

In an accompanying editorial, Michael S. Jaffee, MD, vice chair of neurology at the University of Florida in Gainesville, and colleagues noted that the study raises the question of whether REM sleep “could serve as a biomarker for general health.”

“Since the known roles of REM sleep do not easily suggest a causal link with mortality ... it seems more likely that REM sleep reduction is either a crude marker of health or specific disease states that decrease REM sleep may play an important role in contributing to mortality,” they wrote.

Neurologists should remember that certain medications affect sleep architecture, the editorialists advised. They note that serotonin reuptake inhibitors, selective serotonin and norepinephrine reuptake inhibitors, and tricyclic antidepressants reduce REM sleep, and that gabapentin, prazosin, and bupropion, on the other hand, increase REM sleep. However, data regarding whether these medications have an effect on mortality are insufficient.

The editorialists wrote that the study findings are a “welcome addition to the literature and demonstrate definitively that the association between sleep and mortality extends beyond the simple measure of total sleep time.”

Funding for the MrOS and WSC studies was provided by the National Institutes of Health and the National Institute on Aging. Dr. Ancoli-Israel consults for Eisai and Merck on matters unrelated to the study. Dr. Redline has received grants and personal fees from Jazz Pharmaceuticals, consulting fees from Respicardia, and personal fees from Eisai unrelated to the study. Dr. Jaffee served on a data and safety monitoring board for Helius Medical Technologies and consulted for the National Collegiate Athletic Association and the Department of Defense.

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

Bufexamac, a nonsteroidal anti-inflammatory drug agent used cutaneously and rectally, is well known globally as an initiator of allergic contact dermatitis. In fact, it has been removed from the European market (except Switzerland) for inducing allergic reactions, and is also banned in Japan, New Zealand, and the United States (where it was never approved).¹ This column will primarily discuss recent findings in human trials and weigh in on the issue.

Antioxidant activity

In addition to its known anti-inflammatory activity, bufexamac has been found to exert antioxidant effects. In 2003, Trommer and Neubert demonstrated that bufexamac displayed antioxidant activity in lipid models and HaCaT keratinocytes, as measured through mass spectrometry.² In a 2005 in vitro study of the impact of 47 drugs, plant extracts and ingredients, and polysaccharides on lipid peroxidation engendered by UV irradiation, Trommer and Neubert found that bufexamac was among the drugs shown to exhibit antioxidant activity.³

Minor allergen? Worth using?

In a 2009 study on the prevalence and risk factors for allergic contact dermatitis to topical atopic dermatitis (AD) treatments, Mailhol et al. patch tested 641 children with AD using seven then-common ingredients (chlorhexidine, hexamidine, budesonide, tixocortol pivalate, bufexamac, sodium fusidate and with the current emollient used by the child). Bufexamac was identified as an allergen in only 2.5% of the 41 positive patch tests.⁴

To ban or not to ban

In 2012, the European Medicines Agency’s Committee for Medicinal Products for Human Use recommended that the marketing of formulations containing bufexamac be disallowed throughout the European Union because of a tendency toward inducing severe allergic contact dermatitis.⁵

Given its continuing use in Australia for the local treatment of several dermatoses, Pan and Nixon, in 2012, retrospectively reviewed patch-test data at the Skin and Cancer Foundation Inc. and found 19 cases of positive reactions to bufexamac (5% petrolatum) from 451 people patch tested. In 13 of 19 patients (68%), the reaction to bufexamac was considered to be associated with the identified dermatitis. The authors concluded that allergic contact dermatitis from bufexamac exposure is underreported in the English-language literature and cautioned that physicians should consider bufexamac allergy in patients who have a history of exposure.⁵

Bufexamac remained available over the counter in topical formulations in Australia as of early 2019. In response, Harris et al. presented several cases of patients who experienced severe skin eruptions after using such preparations in support of their advocacy to the Therapeutic Goods Administration in Australia to ban its use.⁶

In the middle of that year, Wong et al. reported on the hospitalization of a 41-year-old administrative worker who applied a first aid cream containing bufexamac (5%), lignocaine (1%), and chlorhexidine (0.1%) to a superficial right foot abrasion and who developed facial edema and widespread polymorphic eruptions 2 hours later. The authors suggested that this case reinforced the need to remove bufexamac from the markets where it remains because of the tendency to provoke severe allergic contact dermatoses and lack of efficacy.¹

Conclusion

Bufexamac offers the somewhat rare opportunity for advocacy. That is to say, I think there is sufficient evidence to justify the removal of this potent allergen from the market in Australia, Switzerland, and other countries where it may be available.

Dr. Baumann is a private practice dermatologist, researcher, author, and entrepreneur who practices in Miami. She founded the Cosmetic Dermatology Center at the University of Miami in 1997. Dr. Baumann has written two textbooks and a New York Times Best Sellers book for consumers. Dr. Baumann has received funding for advisory boards and/or clinical research trials from Allergan, Evolus, Galderma, and Revance. She is the founder and CEO of Skin Type Solutions Franchise Systems LLC. She had no relevant disclosures. Write to her at dermnews@mdedge.com.

References

1. Wong GN et al. Contact Dermatitis. 2019 Jun;80(6):395-7.

2. Trommer H et al. J Pharm Pharmacol. 2003 Oct;55(10):1379-88.

3. Trommer H, Neubert RH. J Pharm Pharm Sci. 2005 Sep 15;8(3):494-506.

4. Mailhol C et al. Allergy. 2009 May;64(5):801-6.

5. Pan Y, Nixon R. Australas J Dermatol. 2012 Aug;53(3):207-10.

6. Harris AG et al. Australas J Dermatol. 2019 Feb;60(1):53-6.

Bufexamac, a nonsteroidal anti-inflammatory drug agent used cutaneously and rectally, is well known globally as an initiator of allergic contact dermatitis. In fact, it has been removed from the European market (except Switzerland) for inducing allergic reactions, and is also banned in Japan, New Zealand, and the United States (where it was never approved).¹ This column will primarily discuss recent findings in human trials and weigh in on the issue.

Antioxidant activity

In addition to its known anti-inflammatory activity, bufexamac has been found to exert antioxidant effects. In 2003, Trommer and Neubert demonstrated that bufexamac displayed antioxidant activity in lipid models and HaCaT keratinocytes, as measured through mass spectrometry.² In a 2005 in vitro study of the impact of 47 drugs, plant extracts and ingredients, and polysaccharides on lipid peroxidation engendered by UV irradiation, Trommer and Neubert found that bufexamac was among the drugs shown to exhibit antioxidant activity.³

Minor allergen? Worth using?

In a 2009 study on the prevalence and risk factors for allergic contact dermatitis to topical atopic dermatitis (AD) treatments, Mailhol et al. patch tested 641 children with AD using seven then-common ingredients (chlorhexidine, hexamidine, budesonide, tixocortol pivalate, bufexamac, sodium fusidate and with the current emollient used by the child). Bufexamac was identified as an allergen in only 2.5% of the 41 positive patch tests.⁴

To ban or not to ban

In 2012, the European Medicines Agency’s Committee for Medicinal Products for Human Use recommended that the marketing of formulations containing bufexamac be disallowed throughout the European Union because of a tendency toward inducing severe allergic contact dermatitis.⁵

Given its continuing use in Australia for the local treatment of several dermatoses, Pan and Nixon, in 2012, retrospectively reviewed patch-test data at the Skin and Cancer Foundation Inc. and found 19 cases of positive reactions to bufexamac (5% petrolatum) from 451 people patch tested. In 13 of 19 patients (68%), the reaction to bufexamac was considered to be associated with the identified dermatitis. The authors concluded that allergic contact dermatitis from bufexamac exposure is underreported in the English-language literature and cautioned that physicians should consider bufexamac allergy in patients who have a history of exposure.⁵

Bufexamac remained available over the counter in topical formulations in Australia as of early 2019. In response, Harris et al. presented several cases of patients who experienced severe skin eruptions after using such preparations in support of their advocacy to the Therapeutic Goods Administration in Australia to ban its use.⁶

In the middle of that year, Wong et al. reported on the hospitalization of a 41-year-old administrative worker who applied a first aid cream containing bufexamac (5%), lignocaine (1%), and chlorhexidine (0.1%) to a superficial right foot abrasion and who developed facial edema and widespread polymorphic eruptions 2 hours later. The authors suggested that this case reinforced the need to remove bufexamac from the markets where it remains because of the tendency to provoke severe allergic contact dermatoses and lack of efficacy.¹

Conclusion

Bufexamac offers the somewhat rare opportunity for advocacy. That is to say, I think there is sufficient evidence to justify the removal of this potent allergen from the market in Australia, Switzerland, and other countries where it may be available.

Dr. Baumann is a private practice dermatologist, researcher, author, and entrepreneur who practices in Miami. She founded the Cosmetic Dermatology Center at the University of Miami in 1997. Dr. Baumann has written two textbooks and a New York Times Best Sellers book for consumers. Dr. Baumann has received funding for advisory boards and/or clinical research trials from Allergan, Evolus, Galderma, and Revance. She is the founder and CEO of Skin Type Solutions Franchise Systems LLC. She had no relevant disclosures. Write to her at dermnews@mdedge.com.

References

1. Wong GN et al. Contact Dermatitis. 2019 Jun;80(6):395-7.

2. Trommer H et al. J Pharm Pharmacol. 2003 Oct;55(10):1379-88.

3. Trommer H, Neubert RH. J Pharm Pharm Sci. 2005 Sep 15;8(3):494-506.

4. Mailhol C et al. Allergy. 2009 May;64(5):801-6.

5. Pan Y, Nixon R. Australas J Dermatol. 2012 Aug;53(3):207-10.

6. Harris AG et al. Australas J Dermatol. 2019 Feb;60(1):53-6.

Bufexamac, a nonsteroidal anti-inflammatory drug agent used cutaneously and rectally, is well known globally as an initiator of allergic contact dermatitis. In fact, it has been removed from the European market (except Switzerland) for inducing allergic reactions, and is also banned in Japan, New Zealand, and the United States (where it was never approved).¹ This column will primarily discuss recent findings in human trials and weigh in on the issue.

Antioxidant activity

In addition to its known anti-inflammatory activity, bufexamac has been found to exert antioxidant effects. In 2003, Trommer and Neubert demonstrated that bufexamac displayed antioxidant activity in lipid models and HaCaT keratinocytes, as measured through mass spectrometry.² In a 2005 in vitro study of the impact of 47 drugs, plant extracts and ingredients, and polysaccharides on lipid peroxidation engendered by UV irradiation, Trommer and Neubert found that bufexamac was among the drugs shown to exhibit antioxidant activity.³

Minor allergen? Worth using?

In a 2009 study on the prevalence and risk factors for allergic contact dermatitis to topical atopic dermatitis (AD) treatments, Mailhol et al. patch tested 641 children with AD using seven then-common ingredients (chlorhexidine, hexamidine, budesonide, tixocortol pivalate, bufexamac, sodium fusidate and with the current emollient used by the child). Bufexamac was identified as an allergen in only 2.5% of the 41 positive patch tests.⁴

To ban or not to ban

In 2012, the European Medicines Agency’s Committee for Medicinal Products for Human Use recommended that the marketing of formulations containing bufexamac be disallowed throughout the European Union because of a tendency toward inducing severe allergic contact dermatitis.⁵

Given its continuing use in Australia for the local treatment of several dermatoses, Pan and Nixon, in 2012, retrospectively reviewed patch-test data at the Skin and Cancer Foundation Inc. and found 19 cases of positive reactions to bufexamac (5% petrolatum) from 451 people patch tested. In 13 of 19 patients (68%), the reaction to bufexamac was considered to be associated with the identified dermatitis. The authors concluded that allergic contact dermatitis from bufexamac exposure is underreported in the English-language literature and cautioned that physicians should consider bufexamac allergy in patients who have a history of exposure.⁵

Bufexamac remained available over the counter in topical formulations in Australia as of early 2019. In response, Harris et al. presented several cases of patients who experienced severe skin eruptions after using such preparations in support of their advocacy to the Therapeutic Goods Administration in Australia to ban its use.⁶

In the middle of that year, Wong et al. reported on the hospitalization of a 41-year-old administrative worker who applied a first aid cream containing bufexamac (5%), lignocaine (1%), and chlorhexidine (0.1%) to a superficial right foot abrasion and who developed facial edema and widespread polymorphic eruptions 2 hours later. The authors suggested that this case reinforced the need to remove bufexamac from the markets where it remains because of the tendency to provoke severe allergic contact dermatoses and lack of efficacy.¹

Conclusion

Bufexamac offers the somewhat rare opportunity for advocacy. That is to say, I think there is sufficient evidence to justify the removal of this potent allergen from the market in Australia, Switzerland, and other countries where it may be available.

Dr. Baumann is a private practice dermatologist, researcher, author, and entrepreneur who practices in Miami. She founded the Cosmetic Dermatology Center at the University of Miami in 1997. Dr. Baumann has written two textbooks and a New York Times Best Sellers book for consumers. Dr. Baumann has received funding for advisory boards and/or clinical research trials from Allergan, Evolus, Galderma, and Revance. She is the founder and CEO of Skin Type Solutions Franchise Systems LLC. She had no relevant disclosures. Write to her at dermnews@mdedge.com.

References

1. Wong GN et al. Contact Dermatitis. 2019 Jun;80(6):395-7.

2. Trommer H et al. J Pharm Pharmacol. 2003 Oct;55(10):1379-88.

3. Trommer H, Neubert RH. J Pharm Pharm Sci. 2005 Sep 15;8(3):494-506.

4. Mailhol C et al. Allergy. 2009 May;64(5):801-6.

5. Pan Y, Nixon R. Australas J Dermatol. 2012 Aug;53(3):207-10.

6. Harris AG et al. Australas J Dermatol. 2019 Feb;60(1):53-6.

Rep. Suzan DelBene (D-Wash.) leads prior authorization reform

As a member of the powerful Ways and Means Committee, which has jurisdiction over the Medicare program, Rep. DelBene has worked closely with the American Gastroenterological Association.

When Rep. DelBene was first elected to Congress in 2012, we met with her to share AGA’s policy priorities. We knew instantly that we had a voice for many of our issues. Rep. DelBene started her career as a young investigator before continuing her education and launching a career in the biotechnology industry. From her firsthand experience, she understands the need for investments in National Institutes of Health research and for access to and coverage of colorectal cancer screenings since a member of her family had the disease.

Since Rep. DelBene has been in office, she has taken the lead on several policy priorities affecting our profession, including patient access and protections and regulatory relief. Rep. DelBene is the lead Democratic sponsor of H.R. 3107, the Improving Seniors’ Timely Access to Care Act, legislation that would streamline prior authorization in Medicare Advantage plans. The legislation hit a milestone of securing 218 cosponsors in the House, which is a majority of the members. We look forward to continuing to work with Rep. DelBene on advancing AGA’s policy priorities.
 

Featured microbiome investigator: Josephine Ni, MD

We’re checking in with a rising star in microbiome research: Dr. Josephine Ni from the University of Pennsylvania, Philadelphia.

Dr. Ni is an instructor of medicine at the University of Pennsylvania, and 2017 recipient of the AGA–Takeda Pharmaceuticals Research Scholar Award in IBD from the AGA Research Foundation.

Congrats to Dr. Ni! While Dr. Ni’s AGA Research Scholar Award concludes at the end of June 2020, we’re proud to share that she has secured two significant grants to continue her work: an NIH KO8 grant and a Burroughs Welcome Fund Award. We catch up with Dr. Ni in the Q&A below.
 

How would you sum up your research in one sentence?
I am interested in better understanding bacterial colonization of the healthy and inflamed intestinal tract; specifically, my current research focuses on characterizing the role of biofilm formation on intestinal colonization.

What effect do you hope your research will have on patients?
I hope that my work on understanding intestinal colonization will allow us to engineer the microbiota in predictable ways, which will pave the way to exclude enteropathogens, deliver specific compounds, and prevent dysbiosis.

What inspired you to focus your research career on the gut microbiome?
Being able to use data and observations from patient cohorts to generate research hypotheses and then translate those hypotheses into mouse models to explore mechanisms has been a very gratifying experience that I learned from my mentor, Gary Wu, MD. There is still so much to learn about the effects of the microbiome on intestinal health and I’m excited to be a part of this process.

What recent publication from your lab best represents your work if anyone wants to learn more?
Ni J et al. A role for bacterial urease in gut dysbiosis and Crohn’s disease. Sci Transl Med. 2017 Nov 15;9(416):eaah6888.

Gastroenterology invites submissions for an issue focused on colorectal cancer

Share your innovative basic and clinical research for consideration.

The past decade has seen significant milestones in our understanding of the epidemiology, clinical and genetic risk factors, and underlying biological mechanisms of colorectal cancer. This progress has also emphasized the need for further advances. To this end, Gastroenterology will publish a thematic issue in honor of Colorectal Cancer (CRC) Awareness Month in March 2021. The aim is to cover research highlighting novel pathways with human correlates, discoveries related to clinical interventions, clinical trials, and high-profile epidemiologic studies.

Help drive progress of CRC understanding and care by contributing your work. Enhanced promotion of the full issue and automatic indexing of your article to PubMed will increase the visibility of your research in the scientific community and beyond.

Submit your research through Gastroenterology‘s streamlined submission system: www.editorialmanager.com/gastro by Sept. 30, 2020. Original articles and brief communications are welcome.

For more information, please contact Gastroenterology’s Managing Editor, Christopher Lowe, at clowe@gastro.org.
 

AGA journals select editorial fellows for 2020-2021 academic year

The AGA journals Gastroenterology, Clinical Gastroenterology and Hepatology (CGH), and Cellular and Molecular Gastroenterology and Hepatology (CMGH) recently selected the recipients of their editorial fellowships, which runs from July 2020 through June 2021. The editorial fellowship program is in its fourth year.

The editorial fellows for each journal are:

Gastroenterology
Ruben Colman, MD
Cincinnati Children’s Hospital Medical Center

John Gubatan, MD
Stanford (Calif.) University Medical Center

CGH
Blake Jones, MD
University of Colorado at Denver, Aurora

Nikhil Thiruvengadam, MD
University of California, San Francisco

CMGH
Samuel Hinman, PhD
University of Washington, Seattle

The editorial fellows will be mentored on the journals’ editorial processes, including peer review and the publication process from manuscript submission to acceptance. They will participate in discussions and conferences with the boards of editors and work closely with the AGA editorial staff. Additionally, the fellows will participate in AGA’s new reviewer education program and will also be offered the opportunity to contribute content to their respective journals.

The journals’ board of editors and editorial staff congratulate the fellows and are excited to work with them over the next year.
 

AGA welcomes new president, M. Bishr Omary, MD, PhD, AGAF

M. Bishr Omary, MD, PhD, AGAF, will begin his term as the 115th president of the AGA Institute on June 1, 2020.

Dr. Omary, an international leader in GI biology and physiology, currently serves as senior vice chancellor for academic affairs and research for Rutgers Biomedical and Health Sciences schools, centers, and institutes at Rutgers University, Newark, N.J.

Eldest of three siblings, Dr. Omary was born and raised to Syrian parents in New York. After his father obtained his MS degree in political science from Columbia University in New York, the family returned to Damascus, Syria, where his father worked in the Ministry of Urban Planning. The family emigrated to the United States in 1968.

“I am eternally grateful to my parents from whom I learned the meaning of hard work and unconditional love. The opportunities in the U.S. open so many doors, compared with many other countries, including Syria then and especially now given the ongoing 9-year civil war that has ravaged the country,” shared Dr. Omary.

When asked about how he will approach his presidency during a global COVID-19 pandemic, Dr. Omary expressed his commitment to urgently working with and for patients, as well as our community of gastroenterologists, researchers, trainees, and other AGA members, to overcome the disruptions created by the pandemic and ultimately be in a better place than we were before. Dr. Omary holds steadfast to AGA’s vision, a world free from digestive diseases.

Dr. Omary’s primary focus, as an internationally recognized biomedical investigator, is understanding the mechanism and developing therapies for several diseases including lipodystrophies, acute liver failure, and porphyrias. He served as chief of gastroenterology and hepatology at Stanford University, then chair of physiology and chief scientific officer while at the University of Michigan, Ann Arbor, before moving to Rutgers.

Dr. Omary has been a long-time AGA leader, most notably chairing the AGA Institute Research Awards Panel and serving as senior associate editor (2006-2011) then editor in chief (2011-2016) of Gastroenterology, AGA’s premier journal.

Dr. Omary has been on the AGA Governing Board for 2 years as vice president then president-elect; his term as AGA president concludes May 2021.

Rep. Suzan DelBene (D-Wash.) leads prior authorization reform

As a member of the powerful Ways and Means Committee, which has jurisdiction over the Medicare program, Rep. DelBene has worked closely with the American Gastroenterological Association.

When Rep. DelBene was first elected to Congress in 2012, we met with her to share AGA’s policy priorities. We knew instantly that we had a voice for many of our issues. Rep. DelBene started her career as a young investigator before continuing her education and launching a career in the biotechnology industry. From her firsthand experience, she understands the need for investments in National Institutes of Health research and for access to and coverage of colorectal cancer screenings since a member of her family had the disease.

Since Rep. DelBene has been in office, she has taken the lead on several policy priorities affecting our profession, including patient access and protections and regulatory relief. Rep. DelBene is the lead Democratic sponsor of H.R. 3107, the Improving Seniors’ Timely Access to Care Act, legislation that would streamline prior authorization in Medicare Advantage plans. The legislation hit a milestone of securing 218 cosponsors in the House, which is a majority of the members. We look forward to continuing to work with Rep. DelBene on advancing AGA’s policy priorities.
 

Featured microbiome investigator: Josephine Ni, MD

We’re checking in with a rising star in microbiome research: Dr. Josephine Ni from the University of Pennsylvania, Philadelphia.

Dr. Ni is an instructor of medicine at the University of Pennsylvania, and 2017 recipient of the AGA–Takeda Pharmaceuticals Research Scholar Award in IBD from the AGA Research Foundation.

Congrats to Dr. Ni! While Dr. Ni’s AGA Research Scholar Award concludes at the end of June 2020, we’re proud to share that she has secured two significant grants to continue her work: an NIH KO8 grant and a Burroughs Welcome Fund Award. We catch up with Dr. Ni in the Q&A below.
 

How would you sum up your research in one sentence?
I am interested in better understanding bacterial colonization of the healthy and inflamed intestinal tract; specifically, my current research focuses on characterizing the role of biofilm formation on intestinal colonization.

What effect do you hope your research will have on patients?
I hope that my work on understanding intestinal colonization will allow us to engineer the microbiota in predictable ways, which will pave the way to exclude enteropathogens, deliver specific compounds, and prevent dysbiosis.

What inspired you to focus your research career on the gut microbiome?
Being able to use data and observations from patient cohorts to generate research hypotheses and then translate those hypotheses into mouse models to explore mechanisms has been a very gratifying experience that I learned from my mentor, Gary Wu, MD. There is still so much to learn about the effects of the microbiome on intestinal health and I’m excited to be a part of this process.

What recent publication from your lab best represents your work if anyone wants to learn more?
Ni J et al. A role for bacterial urease in gut dysbiosis and Crohn’s disease. Sci Transl Med. 2017 Nov 15;9(416):eaah6888.

Gastroenterology invites submissions for an issue focused on colorectal cancer

Share your innovative basic and clinical research for consideration.

The past decade has seen significant milestones in our understanding of the epidemiology, clinical and genetic risk factors, and underlying biological mechanisms of colorectal cancer. This progress has also emphasized the need for further advances. To this end, Gastroenterology will publish a thematic issue in honor of Colorectal Cancer (CRC) Awareness Month in March 2021. The aim is to cover research highlighting novel pathways with human correlates, discoveries related to clinical interventions, clinical trials, and high-profile epidemiologic studies.

Help drive progress of CRC understanding and care by contributing your work. Enhanced promotion of the full issue and automatic indexing of your article to PubMed will increase the visibility of your research in the scientific community and beyond.

Submit your research through Gastroenterology‘s streamlined submission system: www.editorialmanager.com/gastro by Sept. 30, 2020. Original articles and brief communications are welcome.

For more information, please contact Gastroenterology’s Managing Editor, Christopher Lowe, at clowe@gastro.org.
 

AGA journals select editorial fellows for 2020-2021 academic year

The AGA journals Gastroenterology, Clinical Gastroenterology and Hepatology (CGH), and Cellular and Molecular Gastroenterology and Hepatology (CMGH) recently selected the recipients of their editorial fellowships, which runs from July 2020 through June 2021. The editorial fellowship program is in its fourth year.

The editorial fellows for each journal are:

Gastroenterology
Ruben Colman, MD
Cincinnati Children’s Hospital Medical Center

John Gubatan, MD
Stanford (Calif.) University Medical Center

CGH
Blake Jones, MD
University of Colorado at Denver, Aurora

Nikhil Thiruvengadam, MD
University of California, San Francisco

CMGH
Samuel Hinman, PhD
University of Washington, Seattle

The editorial fellows will be mentored on the journals’ editorial processes, including peer review and the publication process from manuscript submission to acceptance. They will participate in discussions and conferences with the boards of editors and work closely with the AGA editorial staff. Additionally, the fellows will participate in AGA’s new reviewer education program and will also be offered the opportunity to contribute content to their respective journals.

The journals’ board of editors and editorial staff congratulate the fellows and are excited to work with them over the next year.
 

AGA welcomes new president, M. Bishr Omary, MD, PhD, AGAF

M. Bishr Omary, MD, PhD, AGAF, will begin his term as the 115th president of the AGA Institute on June 1, 2020.

Dr. Omary, an international leader in GI biology and physiology, currently serves as senior vice chancellor for academic affairs and research for Rutgers Biomedical and Health Sciences schools, centers, and institutes at Rutgers University, Newark, N.J.

Eldest of three siblings, Dr. Omary was born and raised to Syrian parents in New York. After his father obtained his MS degree in political science from Columbia University in New York, the family returned to Damascus, Syria, where his father worked in the Ministry of Urban Planning. The family emigrated to the United States in 1968.

“I am eternally grateful to my parents from whom I learned the meaning of hard work and unconditional love. The opportunities in the U.S. open so many doors, compared with many other countries, including Syria then and especially now given the ongoing 9-year civil war that has ravaged the country,” shared Dr. Omary.

When asked about how he will approach his presidency during a global COVID-19 pandemic, Dr. Omary expressed his commitment to urgently working with and for patients, as well as our community of gastroenterologists, researchers, trainees, and other AGA members, to overcome the disruptions created by the pandemic and ultimately be in a better place than we were before. Dr. Omary holds steadfast to AGA’s vision, a world free from digestive diseases.

Dr. Omary’s primary focus, as an internationally recognized biomedical investigator, is understanding the mechanism and developing therapies for several diseases including lipodystrophies, acute liver failure, and porphyrias. He served as chief of gastroenterology and hepatology at Stanford University, then chair of physiology and chief scientific officer while at the University of Michigan, Ann Arbor, before moving to Rutgers.

Dr. Omary has been a long-time AGA leader, most notably chairing the AGA Institute Research Awards Panel and serving as senior associate editor (2006-2011) then editor in chief (2011-2016) of Gastroenterology, AGA’s premier journal.

Dr. Omary has been on the AGA Governing Board for 2 years as vice president then president-elect; his term as AGA president concludes May 2021.

Rep. Suzan DelBene (D-Wash.) leads prior authorization reform

As a member of the powerful Ways and Means Committee, which has jurisdiction over the Medicare program, Rep. DelBene has worked closely with the American Gastroenterological Association.

When Rep. DelBene was first elected to Congress in 2012, we met with her to share AGA’s policy priorities. We knew instantly that we had a voice for many of our issues. Rep. DelBene started her career as a young investigator before continuing her education and launching a career in the biotechnology industry. From her firsthand experience, she understands the need for investments in National Institutes of Health research and for access to and coverage of colorectal cancer screenings since a member of her family had the disease.

Since Rep. DelBene has been in office, she has taken the lead on several policy priorities affecting our profession, including patient access and protections and regulatory relief. Rep. DelBene is the lead Democratic sponsor of H.R. 3107, the Improving Seniors’ Timely Access to Care Act, legislation that would streamline prior authorization in Medicare Advantage plans. The legislation hit a milestone of securing 218 cosponsors in the House, which is a majority of the members. We look forward to continuing to work with Rep. DelBene on advancing AGA’s policy priorities.
 

Featured microbiome investigator: Josephine Ni, MD

We’re checking in with a rising star in microbiome research: Dr. Josephine Ni from the University of Pennsylvania, Philadelphia.

Dr. Ni is an instructor of medicine at the University of Pennsylvania, and 2017 recipient of the AGA–Takeda Pharmaceuticals Research Scholar Award in IBD from the AGA Research Foundation.

Congrats to Dr. Ni! While Dr. Ni’s AGA Research Scholar Award concludes at the end of June 2020, we’re proud to share that she has secured two significant grants to continue her work: an NIH KO8 grant and a Burroughs Welcome Fund Award. We catch up with Dr. Ni in the Q&A below.
 

How would you sum up your research in one sentence?
I am interested in better understanding bacterial colonization of the healthy and inflamed intestinal tract; specifically, my current research focuses on characterizing the role of biofilm formation on intestinal colonization.

What effect do you hope your research will have on patients?
I hope that my work on understanding intestinal colonization will allow us to engineer the microbiota in predictable ways, which will pave the way to exclude enteropathogens, deliver specific compounds, and prevent dysbiosis.

What inspired you to focus your research career on the gut microbiome?
Being able to use data and observations from patient cohorts to generate research hypotheses and then translate those hypotheses into mouse models to explore mechanisms has been a very gratifying experience that I learned from my mentor, Gary Wu, MD. There is still so much to learn about the effects of the microbiome on intestinal health and I’m excited to be a part of this process.

What recent publication from your lab best represents your work if anyone wants to learn more?
Ni J et al. A role for bacterial urease in gut dysbiosis and Crohn’s disease. Sci Transl Med. 2017 Nov 15;9(416):eaah6888.

Gastroenterology invites submissions for an issue focused on colorectal cancer

Share your innovative basic and clinical research for consideration.

The past decade has seen significant milestones in our understanding of the epidemiology, clinical and genetic risk factors, and underlying biological mechanisms of colorectal cancer. This progress has also emphasized the need for further advances. To this end, Gastroenterology will publish a thematic issue in honor of Colorectal Cancer (CRC) Awareness Month in March 2021. The aim is to cover research highlighting novel pathways with human correlates, discoveries related to clinical interventions, clinical trials, and high-profile epidemiologic studies.

Help drive progress of CRC understanding and care by contributing your work. Enhanced promotion of the full issue and automatic indexing of your article to PubMed will increase the visibility of your research in the scientific community and beyond.

Submit your research through Gastroenterology‘s streamlined submission system: www.editorialmanager.com/gastro by Sept. 30, 2020. Original articles and brief communications are welcome.

For more information, please contact Gastroenterology’s Managing Editor, Christopher Lowe, at clowe@gastro.org.
 

AGA journals select editorial fellows for 2020-2021 academic year

The AGA journals Gastroenterology, Clinical Gastroenterology and Hepatology (CGH), and Cellular and Molecular Gastroenterology and Hepatology (CMGH) recently selected the recipients of their editorial fellowships, which runs from July 2020 through June 2021. The editorial fellowship program is in its fourth year.

The editorial fellows for each journal are:

Gastroenterology
Ruben Colman, MD
Cincinnati Children’s Hospital Medical Center

John Gubatan, MD
Stanford (Calif.) University Medical Center

CGH
Blake Jones, MD
University of Colorado at Denver, Aurora

Nikhil Thiruvengadam, MD
University of California, San Francisco

CMGH
Samuel Hinman, PhD
University of Washington, Seattle

The editorial fellows will be mentored on the journals’ editorial processes, including peer review and the publication process from manuscript submission to acceptance. They will participate in discussions and conferences with the boards of editors and work closely with the AGA editorial staff. Additionally, the fellows will participate in AGA’s new reviewer education program and will also be offered the opportunity to contribute content to their respective journals.

The journals’ board of editors and editorial staff congratulate the fellows and are excited to work with them over the next year.
 

AGA welcomes new president, M. Bishr Omary, MD, PhD, AGAF

M. Bishr Omary, MD, PhD, AGAF, will begin his term as the 115th president of the AGA Institute on June 1, 2020.

Dr. Omary, an international leader in GI biology and physiology, currently serves as senior vice chancellor for academic affairs and research for Rutgers Biomedical and Health Sciences schools, centers, and institutes at Rutgers University, Newark, N.J.

Eldest of three siblings, Dr. Omary was born and raised to Syrian parents in New York. After his father obtained his MS degree in political science from Columbia University in New York, the family returned to Damascus, Syria, where his father worked in the Ministry of Urban Planning. The family emigrated to the United States in 1968.

“I am eternally grateful to my parents from whom I learned the meaning of hard work and unconditional love. The opportunities in the U.S. open so many doors, compared with many other countries, including Syria then and especially now given the ongoing 9-year civil war that has ravaged the country,” shared Dr. Omary.

When asked about how he will approach his presidency during a global COVID-19 pandemic, Dr. Omary expressed his commitment to urgently working with and for patients, as well as our community of gastroenterologists, researchers, trainees, and other AGA members, to overcome the disruptions created by the pandemic and ultimately be in a better place than we were before. Dr. Omary holds steadfast to AGA’s vision, a world free from digestive diseases.

Dr. Omary’s primary focus, as an internationally recognized biomedical investigator, is understanding the mechanism and developing therapies for several diseases including lipodystrophies, acute liver failure, and porphyrias. He served as chief of gastroenterology and hepatology at Stanford University, then chair of physiology and chief scientific officer while at the University of Michigan, Ann Arbor, before moving to Rutgers.

Dr. Omary has been a long-time AGA leader, most notably chairing the AGA Institute Research Awards Panel and serving as senior associate editor (2006-2011) then editor in chief (2011-2016) of Gastroenterology, AGA’s premier journal.

Dr. Omary has been on the AGA Governing Board for 2 years as vice president then president-elect; his term as AGA president concludes May 2021.

Guselkumab is now the second interleukin (IL)–23 inhibitor to be approved by the Food and Drug Administration for the treatment of adults with active psoriatic arthritis (PsA), according to a July 14 announcement from its manufacturer, Janssen.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

The FDA’s approval marks the second indication for guselkumab, which was first approved for adults with plaque psoriasis in 2017.

The agency based its approval on two pivotal phase 3 clinical trials, DISCOVER-1 and DISCOVER-2, which tested the biologic in 1,120 adults with active PsA who were naive to biologics (both trials) or had an inadequate response or intolerance to one or two tumor necrosis factor inhibitors (in about 30% of patients in DISCOVER-1). Part of this pretrial standard treatment could include at least 4 months of Otezla (apremilast), at least 3 months of nonbiologic disease-modifying antirheumatic drugs (DMARDs), or at least 4 weeks of NSAIDs. In both trials, about 58% of patients took methotrexate.

Participants who took guselkumab achieved 20% improvement in American College of Rheumatology response criteria at week 24 at rates of 52% in DISCOVER-1 and 64% in DISCOVER-2, whereas placebo-treated patients had rates of 22% and 33%, respectively.

Guselkumab improved patients’ other symptoms, including skin manifestations of psoriasis, physical functioning, enthesitis, dactylitis, and fatigue, according to the Janssen release.

Guselkumab, a fully human monoclonal antibody that selectively binds to the p19 subunit of IL-23, is administered as a 100-mg subcutaneous injection every 8 weeks, following two starter doses at weeks 0 and 4, and can be used alone or in combination with a conventional DMARD.

In guselkumab clinical trials of patients with PsA, a minority had bronchitis or a decreased neutrophil count, but the safety profile was otherwise generally consistent with what has been seen in patients with plaque psoriasis, according to the company release. Other common side effects described in 1% or more of patients have included upper respiratory infections, headache, injection-site reactions, arthralgia, diarrhea, gastroenteritis, tinea infections, and herpes simplex infections.

jevans@mdedge.com

Guselkumab is now the second interleukin (IL)–23 inhibitor to be approved by the Food and Drug Administration for the treatment of adults with active psoriatic arthritis (PsA), according to a July 14 announcement from its manufacturer, Janssen.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

The FDA’s approval marks the second indication for guselkumab, which was first approved for adults with plaque psoriasis in 2017.

The agency based its approval on two pivotal phase 3 clinical trials, DISCOVER-1 and DISCOVER-2, which tested the biologic in 1,120 adults with active PsA who were naive to biologics (both trials) or had an inadequate response or intolerance to one or two tumor necrosis factor inhibitors (in about 30% of patients in DISCOVER-1). Part of this pretrial standard treatment could include at least 4 months of Otezla (apremilast), at least 3 months of nonbiologic disease-modifying antirheumatic drugs (DMARDs), or at least 4 weeks of NSAIDs. In both trials, about 58% of patients took methotrexate.

Participants who took guselkumab achieved 20% improvement in American College of Rheumatology response criteria at week 24 at rates of 52% in DISCOVER-1 and 64% in DISCOVER-2, whereas placebo-treated patients had rates of 22% and 33%, respectively.

Guselkumab improved patients’ other symptoms, including skin manifestations of psoriasis, physical functioning, enthesitis, dactylitis, and fatigue, according to the Janssen release.

Guselkumab, a fully human monoclonal antibody that selectively binds to the p19 subunit of IL-23, is administered as a 100-mg subcutaneous injection every 8 weeks, following two starter doses at weeks 0 and 4, and can be used alone or in combination with a conventional DMARD.

In guselkumab clinical trials of patients with PsA, a minority had bronchitis or a decreased neutrophil count, but the safety profile was otherwise generally consistent with what has been seen in patients with plaque psoriasis, according to the company release. Other common side effects described in 1% or more of patients have included upper respiratory infections, headache, injection-site reactions, arthralgia, diarrhea, gastroenteritis, tinea infections, and herpes simplex infections.

jevans@mdedge.com

Guselkumab is now the second interleukin (IL)–23 inhibitor to be approved by the Food and Drug Administration for the treatment of adults with active psoriatic arthritis (PsA), according to a July 14 announcement from its manufacturer, Janssen.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

The FDA’s approval marks the second indication for guselkumab, which was first approved for adults with plaque psoriasis in 2017.

The agency based its approval on two pivotal phase 3 clinical trials, DISCOVER-1 and DISCOVER-2, which tested the biologic in 1,120 adults with active PsA who were naive to biologics (both trials) or had an inadequate response or intolerance to one or two tumor necrosis factor inhibitors (in about 30% of patients in DISCOVER-1). Part of this pretrial standard treatment could include at least 4 months of Otezla (apremilast), at least 3 months of nonbiologic disease-modifying antirheumatic drugs (DMARDs), or at least 4 weeks of NSAIDs. In both trials, about 58% of patients took methotrexate.

Participants who took guselkumab achieved 20% improvement in American College of Rheumatology response criteria at week 24 at rates of 52% in DISCOVER-1 and 64% in DISCOVER-2, whereas placebo-treated patients had rates of 22% and 33%, respectively.

Guselkumab improved patients’ other symptoms, including skin manifestations of psoriasis, physical functioning, enthesitis, dactylitis, and fatigue, according to the Janssen release.

Guselkumab, a fully human monoclonal antibody that selectively binds to the p19 subunit of IL-23, is administered as a 100-mg subcutaneous injection every 8 weeks, following two starter doses at weeks 0 and 4, and can be used alone or in combination with a conventional DMARD.

In guselkumab clinical trials of patients with PsA, a minority had bronchitis or a decreased neutrophil count, but the safety profile was otherwise generally consistent with what has been seen in patients with plaque psoriasis, according to the company release. Other common side effects described in 1% or more of patients have included upper respiratory infections, headache, injection-site reactions, arthralgia, diarrhea, gastroenteritis, tinea infections, and herpes simplex infections.

jevans@mdedge.com

Having been a bench research scientist 30 years ago, I am flabbergasted at what is and is not currently possible. In a few weeks, scientists sequenced a novel coronavirus and used the genetic sequence to select candidate molecules for a vaccine. But we still can’t reliably say how much protection a cloth mask provides. Worse yet, even if/when we could reliably quantify contagion, it isn’t clear that the public will believe us anyhow.

Thinkstock

The good news is that the public worldwide did believe scientists about the threat of a pandemic and the need to flatten the curve. Saving lives has not been about the strength of an antibiotic or the skill in managing a ventilator, but the credibility of medical scientists. The degree of acceptance was variable and subject to a variety of delays caused by regional politicians, but overall the scientific advice on social distancing has had a gigantic impact on the spread of the pandemic in the February to June time frame. The bad news is that the public’s trust in that scientific advice has waned, the willingness to accept onerous restrictions has fatigued, and the cooperation for maintaining these social changes is evaporating.

I will leave pontificating about the spread of COVID-19 to other experts in other forums. My focus is on the public’s trust in the professionalism of physicians, nurses, medical scientists, and the health care industry as a whole. That trust has been our most valuable tool in fighting the pandemic so far. There have been situations in which weaknesses in modern science have let society down during the pandemic of the century. In my February 2020 column, at the beginning of the outbreak, a month before it was declared a pandemic, when its magnitude was still unclear, I emphasized the importance of having a trusted scientific spokesperson providing timely, accurate information to the public. That, obviously, did not happen in the United States and the degree of the ensuing disaster is still to be revealed.

Scientists have made some wrong decisions about this novel threat. The advice on masks is an illustrative example. For many years, infection control nurses have insisted that medical students wear a mask to protect themselves, even if they were observing rounds from just inside the doorway of a room of a baby with bronchiolitis. The landfills are full of briefly worn surgical masks. Now the story goes: Surgical masks don’t protect staff; they protect others. Changes like that contribute to a credibility gap.

For 3 months, there was conflicting advice about the appropriateness of masks. In early March 2020, some health care workers were disciplined for wearing personal masks. Now, most scientists recommend the public use masks to reduce contagion. Significant subgroups in the U.S. population have refused, mostly to signal their contrarian politics. In June there was an anecdote of a success story from the Show Me state of Missouri, where a mask is credited for preventing an outbreak from a sick hair stylist.

It is hard to find something more reliable than an anecdote. On June 1, a meta-analysis funded by the World Health Organization was published online by Lancet. It supports the idea that masks are beneficial. It is mostly forest plots, so you can try to interpret it yourself. There were 172 observational studies in the systematic review, and the meta-analysis contains 44 relevant comparative studies and 0 randomized controlled trials. Most of those forest plots have an I2 of 75% or worse, which to me indicates that they are not much more reliable than a good anecdote. My primary conclusion was that modern academic science, in an era with a shortage of toilet paper, should convert to printing on soft tissue paper.

It is important to note that the guesstimated overall benefit of cloth masks was a relative risk of 0.30. That benefit is easily nullified if the false security of a mask causes people to congregate together in groups three times larger or for three times more minutes. N95 masks were more effective.

A different article was published in PNAS on June 11. Its senior author was awarded the Nobel Prize in Chemistry in 1995. That article touted the benefits of masks. The article is facing heavy criticism for flaws in methodology and flaws in the peer review process. A long list of signatories have joined a letter asking for the article’s retraction.

This article, when combined with the two instances of prominent articles being retracted in the prior month by the New England Journal of Medicine and The Lancet, is accumulating evidence the peer review system is not working as intended.

There are many heroes in this pandemic, from the frontline health care workers in hotspots to the grocery workers and cleaning staff. There is hope, indeed some faith, that medical scientists in the foreseeable future will provide treatments and a vaccine for this viral plague. This month, the credibility of scientists again plays a major role as communities respond to outbreaks related to reopening the economy. Let’s celebrate the victories, resolve to fix the impure system, and restore a high level of public trust in science. Lives depend on it.

Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis. He has no relevant financial disclosures. Email him at pdnews@mdedge.com.

Having been a bench research scientist 30 years ago, I am flabbergasted at what is and is not currently possible. In a few weeks, scientists sequenced a novel coronavirus and used the genetic sequence to select candidate molecules for a vaccine. But we still can’t reliably say how much protection a cloth mask provides. Worse yet, even if/when we could reliably quantify contagion, it isn’t clear that the public will believe us anyhow.

Thinkstock

The good news is that the public worldwide did believe scientists about the threat of a pandemic and the need to flatten the curve. Saving lives has not been about the strength of an antibiotic or the skill in managing a ventilator, but the credibility of medical scientists. The degree of acceptance was variable and subject to a variety of delays caused by regional politicians, but overall the scientific advice on social distancing has had a gigantic impact on the spread of the pandemic in the February to June time frame. The bad news is that the public’s trust in that scientific advice has waned, the willingness to accept onerous restrictions has fatigued, and the cooperation for maintaining these social changes is evaporating.

I will leave pontificating about the spread of COVID-19 to other experts in other forums. My focus is on the public’s trust in the professionalism of physicians, nurses, medical scientists, and the health care industry as a whole. That trust has been our most valuable tool in fighting the pandemic so far. There have been situations in which weaknesses in modern science have let society down during the pandemic of the century. In my February 2020 column, at the beginning of the outbreak, a month before it was declared a pandemic, when its magnitude was still unclear, I emphasized the importance of having a trusted scientific spokesperson providing timely, accurate information to the public. That, obviously, did not happen in the United States and the degree of the ensuing disaster is still to be revealed.

Scientists have made some wrong decisions about this novel threat. The advice on masks is an illustrative example. For many years, infection control nurses have insisted that medical students wear a mask to protect themselves, even if they were observing rounds from just inside the doorway of a room of a baby with bronchiolitis. The landfills are full of briefly worn surgical masks. Now the story goes: Surgical masks don’t protect staff; they protect others. Changes like that contribute to a credibility gap.

For 3 months, there was conflicting advice about the appropriateness of masks. In early March 2020, some health care workers were disciplined for wearing personal masks. Now, most scientists recommend the public use masks to reduce contagion. Significant subgroups in the U.S. population have refused, mostly to signal their contrarian politics. In June there was an anecdote of a success story from the Show Me state of Missouri, where a mask is credited for preventing an outbreak from a sick hair stylist.

It is hard to find something more reliable than an anecdote. On June 1, a meta-analysis funded by the World Health Organization was published online by Lancet. It supports the idea that masks are beneficial. It is mostly forest plots, so you can try to interpret it yourself. There were 172 observational studies in the systematic review, and the meta-analysis contains 44 relevant comparative studies and 0 randomized controlled trials. Most of those forest plots have an I2 of 75% or worse, which to me indicates that they are not much more reliable than a good anecdote. My primary conclusion was that modern academic science, in an era with a shortage of toilet paper, should convert to printing on soft tissue paper.

It is important to note that the guesstimated overall benefit of cloth masks was a relative risk of 0.30. That benefit is easily nullified if the false security of a mask causes people to congregate together in groups three times larger or for three times more minutes. N95 masks were more effective.

A different article was published in PNAS on June 11. Its senior author was awarded the Nobel Prize in Chemistry in 1995. That article touted the benefits of masks. The article is facing heavy criticism for flaws in methodology and flaws in the peer review process. A long list of signatories have joined a letter asking for the article’s retraction.

This article, when combined with the two instances of prominent articles being retracted in the prior month by the New England Journal of Medicine and The Lancet, is accumulating evidence the peer review system is not working as intended.

There are many heroes in this pandemic, from the frontline health care workers in hotspots to the grocery workers and cleaning staff. There is hope, indeed some faith, that medical scientists in the foreseeable future will provide treatments and a vaccine for this viral plague. This month, the credibility of scientists again plays a major role as communities respond to outbreaks related to reopening the economy. Let’s celebrate the victories, resolve to fix the impure system, and restore a high level of public trust in science. Lives depend on it.

Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis. He has no relevant financial disclosures. Email him at pdnews@mdedge.com.

Having been a bench research scientist 30 years ago, I am flabbergasted at what is and is not currently possible. In a few weeks, scientists sequenced a novel coronavirus and used the genetic sequence to select candidate molecules for a vaccine. But we still can’t reliably say how much protection a cloth mask provides. Worse yet, even if/when we could reliably quantify contagion, it isn’t clear that the public will believe us anyhow.

Thinkstock

The good news is that the public worldwide did believe scientists about the threat of a pandemic and the need to flatten the curve. Saving lives has not been about the strength of an antibiotic or the skill in managing a ventilator, but the credibility of medical scientists. The degree of acceptance was variable and subject to a variety of delays caused by regional politicians, but overall the scientific advice on social distancing has had a gigantic impact on the spread of the pandemic in the February to June time frame. The bad news is that the public’s trust in that scientific advice has waned, the willingness to accept onerous restrictions has fatigued, and the cooperation for maintaining these social changes is evaporating.

I will leave pontificating about the spread of COVID-19 to other experts in other forums. My focus is on the public’s trust in the professionalism of physicians, nurses, medical scientists, and the health care industry as a whole. That trust has been our most valuable tool in fighting the pandemic so far. There have been situations in which weaknesses in modern science have let society down during the pandemic of the century. In my February 2020 column, at the beginning of the outbreak, a month before it was declared a pandemic, when its magnitude was still unclear, I emphasized the importance of having a trusted scientific spokesperson providing timely, accurate information to the public. That, obviously, did not happen in the United States and the degree of the ensuing disaster is still to be revealed.

Scientists have made some wrong decisions about this novel threat. The advice on masks is an illustrative example. For many years, infection control nurses have insisted that medical students wear a mask to protect themselves, even if they were observing rounds from just inside the doorway of a room of a baby with bronchiolitis. The landfills are full of briefly worn surgical masks. Now the story goes: Surgical masks don’t protect staff; they protect others. Changes like that contribute to a credibility gap.

For 3 months, there was conflicting advice about the appropriateness of masks. In early March 2020, some health care workers were disciplined for wearing personal masks. Now, most scientists recommend the public use masks to reduce contagion. Significant subgroups in the U.S. population have refused, mostly to signal their contrarian politics. In June there was an anecdote of a success story from the Show Me state of Missouri, where a mask is credited for preventing an outbreak from a sick hair stylist.

It is hard to find something more reliable than an anecdote. On June 1, a meta-analysis funded by the World Health Organization was published online by Lancet. It supports the idea that masks are beneficial. It is mostly forest plots, so you can try to interpret it yourself. There were 172 observational studies in the systematic review, and the meta-analysis contains 44 relevant comparative studies and 0 randomized controlled trials. Most of those forest plots have an I2 of 75% or worse, which to me indicates that they are not much more reliable than a good anecdote. My primary conclusion was that modern academic science, in an era with a shortage of toilet paper, should convert to printing on soft tissue paper.

It is important to note that the guesstimated overall benefit of cloth masks was a relative risk of 0.30. That benefit is easily nullified if the false security of a mask causes people to congregate together in groups three times larger or for three times more minutes. N95 masks were more effective.

A different article was published in PNAS on June 11. Its senior author was awarded the Nobel Prize in Chemistry in 1995. That article touted the benefits of masks. The article is facing heavy criticism for flaws in methodology and flaws in the peer review process. A long list of signatories have joined a letter asking for the article’s retraction.

This article, when combined with the two instances of prominent articles being retracted in the prior month by the New England Journal of Medicine and The Lancet, is accumulating evidence the peer review system is not working as intended.

There are many heroes in this pandemic, from the frontline health care workers in hotspots to the grocery workers and cleaning staff. There is hope, indeed some faith, that medical scientists in the foreseeable future will provide treatments and a vaccine for this viral plague. This month, the credibility of scientists again plays a major role as communities respond to outbreaks related to reopening the economy. Let’s celebrate the victories, resolve to fix the impure system, and restore a high level of public trust in science. Lives depend on it.

Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis. He has no relevant financial disclosures. Email him at pdnews@mdedge.com.

A real-time, computer-aided detection system using artificial intelligence significantly improved adenoma detection during high-definition colonoscopy in a multicenter, randomized clinical trial.

The adenoma detection rate was 55% in the intervention group and 40% in the control group, Alessandro Repici, MD, PhD, and his associates wrote in Gastroenterology. Improved detection of smaller adenomas explained the difference. After age, sex, and indication for colonoscopy were controlled for, computer-aided detection (CADe) increased the probability of adenoma detection by 30% (risk ratio, 1.30; 95% confidence interval, 1.14-1.45).

The CADe system did not increase the likelihood of resecting non-neoplastic lesions (26% versus 29% in the control group), said Dr. Repici, of Humanitas Research Hospital in Milano, Italy. “The per-protocol analysis produced similar results,” he and his associates wrote. “The substantial improvement for adenoma detection rate and mean number of adenomas per colonoscopy, without increasing the removal of nonneoplastic lesions, is likely to improve the quality of colonoscopy without affecting its efficiency.”

Screening colonoscopies miss about 25% of adenomas, increasing patients’ risk for colorectal cancer. Although real-time CADe systems can identify colorectal neoplasias, comprehensive studies of the effect of CADe systems on adenoma detection and other colonoscopy quality measures are lacking.

The study included 685 adults from three centers in Italy who underwent screening colonoscopies for colorectal cancer, postpolypectomy surveillance, or workup based on a positive fecal immunochemical test or signs and symptoms of colorectal cancer. Patients were randomly assigned on a one-to-one basis to receive high-definition colonoscopies with or without the CADe system, which consists of an artificial intelligence–based medical device (GI Genius, Medtronic) that processes colonoscopy images in real time and superimposes a green box over suspected lesions. Six experienced endoscopists performed the colonoscopies; the minimum withdrawal time was 6 minutes, and histopathology was the reference standard.

The average number of adenomas detected per colonoscopy was 1.1 (standard deviation, 0.5) in the CADe group and 0.7 (SD, 1.2) in the control group, for an incidence rate ratio of 1.46 (95% CI, 1.15-1.86). The CADe system also significantly improved the detection of adenomas measuring 5 mm or less (34% vs. 27% in the control group; RR, 1.26; 95% CI, 1.01-1.52) and adenomas measuring 6-9 mm (11% vs. 6%, respectively; RR, 1.78; 95% CI, 1.09-2.86). Detection of larger adenomas did not significantly differ between groups. These findings did not vary based on adenoma morphology (polypoid or nonpolypoid) or location (proximal or distal colon), the researchers said.

Detection of multiple adenomas also was higher in the intervention group than in the control group (23% vs. 15%, respectively; RR, 1.50; 95% CI, 1.19-1.95). There were no significant differences in the detection of sessile serrated lesions (7% and 5%) and nonneoplastic lesions (20% and 17%). Average withdrawal times did not significantly differ between groups (417 seconds for CADe and 435 seconds for the control group).

The CADe system is a convolutional neural network that was trained and validated using a series of more than 2,600 histologically confirmed polyps from 840 participants in a prior clinical trial (Gastroenterology 2019;156:2198-207.e1). The system takes an average of 1.5 microseconds to output processed images.

“The addition of real-time CADe to colonoscopy resulted in a 30% and 46% relative increase in adenoma detection rate and the average number of adenomas detected per colonoscopy, demonstrating its efficacy in improving the detection of colorectal neoplasia at screening and diagnostic colonoscopy,” the investigators wrote. “[The s]afety of CADe was demonstrated by the lack of increase of both useless resections and withdrawal time, as well as by the exclusion of any underskilling in the study period.”

Medtronic loaned the equipment for the study. Dr. Repici and the senior author disclosed consulting fees from Medtronic.

SOURCE: Repici A et al. Gastroenterology. 2020 May 3. doi: 10.1053/j.gastro.2020.04.062.

A real-time, computer-aided detection system using artificial intelligence significantly improved adenoma detection during high-definition colonoscopy in a multicenter, randomized clinical trial.

The adenoma detection rate was 55% in the intervention group and 40% in the control group, Alessandro Repici, MD, PhD, and his associates wrote in Gastroenterology. Improved detection of smaller adenomas explained the difference. After age, sex, and indication for colonoscopy were controlled for, computer-aided detection (CADe) increased the probability of adenoma detection by 30% (risk ratio, 1.30; 95% confidence interval, 1.14-1.45).

The CADe system did not increase the likelihood of resecting non-neoplastic lesions (26% versus 29% in the control group), said Dr. Repici, of Humanitas Research Hospital in Milano, Italy. “The per-protocol analysis produced similar results,” he and his associates wrote. “The substantial improvement for adenoma detection rate and mean number of adenomas per colonoscopy, without increasing the removal of nonneoplastic lesions, is likely to improve the quality of colonoscopy without affecting its efficiency.”

Screening colonoscopies miss about 25% of adenomas, increasing patients’ risk for colorectal cancer. Although real-time CADe systems can identify colorectal neoplasias, comprehensive studies of the effect of CADe systems on adenoma detection and other colonoscopy quality measures are lacking.

The study included 685 adults from three centers in Italy who underwent screening colonoscopies for colorectal cancer, postpolypectomy surveillance, or workup based on a positive fecal immunochemical test or signs and symptoms of colorectal cancer. Patients were randomly assigned on a one-to-one basis to receive high-definition colonoscopies with or without the CADe system, which consists of an artificial intelligence–based medical device (GI Genius, Medtronic) that processes colonoscopy images in real time and superimposes a green box over suspected lesions. Six experienced endoscopists performed the colonoscopies; the minimum withdrawal time was 6 minutes, and histopathology was the reference standard.

The average number of adenomas detected per colonoscopy was 1.1 (standard deviation, 0.5) in the CADe group and 0.7 (SD, 1.2) in the control group, for an incidence rate ratio of 1.46 (95% CI, 1.15-1.86). The CADe system also significantly improved the detection of adenomas measuring 5 mm or less (34% vs. 27% in the control group; RR, 1.26; 95% CI, 1.01-1.52) and adenomas measuring 6-9 mm (11% vs. 6%, respectively; RR, 1.78; 95% CI, 1.09-2.86). Detection of larger adenomas did not significantly differ between groups. These findings did not vary based on adenoma morphology (polypoid or nonpolypoid) or location (proximal or distal colon), the researchers said.

Detection of multiple adenomas also was higher in the intervention group than in the control group (23% vs. 15%, respectively; RR, 1.50; 95% CI, 1.19-1.95). There were no significant differences in the detection of sessile serrated lesions (7% and 5%) and nonneoplastic lesions (20% and 17%). Average withdrawal times did not significantly differ between groups (417 seconds for CADe and 435 seconds for the control group).

The CADe system is a convolutional neural network that was trained and validated using a series of more than 2,600 histologically confirmed polyps from 840 participants in a prior clinical trial (Gastroenterology 2019;156:2198-207.e1). The system takes an average of 1.5 microseconds to output processed images.

“The addition of real-time CADe to colonoscopy resulted in a 30% and 46% relative increase in adenoma detection rate and the average number of adenomas detected per colonoscopy, demonstrating its efficacy in improving the detection of colorectal neoplasia at screening and diagnostic colonoscopy,” the investigators wrote. “[The s]afety of CADe was demonstrated by the lack of increase of both useless resections and withdrawal time, as well as by the exclusion of any underskilling in the study period.”

Medtronic loaned the equipment for the study. Dr. Repici and the senior author disclosed consulting fees from Medtronic.

SOURCE: Repici A et al. Gastroenterology. 2020 May 3. doi: 10.1053/j.gastro.2020.04.062.

A real-time, computer-aided detection system using artificial intelligence significantly improved adenoma detection during high-definition colonoscopy in a multicenter, randomized clinical trial.

The adenoma detection rate was 55% in the intervention group and 40% in the control group, Alessandro Repici, MD, PhD, and his associates wrote in Gastroenterology. Improved detection of smaller adenomas explained the difference. After age, sex, and indication for colonoscopy were controlled for, computer-aided detection (CADe) increased the probability of adenoma detection by 30% (risk ratio, 1.30; 95% confidence interval, 1.14-1.45).

The CADe system did not increase the likelihood of resecting non-neoplastic lesions (26% versus 29% in the control group), said Dr. Repici, of Humanitas Research Hospital in Milano, Italy. “The per-protocol analysis produced similar results,” he and his associates wrote. “The substantial improvement for adenoma detection rate and mean number of adenomas per colonoscopy, without increasing the removal of nonneoplastic lesions, is likely to improve the quality of colonoscopy without affecting its efficiency.”

Screening colonoscopies miss about 25% of adenomas, increasing patients’ risk for colorectal cancer. Although real-time CADe systems can identify colorectal neoplasias, comprehensive studies of the effect of CADe systems on adenoma detection and other colonoscopy quality measures are lacking.

The study included 685 adults from three centers in Italy who underwent screening colonoscopies for colorectal cancer, postpolypectomy surveillance, or workup based on a positive fecal immunochemical test or signs and symptoms of colorectal cancer. Patients were randomly assigned on a one-to-one basis to receive high-definition colonoscopies with or without the CADe system, which consists of an artificial intelligence–based medical device (GI Genius, Medtronic) that processes colonoscopy images in real time and superimposes a green box over suspected lesions. Six experienced endoscopists performed the colonoscopies; the minimum withdrawal time was 6 minutes, and histopathology was the reference standard.

The average number of adenomas detected per colonoscopy was 1.1 (standard deviation, 0.5) in the CADe group and 0.7 (SD, 1.2) in the control group, for an incidence rate ratio of 1.46 (95% CI, 1.15-1.86). The CADe system also significantly improved the detection of adenomas measuring 5 mm or less (34% vs. 27% in the control group; RR, 1.26; 95% CI, 1.01-1.52) and adenomas measuring 6-9 mm (11% vs. 6%, respectively; RR, 1.78; 95% CI, 1.09-2.86). Detection of larger adenomas did not significantly differ between groups. These findings did not vary based on adenoma morphology (polypoid or nonpolypoid) or location (proximal or distal colon), the researchers said.

Detection of multiple adenomas also was higher in the intervention group than in the control group (23% vs. 15%, respectively; RR, 1.50; 95% CI, 1.19-1.95). There were no significant differences in the detection of sessile serrated lesions (7% and 5%) and nonneoplastic lesions (20% and 17%). Average withdrawal times did not significantly differ between groups (417 seconds for CADe and 435 seconds for the control group).

The CADe system is a convolutional neural network that was trained and validated using a series of more than 2,600 histologically confirmed polyps from 840 participants in a prior clinical trial (Gastroenterology 2019;156:2198-207.e1). The system takes an average of 1.5 microseconds to output processed images.

“The addition of real-time CADe to colonoscopy resulted in a 30% and 46% relative increase in adenoma detection rate and the average number of adenomas detected per colonoscopy, demonstrating its efficacy in improving the detection of colorectal neoplasia at screening and diagnostic colonoscopy,” the investigators wrote. “[The s]afety of CADe was demonstrated by the lack of increase of both useless resections and withdrawal time, as well as by the exclusion of any underskilling in the study period.”

Medtronic loaned the equipment for the study. Dr. Repici and the senior author disclosed consulting fees from Medtronic.

SOURCE: Repici A et al. Gastroenterology. 2020 May 3. doi: 10.1053/j.gastro.2020.04.062.

High-definition chromoendoscopy significantly outperformed high-definition white-light endoscopy for detecting dysplastic lesions in patients with inflammatory bowel disease, according to the findings of a single-center prospective randomized trial.

In the intention-to-diagnose analysis, rates of dysplasia detection were 11% for high-definition chromoendoscopy and 5% for high-definition white-light endoscopy (P = .032). The per-protocol analysis produced a similar result (12% vs. 5%, respectively; P = .027). High-definition chromoendoscopy also detected significantly more dysplastic lesions per 10 minutes of colonoscope withdrawal time in the per-protocol analysis, although the difference did not reach statistical significance in the intention-to-diagnose analysis.

Overall, the findings “support the use of chromoendoscopy for surveillance of patients with inflammatory bowel diseases,” Bjarki Alexandersson, a PhD student at Karolinska University Hospital in Solna, Stockholm, and his associates wrote in Clinical Gastroenterology and Hepatology. Patients with inflammatory bowel disease are at increased risk for colorectal cancer. Most guidelines support chromoendoscopy for the surveillance of these patients, as do the results of two recent meta-analyses in which chromoendoscopy detected significantly more dysplasias among patients with inflammatory bowel disease than did white light endoscopy. However, in subgroup analyses of these studies, the difference only emerged when comparing chromoendoscopy with standard (not high-definition) white-light endoscopy. “Thus, the evidence in support of chromoendoscopy using high-definition endoscopes is weak,” the researchers wrote.

For the study, they prospectively enrolled 305 patients with ulcerative colitis or Crohn’s disease who were referred for surveillance colonoscopy at an academic hospital in Sweden from March 2011 through April 2016. Participants were randomly assigned to receive either high-definition chromoendoscopy with indigo carmine (152 patients) or high-definition white-light endoscopy (153 patients).

In the intention-to-diagnose analysis, dysplasias were detected in 17 (11%) patients evaluated by high-definition chromoendoscopy, compared with 7 (5%) patients evaluated by high-definition white-light endoscopy (P = .032). After excluding 20 patients for inadequate bowel preparation, 18 patients for protocol violations, and 4 patients for incomplete colonoscopies, the per-protocol population consisted of 263 patients. Dysplasias were detected in 12% of patients evaluated by high-definition chromoendoscopy and in 5% of those evaluated by high-definition white-light endoscopy (P = .027).

All patients also had 32 samples collected by random biopsy, which used to be standard for detecting dysplasia in inflammatory bowel disease but has become more controversial in the era of video endoscopy, the researchers noted. In all, random biopsy evaluation identified dysplasias in nine patients, including six in the high-definition chromoendoscopy group and three in the high-definition white-light endoscopy group. Random biopsies were low-yield, identifying dysplasias in 0.092% of all specimens and 3% of colonoscopies. However, 20% of patients with dysplasias were identified only through random biopsy. This finding resembles that of another recent randomized trial in which 13% of patients with inflammatory bowel disease had dysplasias detected only through random biopsy (Gut. 2018;67:616-24), the researchers noted.

They also evaluated the number of macroscopic dysplastic lesions identified for every 10 minutes of colonoscope withdrawal time. These numbers were not significantly different in the intention-to-diagnose analysis (0.066 lesions in the high-definition chromoendoscopy group vs. 0.027 lesions in the high-definition white-light endoscopy group; P = .056). However, the per-protocol analysis revealed a significant difference (0.073 vs. 0.029 dysplastic lesions, respectively; P = .031).

“Based on our findings, we recommend the use of high-definition chromoendoscopy in inflammatory bowel disease surveillance,” the researchers concluded. They acknowledged several limitations: the study included patients from only one center, most dyplastic lesions were small and, thus, had an unclear natural history, and the endoscopists included both experts and nonexperts.

The Stockholm City Council provided funding. The researchers reported having no conflicts of interest.

SOURCE: Alexandersson B et al. Clin Gastroenterol Hepatol. 2020 Apr 27. doi: 10.1016/j.cgh.2020.04.049.

High-definition chromoendoscopy significantly outperformed high-definition white-light endoscopy for detecting dysplastic lesions in patients with inflammatory bowel disease, according to the findings of a single-center prospective randomized trial.

In the intention-to-diagnose analysis, rates of dysplasia detection were 11% for high-definition chromoendoscopy and 5% for high-definition white-light endoscopy (P = .032). The per-protocol analysis produced a similar result (12% vs. 5%, respectively; P = .027). High-definition chromoendoscopy also detected significantly more dysplastic lesions per 10 minutes of colonoscope withdrawal time in the per-protocol analysis, although the difference did not reach statistical significance in the intention-to-diagnose analysis.

Overall, the findings “support the use of chromoendoscopy for surveillance of patients with inflammatory bowel diseases,” Bjarki Alexandersson, a PhD student at Karolinska University Hospital in Solna, Stockholm, and his associates wrote in Clinical Gastroenterology and Hepatology. Patients with inflammatory bowel disease are at increased risk for colorectal cancer. Most guidelines support chromoendoscopy for the surveillance of these patients, as do the results of two recent meta-analyses in which chromoendoscopy detected significantly more dysplasias among patients with inflammatory bowel disease than did white light endoscopy. However, in subgroup analyses of these studies, the difference only emerged when comparing chromoendoscopy with standard (not high-definition) white-light endoscopy. “Thus, the evidence in support of chromoendoscopy using high-definition endoscopes is weak,” the researchers wrote.

For the study, they prospectively enrolled 305 patients with ulcerative colitis or Crohn’s disease who were referred for surveillance colonoscopy at an academic hospital in Sweden from March 2011 through April 2016. Participants were randomly assigned to receive either high-definition chromoendoscopy with indigo carmine (152 patients) or high-definition white-light endoscopy (153 patients).

In the intention-to-diagnose analysis, dysplasias were detected in 17 (11%) patients evaluated by high-definition chromoendoscopy, compared with 7 (5%) patients evaluated by high-definition white-light endoscopy (P = .032). After excluding 20 patients for inadequate bowel preparation, 18 patients for protocol violations, and 4 patients for incomplete colonoscopies, the per-protocol population consisted of 263 patients. Dysplasias were detected in 12% of patients evaluated by high-definition chromoendoscopy and in 5% of those evaluated by high-definition white-light endoscopy (P = .027).

All patients also had 32 samples collected by random biopsy, which used to be standard for detecting dysplasia in inflammatory bowel disease but has become more controversial in the era of video endoscopy, the researchers noted. In all, random biopsy evaluation identified dysplasias in nine patients, including six in the high-definition chromoendoscopy group and three in the high-definition white-light endoscopy group. Random biopsies were low-yield, identifying dysplasias in 0.092% of all specimens and 3% of colonoscopies. However, 20% of patients with dysplasias were identified only through random biopsy. This finding resembles that of another recent randomized trial in which 13% of patients with inflammatory bowel disease had dysplasias detected only through random biopsy (Gut. 2018;67:616-24), the researchers noted.

They also evaluated the number of macroscopic dysplastic lesions identified for every 10 minutes of colonoscope withdrawal time. These numbers were not significantly different in the intention-to-diagnose analysis (0.066 lesions in the high-definition chromoendoscopy group vs. 0.027 lesions in the high-definition white-light endoscopy group; P = .056). However, the per-protocol analysis revealed a significant difference (0.073 vs. 0.029 dysplastic lesions, respectively; P = .031).

“Based on our findings, we recommend the use of high-definition chromoendoscopy in inflammatory bowel disease surveillance,” the researchers concluded. They acknowledged several limitations: the study included patients from only one center, most dyplastic lesions were small and, thus, had an unclear natural history, and the endoscopists included both experts and nonexperts.

The Stockholm City Council provided funding. The researchers reported having no conflicts of interest.

SOURCE: Alexandersson B et al. Clin Gastroenterol Hepatol. 2020 Apr 27. doi: 10.1016/j.cgh.2020.04.049.

High-definition chromoendoscopy significantly outperformed high-definition white-light endoscopy for detecting dysplastic lesions in patients with inflammatory bowel disease, according to the findings of a single-center prospective randomized trial.

In the intention-to-diagnose analysis, rates of dysplasia detection were 11% for high-definition chromoendoscopy and 5% for high-definition white-light endoscopy (P = .032). The per-protocol analysis produced a similar result (12% vs. 5%, respectively; P = .027). High-definition chromoendoscopy also detected significantly more dysplastic lesions per 10 minutes of colonoscope withdrawal time in the per-protocol analysis, although the difference did not reach statistical significance in the intention-to-diagnose analysis.

Overall, the findings “support the use of chromoendoscopy for surveillance of patients with inflammatory bowel diseases,” Bjarki Alexandersson, a PhD student at Karolinska University Hospital in Solna, Stockholm, and his associates wrote in Clinical Gastroenterology and Hepatology. Patients with inflammatory bowel disease are at increased risk for colorectal cancer. Most guidelines support chromoendoscopy for the surveillance of these patients, as do the results of two recent meta-analyses in which chromoendoscopy detected significantly more dysplasias among patients with inflammatory bowel disease than did white light endoscopy. However, in subgroup analyses of these studies, the difference only emerged when comparing chromoendoscopy with standard (not high-definition) white-light endoscopy. “Thus, the evidence in support of chromoendoscopy using high-definition endoscopes is weak,” the researchers wrote.

For the study, they prospectively enrolled 305 patients with ulcerative colitis or Crohn’s disease who were referred for surveillance colonoscopy at an academic hospital in Sweden from March 2011 through April 2016. Participants were randomly assigned to receive either high-definition chromoendoscopy with indigo carmine (152 patients) or high-definition white-light endoscopy (153 patients).

In the intention-to-diagnose analysis, dysplasias were detected in 17 (11%) patients evaluated by high-definition chromoendoscopy, compared with 7 (5%) patients evaluated by high-definition white-light endoscopy (P = .032). After excluding 20 patients for inadequate bowel preparation, 18 patients for protocol violations, and 4 patients for incomplete colonoscopies, the per-protocol population consisted of 263 patients. Dysplasias were detected in 12% of patients evaluated by high-definition chromoendoscopy and in 5% of those evaluated by high-definition white-light endoscopy (P = .027).

All patients also had 32 samples collected by random biopsy, which used to be standard for detecting dysplasia in inflammatory bowel disease but has become more controversial in the era of video endoscopy, the researchers noted. In all, random biopsy evaluation identified dysplasias in nine patients, including six in the high-definition chromoendoscopy group and three in the high-definition white-light endoscopy group. Random biopsies were low-yield, identifying dysplasias in 0.092% of all specimens and 3% of colonoscopies. However, 20% of patients with dysplasias were identified only through random biopsy. This finding resembles that of another recent randomized trial in which 13% of patients with inflammatory bowel disease had dysplasias detected only through random biopsy (Gut. 2018;67:616-24), the researchers noted.

They also evaluated the number of macroscopic dysplastic lesions identified for every 10 minutes of colonoscope withdrawal time. These numbers were not significantly different in the intention-to-diagnose analysis (0.066 lesions in the high-definition chromoendoscopy group vs. 0.027 lesions in the high-definition white-light endoscopy group; P = .056). However, the per-protocol analysis revealed a significant difference (0.073 vs. 0.029 dysplastic lesions, respectively; P = .031).

“Based on our findings, we recommend the use of high-definition chromoendoscopy in inflammatory bowel disease surveillance,” the researchers concluded. They acknowledged several limitations: the study included patients from only one center, most dyplastic lesions were small and, thus, had an unclear natural history, and the endoscopists included both experts and nonexperts.

The Stockholm City Council provided funding. The researchers reported having no conflicts of interest.

SOURCE: Alexandersson B et al. Clin Gastroenterol Hepatol. 2020 Apr 27. doi: 10.1016/j.cgh.2020.04.049.

Patients with early onset cancers have an increased prevalence of germline pathogenic variants, suggesting that genetic testing would be worthwhile in this population, according to a presentation at the AACR virtual meeting II.

Investigators analyzed blood samples from 1,201 patients who were aged 18-39 years when diagnosed with a solid tumor malignancy.

In this group, there were 877 patients with early onset cancers, defined as cancers for which 39 years of age is greater than 1 standard deviation below the mean age of diagnosis for the cancer type.

The remaining 324 patients had young adult cancers, defined as cancers for which 39 years of age is less than 1 standard deviation below the mean age of diagnosis.

The most common early onset cancers were breast, colorectal, kidney, pancreas, and ovarian cancer.

The most common young adult cancers were sarcoma, brain cancer, and testicular cancer, as expected, said investigator Zsofia K. Stadler, MD, of Memorial Sloan Kettering Cancer Center in New York.

Dr. Stadler and colleagues performed next-generation sequencing of the patient samples using a panel of up to 88 genes previously implicated in cancer predisposition. This revealed a significantly higher prevalence of germline mutations in patients with early onset cancers than in those with young adult cancers – 21% and 13%, respectively (P = .002).

In patients with only high- and moderate-risk cancer susceptibility genes, the prevalence was 15% in the early onset group and 10% in the young adult group (P = .01). “Among the early onset cancer group, pancreas, breast, and kidney cancer patients harbored the highest rates of germline mutations,” Dr. Stadler said, noting that the spectrum of mutated genes differed in early onset and young adult cancer patients.

“In early onset patients, the most commonly mutated genes were BRCA1 and BRCA2 [4.9%], Lynch syndrome genes [2.2%], ATM [1.6%], and CHECK2 [1.7%],” Dr. Stadler said. “On the other hand, in young adults, TP53 mutations [2.2%], and SDHA and SDHB mutations dominated [1.9%], with the majority of mutations occurring in sarcoma patients.”

These findings suggest the prevalence of inherited cancer susceptibility syndromes in young adults with cancer is not uniform.

“We found a very high prevalence of germline mutations in young patients with cancer types that typically present at later ages,” Dr. Stadler said, referring to the early onset patients.

Conversely, the young adult cancer patients had a prevalence and spectrum of mutations more similar to what is seen in pediatric cancer populations, she noted.

The findings are surprising, according to AACR past president Elaine R. Mardis, PhD, of The Ohio State University in Columbus.

Dr. Mardis said the results show that, in young adults with early onset cancers, “the germline prevalence of these mutations is significantly higher than we had previously thought.”

“Although representing only about 4% of all cancers, young adults with cancer ... face unique challenges,” Dr. Stadler said. “Identifying whether a young patient’s cancer occurred in the setting of an inherited cancer predisposition syndrome is especially important in this patient population.”

Such knowledge “can significantly impact the risk of second primary cancers and the need for increased surveillance measures or even risk-reducing surgeries,” Dr. Stadler explained. She added that it can also have implications for identifying at-risk family members, such as younger siblings or children who should pursue genetic testing and appropriate prevention measures.

“Our results suggest that, among patients with early onset cancer, the increased prevalence of germline mutations supports a role for genetic testing, irrespective of tumor type,” Dr. Stadler said.

This study was partially funded by the Precision, Interception and Prevention Program, the Robert and Katie Niehaus Center for Inherited Cancer Genomics, the Marie-Josee and Henry R. Kravis Center for Molecular Oncology, and a National Cancer Institute Cancer Center Core Grant. Dr. Stadler reported that an immediate family member serves as a consultant in ophthalmology for Allergan, Adverum Biotechnologies, Alimera Sciences, BioMarin, Fortress Biotech, Genentech/Roche, Novartis, Optos, Regeneron, Regenxbio, and Spark Therapeutics. Dr. Mardis disclosed relationships with Qiagen NV, Pact Pharma LLC, Moderna Inc., and Interpreta LLC.

sworcester@mdedge.com

SOURCE: Stadler Z et al. AACR 2020, Abstract 1122.

Patients with early onset cancers have an increased prevalence of germline pathogenic variants, suggesting that genetic testing would be worthwhile in this population, according to a presentation at the AACR virtual meeting II.

Investigators analyzed blood samples from 1,201 patients who were aged 18-39 years when diagnosed with a solid tumor malignancy.

In this group, there were 877 patients with early onset cancers, defined as cancers for which 39 years of age is greater than 1 standard deviation below the mean age of diagnosis for the cancer type.

The remaining 324 patients had young adult cancers, defined as cancers for which 39 years of age is less than 1 standard deviation below the mean age of diagnosis.

The most common early onset cancers were breast, colorectal, kidney, pancreas, and ovarian cancer.

The most common young adult cancers were sarcoma, brain cancer, and testicular cancer, as expected, said investigator Zsofia K. Stadler, MD, of Memorial Sloan Kettering Cancer Center in New York.

Dr. Stadler and colleagues performed next-generation sequencing of the patient samples using a panel of up to 88 genes previously implicated in cancer predisposition. This revealed a significantly higher prevalence of germline mutations in patients with early onset cancers than in those with young adult cancers – 21% and 13%, respectively (P = .002).

In patients with only high- and moderate-risk cancer susceptibility genes, the prevalence was 15% in the early onset group and 10% in the young adult group (P = .01). “Among the early onset cancer group, pancreas, breast, and kidney cancer patients harbored the highest rates of germline mutations,” Dr. Stadler said, noting that the spectrum of mutated genes differed in early onset and young adult cancer patients.

“In early onset patients, the most commonly mutated genes were BRCA1 and BRCA2 [4.9%], Lynch syndrome genes [2.2%], ATM [1.6%], and CHECK2 [1.7%],” Dr. Stadler said. “On the other hand, in young adults, TP53 mutations [2.2%], and SDHA and SDHB mutations dominated [1.9%], with the majority of mutations occurring in sarcoma patients.”

These findings suggest the prevalence of inherited cancer susceptibility syndromes in young adults with cancer is not uniform.

“We found a very high prevalence of germline mutations in young patients with cancer types that typically present at later ages,” Dr. Stadler said, referring to the early onset patients.

Conversely, the young adult cancer patients had a prevalence and spectrum of mutations more similar to what is seen in pediatric cancer populations, she noted.

The findings are surprising, according to AACR past president Elaine R. Mardis, PhD, of The Ohio State University in Columbus.

Dr. Mardis said the results show that, in young adults with early onset cancers, “the germline prevalence of these mutations is significantly higher than we had previously thought.”

“Although representing only about 4% of all cancers, young adults with cancer ... face unique challenges,” Dr. Stadler said. “Identifying whether a young patient’s cancer occurred in the setting of an inherited cancer predisposition syndrome is especially important in this patient population.”

Such knowledge “can significantly impact the risk of second primary cancers and the need for increased surveillance measures or even risk-reducing surgeries,” Dr. Stadler explained. She added that it can also have implications for identifying at-risk family members, such as younger siblings or children who should pursue genetic testing and appropriate prevention measures.

“Our results suggest that, among patients with early onset cancer, the increased prevalence of germline mutations supports a role for genetic testing, irrespective of tumor type,” Dr. Stadler said.

This study was partially funded by the Precision, Interception and Prevention Program, the Robert and Katie Niehaus Center for Inherited Cancer Genomics, the Marie-Josee and Henry R. Kravis Center for Molecular Oncology, and a National Cancer Institute Cancer Center Core Grant. Dr. Stadler reported that an immediate family member serves as a consultant in ophthalmology for Allergan, Adverum Biotechnologies, Alimera Sciences, BioMarin, Fortress Biotech, Genentech/Roche, Novartis, Optos, Regeneron, Regenxbio, and Spark Therapeutics. Dr. Mardis disclosed relationships with Qiagen NV, Pact Pharma LLC, Moderna Inc., and Interpreta LLC.

sworcester@mdedge.com

SOURCE: Stadler Z et al. AACR 2020, Abstract 1122.

Patients with early onset cancers have an increased prevalence of germline pathogenic variants, suggesting that genetic testing would be worthwhile in this population, according to a presentation at the AACR virtual meeting II.

Investigators analyzed blood samples from 1,201 patients who were aged 18-39 years when diagnosed with a solid tumor malignancy.

In this group, there were 877 patients with early onset cancers, defined as cancers for which 39 years of age is greater than 1 standard deviation below the mean age of diagnosis for the cancer type.

The remaining 324 patients had young adult cancers, defined as cancers for which 39 years of age is less than 1 standard deviation below the mean age of diagnosis.

The most common early onset cancers were breast, colorectal, kidney, pancreas, and ovarian cancer.

The most common young adult cancers were sarcoma, brain cancer, and testicular cancer, as expected, said investigator Zsofia K. Stadler, MD, of Memorial Sloan Kettering Cancer Center in New York.

Dr. Stadler and colleagues performed next-generation sequencing of the patient samples using a panel of up to 88 genes previously implicated in cancer predisposition. This revealed a significantly higher prevalence of germline mutations in patients with early onset cancers than in those with young adult cancers – 21% and 13%, respectively (P = .002).

In patients with only high- and moderate-risk cancer susceptibility genes, the prevalence was 15% in the early onset group and 10% in the young adult group (P = .01). “Among the early onset cancer group, pancreas, breast, and kidney cancer patients harbored the highest rates of germline mutations,” Dr. Stadler said, noting that the spectrum of mutated genes differed in early onset and young adult cancer patients.

“In early onset patients, the most commonly mutated genes were BRCA1 and BRCA2 [4.9%], Lynch syndrome genes [2.2%], ATM [1.6%], and CHECK2 [1.7%],” Dr. Stadler said. “On the other hand, in young adults, TP53 mutations [2.2%], and SDHA and SDHB mutations dominated [1.9%], with the majority of mutations occurring in sarcoma patients.”

These findings suggest the prevalence of inherited cancer susceptibility syndromes in young adults with cancer is not uniform.

“We found a very high prevalence of germline mutations in young patients with cancer types that typically present at later ages,” Dr. Stadler said, referring to the early onset patients.

Conversely, the young adult cancer patients had a prevalence and spectrum of mutations more similar to what is seen in pediatric cancer populations, she noted.

The findings are surprising, according to AACR past president Elaine R. Mardis, PhD, of The Ohio State University in Columbus.

Dr. Mardis said the results show that, in young adults with early onset cancers, “the germline prevalence of these mutations is significantly higher than we had previously thought.”

“Although representing only about 4% of all cancers, young adults with cancer ... face unique challenges,” Dr. Stadler said. “Identifying whether a young patient’s cancer occurred in the setting of an inherited cancer predisposition syndrome is especially important in this patient population.”

Such knowledge “can significantly impact the risk of second primary cancers and the need for increased surveillance measures or even risk-reducing surgeries,” Dr. Stadler explained. She added that it can also have implications for identifying at-risk family members, such as younger siblings or children who should pursue genetic testing and appropriate prevention measures.

“Our results suggest that, among patients with early onset cancer, the increased prevalence of germline mutations supports a role for genetic testing, irrespective of tumor type,” Dr. Stadler said.

This study was partially funded by the Precision, Interception and Prevention Program, the Robert and Katie Niehaus Center for Inherited Cancer Genomics, the Marie-Josee and Henry R. Kravis Center for Molecular Oncology, and a National Cancer Institute Cancer Center Core Grant. Dr. Stadler reported that an immediate family member serves as a consultant in ophthalmology for Allergan, Adverum Biotechnologies, Alimera Sciences, BioMarin, Fortress Biotech, Genentech/Roche, Novartis, Optos, Regeneron, Regenxbio, and Spark Therapeutics. Dr. Mardis disclosed relationships with Qiagen NV, Pact Pharma LLC, Moderna Inc., and Interpreta LLC.

sworcester@mdedge.com

SOURCE: Stadler Z et al. AACR 2020, Abstract 1122.

Swapping out intravenous fentanyl in favor of IV acetaminophen in patients with ST-elevation MI (STEMI) provides comparable pain relief but with desirably higher blood levels of ticagrelor both immediately after primary percutaneous intervention and 1 hour post procedure.

Bruce Jancin/Frontline Medical News

That’s according to results of the Dutch ON-TIME 3 trial, presented by Anne H. Tavenier, MD, at the virtual annual meeting of the European Association of Percutaneous Cardiovascular Interventions.

“Our trial results have implications for the prehospital treatment of STEMI patients,” said Dr. Tavenier, a cardiologist at the Isala Clinic in Zwolle, the Netherlands.

The explanation for the success of this novel STEMI pain management strategy? The synthetic opioid fentanyl impairs gastrointestinal absorption of oral P2Y12 receptor antagonists such as ticagrelor. Opiates do so as well, whereas acetaminophen does not, she explained.

The potent platelet inhibition provided by oral P2Y12 inhibitors is crucial to successful primary PCI for STEMI. But these platelet inhibitory effects are inherently slowed in STEMI patients owing to hemodynamic changes and delayed GI absorption. And even though both American College of Cardiology/American Heart Association and European Society of Cardiology guidelines recommend the use of opioids for pain control in STEMI patients, the fact is that these medications further delay the absorption of oral P2Y12 inhibitors. And this delay is further exacerbated by the nausea and vomiting which are common side effects of IV fentanyl, she continued.

The impetus for the ON-TIME 3 trial was straightforward, the cardiologist said: “For years, STEMI patients have been treated with morphine or morphinelike drugs like fentanyl because of pain or sympathetic stress. To date, trials investigating alternative analgesics to opioids have been scarce.”

ON-TIME 3 was a multicenter, open-label, phase 4 clinical trial in which 195 STEMI patients with a self-reported pain score of at least 4 on a 0-10 scale received crushed ticagrelor in the ambulance along with either 1,000 mg of IV acetaminophen or fentanyl at 1-2 mcg/kg.

Ticagrelor blood levels were significantly higher in the IV acetaminophen group when measured just prior to primary PCI (151 ng/mL versus 60 ng/mL in the IV fentanyl group; immediately after PCI (326 versus 115 ng/mL), and 1 hour post PCI (488 versus 372 ng/mL).

However, there was no significant between-group difference in levels of platelet reactivity units measured immediately after primary PCI, Dr. Tavenier added.

Discussant Christoph K. Naber, MD, PhD, confessed that prior to ON-TIME 3 he was unaware that administering opioids to STEMI patients results in delayed absorption of oral P2Y12 inhibitors. Upon delving into the literature, however, he found that this is indeed a well-documented problem.

“The open question I have about this very elegant trial is whether the increased P2Y12 levels will translate into a measurable difference in clinical outcomes,” said Dr. Naber, an interventional cardiologist at the Wilhemshaven (Germany) Clinic.

The answer to that question would require a larger, longer-term trial. And he’s disinclined to wait around for that to happen.

“I think when we look at the risk balance, the risk of switching from an opioid to acetaminophen, if it works for the patient, is rather low. So this might be something to introduce in my practice,” the cardiologist said.

Dr. Tavenier and Dr. Naber reported having no financial conflicts of interest.

bjancin@mdedge.com

SOURCE: Tavenier AH. EuroPCR 2020.

Swapping out intravenous fentanyl in favor of IV acetaminophen in patients with ST-elevation MI (STEMI) provides comparable pain relief but with desirably higher blood levels of ticagrelor both immediately after primary percutaneous intervention and 1 hour post procedure.

Bruce Jancin/Frontline Medical News

That’s according to results of the Dutch ON-TIME 3 trial, presented by Anne H. Tavenier, MD, at the virtual annual meeting of the European Association of Percutaneous Cardiovascular Interventions.

“Our trial results have implications for the prehospital treatment of STEMI patients,” said Dr. Tavenier, a cardiologist at the Isala Clinic in Zwolle, the Netherlands.

The explanation for the success of this novel STEMI pain management strategy? The synthetic opioid fentanyl impairs gastrointestinal absorption of oral P2Y12 receptor antagonists such as ticagrelor. Opiates do so as well, whereas acetaminophen does not, she explained.

The potent platelet inhibition provided by oral P2Y12 inhibitors is crucial to successful primary PCI for STEMI. But these platelet inhibitory effects are inherently slowed in STEMI patients owing to hemodynamic changes and delayed GI absorption. And even though both American College of Cardiology/American Heart Association and European Society of Cardiology guidelines recommend the use of opioids for pain control in STEMI patients, the fact is that these medications further delay the absorption of oral P2Y12 inhibitors. And this delay is further exacerbated by the nausea and vomiting which are common side effects of IV fentanyl, she continued.

The impetus for the ON-TIME 3 trial was straightforward, the cardiologist said: “For years, STEMI patients have been treated with morphine or morphinelike drugs like fentanyl because of pain or sympathetic stress. To date, trials investigating alternative analgesics to opioids have been scarce.”

ON-TIME 3 was a multicenter, open-label, phase 4 clinical trial in which 195 STEMI patients with a self-reported pain score of at least 4 on a 0-10 scale received crushed ticagrelor in the ambulance along with either 1,000 mg of IV acetaminophen or fentanyl at 1-2 mcg/kg.

Ticagrelor blood levels were significantly higher in the IV acetaminophen group when measured just prior to primary PCI (151 ng/mL versus 60 ng/mL in the IV fentanyl group; immediately after PCI (326 versus 115 ng/mL), and 1 hour post PCI (488 versus 372 ng/mL).

However, there was no significant between-group difference in levels of platelet reactivity units measured immediately after primary PCI, Dr. Tavenier added.

Discussant Christoph K. Naber, MD, PhD, confessed that prior to ON-TIME 3 he was unaware that administering opioids to STEMI patients results in delayed absorption of oral P2Y12 inhibitors. Upon delving into the literature, however, he found that this is indeed a well-documented problem.

“The open question I have about this very elegant trial is whether the increased P2Y12 levels will translate into a measurable difference in clinical outcomes,” said Dr. Naber, an interventional cardiologist at the Wilhemshaven (Germany) Clinic.

The answer to that question would require a larger, longer-term trial. And he’s disinclined to wait around for that to happen.

“I think when we look at the risk balance, the risk of switching from an opioid to acetaminophen, if it works for the patient, is rather low. So this might be something to introduce in my practice,” the cardiologist said.

Dr. Tavenier and Dr. Naber reported having no financial conflicts of interest.

bjancin@mdedge.com

SOURCE: Tavenier AH. EuroPCR 2020.

Swapping out intravenous fentanyl in favor of IV acetaminophen in patients with ST-elevation MI (STEMI) provides comparable pain relief but with desirably higher blood levels of ticagrelor both immediately after primary percutaneous intervention and 1 hour post procedure.

Bruce Jancin/Frontline Medical News

That’s according to results of the Dutch ON-TIME 3 trial, presented by Anne H. Tavenier, MD, at the virtual annual meeting of the European Association of Percutaneous Cardiovascular Interventions.

“Our trial results have implications for the prehospital treatment of STEMI patients,” said Dr. Tavenier, a cardiologist at the Isala Clinic in Zwolle, the Netherlands.

The explanation for the success of this novel STEMI pain management strategy? The synthetic opioid fentanyl impairs gastrointestinal absorption of oral P2Y12 receptor antagonists such as ticagrelor. Opiates do so as well, whereas acetaminophen does not, she explained.

The potent platelet inhibition provided by oral P2Y12 inhibitors is crucial to successful primary PCI for STEMI. But these platelet inhibitory effects are inherently slowed in STEMI patients owing to hemodynamic changes and delayed GI absorption. And even though both American College of Cardiology/American Heart Association and European Society of Cardiology guidelines recommend the use of opioids for pain control in STEMI patients, the fact is that these medications further delay the absorption of oral P2Y12 inhibitors. And this delay is further exacerbated by the nausea and vomiting which are common side effects of IV fentanyl, she continued.

The impetus for the ON-TIME 3 trial was straightforward, the cardiologist said: “For years, STEMI patients have been treated with morphine or morphinelike drugs like fentanyl because of pain or sympathetic stress. To date, trials investigating alternative analgesics to opioids have been scarce.”

ON-TIME 3 was a multicenter, open-label, phase 4 clinical trial in which 195 STEMI patients with a self-reported pain score of at least 4 on a 0-10 scale received crushed ticagrelor in the ambulance along with either 1,000 mg of IV acetaminophen or fentanyl at 1-2 mcg/kg.

Ticagrelor blood levels were significantly higher in the IV acetaminophen group when measured just prior to primary PCI (151 ng/mL versus 60 ng/mL in the IV fentanyl group; immediately after PCI (326 versus 115 ng/mL), and 1 hour post PCI (488 versus 372 ng/mL).

However, there was no significant between-group difference in levels of platelet reactivity units measured immediately after primary PCI, Dr. Tavenier added.

Discussant Christoph K. Naber, MD, PhD, confessed that prior to ON-TIME 3 he was unaware that administering opioids to STEMI patients results in delayed absorption of oral P2Y12 inhibitors. Upon delving into the literature, however, he found that this is indeed a well-documented problem.

“The open question I have about this very elegant trial is whether the increased P2Y12 levels will translate into a measurable difference in clinical outcomes,” said Dr. Naber, an interventional cardiologist at the Wilhemshaven (Germany) Clinic.

The answer to that question would require a larger, longer-term trial. And he’s disinclined to wait around for that to happen.

“I think when we look at the risk balance, the risk of switching from an opioid to acetaminophen, if it works for the patient, is rather low. So this might be something to introduce in my practice,” the cardiologist said.

Dr. Tavenier and Dr. Naber reported having no financial conflicts of interest.

bjancin@mdedge.com

SOURCE: Tavenier AH. EuroPCR 2020.