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Height an ‘overlooked risk factor’ for colorectal cancer?
A new meta-analysis provides more evidence that
“There are well-known modifiable dietary associations for colorectal cancer, such as processed red meats and smoking, but guidelines currently are fixated on family history, and height is clinically neglected when it comes to risk screening,” study investigator Gerard Mullin, MD, with Johns Hopkins University, Baltimore, said in a news release. This large study “builds on evidence that taller height is an overlooked risk factor and should be considered when evaluating and recommending patients for colorectal cancer screenings.”
The study was published online March 1 in Cancer Epidemiology, Biomarkers & Prevention.
The evidence: Height and cancer risk
Height has been actively studied as a potential nonmodifiable risk factor for a range of cancers, including CRC.
In one large prospective study of postmenopausal women, researchers found a modest but statistically significant positive association between height and risk for any cancer and for melanoma, multiple myeloma, and cancers of the thyroid, ovary, colorectum, and endometrium.
A separate study found that tall men, especially those who are long-legged, may be at increased risk for prostate cancer, including high-grade tumors, relative to men of more modest stature.
However, the study authors point out, past studies have also produced mixed results, used inconsistent measures of height, and failed to include the risk of adenomas.
In the current meta-analysis, the investigators included 47 international, observational studies involving 280,644 adults with CRC and 14,139 cases of colorectal adenoma.
Because the definition of tallness differs around the world, the researchers compared the highest versus the lowest height percentile of various study groups. The findings were adjusted for demographic, socioeconomic, behavioral, and other known risk factors for CRC.
Overall, the investigators found that the tallest individuals within the highest percentile of height had a 24% higher risk of developing CRC compared to the shortest individuals within the lowest percentile (hazard ratio [HR], 1.24; P < .001).
In addition, they found that every 10-cm increase (about 4 inches) in height was associated with a 14% increased risk of developing CRC (HR, 1.14; P < .001) and a 6% increased likelihood of adenomas (odds ratio [OR], 1.06; P = .03).
In the United States, the average height for men is 5 feet, 9 inches, and for women it is 5 feet, 4 inches, which means men who are 6 feet, 1 inch and women who are 5 feet, 8 inches or taller have a 14% increased risk of CRC and a 6% increased risk of adenomas, the researchers explained.
According to co–first author Elinor Zhou, MD, also with Johns Hopkins University, a potential explanation for this link “is that adult height correlates with body organ size. More active proliferation in organs of taller people could increase the possibility of mutations leading to malignant transformation.”
The study authors said more research is needed to identify particular subgroups of tall people at risk for CRC.
“For instance, tall athletes and individuals with inherited tallness, such as those with Marfan syndrome, could be screened earlier and the impact of height further explored,” Dr. Zhou said.
Plus, Dr. Zhou added, more studies are needed to “definitively say at what height you would need earlier colorectal cancer screening.”
The current study was supported by grants from Bloomberg Philanthropies, intramural funds, and the Johns Hopkins Cancer Center Support Grant. The authors declared no conflicts of interest.
A version of this article first appeared on Medscape.com.
A new meta-analysis provides more evidence that
“There are well-known modifiable dietary associations for colorectal cancer, such as processed red meats and smoking, but guidelines currently are fixated on family history, and height is clinically neglected when it comes to risk screening,” study investigator Gerard Mullin, MD, with Johns Hopkins University, Baltimore, said in a news release. This large study “builds on evidence that taller height is an overlooked risk factor and should be considered when evaluating and recommending patients for colorectal cancer screenings.”
The study was published online March 1 in Cancer Epidemiology, Biomarkers & Prevention.
The evidence: Height and cancer risk
Height has been actively studied as a potential nonmodifiable risk factor for a range of cancers, including CRC.
In one large prospective study of postmenopausal women, researchers found a modest but statistically significant positive association between height and risk for any cancer and for melanoma, multiple myeloma, and cancers of the thyroid, ovary, colorectum, and endometrium.
A separate study found that tall men, especially those who are long-legged, may be at increased risk for prostate cancer, including high-grade tumors, relative to men of more modest stature.
However, the study authors point out, past studies have also produced mixed results, used inconsistent measures of height, and failed to include the risk of adenomas.
In the current meta-analysis, the investigators included 47 international, observational studies involving 280,644 adults with CRC and 14,139 cases of colorectal adenoma.
Because the definition of tallness differs around the world, the researchers compared the highest versus the lowest height percentile of various study groups. The findings were adjusted for demographic, socioeconomic, behavioral, and other known risk factors for CRC.
Overall, the investigators found that the tallest individuals within the highest percentile of height had a 24% higher risk of developing CRC compared to the shortest individuals within the lowest percentile (hazard ratio [HR], 1.24; P < .001).
In addition, they found that every 10-cm increase (about 4 inches) in height was associated with a 14% increased risk of developing CRC (HR, 1.14; P < .001) and a 6% increased likelihood of adenomas (odds ratio [OR], 1.06; P = .03).
In the United States, the average height for men is 5 feet, 9 inches, and for women it is 5 feet, 4 inches, which means men who are 6 feet, 1 inch and women who are 5 feet, 8 inches or taller have a 14% increased risk of CRC and a 6% increased risk of adenomas, the researchers explained.
According to co–first author Elinor Zhou, MD, also with Johns Hopkins University, a potential explanation for this link “is that adult height correlates with body organ size. More active proliferation in organs of taller people could increase the possibility of mutations leading to malignant transformation.”
The study authors said more research is needed to identify particular subgroups of tall people at risk for CRC.
“For instance, tall athletes and individuals with inherited tallness, such as those with Marfan syndrome, could be screened earlier and the impact of height further explored,” Dr. Zhou said.
Plus, Dr. Zhou added, more studies are needed to “definitively say at what height you would need earlier colorectal cancer screening.”
The current study was supported by grants from Bloomberg Philanthropies, intramural funds, and the Johns Hopkins Cancer Center Support Grant. The authors declared no conflicts of interest.
A version of this article first appeared on Medscape.com.
A new meta-analysis provides more evidence that
“There are well-known modifiable dietary associations for colorectal cancer, such as processed red meats and smoking, but guidelines currently are fixated on family history, and height is clinically neglected when it comes to risk screening,” study investigator Gerard Mullin, MD, with Johns Hopkins University, Baltimore, said in a news release. This large study “builds on evidence that taller height is an overlooked risk factor and should be considered when evaluating and recommending patients for colorectal cancer screenings.”
The study was published online March 1 in Cancer Epidemiology, Biomarkers & Prevention.
The evidence: Height and cancer risk
Height has been actively studied as a potential nonmodifiable risk factor for a range of cancers, including CRC.
In one large prospective study of postmenopausal women, researchers found a modest but statistically significant positive association between height and risk for any cancer and for melanoma, multiple myeloma, and cancers of the thyroid, ovary, colorectum, and endometrium.
A separate study found that tall men, especially those who are long-legged, may be at increased risk for prostate cancer, including high-grade tumors, relative to men of more modest stature.
However, the study authors point out, past studies have also produced mixed results, used inconsistent measures of height, and failed to include the risk of adenomas.
In the current meta-analysis, the investigators included 47 international, observational studies involving 280,644 adults with CRC and 14,139 cases of colorectal adenoma.
Because the definition of tallness differs around the world, the researchers compared the highest versus the lowest height percentile of various study groups. The findings were adjusted for demographic, socioeconomic, behavioral, and other known risk factors for CRC.
Overall, the investigators found that the tallest individuals within the highest percentile of height had a 24% higher risk of developing CRC compared to the shortest individuals within the lowest percentile (hazard ratio [HR], 1.24; P < .001).
In addition, they found that every 10-cm increase (about 4 inches) in height was associated with a 14% increased risk of developing CRC (HR, 1.14; P < .001) and a 6% increased likelihood of adenomas (odds ratio [OR], 1.06; P = .03).
In the United States, the average height for men is 5 feet, 9 inches, and for women it is 5 feet, 4 inches, which means men who are 6 feet, 1 inch and women who are 5 feet, 8 inches or taller have a 14% increased risk of CRC and a 6% increased risk of adenomas, the researchers explained.
According to co–first author Elinor Zhou, MD, also with Johns Hopkins University, a potential explanation for this link “is that adult height correlates with body organ size. More active proliferation in organs of taller people could increase the possibility of mutations leading to malignant transformation.”
The study authors said more research is needed to identify particular subgroups of tall people at risk for CRC.
“For instance, tall athletes and individuals with inherited tallness, such as those with Marfan syndrome, could be screened earlier and the impact of height further explored,” Dr. Zhou said.
Plus, Dr. Zhou added, more studies are needed to “definitively say at what height you would need earlier colorectal cancer screening.”
The current study was supported by grants from Bloomberg Philanthropies, intramural funds, and the Johns Hopkins Cancer Center Support Grant. The authors declared no conflicts of interest.
A version of this article first appeared on Medscape.com.
FROM CANCER EPIDEMIOLOGY, BIOMARKERS & PREVENTION
Prescription video game focuses attention in ADHD
Investigators found children who used the video game-based therapy (EndeavorRx) experienced increased brain activity related to attention function, as measured by EEG, which correlated with improvements in objective behavioral measures of attention.
“While the previous multicenter trials show attention improvement for children using EndeavorRx, this is the first study to look at the brain activity in children with a primary concern of ADHD,” principal investigator Elysa Marco, MD, clinical executive for neurodevelopmental medicine at Cortica Healthcare, San Rafael, Calif., said in news release.
“It is exciting to see measurable improvement on the EEGs that correlates with the behavioral benefits,” said Dr. Marco.
The study was recently published online in PLOS ONE.
Measurable changes
As previously reported by this news organization, the Food and Drug Administration approved EndeavorRx in June 2020 as a prescription video game–based therapeutic device for children aged 8-12 years with primarily inattentive or combined-type ADHD, who have a demonstrated attention issue.
“The device is intended for use as part of a therapeutic program that may include clinician-directed therapy, medication, and/or educational programs, which further address symptoms of the disorder,” the FDA said upon approval.
In the current unblinded, single-arm study, the researchers assessed 25 children (aged 8-12 years) with a confirmed diagnosis of ADHD on neural, behavioral, and clinical metrics of attention before and after a 4-week at-home intervention.
Participants were instructed to use EndeavorRx for about 25 minutes a day at least 5 days a week for 4 weeks, as recommended by the FDA.
“EndeavorRx enhanced midline frontal theta (MFT) activity, suggesting that patients who used EndeavorRx for 4 weeks showed changes in measurable brain function,” Anil S. Jina, MD, chief medical officer of Akili Interactive, told this news organization. Dr. Jina was not involved with the study.
There was also a correlation between MFT activity and attention functioning, “suggesting that children who experienced the largest gains in MFT activity as measured by EEG also showed the greatest improvements in computerized performance tests designed to measure attention,” Dr. Jina said.
In addition, parents reported significantly fewer inattention symptoms in children after EndeavorRx treatment, as measured by the Vanderbilt ADHD Diagnostic Rating Scale.
‘Not just another video game’
EndeavorRx has been evaluated in five clinical studies involving more than 600 children with ADHD, including the STARS-ADHD trial, a prospective, randomized, controlled study published in The Lancet Digital Health.
The STARS-ADHD trial randomly allocated 348 children to either EndeavorRx treatment or a controlled intervention, which was a word game.
The researchers reported statistically significant improvements in attentional functioning in the EndeavorRx group as rated by test of variables of attention.
“This is not just another video game,” STARS-ADHD trialist Scott H. Kollins, PhD, MS, a clinical psychologist at Duke Health’s ADHD Clinic in Durham, N.C., who helped developed it, previously told this news organization. 
The tool’s adaptive algorithms adjust and monitor task difficulty based on performance, using a video game format and rewards to engage users, he explained. EndeavorRx is a challenge to play by design.
“The treatment was programmed into the gameplay experience and designed to challenge a child’s attentional control during gameplay, requiring focus and flexibility to manage tasks at the same time,” Dr. Jina said in an interview.
“Unlike a video game that is designed only for entertainment purposes, to drive efficacy, EndeavorRx is designed to be challenging and can therefore sometimes feel repetitive, and frustrating to some children,” Dr. Jina said.
Commenting on the study, Stephen Faraone, PhD, distinguished professor of psychiatry and vice chair of research, department of psychiatry, State University of New York, Syracuse, said this study “supports the idea that EndeavorRx improves a neural measure of attention.
“The limitation is that we don’t know if this translates into clinically relevant outcomes,” cautioned Dr. Faraone, who was not associated with the current study.
“The main caveat about EndeavorRx is that it was cleared by the FDA for improving a computer-based measure of inattention, not inattentive symptoms as reported by the parents of children with ADHD,” he noted.
Several authors have disclosed financial relationships with Akili Interactive Labs, which funded the study. Dr. Faraone was an investigator on the STARS-ADHD trial.
A version of this article first appeared on Medscape.com.
Investigators found children who used the video game-based therapy (EndeavorRx) experienced increased brain activity related to attention function, as measured by EEG, which correlated with improvements in objective behavioral measures of attention.
“While the previous multicenter trials show attention improvement for children using EndeavorRx, this is the first study to look at the brain activity in children with a primary concern of ADHD,” principal investigator Elysa Marco, MD, clinical executive for neurodevelopmental medicine at Cortica Healthcare, San Rafael, Calif., said in news release.
“It is exciting to see measurable improvement on the EEGs that correlates with the behavioral benefits,” said Dr. Marco.
The study was recently published online in PLOS ONE.
Measurable changes
As previously reported by this news organization, the Food and Drug Administration approved EndeavorRx in June 2020 as a prescription video game–based therapeutic device for children aged 8-12 years with primarily inattentive or combined-type ADHD, who have a demonstrated attention issue.
“The device is intended for use as part of a therapeutic program that may include clinician-directed therapy, medication, and/or educational programs, which further address symptoms of the disorder,” the FDA said upon approval.
In the current unblinded, single-arm study, the researchers assessed 25 children (aged 8-12 years) with a confirmed diagnosis of ADHD on neural, behavioral, and clinical metrics of attention before and after a 4-week at-home intervention.
Participants were instructed to use EndeavorRx for about 25 minutes a day at least 5 days a week for 4 weeks, as recommended by the FDA.
“EndeavorRx enhanced midline frontal theta (MFT) activity, suggesting that patients who used EndeavorRx for 4 weeks showed changes in measurable brain function,” Anil S. Jina, MD, chief medical officer of Akili Interactive, told this news organization. Dr. Jina was not involved with the study.
There was also a correlation between MFT activity and attention functioning, “suggesting that children who experienced the largest gains in MFT activity as measured by EEG also showed the greatest improvements in computerized performance tests designed to measure attention,” Dr. Jina said.
In addition, parents reported significantly fewer inattention symptoms in children after EndeavorRx treatment, as measured by the Vanderbilt ADHD Diagnostic Rating Scale.
‘Not just another video game’
EndeavorRx has been evaluated in five clinical studies involving more than 600 children with ADHD, including the STARS-ADHD trial, a prospective, randomized, controlled study published in The Lancet Digital Health.
The STARS-ADHD trial randomly allocated 348 children to either EndeavorRx treatment or a controlled intervention, which was a word game.
The researchers reported statistically significant improvements in attentional functioning in the EndeavorRx group as rated by test of variables of attention.
“This is not just another video game,” STARS-ADHD trialist Scott H. Kollins, PhD, MS, a clinical psychologist at Duke Health’s ADHD Clinic in Durham, N.C., who helped developed it, previously told this news organization.
The tool’s adaptive algorithms adjust and monitor task difficulty based on performance, using a video game format and rewards to engage users, he explained. EndeavorRx is a challenge to play by design.
“The treatment was programmed into the gameplay experience and designed to challenge a child’s attentional control during gameplay, requiring focus and flexibility to manage tasks at the same time,” Dr. Jina said in an interview.
“Unlike a video game that is designed only for entertainment purposes, to drive efficacy, EndeavorRx is designed to be challenging and can therefore sometimes feel repetitive, and frustrating to some children,” Dr. Jina said.
Commenting on the study, Stephen Faraone, PhD, distinguished professor of psychiatry and vice chair of research, department of psychiatry, State University of New York, Syracuse, said this study “supports the idea that EndeavorRx improves a neural measure of attention.
“The limitation is that we don’t know if this translates into clinically relevant outcomes,” cautioned Dr. Faraone, who was not associated with the current study.
“The main caveat about EndeavorRx is that it was cleared by the FDA for improving a computer-based measure of inattention, not inattentive symptoms as reported by the parents of children with ADHD,” he noted.
Several authors have disclosed financial relationships with Akili Interactive Labs, which funded the study. Dr. Faraone was an investigator on the STARS-ADHD trial.
A version of this article first appeared on Medscape.com.
Investigators found children who used the video game-based therapy (EndeavorRx) experienced increased brain activity related to attention function, as measured by EEG, which correlated with improvements in objective behavioral measures of attention.
“While the previous multicenter trials show attention improvement for children using EndeavorRx, this is the first study to look at the brain activity in children with a primary concern of ADHD,” principal investigator Elysa Marco, MD, clinical executive for neurodevelopmental medicine at Cortica Healthcare, San Rafael, Calif., said in news release.
“It is exciting to see measurable improvement on the EEGs that correlates with the behavioral benefits,” said Dr. Marco.
The study was recently published online in PLOS ONE.
Measurable changes
As previously reported by this news organization, the Food and Drug Administration approved EndeavorRx in June 2020 as a prescription video game–based therapeutic device for children aged 8-12 years with primarily inattentive or combined-type ADHD, who have a demonstrated attention issue.
“The device is intended for use as part of a therapeutic program that may include clinician-directed therapy, medication, and/or educational programs, which further address symptoms of the disorder,” the FDA said upon approval.
In the current unblinded, single-arm study, the researchers assessed 25 children (aged 8-12 years) with a confirmed diagnosis of ADHD on neural, behavioral, and clinical metrics of attention before and after a 4-week at-home intervention.
Participants were instructed to use EndeavorRx for about 25 minutes a day at least 5 days a week for 4 weeks, as recommended by the FDA.
“EndeavorRx enhanced midline frontal theta (MFT) activity, suggesting that patients who used EndeavorRx for 4 weeks showed changes in measurable brain function,” Anil S. Jina, MD, chief medical officer of Akili Interactive, told this news organization. Dr. Jina was not involved with the study.
There was also a correlation between MFT activity and attention functioning, “suggesting that children who experienced the largest gains in MFT activity as measured by EEG also showed the greatest improvements in computerized performance tests designed to measure attention,” Dr. Jina said.
In addition, parents reported significantly fewer inattention symptoms in children after EndeavorRx treatment, as measured by the Vanderbilt ADHD Diagnostic Rating Scale.
‘Not just another video game’
EndeavorRx has been evaluated in five clinical studies involving more than 600 children with ADHD, including the STARS-ADHD trial, a prospective, randomized, controlled study published in The Lancet Digital Health.
The STARS-ADHD trial randomly allocated 348 children to either EndeavorRx treatment or a controlled intervention, which was a word game.
The researchers reported statistically significant improvements in attentional functioning in the EndeavorRx group as rated by test of variables of attention.
“This is not just another video game,” STARS-ADHD trialist Scott H. Kollins, PhD, MS, a clinical psychologist at Duke Health’s ADHD Clinic in Durham, N.C., who helped developed it, previously told this news organization.
The tool’s adaptive algorithms adjust and monitor task difficulty based on performance, using a video game format and rewards to engage users, he explained. EndeavorRx is a challenge to play by design.
“The treatment was programmed into the gameplay experience and designed to challenge a child’s attentional control during gameplay, requiring focus and flexibility to manage tasks at the same time,” Dr. Jina said in an interview.
“Unlike a video game that is designed only for entertainment purposes, to drive efficacy, EndeavorRx is designed to be challenging and can therefore sometimes feel repetitive, and frustrating to some children,” Dr. Jina said.
Commenting on the study, Stephen Faraone, PhD, distinguished professor of psychiatry and vice chair of research, department of psychiatry, State University of New York, Syracuse, said this study “supports the idea that EndeavorRx improves a neural measure of attention.
“The limitation is that we don’t know if this translates into clinically relevant outcomes,” cautioned Dr. Faraone, who was not associated with the current study.
“The main caveat about EndeavorRx is that it was cleared by the FDA for improving a computer-based measure of inattention, not inattentive symptoms as reported by the parents of children with ADHD,” he noted.
Several authors have disclosed financial relationships with Akili Interactive Labs, which funded the study. Dr. Faraone was an investigator on the STARS-ADHD trial.
A version of this article first appeared on Medscape.com.
Early menopause, early dementia risk, study suggests
Earlier menopause appears to be associated with a higher risk of dementia, and earlier onset of dementia, compared with menopause at normal age or later, according to a large study.
“Being aware of this increased risk can help women practice strategies to prevent dementia and to work with their physicians to closely monitor their cognitive status as they age,” study investigator Wenting Hao, MD, with Shandong University, Jinan, China, says in a news release.
The findings were presented in an e-poster March 1 at the Epidemiology, Prevention, Lifestyle & Cardiometabolic Health (EPI|Lifestyle) 2022 conference sponsored by the American Heart Association.
UK Biobank data
Dr. Hao and colleagues examined health data for 153,291 women who were 60 years old on average when they became participants in the UK Biobank.
Age at menopause was categorized as premature (younger than age 40), early (40 to 44 years), reference (45 to 51), 52 to 55 years, and 55+ years.
Compared with women who entered menopause around age 50 years (reference), women who experienced premature menopause were 35% more likely to develop some type of dementia later in life (hazard ratio, 1.35; 95% confidence interval, 1.22 to 1.91).
Women with early menopause were also more likely to develop early-onset dementia, that is, before age 65 (HR, 1.31; 95% confidence interval, 1.07 to 1.72).
Women who entered menopause later (at age 52+) had dementia risk similar to women who entered menopause at the average age of 50 to 51 years.
The results were adjusted for relevant cofactors, including age at last exam, race, educational level, cigarette and alcohol use, body mass index, cardiovascular disease, diabetes, income, and leisure and physical activities.
Blame it on estrogen?
Reduced estrogen levels may be a factor in the possible connection between early menopause and dementia, Dr. Hao and her colleagues say.
Estradiol plays a key role in a range of neurological functions, so the reduction of endogenous estrogen at menopause may aggravate brain changes related to neurodegenerative disease and speed up progression of dementia, they explain.
“We know that the lack of estrogen over the long term enhances oxidative stress, which may increase brain aging and lead to cognitive impairment,” Dr. Hao adds.
Limitations of the study include reliance on self-reported information about age at menopause onset.
Also, the researchers did not evaluate dementia rates in women who had a naturally occurring early menopause separate from the women with surgery-induced menopause, which may affect the results.
Finally, the data used for this study included mostly White women living in the U.K. and may not generalize to other populations.
Supportive evidence, critical area of research
The U.K. study supports results of a previously reported Kaiser Permanente study, which showed women who entered menopause at age 45 or younger were at 28% greater dementia risk, compared with women who experienced menopause after age 45.
Reached for comment, Heather Snyder, PhD, Alzheimer’s Association vice president of medical and scientific relations, noted that nearly two-thirds of Americans with Alzheimer’s are women.
“We know Alzheimer’s and other dementias impact a greater number of women than men, but we don’t know why,” she told this news organization.
“Lifelong differences in women may affect their risk or affect what is contributing to their underlying biology of the disease, and we need more research to better understand what may be these contributing factors,” said Dr. Snyder.
“Reproductive history is one critical area being studied. The physical and hormonal changes that occur during menopause – as well as other hormonal changes throughout life – are considerable, and it’s important to understand what impact, if any, these changes may have on the brain,” Dr. Snyder added.
“The potential link between reproduction history and brain health is intriguing, but much more research in this area is needed to understand these links,” she said.
The study was funded by the Start-up Foundation for Scientific Research at Shandong University. Dr. Hao and Dr. Snyder have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Earlier menopause appears to be associated with a higher risk of dementia, and earlier onset of dementia, compared with menopause at normal age or later, according to a large study.
“Being aware of this increased risk can help women practice strategies to prevent dementia and to work with their physicians to closely monitor their cognitive status as they age,” study investigator Wenting Hao, MD, with Shandong University, Jinan, China, says in a news release.
The findings were presented in an e-poster March 1 at the Epidemiology, Prevention, Lifestyle & Cardiometabolic Health (EPI|Lifestyle) 2022 conference sponsored by the American Heart Association.
UK Biobank data
Dr. Hao and colleagues examined health data for 153,291 women who were 60 years old on average when they became participants in the UK Biobank.
Age at menopause was categorized as premature (younger than age 40), early (40 to 44 years), reference (45 to 51), 52 to 55 years, and 55+ years.
Compared with women who entered menopause around age 50 years (reference), women who experienced premature menopause were 35% more likely to develop some type of dementia later in life (hazard ratio, 1.35; 95% confidence interval, 1.22 to 1.91).
Women with early menopause were also more likely to develop early-onset dementia, that is, before age 65 (HR, 1.31; 95% confidence interval, 1.07 to 1.72).
Women who entered menopause later (at age 52+) had dementia risk similar to women who entered menopause at the average age of 50 to 51 years.
The results were adjusted for relevant cofactors, including age at last exam, race, educational level, cigarette and alcohol use, body mass index, cardiovascular disease, diabetes, income, and leisure and physical activities.
Blame it on estrogen?
Reduced estrogen levels may be a factor in the possible connection between early menopause and dementia, Dr. Hao and her colleagues say.
Estradiol plays a key role in a range of neurological functions, so the reduction of endogenous estrogen at menopause may aggravate brain changes related to neurodegenerative disease and speed up progression of dementia, they explain.
“We know that the lack of estrogen over the long term enhances oxidative stress, which may increase brain aging and lead to cognitive impairment,” Dr. Hao adds.
Limitations of the study include reliance on self-reported information about age at menopause onset.
Also, the researchers did not evaluate dementia rates in women who had a naturally occurring early menopause separate from the women with surgery-induced menopause, which may affect the results.
Finally, the data used for this study included mostly White women living in the U.K. and may not generalize to other populations.
Supportive evidence, critical area of research
The U.K. study supports results of a previously reported Kaiser Permanente study, which showed women who entered menopause at age 45 or younger were at 28% greater dementia risk, compared with women who experienced menopause after age 45.
Reached for comment, Heather Snyder, PhD, Alzheimer’s Association vice president of medical and scientific relations, noted that nearly two-thirds of Americans with Alzheimer’s are women.
“We know Alzheimer’s and other dementias impact a greater number of women than men, but we don’t know why,” she told this news organization.
“Lifelong differences in women may affect their risk or affect what is contributing to their underlying biology of the disease, and we need more research to better understand what may be these contributing factors,” said Dr. Snyder.
“Reproductive history is one critical area being studied. The physical and hormonal changes that occur during menopause – as well as other hormonal changes throughout life – are considerable, and it’s important to understand what impact, if any, these changes may have on the brain,” Dr. Snyder added.
“The potential link between reproduction history and brain health is intriguing, but much more research in this area is needed to understand these links,” she said.
The study was funded by the Start-up Foundation for Scientific Research at Shandong University. Dr. Hao and Dr. Snyder have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Earlier menopause appears to be associated with a higher risk of dementia, and earlier onset of dementia, compared with menopause at normal age or later, according to a large study.
“Being aware of this increased risk can help women practice strategies to prevent dementia and to work with their physicians to closely monitor their cognitive status as they age,” study investigator Wenting Hao, MD, with Shandong University, Jinan, China, says in a news release.
The findings were presented in an e-poster March 1 at the Epidemiology, Prevention, Lifestyle & Cardiometabolic Health (EPI|Lifestyle) 2022 conference sponsored by the American Heart Association.
UK Biobank data
Dr. Hao and colleagues examined health data for 153,291 women who were 60 years old on average when they became participants in the UK Biobank.
Age at menopause was categorized as premature (younger than age 40), early (40 to 44 years), reference (45 to 51), 52 to 55 years, and 55+ years.
Compared with women who entered menopause around age 50 years (reference), women who experienced premature menopause were 35% more likely to develop some type of dementia later in life (hazard ratio, 1.35; 95% confidence interval, 1.22 to 1.91).
Women with early menopause were also more likely to develop early-onset dementia, that is, before age 65 (HR, 1.31; 95% confidence interval, 1.07 to 1.72).
Women who entered menopause later (at age 52+) had dementia risk similar to women who entered menopause at the average age of 50 to 51 years.
The results were adjusted for relevant cofactors, including age at last exam, race, educational level, cigarette and alcohol use, body mass index, cardiovascular disease, diabetes, income, and leisure and physical activities.
Blame it on estrogen?
Reduced estrogen levels may be a factor in the possible connection between early menopause and dementia, Dr. Hao and her colleagues say.
Estradiol plays a key role in a range of neurological functions, so the reduction of endogenous estrogen at menopause may aggravate brain changes related to neurodegenerative disease and speed up progression of dementia, they explain.
“We know that the lack of estrogen over the long term enhances oxidative stress, which may increase brain aging and lead to cognitive impairment,” Dr. Hao adds.
Limitations of the study include reliance on self-reported information about age at menopause onset.
Also, the researchers did not evaluate dementia rates in women who had a naturally occurring early menopause separate from the women with surgery-induced menopause, which may affect the results.
Finally, the data used for this study included mostly White women living in the U.K. and may not generalize to other populations.
Supportive evidence, critical area of research
The U.K. study supports results of a previously reported Kaiser Permanente study, which showed women who entered menopause at age 45 or younger were at 28% greater dementia risk, compared with women who experienced menopause after age 45.
Reached for comment, Heather Snyder, PhD, Alzheimer’s Association vice president of medical and scientific relations, noted that nearly two-thirds of Americans with Alzheimer’s are women.
“We know Alzheimer’s and other dementias impact a greater number of women than men, but we don’t know why,” she told this news organization.
“Lifelong differences in women may affect their risk or affect what is contributing to their underlying biology of the disease, and we need more research to better understand what may be these contributing factors,” said Dr. Snyder.
“Reproductive history is one critical area being studied. The physical and hormonal changes that occur during menopause – as well as other hormonal changes throughout life – are considerable, and it’s important to understand what impact, if any, these changes may have on the brain,” Dr. Snyder added.
“The potential link between reproduction history and brain health is intriguing, but much more research in this area is needed to understand these links,” she said.
The study was funded by the Start-up Foundation for Scientific Research at Shandong University. Dr. Hao and Dr. Snyder have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Pandemic continues to exact a high toll on gastroenterologists’ well-being
The COVID-19 pandemic continues to take a toll on the happiness, wellness, and lifestyles of many segments of the population, but especially those in the health care field, including gastroenterologists.
The newly released Medscape Gastroenterologist Lifestyle, Happiness & Burnout Report 2022 explores gastroenterologists’ level of happiness in their personal and professional lives and how they maintain their mental and physical health.
Prior to the global pandemic, 8 in 10 (80%) gastroenterologists said they were “very” or “somewhat” happy outside of work, similar to physicians overall (81%).
But as the pandemic has worn on, feelings have shifted, and there are clear signs of stress and strain on those in the health care field.
Now, the percentage of gastroenterologists who say they are currently “very” or “somewhat” happy outside of work has dropped to 60%, about the same as physicians overall (59%).
Buried in paperwork
In 2021’s report, 42% of gastroenterologists reported burnout; that’s risen to 47% this year.
When it comes to burnout, gastroenterologists remain in the middle range of burned-out physicians.
Perhaps not surprising given the challenges of the COVID-19 pandemic, burnout rates are highest among emergency medicine and critical care specialists.
About half of gastroenterologists (52%) report being more burned out now than during the initial quarantine months of the pandemic, similar to physicians overall (55%). About 4 in 10 (39%) said their burnout was the same.
Female gastroenterologists report burnout at a greater rate than their male colleagues – 57% versus 46%.
“There’s no question that women have reported far more role strain during the pandemic than men,” said Carol A. Bernstein, MD, a psychiatrist at Montefiore Health System and professor and vice chair for faculty development and well-being at Albert Einstein College of Medicine, New York.
“Often women assumed more of the childcare and home-schooling responsibilities in their households. As [a] result, we know that more women dropped out of the workforce. Also, past studies indicate that women are more likely to report feelings of burnout than men,” Dr. Bernstein noted.
The volume of bureaucratic tasks is the main driver of gastroenterologist burnout, similar to that for physicians overall. Lack of respect from colleagues and more time devoted to electronic health records were also selected as major factors in this year’s report.
Gastroenterologists’ top ways to quell burnout are reducing their hours on the job (24%), changing workflow or staffing to ease their workload (23%), and taking advantage of meditation or other stress-reduction methods (18%) – similar to physicians overall.
Roughly one-third (34%) of gastroenterologists feel that their personality type contributes to their burnout, similar to physicians overall. Six in 10 gastroenterologists (60%) say burnout affects their relationships, similar to physicians overall (68%).
Seeking better work-life balance
More than half of gastroenterologists (57%) said they are willing to take a cut in pay in order to achieve a better work-life balance or have more free time – similar among physicians overall (55%).
About 16% of gastroenterologists reported clinical depression (severe depression lasting some time and not caused by grief), while 71% reported colloquial depression (feeling down, blue, sad).
About half (53%) of depressed gastroenterologists said their depression does not have an impact on relationships with patients.
Among those who saw an impact, the major behaviors they reported included being easily exasperated with patients (44%) and feeling less motivated to take patient notes carefully (20%).
To maintain well-being, gastroenterologists often choose to spend their time with their loved ones (59%), do the things they enjoy (58%), exercise (57%), get plenty of sleep (42%), and eat right (35%).
Perhaps not surprisingly, more gastroenterologists were happy with their work-life balance before the pandemic than now (70% vs. 44%). The same holds for physicians overall.
Before the pandemic, 22% of gastroenterologists reported being unhappy with their work-life balance. That has risen to 39% this year.
Most gastroenterologists are currently in a committed relationship, with 90% either married or living with a partner, a somewhat higher percentage than physicians overall (83%).
About 83% of gastroenterologists say they are in a “very good” or “good” marriage. This is down somewhat from the 2021 report (89%).
Nearly 6 in 10 gastroenterologists have partners who do not work in medicine. This is similar to the proportion among all physicians.
Findings from Medscape’s latest happiness, wellness, and lifestyle survey are based on 13,069 Medscape member physicians (61% male) practicing in the United States who completed an online survey conducted between June 29, 2021, and Sept. 26, 2021. Most respondents were between 35 and 64 years old.
A version of this article first appeared on Medscape.com.
The COVID-19 pandemic continues to take a toll on the happiness, wellness, and lifestyles of many segments of the population, but especially those in the health care field, including gastroenterologists.
The newly released Medscape Gastroenterologist Lifestyle, Happiness & Burnout Report 2022 explores gastroenterologists’ level of happiness in their personal and professional lives and how they maintain their mental and physical health.
Prior to the global pandemic, 8 in 10 (80%) gastroenterologists said they were “very” or “somewhat” happy outside of work, similar to physicians overall (81%).
But as the pandemic has worn on, feelings have shifted, and there are clear signs of stress and strain on those in the health care field.
Now, the percentage of gastroenterologists who say they are currently “very” or “somewhat” happy outside of work has dropped to 60%, about the same as physicians overall (59%).
Buried in paperwork
In 2021’s report, 42% of gastroenterologists reported burnout; that’s risen to 47% this year.
When it comes to burnout, gastroenterologists remain in the middle range of burned-out physicians.
Perhaps not surprising given the challenges of the COVID-19 pandemic, burnout rates are highest among emergency medicine and critical care specialists.
About half of gastroenterologists (52%) report being more burned out now than during the initial quarantine months of the pandemic, similar to physicians overall (55%). About 4 in 10 (39%) said their burnout was the same.
Female gastroenterologists report burnout at a greater rate than their male colleagues – 57% versus 46%.
“There’s no question that women have reported far more role strain during the pandemic than men,” said Carol A. Bernstein, MD, a psychiatrist at Montefiore Health System and professor and vice chair for faculty development and well-being at Albert Einstein College of Medicine, New York.
“Often women assumed more of the childcare and home-schooling responsibilities in their households. As [a] result, we know that more women dropped out of the workforce. Also, past studies indicate that women are more likely to report feelings of burnout than men,” Dr. Bernstein noted.
The volume of bureaucratic tasks is the main driver of gastroenterologist burnout, similar to that for physicians overall. Lack of respect from colleagues and more time devoted to electronic health records were also selected as major factors in this year’s report.
Gastroenterologists’ top ways to quell burnout are reducing their hours on the job (24%), changing workflow or staffing to ease their workload (23%), and taking advantage of meditation or other stress-reduction methods (18%) – similar to physicians overall.
Roughly one-third (34%) of gastroenterologists feel that their personality type contributes to their burnout, similar to physicians overall. Six in 10 gastroenterologists (60%) say burnout affects their relationships, similar to physicians overall (68%).
Seeking better work-life balance
More than half of gastroenterologists (57%) said they are willing to take a cut in pay in order to achieve a better work-life balance or have more free time – similar among physicians overall (55%).
About 16% of gastroenterologists reported clinical depression (severe depression lasting some time and not caused by grief), while 71% reported colloquial depression (feeling down, blue, sad).
About half (53%) of depressed gastroenterologists said their depression does not have an impact on relationships with patients.
Among those who saw an impact, the major behaviors they reported included being easily exasperated with patients (44%) and feeling less motivated to take patient notes carefully (20%).
To maintain well-being, gastroenterologists often choose to spend their time with their loved ones (59%), do the things they enjoy (58%), exercise (57%), get plenty of sleep (42%), and eat right (35%).
Perhaps not surprisingly, more gastroenterologists were happy with their work-life balance before the pandemic than now (70% vs. 44%). The same holds for physicians overall.
Before the pandemic, 22% of gastroenterologists reported being unhappy with their work-life balance. That has risen to 39% this year.
Most gastroenterologists are currently in a committed relationship, with 90% either married or living with a partner, a somewhat higher percentage than physicians overall (83%).
About 83% of gastroenterologists say they are in a “very good” or “good” marriage. This is down somewhat from the 2021 report (89%).
Nearly 6 in 10 gastroenterologists have partners who do not work in medicine. This is similar to the proportion among all physicians.
Findings from Medscape’s latest happiness, wellness, and lifestyle survey are based on 13,069 Medscape member physicians (61% male) practicing in the United States who completed an online survey conducted between June 29, 2021, and Sept. 26, 2021. Most respondents were between 35 and 64 years old.
A version of this article first appeared on Medscape.com.
The COVID-19 pandemic continues to take a toll on the happiness, wellness, and lifestyles of many segments of the population, but especially those in the health care field, including gastroenterologists.
The newly released Medscape Gastroenterologist Lifestyle, Happiness & Burnout Report 2022 explores gastroenterologists’ level of happiness in their personal and professional lives and how they maintain their mental and physical health.
Prior to the global pandemic, 8 in 10 (80%) gastroenterologists said they were “very” or “somewhat” happy outside of work, similar to physicians overall (81%).
But as the pandemic has worn on, feelings have shifted, and there are clear signs of stress and strain on those in the health care field.
Now, the percentage of gastroenterologists who say they are currently “very” or “somewhat” happy outside of work has dropped to 60%, about the same as physicians overall (59%).
Buried in paperwork
In 2021’s report, 42% of gastroenterologists reported burnout; that’s risen to 47% this year.
When it comes to burnout, gastroenterologists remain in the middle range of burned-out physicians.
Perhaps not surprising given the challenges of the COVID-19 pandemic, burnout rates are highest among emergency medicine and critical care specialists.
About half of gastroenterologists (52%) report being more burned out now than during the initial quarantine months of the pandemic, similar to physicians overall (55%). About 4 in 10 (39%) said their burnout was the same.
Female gastroenterologists report burnout at a greater rate than their male colleagues – 57% versus 46%.
“There’s no question that women have reported far more role strain during the pandemic than men,” said Carol A. Bernstein, MD, a psychiatrist at Montefiore Health System and professor and vice chair for faculty development and well-being at Albert Einstein College of Medicine, New York.
“Often women assumed more of the childcare and home-schooling responsibilities in their households. As [a] result, we know that more women dropped out of the workforce. Also, past studies indicate that women are more likely to report feelings of burnout than men,” Dr. Bernstein noted.
The volume of bureaucratic tasks is the main driver of gastroenterologist burnout, similar to that for physicians overall. Lack of respect from colleagues and more time devoted to electronic health records were also selected as major factors in this year’s report.
Gastroenterologists’ top ways to quell burnout are reducing their hours on the job (24%), changing workflow or staffing to ease their workload (23%), and taking advantage of meditation or other stress-reduction methods (18%) – similar to physicians overall.
Roughly one-third (34%) of gastroenterologists feel that their personality type contributes to their burnout, similar to physicians overall. Six in 10 gastroenterologists (60%) say burnout affects their relationships, similar to physicians overall (68%).
Seeking better work-life balance
More than half of gastroenterologists (57%) said they are willing to take a cut in pay in order to achieve a better work-life balance or have more free time – similar among physicians overall (55%).
About 16% of gastroenterologists reported clinical depression (severe depression lasting some time and not caused by grief), while 71% reported colloquial depression (feeling down, blue, sad).
About half (53%) of depressed gastroenterologists said their depression does not have an impact on relationships with patients.
Among those who saw an impact, the major behaviors they reported included being easily exasperated with patients (44%) and feeling less motivated to take patient notes carefully (20%).
To maintain well-being, gastroenterologists often choose to spend their time with their loved ones (59%), do the things they enjoy (58%), exercise (57%), get plenty of sleep (42%), and eat right (35%).
Perhaps not surprisingly, more gastroenterologists were happy with their work-life balance before the pandemic than now (70% vs. 44%). The same holds for physicians overall.
Before the pandemic, 22% of gastroenterologists reported being unhappy with their work-life balance. That has risen to 39% this year.
Most gastroenterologists are currently in a committed relationship, with 90% either married or living with a partner, a somewhat higher percentage than physicians overall (83%).
About 83% of gastroenterologists say they are in a “very good” or “good” marriage. This is down somewhat from the 2021 report (89%).
Nearly 6 in 10 gastroenterologists have partners who do not work in medicine. This is similar to the proportion among all physicians.
Findings from Medscape’s latest happiness, wellness, and lifestyle survey are based on 13,069 Medscape member physicians (61% male) practicing in the United States who completed an online survey conducted between June 29, 2021, and Sept. 26, 2021. Most respondents were between 35 and 64 years old.
A version of this article first appeared on Medscape.com.
Mindfulness intervention curbs opioid misuse, chronic pain
In a randomized clinical trial, 250 adults with both opioid misuse and chronic pain received either the intervention, called mindfulness-oriented recovery enhancement (MORE), or supportive psychotherapy.
Results showed the first group was twice as likely to reduce opioid misuse after 9 months than the latter group.
The intervention was developed by Eric Garland, PhD, director of the Center on Mindfulness and Integrative Health Intervention Development (C-MIIND), University of Utah, Salt Lake City. “As the largest and longest-term clinical trial of MORE ever conducted, this study definitively establishes the efficacy of MORE as a treatment for chronic pain and opioid misuse,” he told this news organization.
The findings were published online Feb. 28 in JAMA Internal Medicine.
Self-regulation
Study participants included 250 adults (64% women; mean age, 51.8 years) with co-occurring opioid misuse and chronic pain who were randomly allocated to receive MORE or supportive psychotherapy, which served as a control group.
Both interventions were delivered by trained clinical social workers in six primary care clinics in Utah to groups of 6-12 participants across 8 weekly 2-hour sessions.
The MORE intervention, detailed on Dr. Garland’s website, provides sequenced training in mindfulness, reappraisal, and savoring skills.
Mindfulness consisted of meditation on breathing and body sensations to strengthen self-regulation of compulsive opioid use and to mitigate pain and opioid craving by reinterpreting these experiences as innocuous sensory information.
Reappraisal consisted of reframing maladaptive thoughts to decrease negative emotions and engender meaning in life.
Savoring consisted of training in focusing awareness on pleasurable events and sensations to amplify positive emotions and reward.
Fewer depressive symptoms
Through 9 months of follow-up, the MORE group had about a twofold greater likelihood than the supportive psychotherapy group for reduction in opioid misuse (odds ratio [OR], 2.06; 95% confidence interval, 1.17-3.61; P = .01)
“MORE reduced opioid misuse by 45% 9 months after the end of treatment, more than doubling the effect of standard supportive psychotherapy and exceeding the effect size of other therapies for opioid misuse among people with chronic pain,” Dr. Garland said.
Members of the MORE group experienced greater reduction in pain severity and pain-related functional interference compared with members of the control group.
“MORE’s effect size on chronic pain symptoms was greater than that observed for CBT, the current gold standard psychological treatment for chronic pain,” Dr. Garland noted.
Compared with supportive psychotherapy, MORE decreased emotional distress, depressive symptoms, and real-time reports of opioid craving in daily life.
“Although nearly 70% of participants met criteria for depression at the beginning of the trial, on average, patients in MORE no longer exhibited symptoms consistent with major depressive disorder by the end of the study,” Dr. Garland said.
The current study builds on prior studies of MORE showing similar results, as reported previously by this news organization.
MORE can be successfully delivered in routine primary care, Dr. Garland noted. “In this trial, we delivered MORE in conference rooms, break rooms, and lunch rooms at community primary care clinics,” he added.
‘Powerful program’
To date, Dr. Garland has trained more than 450 physicians, nurses, social workers, and psychologists in health care systems across the country to implement MORE as an insurance-reimbursable group visit for patients in need.
One of them is Nancy Sudak, MD, chief well-being officer and director of integrative health, Essentia Health, Duluth, Minn.
“MORE is a very powerful program that teaches patients how to turn down the volume of their pain. I’ve been quite impressed by the power of MORE,” Dr. Sudak told this news organization
She noted that “buy-in” from patients is key – and the more a clinician knows a patient, the easier the buy-in.
“I recruited most of the patients in my groups from my own practice, so I already knew the patients quite well and there wasn’t really a need to sell it,” Dr. Sudak said.
“We have tried to operationalize it through our system and find that, as long as our recruitment techniques are robust enough, it’s not that hard to find patients to fill the groups, especially because chronic pain is just so common,” she added.
Dr. Sudak has found that patients who participate in MORE “bond and learn with each other and support each other. Patients love it, providers love it, and it’s a way to address isolation and loneliness” that can come with certain conditions.
“There are really only upsides to the group visit model and I think we’ll be seeing quite a bit more of it in the future,” she added.
Evidence-based data
Anna Parisi, PhD, is also delivering MORE to patients. She told this news organization, she was “really drawn” to the MORE program because oftentimes patients who require the most sophisticated therapies receive the ones with the least evidence.
This is often “what folks in the community are getting when they’re struggling with substance use,” added Dr. Parisi, a postdoctoral research associate working with Dr. Garland at the University of Utah. Dr. Parisi was not a coauthor on the current study.
“With MORE, all of the strategies and techniques are tied to mechanistic studies of their efficacy, so you know that what you’re delivering has a rationale behind it,” she said.
Like Dr. Sudak, Dr. Parisi said her patients, for the most part, have been receptive to the program. Although at first some were skeptical about mindfulness – with one patient using the term “tree-hugging” – they found immediate benefit even after the first session.
“That really helps them stay motivated to finish the program,” Dr. Parisi said.
This work was supported by a grant from the National Institute on Drug Abuse. Dr. Garland serves as director of the Center on Mindfulness and Integrative Health Intervention Development, which provides MORE, mindfulness-based therapy, and CBT in the context of research trials for no cost to research participants. He receives honoraria and payment for delivering seminars, lectures, and teaching engagements related to training clinicians in MORE and mindfulness and receives royalties from BehaVR and from the sales of books related to MORE outside the submitted work. Dr. Sudak and Dr. Parisi have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
In a randomized clinical trial, 250 adults with both opioid misuse and chronic pain received either the intervention, called mindfulness-oriented recovery enhancement (MORE), or supportive psychotherapy.
Results showed the first group was twice as likely to reduce opioid misuse after 9 months than the latter group.
The intervention was developed by Eric Garland, PhD, director of the Center on Mindfulness and Integrative Health Intervention Development (C-MIIND), University of Utah, Salt Lake City. “As the largest and longest-term clinical trial of MORE ever conducted, this study definitively establishes the efficacy of MORE as a treatment for chronic pain and opioid misuse,” he told this news organization.
The findings were published online Feb. 28 in JAMA Internal Medicine.
Self-regulation
Study participants included 250 adults (64% women; mean age, 51.8 years) with co-occurring opioid misuse and chronic pain who were randomly allocated to receive MORE or supportive psychotherapy, which served as a control group.
Both interventions were delivered by trained clinical social workers in six primary care clinics in Utah to groups of 6-12 participants across 8 weekly 2-hour sessions.
The MORE intervention, detailed on Dr. Garland’s website, provides sequenced training in mindfulness, reappraisal, and savoring skills.
Mindfulness consisted of meditation on breathing and body sensations to strengthen self-regulation of compulsive opioid use and to mitigate pain and opioid craving by reinterpreting these experiences as innocuous sensory information.
Reappraisal consisted of reframing maladaptive thoughts to decrease negative emotions and engender meaning in life.
Savoring consisted of training in focusing awareness on pleasurable events and sensations to amplify positive emotions and reward.
Fewer depressive symptoms
Through 9 months of follow-up, the MORE group had about a twofold greater likelihood than the supportive psychotherapy group for reduction in opioid misuse (odds ratio [OR], 2.06; 95% confidence interval, 1.17-3.61; P = .01)
“MORE reduced opioid misuse by 45% 9 months after the end of treatment, more than doubling the effect of standard supportive psychotherapy and exceeding the effect size of other therapies for opioid misuse among people with chronic pain,” Dr. Garland said.
Members of the MORE group experienced greater reduction in pain severity and pain-related functional interference compared with members of the control group.
“MORE’s effect size on chronic pain symptoms was greater than that observed for CBT, the current gold standard psychological treatment for chronic pain,” Dr. Garland noted.
Compared with supportive psychotherapy, MORE decreased emotional distress, depressive symptoms, and real-time reports of opioid craving in daily life.
“Although nearly 70% of participants met criteria for depression at the beginning of the trial, on average, patients in MORE no longer exhibited symptoms consistent with major depressive disorder by the end of the study,” Dr. Garland said.
The current study builds on prior studies of MORE showing similar results, as reported previously by this news organization.
MORE can be successfully delivered in routine primary care, Dr. Garland noted. “In this trial, we delivered MORE in conference rooms, break rooms, and lunch rooms at community primary care clinics,” he added.
‘Powerful program’
To date, Dr. Garland has trained more than 450 physicians, nurses, social workers, and psychologists in health care systems across the country to implement MORE as an insurance-reimbursable group visit for patients in need.
One of them is Nancy Sudak, MD, chief well-being officer and director of integrative health, Essentia Health, Duluth, Minn.
“MORE is a very powerful program that teaches patients how to turn down the volume of their pain. I’ve been quite impressed by the power of MORE,” Dr. Sudak told this news organization
She noted that “buy-in” from patients is key – and the more a clinician knows a patient, the easier the buy-in.
“I recruited most of the patients in my groups from my own practice, so I already knew the patients quite well and there wasn’t really a need to sell it,” Dr. Sudak said.
“We have tried to operationalize it through our system and find that, as long as our recruitment techniques are robust enough, it’s not that hard to find patients to fill the groups, especially because chronic pain is just so common,” she added.
Dr. Sudak has found that patients who participate in MORE “bond and learn with each other and support each other. Patients love it, providers love it, and it’s a way to address isolation and loneliness” that can come with certain conditions.
“There are really only upsides to the group visit model and I think we’ll be seeing quite a bit more of it in the future,” she added.
Evidence-based data
Anna Parisi, PhD, is also delivering MORE to patients. She told this news organization, she was “really drawn” to the MORE program because oftentimes patients who require the most sophisticated therapies receive the ones with the least evidence.
This is often “what folks in the community are getting when they’re struggling with substance use,” added Dr. Parisi, a postdoctoral research associate working with Dr. Garland at the University of Utah. Dr. Parisi was not a coauthor on the current study.
“With MORE, all of the strategies and techniques are tied to mechanistic studies of their efficacy, so you know that what you’re delivering has a rationale behind it,” she said.
Like Dr. Sudak, Dr. Parisi said her patients, for the most part, have been receptive to the program. Although at first some were skeptical about mindfulness – with one patient using the term “tree-hugging” – they found immediate benefit even after the first session.
“That really helps them stay motivated to finish the program,” Dr. Parisi said.
This work was supported by a grant from the National Institute on Drug Abuse. Dr. Garland serves as director of the Center on Mindfulness and Integrative Health Intervention Development, which provides MORE, mindfulness-based therapy, and CBT in the context of research trials for no cost to research participants. He receives honoraria and payment for delivering seminars, lectures, and teaching engagements related to training clinicians in MORE and mindfulness and receives royalties from BehaVR and from the sales of books related to MORE outside the submitted work. Dr. Sudak and Dr. Parisi have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
In a randomized clinical trial, 250 adults with both opioid misuse and chronic pain received either the intervention, called mindfulness-oriented recovery enhancement (MORE), or supportive psychotherapy.
Results showed the first group was twice as likely to reduce opioid misuse after 9 months than the latter group.
The intervention was developed by Eric Garland, PhD, director of the Center on Mindfulness and Integrative Health Intervention Development (C-MIIND), University of Utah, Salt Lake City. “As the largest and longest-term clinical trial of MORE ever conducted, this study definitively establishes the efficacy of MORE as a treatment for chronic pain and opioid misuse,” he told this news organization.
The findings were published online Feb. 28 in JAMA Internal Medicine.
Self-regulation
Study participants included 250 adults (64% women; mean age, 51.8 years) with co-occurring opioid misuse and chronic pain who were randomly allocated to receive MORE or supportive psychotherapy, which served as a control group.
Both interventions were delivered by trained clinical social workers in six primary care clinics in Utah to groups of 6-12 participants across 8 weekly 2-hour sessions.
The MORE intervention, detailed on Dr. Garland’s website, provides sequenced training in mindfulness, reappraisal, and savoring skills.
Mindfulness consisted of meditation on breathing and body sensations to strengthen self-regulation of compulsive opioid use and to mitigate pain and opioid craving by reinterpreting these experiences as innocuous sensory information.
Reappraisal consisted of reframing maladaptive thoughts to decrease negative emotions and engender meaning in life.
Savoring consisted of training in focusing awareness on pleasurable events and sensations to amplify positive emotions and reward.
Fewer depressive symptoms
Through 9 months of follow-up, the MORE group had about a twofold greater likelihood than the supportive psychotherapy group for reduction in opioid misuse (odds ratio [OR], 2.06; 95% confidence interval, 1.17-3.61; P = .01)
“MORE reduced opioid misuse by 45% 9 months after the end of treatment, more than doubling the effect of standard supportive psychotherapy and exceeding the effect size of other therapies for opioid misuse among people with chronic pain,” Dr. Garland said.
Members of the MORE group experienced greater reduction in pain severity and pain-related functional interference compared with members of the control group.
“MORE’s effect size on chronic pain symptoms was greater than that observed for CBT, the current gold standard psychological treatment for chronic pain,” Dr. Garland noted.
Compared with supportive psychotherapy, MORE decreased emotional distress, depressive symptoms, and real-time reports of opioid craving in daily life.
“Although nearly 70% of participants met criteria for depression at the beginning of the trial, on average, patients in MORE no longer exhibited symptoms consistent with major depressive disorder by the end of the study,” Dr. Garland said.
The current study builds on prior studies of MORE showing similar results, as reported previously by this news organization.
MORE can be successfully delivered in routine primary care, Dr. Garland noted. “In this trial, we delivered MORE in conference rooms, break rooms, and lunch rooms at community primary care clinics,” he added.
‘Powerful program’
To date, Dr. Garland has trained more than 450 physicians, nurses, social workers, and psychologists in health care systems across the country to implement MORE as an insurance-reimbursable group visit for patients in need.
One of them is Nancy Sudak, MD, chief well-being officer and director of integrative health, Essentia Health, Duluth, Minn.
“MORE is a very powerful program that teaches patients how to turn down the volume of their pain. I’ve been quite impressed by the power of MORE,” Dr. Sudak told this news organization
She noted that “buy-in” from patients is key – and the more a clinician knows a patient, the easier the buy-in.
“I recruited most of the patients in my groups from my own practice, so I already knew the patients quite well and there wasn’t really a need to sell it,” Dr. Sudak said.
“We have tried to operationalize it through our system and find that, as long as our recruitment techniques are robust enough, it’s not that hard to find patients to fill the groups, especially because chronic pain is just so common,” she added.
Dr. Sudak has found that patients who participate in MORE “bond and learn with each other and support each other. Patients love it, providers love it, and it’s a way to address isolation and loneliness” that can come with certain conditions.
“There are really only upsides to the group visit model and I think we’ll be seeing quite a bit more of it in the future,” she added.
Evidence-based data
Anna Parisi, PhD, is also delivering MORE to patients. She told this news organization, she was “really drawn” to the MORE program because oftentimes patients who require the most sophisticated therapies receive the ones with the least evidence.
This is often “what folks in the community are getting when they’re struggling with substance use,” added Dr. Parisi, a postdoctoral research associate working with Dr. Garland at the University of Utah. Dr. Parisi was not a coauthor on the current study.
“With MORE, all of the strategies and techniques are tied to mechanistic studies of their efficacy, so you know that what you’re delivering has a rationale behind it,” she said.
Like Dr. Sudak, Dr. Parisi said her patients, for the most part, have been receptive to the program. Although at first some were skeptical about mindfulness – with one patient using the term “tree-hugging” – they found immediate benefit even after the first session.
“That really helps them stay motivated to finish the program,” Dr. Parisi said.
This work was supported by a grant from the National Institute on Drug Abuse. Dr. Garland serves as director of the Center on Mindfulness and Integrative Health Intervention Development, which provides MORE, mindfulness-based therapy, and CBT in the context of research trials for no cost to research participants. He receives honoraria and payment for delivering seminars, lectures, and teaching engagements related to training clinicians in MORE and mindfulness and receives royalties from BehaVR and from the sales of books related to MORE outside the submitted work. Dr. Sudak and Dr. Parisi have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
ASGE, Medtronic partner to provide AI-assisted colonoscopy to underserved areas
Through the Medtronic Health Equity Assistance Program for colon cancer screening, the company will donate 50 GI Genius intelligent endoscopy modules to endoscopy centers across the country.
The Medtronic program will provide selected facilities with GI Genius modules at no cost, so they can be used to assist colonoscopy procedures, a spokesperson for Medtronic told this news organization.
These procedures include screening, diagnostic, or surveillance colonoscopy, and coverage can vary from Medicare, Medicaid, and private insurers.
The use of GI Genius during such procedures does not affect the cost or coverage of the procedure; it simply ensures they receive improved polyp detection compared to non–artificial intelligence (AI)-assisted procedures, the spokesperson explained.
The U.S. Food and Drug Administration authorized GI Genius in April 2021. The system uses AI to improve detection of colorectal polyps or suspected tumors in real time during colonoscopies.
In the pivotal clinical trial, the combination of standard colonoscopy and the GI Genius module identified laboratory-confirmed adenomas or carcinomas in 54.8% patients, compared with 40.4% of patients who underwent colonoscopy alone – an improvement of 14%.
Addressing gaps in screening
CRC remains the third most common and third deadliest cancer among adults in the United States. However, when caught early, certain types of CRC have a 5-year survival rate of up to 91%.
Donation of 50 GI Genius systems to endoscopy centers in low-income and underserved areas could potentially benefit more than 350,000 patients over 3 years, Medtronic said in a news release.
“Addressing gaps in colorectal cancer screening is complex. We know that Black adults are more likely to be diagnosed and subsequently die from this disease. There are also disparities in screenings among different groups, including adults in rural communities,” ASGE President Douglas K. Rex, MD, said in the release.
“Colonoscopy is critical in preventing colorectal cancer, and as the global leader in gastrointestinal endoscopy, ASGE is working together with Medtronic to ensure that providers receive screening technology and are able to use them in communities where they are most needed,” Dr. Rex added.
ASGE is independently leading the application and selection process for the devices. To apply, visit the ASGE program website. Initial recipients will be announced in March 2022 during Colorectal Cancer Awareness Month.
AWS is providing the computing credits to fund the program and continues to work with Medtronic on health equity.
“Individual health outcomes should not depend on socioeconomic status, race, ethnicity, or neighborhood,” Maggie Carter, global lead for social impact at AWS, said in the release.
“We are pleased to support Medtronic and ASGE as part of AWS’ recently launched health equity program to help these organizations bring effective screening tools to the communities that need them most,” said Ms. Carter.
“The crisis of health inequities cannot be solved without expanding access to health care technologies that put people first,” added Geoff Martha, Medtronic chairman and chief executive officer.
“We must begin with local efforts that consider the needs of the community. This program is an important step towards ensuring that our powerful technologies help reduce disparities, improve care, and enhance patient outcomes,” Mr. Martha said.
A version of this article first appeared on Medscape.com.
Through the Medtronic Health Equity Assistance Program for colon cancer screening, the company will donate 50 GI Genius intelligent endoscopy modules to endoscopy centers across the country.
The Medtronic program will provide selected facilities with GI Genius modules at no cost, so they can be used to assist colonoscopy procedures, a spokesperson for Medtronic told this news organization.
These procedures include screening, diagnostic, or surveillance colonoscopy, and coverage can vary from Medicare, Medicaid, and private insurers.
The use of GI Genius during such procedures does not affect the cost or coverage of the procedure; it simply ensures they receive improved polyp detection compared to non–artificial intelligence (AI)-assisted procedures, the spokesperson explained.
The U.S. Food and Drug Administration authorized GI Genius in April 2021. The system uses AI to improve detection of colorectal polyps or suspected tumors in real time during colonoscopies.
In the pivotal clinical trial, the combination of standard colonoscopy and the GI Genius module identified laboratory-confirmed adenomas or carcinomas in 54.8% patients, compared with 40.4% of patients who underwent colonoscopy alone – an improvement of 14%.
Addressing gaps in screening
CRC remains the third most common and third deadliest cancer among adults in the United States. However, when caught early, certain types of CRC have a 5-year survival rate of up to 91%.
Donation of 50 GI Genius systems to endoscopy centers in low-income and underserved areas could potentially benefit more than 350,000 patients over 3 years, Medtronic said in a news release.
“Addressing gaps in colorectal cancer screening is complex. We know that Black adults are more likely to be diagnosed and subsequently die from this disease. There are also disparities in screenings among different groups, including adults in rural communities,” ASGE President Douglas K. Rex, MD, said in the release.
“Colonoscopy is critical in preventing colorectal cancer, and as the global leader in gastrointestinal endoscopy, ASGE is working together with Medtronic to ensure that providers receive screening technology and are able to use them in communities where they are most needed,” Dr. Rex added.
ASGE is independently leading the application and selection process for the devices. To apply, visit the ASGE program website. Initial recipients will be announced in March 2022 during Colorectal Cancer Awareness Month.
AWS is providing the computing credits to fund the program and continues to work with Medtronic on health equity.
“Individual health outcomes should not depend on socioeconomic status, race, ethnicity, or neighborhood,” Maggie Carter, global lead for social impact at AWS, said in the release.
“We are pleased to support Medtronic and ASGE as part of AWS’ recently launched health equity program to help these organizations bring effective screening tools to the communities that need them most,” said Ms. Carter.
“The crisis of health inequities cannot be solved without expanding access to health care technologies that put people first,” added Geoff Martha, Medtronic chairman and chief executive officer.
“We must begin with local efforts that consider the needs of the community. This program is an important step towards ensuring that our powerful technologies help reduce disparities, improve care, and enhance patient outcomes,” Mr. Martha said.
A version of this article first appeared on Medscape.com.
Through the Medtronic Health Equity Assistance Program for colon cancer screening, the company will donate 50 GI Genius intelligent endoscopy modules to endoscopy centers across the country.
The Medtronic program will provide selected facilities with GI Genius modules at no cost, so they can be used to assist colonoscopy procedures, a spokesperson for Medtronic told this news organization.
These procedures include screening, diagnostic, or surveillance colonoscopy, and coverage can vary from Medicare, Medicaid, and private insurers.
The use of GI Genius during such procedures does not affect the cost or coverage of the procedure; it simply ensures they receive improved polyp detection compared to non–artificial intelligence (AI)-assisted procedures, the spokesperson explained.
The U.S. Food and Drug Administration authorized GI Genius in April 2021. The system uses AI to improve detection of colorectal polyps or suspected tumors in real time during colonoscopies.
In the pivotal clinical trial, the combination of standard colonoscopy and the GI Genius module identified laboratory-confirmed adenomas or carcinomas in 54.8% patients, compared with 40.4% of patients who underwent colonoscopy alone – an improvement of 14%.
Addressing gaps in screening
CRC remains the third most common and third deadliest cancer among adults in the United States. However, when caught early, certain types of CRC have a 5-year survival rate of up to 91%.
Donation of 50 GI Genius systems to endoscopy centers in low-income and underserved areas could potentially benefit more than 350,000 patients over 3 years, Medtronic said in a news release.
“Addressing gaps in colorectal cancer screening is complex. We know that Black adults are more likely to be diagnosed and subsequently die from this disease. There are also disparities in screenings among different groups, including adults in rural communities,” ASGE President Douglas K. Rex, MD, said in the release.
“Colonoscopy is critical in preventing colorectal cancer, and as the global leader in gastrointestinal endoscopy, ASGE is working together with Medtronic to ensure that providers receive screening technology and are able to use them in communities where they are most needed,” Dr. Rex added.
ASGE is independently leading the application and selection process for the devices. To apply, visit the ASGE program website. Initial recipients will be announced in March 2022 during Colorectal Cancer Awareness Month.
AWS is providing the computing credits to fund the program and continues to work with Medtronic on health equity.
“Individual health outcomes should not depend on socioeconomic status, race, ethnicity, or neighborhood,” Maggie Carter, global lead for social impact at AWS, said in the release.
“We are pleased to support Medtronic and ASGE as part of AWS’ recently launched health equity program to help these organizations bring effective screening tools to the communities that need them most,” said Ms. Carter.
“The crisis of health inequities cannot be solved without expanding access to health care technologies that put people first,” added Geoff Martha, Medtronic chairman and chief executive officer.
“We must begin with local efforts that consider the needs of the community. This program is an important step towards ensuring that our powerful technologies help reduce disparities, improve care, and enhance patient outcomes,” Mr. Martha said.
A version of this article first appeared on Medscape.com.
Sublingual dexmedetomidine may rapidly calm bipolar agitation
The phase 3 SERENITY II trial included almost 400 adults with bipolar I or II disorder and acute agitation.
Results showed relief from acute agitation kicked in beginning at 20 minutes after administration of the treatment and continued to 120 minutes, principal investigator Sheldon H. Preskorn, MD, professor, department of psychiatry and behavioral sciences, University of Kansas, Wichita, and colleagues reported.
“Patients who are mild to moderately agitated in whom there is the potential for escalation to more severe agitation,” are good candidates for sublingual dexmedetomidine, Dr. Preskorn told this news organization.
He noted that, while “comparative claims require comparative studies,” a key advantage is that it “can be self-administered by patients reliably because of the adherence of the film to the mucosa.”
The findings were published online Feb. 22, 2022 in JAMA.
Tough-to-manage symptom
Preliminary results were presented at the 2021 annual meeting of the American Psychiatric Association and reported by this news organization at that time.
Agitation is a common and tough-to-manage symptom associated with multiple neuropsychiatric conditions, including bipolar disorder.
The phase 3 SERENITY II trial enrolled 380 adults (mean age, 45 years; 55% women) with bipolar I or II disorder and acute agitation in the emergency department.
All participants had a total score of 14 or greater on the five items of the Positive and Negative Syndrome Scale–Excited Component (PEC) scale at baseline and a score of 4 or greater on at least one PEC item.
Patients were randomly allocated to a single dose of sublingual dexmedetomidine (120 mcg or 180 mcg) or placebo. All but two patients completed the study.
Baseline agitation was mild to moderate, with an overall mean PEC total score of 18.
Rapid relief
Mean change from baseline in the PEC total score at 2 hours (primary endpoint) was –9 and –10.4 with the 120-mcg and 180-mcg doses of sublingual dexmedetomidine, respectively, versus –4.9 for placebo.
Least-square mean differences from placebo in the sublingual dexmedetomidine groups at 2 hours were statistically significant for both doses (both, P < .001 vs. placebo).
Statistically significant treatment effects were first evident 20 minutes after dosing for both of the dexmedetomidine doses versus placebo.
Patients in both active-treatment groups showed greater improvement in PEC total score than patients in the placebo group at all subsequent time points through 2 hours post dosing.
Sublingual dexmedetomidine was also associated with significant improvement on the secondary outcomes of Clinical Global Impressions–Improvement and Agitation-Calmness Evaluation Scale.
Adverse events occurred in 35.7% and 34.9% of patients taking 180 mcg and 120 mcg sublingual dexmedetomidine, respectively, compared with 17.5% of patients taking placebo. The most commonly reported adverse events were somnolence, dry mouth, hypotension, and dizziness. No treatment-related serious or severe adverse events were reported.
FDA action date: April 5
In an accompanying editorial, John K. Hsiao, MD, National Institutes of Health, Bethesda, Md., noted that an “out-of-control, agitated, possibly aggressive patient in a medical setting is a crisis demanding swift and safe resolution.
“Today, emergency departments now rival and perhaps surpass psychiatric units as settings where out-of-control, agitated patients must be managed,” Dr. Hsiao said.
The current study “provides evidence to support a novel, potentially important addition to the armamentarium for managing behavioral agitation,” he wrote.
BioXcel Therapeutics has submitted a new drug application to the Food and Drug Administration. The Prescription Drug User Fee Act target action date is April 5.
In a statement, Frank D. Yocca, PhD, chief scientific officer of BioXcel Therapeutics, said the company is looking forward to potential FDA approval of the treatment for agitation associated with bipolar disorders and schizophrenia.
“Building on the strength of these compelling data, we are also confidently progressing BXCL501 as a potential acute treatment for agitation associated with Alzheimer’s disease,” Dr. Yocca added.
The study was funded by BioXcel Therapeutics. Dr. Preskorn reported receiving consulting fees from BioXcel and receiving research grants from, serving as a consultant for, on advisory boards of, and on the speakers bureau of Alkermes, BioXcel Therapeutics, Eisai, Janssen, Novartis, Otsuka, Sunovion, and Usona Institute. Dr. Hsiao has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The phase 3 SERENITY II trial included almost 400 adults with bipolar I or II disorder and acute agitation.
Results showed relief from acute agitation kicked in beginning at 20 minutes after administration of the treatment and continued to 120 minutes, principal investigator Sheldon H. Preskorn, MD, professor, department of psychiatry and behavioral sciences, University of Kansas, Wichita, and colleagues reported.
“Patients who are mild to moderately agitated in whom there is the potential for escalation to more severe agitation,” are good candidates for sublingual dexmedetomidine, Dr. Preskorn told this news organization.
He noted that, while “comparative claims require comparative studies,” a key advantage is that it “can be self-administered by patients reliably because of the adherence of the film to the mucosa.”
The findings were published online Feb. 22, 2022 in JAMA.
Tough-to-manage symptom
Preliminary results were presented at the 2021 annual meeting of the American Psychiatric Association and reported by this news organization at that time.
Agitation is a common and tough-to-manage symptom associated with multiple neuropsychiatric conditions, including bipolar disorder.
The phase 3 SERENITY II trial enrolled 380 adults (mean age, 45 years; 55% women) with bipolar I or II disorder and acute agitation in the emergency department.
All participants had a total score of 14 or greater on the five items of the Positive and Negative Syndrome Scale–Excited Component (PEC) scale at baseline and a score of 4 or greater on at least one PEC item.
Patients were randomly allocated to a single dose of sublingual dexmedetomidine (120 mcg or 180 mcg) or placebo. All but two patients completed the study.
Baseline agitation was mild to moderate, with an overall mean PEC total score of 18.
Rapid relief
Mean change from baseline in the PEC total score at 2 hours (primary endpoint) was –9 and –10.4 with the 120-mcg and 180-mcg doses of sublingual dexmedetomidine, respectively, versus –4.9 for placebo.
Least-square mean differences from placebo in the sublingual dexmedetomidine groups at 2 hours were statistically significant for both doses (both, P < .001 vs. placebo).
Statistically significant treatment effects were first evident 20 minutes after dosing for both of the dexmedetomidine doses versus placebo.
Patients in both active-treatment groups showed greater improvement in PEC total score than patients in the placebo group at all subsequent time points through 2 hours post dosing.
Sublingual dexmedetomidine was also associated with significant improvement on the secondary outcomes of Clinical Global Impressions–Improvement and Agitation-Calmness Evaluation Scale.
Adverse events occurred in 35.7% and 34.9% of patients taking 180 mcg and 120 mcg sublingual dexmedetomidine, respectively, compared with 17.5% of patients taking placebo. The most commonly reported adverse events were somnolence, dry mouth, hypotension, and dizziness. No treatment-related serious or severe adverse events were reported.
FDA action date: April 5
In an accompanying editorial, John K. Hsiao, MD, National Institutes of Health, Bethesda, Md., noted that an “out-of-control, agitated, possibly aggressive patient in a medical setting is a crisis demanding swift and safe resolution.
“Today, emergency departments now rival and perhaps surpass psychiatric units as settings where out-of-control, agitated patients must be managed,” Dr. Hsiao said.
The current study “provides evidence to support a novel, potentially important addition to the armamentarium for managing behavioral agitation,” he wrote.
BioXcel Therapeutics has submitted a new drug application to the Food and Drug Administration. The Prescription Drug User Fee Act target action date is April 5.
In a statement, Frank D. Yocca, PhD, chief scientific officer of BioXcel Therapeutics, said the company is looking forward to potential FDA approval of the treatment for agitation associated with bipolar disorders and schizophrenia.
“Building on the strength of these compelling data, we are also confidently progressing BXCL501 as a potential acute treatment for agitation associated with Alzheimer’s disease,” Dr. Yocca added.
The study was funded by BioXcel Therapeutics. Dr. Preskorn reported receiving consulting fees from BioXcel and receiving research grants from, serving as a consultant for, on advisory boards of, and on the speakers bureau of Alkermes, BioXcel Therapeutics, Eisai, Janssen, Novartis, Otsuka, Sunovion, and Usona Institute. Dr. Hsiao has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The phase 3 SERENITY II trial included almost 400 adults with bipolar I or II disorder and acute agitation.
Results showed relief from acute agitation kicked in beginning at 20 minutes after administration of the treatment and continued to 120 minutes, principal investigator Sheldon H. Preskorn, MD, professor, department of psychiatry and behavioral sciences, University of Kansas, Wichita, and colleagues reported.
“Patients who are mild to moderately agitated in whom there is the potential for escalation to more severe agitation,” are good candidates for sublingual dexmedetomidine, Dr. Preskorn told this news organization.
He noted that, while “comparative claims require comparative studies,” a key advantage is that it “can be self-administered by patients reliably because of the adherence of the film to the mucosa.”
The findings were published online Feb. 22, 2022 in JAMA.
Tough-to-manage symptom
Preliminary results were presented at the 2021 annual meeting of the American Psychiatric Association and reported by this news organization at that time.
Agitation is a common and tough-to-manage symptom associated with multiple neuropsychiatric conditions, including bipolar disorder.
The phase 3 SERENITY II trial enrolled 380 adults (mean age, 45 years; 55% women) with bipolar I or II disorder and acute agitation in the emergency department.
All participants had a total score of 14 or greater on the five items of the Positive and Negative Syndrome Scale–Excited Component (PEC) scale at baseline and a score of 4 or greater on at least one PEC item.
Patients were randomly allocated to a single dose of sublingual dexmedetomidine (120 mcg or 180 mcg) or placebo. All but two patients completed the study.
Baseline agitation was mild to moderate, with an overall mean PEC total score of 18.
Rapid relief
Mean change from baseline in the PEC total score at 2 hours (primary endpoint) was –9 and –10.4 with the 120-mcg and 180-mcg doses of sublingual dexmedetomidine, respectively, versus –4.9 for placebo.
Least-square mean differences from placebo in the sublingual dexmedetomidine groups at 2 hours were statistically significant for both doses (both, P < .001 vs. placebo).
Statistically significant treatment effects were first evident 20 minutes after dosing for both of the dexmedetomidine doses versus placebo.
Patients in both active-treatment groups showed greater improvement in PEC total score than patients in the placebo group at all subsequent time points through 2 hours post dosing.
Sublingual dexmedetomidine was also associated with significant improvement on the secondary outcomes of Clinical Global Impressions–Improvement and Agitation-Calmness Evaluation Scale.
Adverse events occurred in 35.7% and 34.9% of patients taking 180 mcg and 120 mcg sublingual dexmedetomidine, respectively, compared with 17.5% of patients taking placebo. The most commonly reported adverse events were somnolence, dry mouth, hypotension, and dizziness. No treatment-related serious or severe adverse events were reported.
FDA action date: April 5
In an accompanying editorial, John K. Hsiao, MD, National Institutes of Health, Bethesda, Md., noted that an “out-of-control, agitated, possibly aggressive patient in a medical setting is a crisis demanding swift and safe resolution.
“Today, emergency departments now rival and perhaps surpass psychiatric units as settings where out-of-control, agitated patients must be managed,” Dr. Hsiao said.
The current study “provides evidence to support a novel, potentially important addition to the armamentarium for managing behavioral agitation,” he wrote.
BioXcel Therapeutics has submitted a new drug application to the Food and Drug Administration. The Prescription Drug User Fee Act target action date is April 5.
In a statement, Frank D. Yocca, PhD, chief scientific officer of BioXcel Therapeutics, said the company is looking forward to potential FDA approval of the treatment for agitation associated with bipolar disorders and schizophrenia.
“Building on the strength of these compelling data, we are also confidently progressing BXCL501 as a potential acute treatment for agitation associated with Alzheimer’s disease,” Dr. Yocca added.
The study was funded by BioXcel Therapeutics. Dr. Preskorn reported receiving consulting fees from BioXcel and receiving research grants from, serving as a consultant for, on advisory boards of, and on the speakers bureau of Alkermes, BioXcel Therapeutics, Eisai, Janssen, Novartis, Otsuka, Sunovion, and Usona Institute. Dr. Hsiao has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM JAMA
Excess sodium in soluble acetaminophen tied to CVD risk, death
a large observational study of more than 300,000 adults suggests.
“Numerous studies have reported that high sodium intake is associated with increased risks of cardiovascular disease,” Yuqing Zhang, DSc, with Massachusetts General Hospital and Harvard Medical School, Boston, told this news organization. “Given that the pain relief effect of non–sodium-containing acetaminophen is similar to that of sodium-containing acetaminophen, clinicians may prescribe non–sodium-containing acetaminophen to their patients to minimize the risk of CVD and mortality,” Dr. Zhang said.
The study was published online Feb. 24 in the European Heart Journal.
‘Compelling results’
Dr. Zhang and colleagues note that the effervescent and soluble formulations of 0.5 g acetaminophen contain 0.44 and 0.39 g of sodium, respectively.
Therefore, the intake of maximum daily dose (4 g/day) of sodium-containing acetaminophen corresponds to the ingestion of more than 3 g of sodium, a dose that alone exceeds the recommended total daily sodium intake allowance of the World Health Organization (2 g/day).
“This hidden extra sodium intake is often overlooked,” Dr. Zhang told this news organization.
Using data from the Health Improvement Network, a U.K. primary care database, the researchers examined 4,532 patients with hypertension taking sodium-containing acetaminophen and compared them with 146,866 patients with hypertension taking non–sodium-containing acetaminophen (tablet, capsule, or oral suspension formulations).
After 1 year, the risk of incident CVD (myocardial infarction, stroke, and heart failure) was 5.6% in those taking sodium-containing acetaminophen, compared with 4.6% in those taking non–sodium-containing acetaminophen (average weighted hazard ratio, 1.59; 95% confidence interval, 1.32-1.92).
A separate analysis of normotensive patients taking sodium-containing acetaminophen (n = 5,351) or non–sodium-containing acetaminophen (n = 141,948) gave similar results.
The 1-year risk of incident CVD was 4.4% in those taking sodium-containing acetaminophen vs. 3.7% among those taking non–sodium-containing acetaminophen (average weighted HR, 1.45; 95% CI, 1.18-1.79).
There was also evidence of a dose-response relationship.
In those with hypertension, CVD risk increased by roughly one-quarter (odds ratio, 1.26) for those with one prescription of sodium-containing acetaminophen and by nearly one half (OR, 1.45) for those with five or more prescriptions of sodium-containing acetaminophen. Similar findings were observed among adults without hypertension.
Mortality at 1 year was also higher in those taking sodium-containing acetaminophen than non–sodium-containing acetaminophen, in patients with hypertension (7.6% vs. 6.1%) and without hypertension (7.3% vs. 5.9%).
“The results are compelling,” write the authors of an editorial published with the study.
“The direct message from this study is clear – there are likely to be millions of people worldwide taking paracetamol on a daily basis in a ‘fast-acting’ effervescent or soluble formulation who are increasing their risks of cardiovascular disease and premature death,” say Aletta Schutte, PhD, and Bruce Neal, MBChB, PhD, of the George Institute for Global Health, Sydney.
“The weight of the evidence makes ongoing inaction on sodium-containing medications untenable. The widespread use of effervescent medication in the general population, and the enormous doses of sodium that can be consumed inadvertently by unsuspecting consumers requires urgent action,” Dr. Schutte and Dr. Neal say.
The study was supported by the National Natural Science Foundation of China, the National Key Research and Development Project, the Project Program of National Clinical Research Center for Geriatric Disorders, the Key Research and Development Program of Hunan Province, and the Science and Technology Program of Hunan Province. Dr. Zhang, Dr. Schutte, and Dr. Neal have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
a large observational study of more than 300,000 adults suggests.
“Numerous studies have reported that high sodium intake is associated with increased risks of cardiovascular disease,” Yuqing Zhang, DSc, with Massachusetts General Hospital and Harvard Medical School, Boston, told this news organization. “Given that the pain relief effect of non–sodium-containing acetaminophen is similar to that of sodium-containing acetaminophen, clinicians may prescribe non–sodium-containing acetaminophen to their patients to minimize the risk of CVD and mortality,” Dr. Zhang said.
The study was published online Feb. 24 in the European Heart Journal.
‘Compelling results’
Dr. Zhang and colleagues note that the effervescent and soluble formulations of 0.5 g acetaminophen contain 0.44 and 0.39 g of sodium, respectively.
Therefore, the intake of maximum daily dose (4 g/day) of sodium-containing acetaminophen corresponds to the ingestion of more than 3 g of sodium, a dose that alone exceeds the recommended total daily sodium intake allowance of the World Health Organization (2 g/day).
“This hidden extra sodium intake is often overlooked,” Dr. Zhang told this news organization.
Using data from the Health Improvement Network, a U.K. primary care database, the researchers examined 4,532 patients with hypertension taking sodium-containing acetaminophen and compared them with 146,866 patients with hypertension taking non–sodium-containing acetaminophen (tablet, capsule, or oral suspension formulations).
After 1 year, the risk of incident CVD (myocardial infarction, stroke, and heart failure) was 5.6% in those taking sodium-containing acetaminophen, compared with 4.6% in those taking non–sodium-containing acetaminophen (average weighted hazard ratio, 1.59; 95% confidence interval, 1.32-1.92).
A separate analysis of normotensive patients taking sodium-containing acetaminophen (n = 5,351) or non–sodium-containing acetaminophen (n = 141,948) gave similar results.
The 1-year risk of incident CVD was 4.4% in those taking sodium-containing acetaminophen vs. 3.7% among those taking non–sodium-containing acetaminophen (average weighted HR, 1.45; 95% CI, 1.18-1.79).
There was also evidence of a dose-response relationship.
In those with hypertension, CVD risk increased by roughly one-quarter (odds ratio, 1.26) for those with one prescription of sodium-containing acetaminophen and by nearly one half (OR, 1.45) for those with five or more prescriptions of sodium-containing acetaminophen. Similar findings were observed among adults without hypertension.
Mortality at 1 year was also higher in those taking sodium-containing acetaminophen than non–sodium-containing acetaminophen, in patients with hypertension (7.6% vs. 6.1%) and without hypertension (7.3% vs. 5.9%).
“The results are compelling,” write the authors of an editorial published with the study.
“The direct message from this study is clear – there are likely to be millions of people worldwide taking paracetamol on a daily basis in a ‘fast-acting’ effervescent or soluble formulation who are increasing their risks of cardiovascular disease and premature death,” say Aletta Schutte, PhD, and Bruce Neal, MBChB, PhD, of the George Institute for Global Health, Sydney.
“The weight of the evidence makes ongoing inaction on sodium-containing medications untenable. The widespread use of effervescent medication in the general population, and the enormous doses of sodium that can be consumed inadvertently by unsuspecting consumers requires urgent action,” Dr. Schutte and Dr. Neal say.
The study was supported by the National Natural Science Foundation of China, the National Key Research and Development Project, the Project Program of National Clinical Research Center for Geriatric Disorders, the Key Research and Development Program of Hunan Province, and the Science and Technology Program of Hunan Province. Dr. Zhang, Dr. Schutte, and Dr. Neal have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
a large observational study of more than 300,000 adults suggests.
“Numerous studies have reported that high sodium intake is associated with increased risks of cardiovascular disease,” Yuqing Zhang, DSc, with Massachusetts General Hospital and Harvard Medical School, Boston, told this news organization. “Given that the pain relief effect of non–sodium-containing acetaminophen is similar to that of sodium-containing acetaminophen, clinicians may prescribe non–sodium-containing acetaminophen to their patients to minimize the risk of CVD and mortality,” Dr. Zhang said.
The study was published online Feb. 24 in the European Heart Journal.
‘Compelling results’
Dr. Zhang and colleagues note that the effervescent and soluble formulations of 0.5 g acetaminophen contain 0.44 and 0.39 g of sodium, respectively.
Therefore, the intake of maximum daily dose (4 g/day) of sodium-containing acetaminophen corresponds to the ingestion of more than 3 g of sodium, a dose that alone exceeds the recommended total daily sodium intake allowance of the World Health Organization (2 g/day).
“This hidden extra sodium intake is often overlooked,” Dr. Zhang told this news organization.
Using data from the Health Improvement Network, a U.K. primary care database, the researchers examined 4,532 patients with hypertension taking sodium-containing acetaminophen and compared them with 146,866 patients with hypertension taking non–sodium-containing acetaminophen (tablet, capsule, or oral suspension formulations).
After 1 year, the risk of incident CVD (myocardial infarction, stroke, and heart failure) was 5.6% in those taking sodium-containing acetaminophen, compared with 4.6% in those taking non–sodium-containing acetaminophen (average weighted hazard ratio, 1.59; 95% confidence interval, 1.32-1.92).
A separate analysis of normotensive patients taking sodium-containing acetaminophen (n = 5,351) or non–sodium-containing acetaminophen (n = 141,948) gave similar results.
The 1-year risk of incident CVD was 4.4% in those taking sodium-containing acetaminophen vs. 3.7% among those taking non–sodium-containing acetaminophen (average weighted HR, 1.45; 95% CI, 1.18-1.79).
There was also evidence of a dose-response relationship.
In those with hypertension, CVD risk increased by roughly one-quarter (odds ratio, 1.26) for those with one prescription of sodium-containing acetaminophen and by nearly one half (OR, 1.45) for those with five or more prescriptions of sodium-containing acetaminophen. Similar findings were observed among adults without hypertension.
Mortality at 1 year was also higher in those taking sodium-containing acetaminophen than non–sodium-containing acetaminophen, in patients with hypertension (7.6% vs. 6.1%) and without hypertension (7.3% vs. 5.9%).
“The results are compelling,” write the authors of an editorial published with the study.
“The direct message from this study is clear – there are likely to be millions of people worldwide taking paracetamol on a daily basis in a ‘fast-acting’ effervescent or soluble formulation who are increasing their risks of cardiovascular disease and premature death,” say Aletta Schutte, PhD, and Bruce Neal, MBChB, PhD, of the George Institute for Global Health, Sydney.
“The weight of the evidence makes ongoing inaction on sodium-containing medications untenable. The widespread use of effervescent medication in the general population, and the enormous doses of sodium that can be consumed inadvertently by unsuspecting consumers requires urgent action,” Dr. Schutte and Dr. Neal say.
The study was supported by the National Natural Science Foundation of China, the National Key Research and Development Project, the Project Program of National Clinical Research Center for Geriatric Disorders, the Key Research and Development Program of Hunan Province, and the Science and Technology Program of Hunan Province. Dr. Zhang, Dr. Schutte, and Dr. Neal have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM THE EUROPEAN HEART JOURNAL
AHA targets ‘low-value’ heart care in new scientific statement
Low-value health care services that provide little or no benefit to patients are “common, potentially harmful, and costly,” and there is a critical need to reduce this kind of care, the American Heart Association said in a newly released scientific statement.
Each year, nearly half of patients in the United States will receive at least one low-value test or procedure, with the attendant risk of avoidable complications from cascades of care and excess costs to individuals and society, the authors noted. Reducing low-value care is particularly important in cardiology, given the high prevalence and costs of cardiovascular disease in the United States.
The statement was published online Feb. 22, 2022, in Circulation: Cardiovascular Quality and Outcomes.
High burden with uncertain benefit
“Cardiovascular disease is common and can present suddenly, such as a heart attack or abnormal heart rhythm,” Vinay Kini, MD, chair of the statement writing group and assistant professor of medicine at Weill Cornell Medicine, New York, said in a news release.
“Our desire to be vigilant about treating and preventing cardiovascular disease may sometimes lead to use of tests and procedures where the benefits to patients may be uncertain,” Dr. Kini said. “This may impose burdens on patients, in the form of increased risk of physical harm from the low-value procedure or potential complications, as well as follow-up care and out-of-pocket financial costs.”
For example, studies have shown that up to one in five echocardiograms and up to half of all stress tests performed in the United States may be rated as rarely appropriate, based on established guidelines for their use.
In addition, up to 15% of percutaneous coronary interventions (PCIs) are classified as rarely appropriate, the writing group said.
Annually, among Medicare fee-for-service beneficiaries, low-value stress testing in patients with stable coronary artery disease is estimated to cost between $212 million and $2.1 billion, while costs of PCI for stable CAD range from $212 million to $2.8 billion, the writing group noted.
“At best, spending on low-value care potentially diverts resources from higher-value services that would benefit patients more effectively at the same or reduced cost. At worst, low-value care results in physical harm in the form of preventable morbidity and mortality,” they said.
“Thus, reducing low-value care is one of the few patient-centered solutions that directly address both the need to control health care spending and the societal imperative to devote its limited resources to beneficial health care services that improve health,” they added.
The group outlines several ways to reduce low-value cardiovascular care targeting patients, providers, and payers/policymakers.
For patients, education and shared decision-making may help reduce low-value care and dispel misconceptions about the intended purpose of test or treatment, they suggested.
For clinicians, a “layered” approach to reducing low-value care may be most effective, such as through education, audit and feedback, and behavioral science tools (“nudges”) to shift behaviors and practices, they said.
For payers and policy leaders, interventions to reduce low-value care include national insurance coverage determinations; prior authorization; alternative payment models that reward lower costs and higher-quality health care; value-based insurance designs that financially penalize low-value care; and medical liability reform to reduce defensive medical practices.
Low-value cardiovascular care is a complex problem, the writing group acknowledged, and achieving meaningful reductions in low-value cardiovascular care will require a multidisciplinary approach that includes continuous research, implementation, evaluation, and adjustment while ensuring equitable access to care.
“Each approach has benefits and drawbacks,” Dr. Kini said. “For example, prior authorization imposes a large burden on health care professionals to obtain insurance approval for tests and treatments. Prior authorization and some value-based payment models may unintentionally worsen existing racial and ethnic health care disparities.
“A one-size-fits-all approach to reducing low-value care is unlikely to succeed; rather, acting through multiple perspectives and frequently measuring impacts and potential unintended consequences is critical,” he concluded.
The scientific statement was prepared by the volunteer writing group on behalf of the AHA’s Council on Quality of Care and Outcomes Research.
The research had no commercial funding. Dr. Kini disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Low-value health care services that provide little or no benefit to patients are “common, potentially harmful, and costly,” and there is a critical need to reduce this kind of care, the American Heart Association said in a newly released scientific statement.
Each year, nearly half of patients in the United States will receive at least one low-value test or procedure, with the attendant risk of avoidable complications from cascades of care and excess costs to individuals and society, the authors noted. Reducing low-value care is particularly important in cardiology, given the high prevalence and costs of cardiovascular disease in the United States.
The statement was published online Feb. 22, 2022, in Circulation: Cardiovascular Quality and Outcomes.
High burden with uncertain benefit
“Cardiovascular disease is common and can present suddenly, such as a heart attack or abnormal heart rhythm,” Vinay Kini, MD, chair of the statement writing group and assistant professor of medicine at Weill Cornell Medicine, New York, said in a news release.
“Our desire to be vigilant about treating and preventing cardiovascular disease may sometimes lead to use of tests and procedures where the benefits to patients may be uncertain,” Dr. Kini said. “This may impose burdens on patients, in the form of increased risk of physical harm from the low-value procedure or potential complications, as well as follow-up care and out-of-pocket financial costs.”
For example, studies have shown that up to one in five echocardiograms and up to half of all stress tests performed in the United States may be rated as rarely appropriate, based on established guidelines for their use.
In addition, up to 15% of percutaneous coronary interventions (PCIs) are classified as rarely appropriate, the writing group said.
Annually, among Medicare fee-for-service beneficiaries, low-value stress testing in patients with stable coronary artery disease is estimated to cost between $212 million and $2.1 billion, while costs of PCI for stable CAD range from $212 million to $2.8 billion, the writing group noted.
“At best, spending on low-value care potentially diverts resources from higher-value services that would benefit patients more effectively at the same or reduced cost. At worst, low-value care results in physical harm in the form of preventable morbidity and mortality,” they said.
“Thus, reducing low-value care is one of the few patient-centered solutions that directly address both the need to control health care spending and the societal imperative to devote its limited resources to beneficial health care services that improve health,” they added.
The group outlines several ways to reduce low-value cardiovascular care targeting patients, providers, and payers/policymakers.
For patients, education and shared decision-making may help reduce low-value care and dispel misconceptions about the intended purpose of test or treatment, they suggested.
For clinicians, a “layered” approach to reducing low-value care may be most effective, such as through education, audit and feedback, and behavioral science tools (“nudges”) to shift behaviors and practices, they said.
For payers and policy leaders, interventions to reduce low-value care include national insurance coverage determinations; prior authorization; alternative payment models that reward lower costs and higher-quality health care; value-based insurance designs that financially penalize low-value care; and medical liability reform to reduce defensive medical practices.
Low-value cardiovascular care is a complex problem, the writing group acknowledged, and achieving meaningful reductions in low-value cardiovascular care will require a multidisciplinary approach that includes continuous research, implementation, evaluation, and adjustment while ensuring equitable access to care.
“Each approach has benefits and drawbacks,” Dr. Kini said. “For example, prior authorization imposes a large burden on health care professionals to obtain insurance approval for tests and treatments. Prior authorization and some value-based payment models may unintentionally worsen existing racial and ethnic health care disparities.
“A one-size-fits-all approach to reducing low-value care is unlikely to succeed; rather, acting through multiple perspectives and frequently measuring impacts and potential unintended consequences is critical,” he concluded.
The scientific statement was prepared by the volunteer writing group on behalf of the AHA’s Council on Quality of Care and Outcomes Research.
The research had no commercial funding. Dr. Kini disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Low-value health care services that provide little or no benefit to patients are “common, potentially harmful, and costly,” and there is a critical need to reduce this kind of care, the American Heart Association said in a newly released scientific statement.
Each year, nearly half of patients in the United States will receive at least one low-value test or procedure, with the attendant risk of avoidable complications from cascades of care and excess costs to individuals and society, the authors noted. Reducing low-value care is particularly important in cardiology, given the high prevalence and costs of cardiovascular disease in the United States.
The statement was published online Feb. 22, 2022, in Circulation: Cardiovascular Quality and Outcomes.
High burden with uncertain benefit
“Cardiovascular disease is common and can present suddenly, such as a heart attack or abnormal heart rhythm,” Vinay Kini, MD, chair of the statement writing group and assistant professor of medicine at Weill Cornell Medicine, New York, said in a news release.
“Our desire to be vigilant about treating and preventing cardiovascular disease may sometimes lead to use of tests and procedures where the benefits to patients may be uncertain,” Dr. Kini said. “This may impose burdens on patients, in the form of increased risk of physical harm from the low-value procedure or potential complications, as well as follow-up care and out-of-pocket financial costs.”
For example, studies have shown that up to one in five echocardiograms and up to half of all stress tests performed in the United States may be rated as rarely appropriate, based on established guidelines for their use.
In addition, up to 15% of percutaneous coronary interventions (PCIs) are classified as rarely appropriate, the writing group said.
Annually, among Medicare fee-for-service beneficiaries, low-value stress testing in patients with stable coronary artery disease is estimated to cost between $212 million and $2.1 billion, while costs of PCI for stable CAD range from $212 million to $2.8 billion, the writing group noted.
“At best, spending on low-value care potentially diverts resources from higher-value services that would benefit patients more effectively at the same or reduced cost. At worst, low-value care results in physical harm in the form of preventable morbidity and mortality,” they said.
“Thus, reducing low-value care is one of the few patient-centered solutions that directly address both the need to control health care spending and the societal imperative to devote its limited resources to beneficial health care services that improve health,” they added.
The group outlines several ways to reduce low-value cardiovascular care targeting patients, providers, and payers/policymakers.
For patients, education and shared decision-making may help reduce low-value care and dispel misconceptions about the intended purpose of test or treatment, they suggested.
For clinicians, a “layered” approach to reducing low-value care may be most effective, such as through education, audit and feedback, and behavioral science tools (“nudges”) to shift behaviors and practices, they said.
For payers and policy leaders, interventions to reduce low-value care include national insurance coverage determinations; prior authorization; alternative payment models that reward lower costs and higher-quality health care; value-based insurance designs that financially penalize low-value care; and medical liability reform to reduce defensive medical practices.
Low-value cardiovascular care is a complex problem, the writing group acknowledged, and achieving meaningful reductions in low-value cardiovascular care will require a multidisciplinary approach that includes continuous research, implementation, evaluation, and adjustment while ensuring equitable access to care.
“Each approach has benefits and drawbacks,” Dr. Kini said. “For example, prior authorization imposes a large burden on health care professionals to obtain insurance approval for tests and treatments. Prior authorization and some value-based payment models may unintentionally worsen existing racial and ethnic health care disparities.
“A one-size-fits-all approach to reducing low-value care is unlikely to succeed; rather, acting through multiple perspectives and frequently measuring impacts and potential unintended consequences is critical,” he concluded.
The scientific statement was prepared by the volunteer writing group on behalf of the AHA’s Council on Quality of Care and Outcomes Research.
The research had no commercial funding. Dr. Kini disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM CIRCULATION: CARDIOVASCULAR QUALITY AND OUTCOMES
Poor trial representation tied to worse breast cancer survival
Women with early-stage breast cancer who are poorly represented in clinical trials have worse survival than their well-represented peers, according to a real-world analysis.
The study shows that more than half of women with early breast cancer are not well represented in clinical trials because of age, comorbidities, or race, yet they receive therapies based on the results of these trials.
“The most interesting finding is that patients with comorbidities resulting in lab abnormalities that would typically exclude them from receiving medication on a trial are still frequently receiving these medications and have an almost threefold higher mortality,” Gabrielle Rocque, MD, with the division of hematology and oncology, University of Alabama at Birmingham, told this news organization.
“We need to do a deeper dive to better understand what is driving this mortality difference and test specific medications in patients with these conditions to understand the optimal treatment for this population,” Dr. Rocque added.
The study was published Feb. 1 in JCO Oncology Practice.
Many patient groups are not well represented in clinical trials, including patients of color, older patients, and those with comorbidities, and it remains unclear how treatment outcomes may differ among these patients, compared with those who are well represented in trials.
To investigate, Dr. Rocque and colleagues looked at 11,770 women diagnosed with stage I-III breast cancer between 2005 and 2015 in the American Society of Clinical Oncology CancerLinQ database.
White women between 45 and 69 years of age with no comorbid conditions were considered well represented and made up 48% of the cohort.
Non-White women and/or those younger than 45 years or older than 70 were considered under represented and made up 45% of the cohort. The unrepresented group (7%) included women with comorbidities – such as liver disease, renal insufficiency, thrombocytopenia, anemia, or uncontrolled diabetes – or concurrent cancer.
The majority of the women received a high-intensity chemotherapy regimen, including 58% of unrepresented, 66% of underrepresented, and 63% of well-represented patients.
Compared with well-represented women, unrepresented women had a higher risk of death at 5 years (adjusted hazard ratio, 2.71; 95% confidence interval, 2.08-3.52).
Overall, the team found no significant increase in the risk of death at 5 years in underrepresented vs. well-represented women (aHR, 1.19; 95% CI, 0.98-1.45). However, that risk varied with age. Among underrepresented women, those aged 70 and older had more than a twofold higher risk of 5-year mortality (aHR, 2.21), while those younger than 45 had a lower risk of 5-year mortality (aHR, 0.63), compared with those aged 45-69 years.
For three cancer subtypes, unrepresented patients had a greater than twofold higher risk of 5-year mortality, compared with well-represented patients (aHR, 2.50 for HER2-positive disease; aHR, 2.54 for HR-positive/HER2-negative disease; and aHR, 2.75 for triple-negative disease).
Underrepresented patients with HR-positive/HER2-negative disease had a 38% increased risk of 5-year mortality, compared with their well-represented peers (aHR, 1.38). However, there were no significant differences in 5-year mortality for underrepresented vs. well-represented patients with HER2-positive or triple-negative subtypes.
Risky business?
This analysis shows that unrepresented populations receive common treatment regimens at a similar rate as well-represented patients, the researchers note.
“By excluding patients with differing clinical conditions from trials but including them in the population to which drugs can be disseminated, one runs the risk of inadvertently causing injury,” the authors caution.
“To inform the practice of evidence-based medicine in an equitable manner, our findings support a need to both expand clinical trial inclusion criteria and report on clinical trial outcomes by clinical and demographic characteristics,” Dr. Rocque and colleagues conclude.
Charles Shapiro, MD, professor of medicine, hematology, and medical oncology, Icahn School of Medicine at Mount Sinai, New York, is not surprised by the findings of this study.
“We know that clinical trials are too restrictive and include only a selected population largely without comorbidities, but in the real world, people have comorbidities,” Dr. Shapiro, who was not involved in the research, told this news organization.
The study “starkly illustrates” the poorer survival of populations not represented in clinical trials.
“It could be that we need to change clinical trials, maybe ask fewer questions or maybe ask more important questions and loosen the eligibility up, because in the real world, there are people with comorbidities and people who are over 70,” Dr. Shapiro stated.
Are strides being made to change that? “Not really,” Dr. Shapiro said in an interview.
The study was supported by grants from the Robert Wood Johnson Foundation and the American Cancer Society. Dr. Rocque has served as a consultant or advisor for Pfizer; has received research funding from Carevive Systems, Genentech, and Pfizer; and has received travel, accommodations, and expenses from Carevive. Dr. Shapiro has financial relationships with UptoDate, 2nd MD, and Anthenum.
A version of this article first appeared on Medscape.com.
Women with early-stage breast cancer who are poorly represented in clinical trials have worse survival than their well-represented peers, according to a real-world analysis.
The study shows that more than half of women with early breast cancer are not well represented in clinical trials because of age, comorbidities, or race, yet they receive therapies based on the results of these trials.
“The most interesting finding is that patients with comorbidities resulting in lab abnormalities that would typically exclude them from receiving medication on a trial are still frequently receiving these medications and have an almost threefold higher mortality,” Gabrielle Rocque, MD, with the division of hematology and oncology, University of Alabama at Birmingham, told this news organization.
“We need to do a deeper dive to better understand what is driving this mortality difference and test specific medications in patients with these conditions to understand the optimal treatment for this population,” Dr. Rocque added.
The study was published Feb. 1 in JCO Oncology Practice.
Many patient groups are not well represented in clinical trials, including patients of color, older patients, and those with comorbidities, and it remains unclear how treatment outcomes may differ among these patients, compared with those who are well represented in trials.
To investigate, Dr. Rocque and colleagues looked at 11,770 women diagnosed with stage I-III breast cancer between 2005 and 2015 in the American Society of Clinical Oncology CancerLinQ database.
White women between 45 and 69 years of age with no comorbid conditions were considered well represented and made up 48% of the cohort.
Non-White women and/or those younger than 45 years or older than 70 were considered under represented and made up 45% of the cohort. The unrepresented group (7%) included women with comorbidities – such as liver disease, renal insufficiency, thrombocytopenia, anemia, or uncontrolled diabetes – or concurrent cancer.
The majority of the women received a high-intensity chemotherapy regimen, including 58% of unrepresented, 66% of underrepresented, and 63% of well-represented patients.
Compared with well-represented women, unrepresented women had a higher risk of death at 5 years (adjusted hazard ratio, 2.71; 95% confidence interval, 2.08-3.52).
Overall, the team found no significant increase in the risk of death at 5 years in underrepresented vs. well-represented women (aHR, 1.19; 95% CI, 0.98-1.45). However, that risk varied with age. Among underrepresented women, those aged 70 and older had more than a twofold higher risk of 5-year mortality (aHR, 2.21), while those younger than 45 had a lower risk of 5-year mortality (aHR, 0.63), compared with those aged 45-69 years.
For three cancer subtypes, unrepresented patients had a greater than twofold higher risk of 5-year mortality, compared with well-represented patients (aHR, 2.50 for HER2-positive disease; aHR, 2.54 for HR-positive/HER2-negative disease; and aHR, 2.75 for triple-negative disease).
Underrepresented patients with HR-positive/HER2-negative disease had a 38% increased risk of 5-year mortality, compared with their well-represented peers (aHR, 1.38). However, there were no significant differences in 5-year mortality for underrepresented vs. well-represented patients with HER2-positive or triple-negative subtypes.
Risky business?
This analysis shows that unrepresented populations receive common treatment regimens at a similar rate as well-represented patients, the researchers note.
“By excluding patients with differing clinical conditions from trials but including them in the population to which drugs can be disseminated, one runs the risk of inadvertently causing injury,” the authors caution.
“To inform the practice of evidence-based medicine in an equitable manner, our findings support a need to both expand clinical trial inclusion criteria and report on clinical trial outcomes by clinical and demographic characteristics,” Dr. Rocque and colleagues conclude.
Charles Shapiro, MD, professor of medicine, hematology, and medical oncology, Icahn School of Medicine at Mount Sinai, New York, is not surprised by the findings of this study.
“We know that clinical trials are too restrictive and include only a selected population largely without comorbidities, but in the real world, people have comorbidities,” Dr. Shapiro, who was not involved in the research, told this news organization.
The study “starkly illustrates” the poorer survival of populations not represented in clinical trials.
“It could be that we need to change clinical trials, maybe ask fewer questions or maybe ask more important questions and loosen the eligibility up, because in the real world, there are people with comorbidities and people who are over 70,” Dr. Shapiro stated.
Are strides being made to change that? “Not really,” Dr. Shapiro said in an interview.
The study was supported by grants from the Robert Wood Johnson Foundation and the American Cancer Society. Dr. Rocque has served as a consultant or advisor for Pfizer; has received research funding from Carevive Systems, Genentech, and Pfizer; and has received travel, accommodations, and expenses from Carevive. Dr. Shapiro has financial relationships with UptoDate, 2nd MD, and Anthenum.
A version of this article first appeared on Medscape.com.
Women with early-stage breast cancer who are poorly represented in clinical trials have worse survival than their well-represented peers, according to a real-world analysis.
The study shows that more than half of women with early breast cancer are not well represented in clinical trials because of age, comorbidities, or race, yet they receive therapies based on the results of these trials.
“The most interesting finding is that patients with comorbidities resulting in lab abnormalities that would typically exclude them from receiving medication on a trial are still frequently receiving these medications and have an almost threefold higher mortality,” Gabrielle Rocque, MD, with the division of hematology and oncology, University of Alabama at Birmingham, told this news organization.
“We need to do a deeper dive to better understand what is driving this mortality difference and test specific medications in patients with these conditions to understand the optimal treatment for this population,” Dr. Rocque added.
The study was published Feb. 1 in JCO Oncology Practice.
Many patient groups are not well represented in clinical trials, including patients of color, older patients, and those with comorbidities, and it remains unclear how treatment outcomes may differ among these patients, compared with those who are well represented in trials.
To investigate, Dr. Rocque and colleagues looked at 11,770 women diagnosed with stage I-III breast cancer between 2005 and 2015 in the American Society of Clinical Oncology CancerLinQ database.
White women between 45 and 69 years of age with no comorbid conditions were considered well represented and made up 48% of the cohort.
Non-White women and/or those younger than 45 years or older than 70 were considered under represented and made up 45% of the cohort. The unrepresented group (7%) included women with comorbidities – such as liver disease, renal insufficiency, thrombocytopenia, anemia, or uncontrolled diabetes – or concurrent cancer.
The majority of the women received a high-intensity chemotherapy regimen, including 58% of unrepresented, 66% of underrepresented, and 63% of well-represented patients.
Compared with well-represented women, unrepresented women had a higher risk of death at 5 years (adjusted hazard ratio, 2.71; 95% confidence interval, 2.08-3.52).
Overall, the team found no significant increase in the risk of death at 5 years in underrepresented vs. well-represented women (aHR, 1.19; 95% CI, 0.98-1.45). However, that risk varied with age. Among underrepresented women, those aged 70 and older had more than a twofold higher risk of 5-year mortality (aHR, 2.21), while those younger than 45 had a lower risk of 5-year mortality (aHR, 0.63), compared with those aged 45-69 years.
For three cancer subtypes, unrepresented patients had a greater than twofold higher risk of 5-year mortality, compared with well-represented patients (aHR, 2.50 for HER2-positive disease; aHR, 2.54 for HR-positive/HER2-negative disease; and aHR, 2.75 for triple-negative disease).
Underrepresented patients with HR-positive/HER2-negative disease had a 38% increased risk of 5-year mortality, compared with their well-represented peers (aHR, 1.38). However, there were no significant differences in 5-year mortality for underrepresented vs. well-represented patients with HER2-positive or triple-negative subtypes.
Risky business?
This analysis shows that unrepresented populations receive common treatment regimens at a similar rate as well-represented patients, the researchers note.
“By excluding patients with differing clinical conditions from trials but including them in the population to which drugs can be disseminated, one runs the risk of inadvertently causing injury,” the authors caution.
“To inform the practice of evidence-based medicine in an equitable manner, our findings support a need to both expand clinical trial inclusion criteria and report on clinical trial outcomes by clinical and demographic characteristics,” Dr. Rocque and colleagues conclude.
Charles Shapiro, MD, professor of medicine, hematology, and medical oncology, Icahn School of Medicine at Mount Sinai, New York, is not surprised by the findings of this study.
“We know that clinical trials are too restrictive and include only a selected population largely without comorbidities, but in the real world, people have comorbidities,” Dr. Shapiro, who was not involved in the research, told this news organization.
The study “starkly illustrates” the poorer survival of populations not represented in clinical trials.
“It could be that we need to change clinical trials, maybe ask fewer questions or maybe ask more important questions and loosen the eligibility up, because in the real world, there are people with comorbidities and people who are over 70,” Dr. Shapiro stated.
Are strides being made to change that? “Not really,” Dr. Shapiro said in an interview.
The study was supported by grants from the Robert Wood Johnson Foundation and the American Cancer Society. Dr. Rocque has served as a consultant or advisor for Pfizer; has received research funding from Carevive Systems, Genentech, and Pfizer; and has received travel, accommodations, and expenses from Carevive. Dr. Shapiro has financial relationships with UptoDate, 2nd MD, and Anthenum.
A version of this article first appeared on Medscape.com.
FROM JCO ONCOLOGY PRACTICE