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IRL Togetherness: Family Media Options and Agreements
In July, the United States Senate passed the Kids Online Safety Act, which will need to be taken up and passed by the House prior to becoming law. This bill was designed based on emerging research showing how social media impacts the developing regions of the adolescent brain, including those involved in the growing “stop and think” pathways.
Whether this bill is passed or not, parents are already having conversations with their children’s primary care providers about how to navigate digital versus In Real Life (IRL) aspects of parenting. Why should families and primary care providers care about creating opportunities to put down devices together? We have few new ways of explaining social media’s impact on adolescent development. These angles can empower families and give tweens an increased sense of efficacy around family social media agreements. Dr. Mitch Prinstein (chief science officer for the American Psychological Association) explains how apps take children’s data from other apps to make a profit.1 When kids understand what motivates technology companies, they are more likely to buy into efforts to curtail use. He also explains that adolescent brain size and function decreases with increased social media use and resulting lack of sleep.2
Prioritizing IRL togetherness is increasingly showing up in media itself. In Inside Out 2 the coach collects players’ phones at the beginning of their intensive training weekend, allowing for Riley to have IRL social successes and failures, and resulting growth. Gather, a recently published young adult novel by Kenneth M. Cadow, is written from the perspective of Ian Gray, a teen whose mother struggles with addiction. We experience Ian’s perspective at the house of a friend. This fictional family all put their devices in a basket upon entering their home, allowing the family to interact in a more present and positive way with one another.
Increasingly, social media use is being recognized as a societal, rather than simply an individual problem. Smartphones are being banned in middle schools as there is growing recognition that students cannot learn when they have such easy access to addictive apps. More families are choosing options for the right amount of connectivity for a child’s developmental level by waiting on devices altogether or by purchasing devices without access to social media like flip phones, Gabb phones and watches, using the Bark app, and similar alternatives to fully connected devices.
Parental anxiety plays a role as well. Some of the devices listed above allow for parents to listen in on their child’s device if, for example, the child does not answer the phone. While this may potentially be important if a child requires additional support, for example with a higher-need developmental disability, for those with typical development, it robs children of independence.
What can be done about these huge technology pressures in a 15-minute primary care visit as we await more science to inform laws governing social media’s influence on child development?
Enter the Family Media Agreement. Media agreements for kids have been around for years, and there is growing understanding that when parents follow similar rules to put down devices and be present at home, adolescents are more amenable to follow suit. It’s a communication tool for parents and their growing children to help determine right-sized parameters around device and social media use.
Primary care providers can have paper copies of these available. There are also online options that can be updated as needed. Primary care providers might follow up at the next visit to see how the agreement, and more importantly mixing ideas and communication around the agreement, is working. Providers can explain that these agreements are documents that are expected to be changed with time as family needs evolve. They can help not only set rules but provide an opportunity to practice transferring more autonomy over time, as the child reaches different stages of development. Some frequently used Family Media Agreements are available to print through Common Sense Media,3 or online through the American Academy of Pediatrics’ healthychildren.org website.4
Ultimately, if children call their parents every time they are faced with a problem, rather than looking around for a helpful person or problem solving on their own, they miss a chance to practice developing skills needed as an adult. If an adult listens in on a child’s life rather than waiting to have a conversation, the adult misses out on the opportunity to experience and instill trust that the child can handle adversity and gain age-appropriate independence. Similarly, if kids become too focused on social media “likes” to engage in noticing and being friendly and helpful to those around them, as Dr. Prinstein points out in his workbook for tweens and parents, Like Ability,5 they are not developing the skills needed to build a society where we all have an opportunity to thrive and build what is needed together. In the setting of addictive products capturing everyone’s attention, Family Media Agreements are a concrete place to start these conversations: Clinicians can empower families and growing adolescents to reclaim their time for their own IRL priorities.
Dr. Spottswood is a child psychiatrist practicing in an integrated care clinic at the Community Health Centers of Burlington, Vermont, a Federally Qualified Health Center. She is also the medical director of the Vermont Child Psychiatry Access Program and a clinical assistant professor in the department of psychiatry at the University of Vermont.
References
1. Raffoul A et al. Social media platforms generate billions of dollars in revenue from U.S. youth: Findings from a simulated revenue model. PLoS One. 2023 Dec 27;18(12):e0295337. doi: 10.1371/journal.pone.0295337.
2. Telzer EH et al. Sleep variability in adolescence is associated with altered brain development. Dev Cogn Neurosci. 2015 Aug:14:16-22. doi: 10.1016/j.dcn.2015.05.007.
3. Common Sense Family Media Agreement. https://www.commonsensemedia.org/sites/default/files/featured-content/files/common_sense_family_media_agreement.pdf.
4. Healthy Children Family Media Plan. https://www.healthychildren.org/English/fmp/Pages/MediaPlan.aspx.
5. Getz L, Prinstein M. Like Ability: The Truth About Popularity. Washington: Magination Press, 2022. https://www.apa.org/pubs/magination/like-ability.
In July, the United States Senate passed the Kids Online Safety Act, which will need to be taken up and passed by the House prior to becoming law. This bill was designed based on emerging research showing how social media impacts the developing regions of the adolescent brain, including those involved in the growing “stop and think” pathways.
Whether this bill is passed or not, parents are already having conversations with their children’s primary care providers about how to navigate digital versus In Real Life (IRL) aspects of parenting. Why should families and primary care providers care about creating opportunities to put down devices together? We have few new ways of explaining social media’s impact on adolescent development. These angles can empower families and give tweens an increased sense of efficacy around family social media agreements. Dr. Mitch Prinstein (chief science officer for the American Psychological Association) explains how apps take children’s data from other apps to make a profit.1 When kids understand what motivates technology companies, they are more likely to buy into efforts to curtail use. He also explains that adolescent brain size and function decreases with increased social media use and resulting lack of sleep.2
Prioritizing IRL togetherness is increasingly showing up in media itself. In Inside Out 2 the coach collects players’ phones at the beginning of their intensive training weekend, allowing for Riley to have IRL social successes and failures, and resulting growth. Gather, a recently published young adult novel by Kenneth M. Cadow, is written from the perspective of Ian Gray, a teen whose mother struggles with addiction. We experience Ian’s perspective at the house of a friend. This fictional family all put their devices in a basket upon entering their home, allowing the family to interact in a more present and positive way with one another.
Increasingly, social media use is being recognized as a societal, rather than simply an individual problem. Smartphones are being banned in middle schools as there is growing recognition that students cannot learn when they have such easy access to addictive apps. More families are choosing options for the right amount of connectivity for a child’s developmental level by waiting on devices altogether or by purchasing devices without access to social media like flip phones, Gabb phones and watches, using the Bark app, and similar alternatives to fully connected devices.
Parental anxiety plays a role as well. Some of the devices listed above allow for parents to listen in on their child’s device if, for example, the child does not answer the phone. While this may potentially be important if a child requires additional support, for example with a higher-need developmental disability, for those with typical development, it robs children of independence.
What can be done about these huge technology pressures in a 15-minute primary care visit as we await more science to inform laws governing social media’s influence on child development?
Enter the Family Media Agreement. Media agreements for kids have been around for years, and there is growing understanding that when parents follow similar rules to put down devices and be present at home, adolescents are more amenable to follow suit. It’s a communication tool for parents and their growing children to help determine right-sized parameters around device and social media use.
Primary care providers can have paper copies of these available. There are also online options that can be updated as needed. Primary care providers might follow up at the next visit to see how the agreement, and more importantly mixing ideas and communication around the agreement, is working. Providers can explain that these agreements are documents that are expected to be changed with time as family needs evolve. They can help not only set rules but provide an opportunity to practice transferring more autonomy over time, as the child reaches different stages of development. Some frequently used Family Media Agreements are available to print through Common Sense Media,3 or online through the American Academy of Pediatrics’ healthychildren.org website.4
Ultimately, if children call their parents every time they are faced with a problem, rather than looking around for a helpful person or problem solving on their own, they miss a chance to practice developing skills needed as an adult. If an adult listens in on a child’s life rather than waiting to have a conversation, the adult misses out on the opportunity to experience and instill trust that the child can handle adversity and gain age-appropriate independence. Similarly, if kids become too focused on social media “likes” to engage in noticing and being friendly and helpful to those around them, as Dr. Prinstein points out in his workbook for tweens and parents, Like Ability,5 they are not developing the skills needed to build a society where we all have an opportunity to thrive and build what is needed together. In the setting of addictive products capturing everyone’s attention, Family Media Agreements are a concrete place to start these conversations: Clinicians can empower families and growing adolescents to reclaim their time for their own IRL priorities.
Dr. Spottswood is a child psychiatrist practicing in an integrated care clinic at the Community Health Centers of Burlington, Vermont, a Federally Qualified Health Center. She is also the medical director of the Vermont Child Psychiatry Access Program and a clinical assistant professor in the department of psychiatry at the University of Vermont.
References
1. Raffoul A et al. Social media platforms generate billions of dollars in revenue from U.S. youth: Findings from a simulated revenue model. PLoS One. 2023 Dec 27;18(12):e0295337. doi: 10.1371/journal.pone.0295337.
2. Telzer EH et al. Sleep variability in adolescence is associated with altered brain development. Dev Cogn Neurosci. 2015 Aug:14:16-22. doi: 10.1016/j.dcn.2015.05.007.
3. Common Sense Family Media Agreement. https://www.commonsensemedia.org/sites/default/files/featured-content/files/common_sense_family_media_agreement.pdf.
4. Healthy Children Family Media Plan. https://www.healthychildren.org/English/fmp/Pages/MediaPlan.aspx.
5. Getz L, Prinstein M. Like Ability: The Truth About Popularity. Washington: Magination Press, 2022. https://www.apa.org/pubs/magination/like-ability.
In July, the United States Senate passed the Kids Online Safety Act, which will need to be taken up and passed by the House prior to becoming law. This bill was designed based on emerging research showing how social media impacts the developing regions of the adolescent brain, including those involved in the growing “stop and think” pathways.
Whether this bill is passed or not, parents are already having conversations with their children’s primary care providers about how to navigate digital versus In Real Life (IRL) aspects of parenting. Why should families and primary care providers care about creating opportunities to put down devices together? We have few new ways of explaining social media’s impact on adolescent development. These angles can empower families and give tweens an increased sense of efficacy around family social media agreements. Dr. Mitch Prinstein (chief science officer for the American Psychological Association) explains how apps take children’s data from other apps to make a profit.1 When kids understand what motivates technology companies, they are more likely to buy into efforts to curtail use. He also explains that adolescent brain size and function decreases with increased social media use and resulting lack of sleep.2
Prioritizing IRL togetherness is increasingly showing up in media itself. In Inside Out 2 the coach collects players’ phones at the beginning of their intensive training weekend, allowing for Riley to have IRL social successes and failures, and resulting growth. Gather, a recently published young adult novel by Kenneth M. Cadow, is written from the perspective of Ian Gray, a teen whose mother struggles with addiction. We experience Ian’s perspective at the house of a friend. This fictional family all put their devices in a basket upon entering their home, allowing the family to interact in a more present and positive way with one another.
Increasingly, social media use is being recognized as a societal, rather than simply an individual problem. Smartphones are being banned in middle schools as there is growing recognition that students cannot learn when they have such easy access to addictive apps. More families are choosing options for the right amount of connectivity for a child’s developmental level by waiting on devices altogether or by purchasing devices without access to social media like flip phones, Gabb phones and watches, using the Bark app, and similar alternatives to fully connected devices.
Parental anxiety plays a role as well. Some of the devices listed above allow for parents to listen in on their child’s device if, for example, the child does not answer the phone. While this may potentially be important if a child requires additional support, for example with a higher-need developmental disability, for those with typical development, it robs children of independence.
What can be done about these huge technology pressures in a 15-minute primary care visit as we await more science to inform laws governing social media’s influence on child development?
Enter the Family Media Agreement. Media agreements for kids have been around for years, and there is growing understanding that when parents follow similar rules to put down devices and be present at home, adolescents are more amenable to follow suit. It’s a communication tool for parents and their growing children to help determine right-sized parameters around device and social media use.
Primary care providers can have paper copies of these available. There are also online options that can be updated as needed. Primary care providers might follow up at the next visit to see how the agreement, and more importantly mixing ideas and communication around the agreement, is working. Providers can explain that these agreements are documents that are expected to be changed with time as family needs evolve. They can help not only set rules but provide an opportunity to practice transferring more autonomy over time, as the child reaches different stages of development. Some frequently used Family Media Agreements are available to print through Common Sense Media,3 or online through the American Academy of Pediatrics’ healthychildren.org website.4
Ultimately, if children call their parents every time they are faced with a problem, rather than looking around for a helpful person or problem solving on their own, they miss a chance to practice developing skills needed as an adult. If an adult listens in on a child’s life rather than waiting to have a conversation, the adult misses out on the opportunity to experience and instill trust that the child can handle adversity and gain age-appropriate independence. Similarly, if kids become too focused on social media “likes” to engage in noticing and being friendly and helpful to those around them, as Dr. Prinstein points out in his workbook for tweens and parents, Like Ability,5 they are not developing the skills needed to build a society where we all have an opportunity to thrive and build what is needed together. In the setting of addictive products capturing everyone’s attention, Family Media Agreements are a concrete place to start these conversations: Clinicians can empower families and growing adolescents to reclaim their time for their own IRL priorities.
Dr. Spottswood is a child psychiatrist practicing in an integrated care clinic at the Community Health Centers of Burlington, Vermont, a Federally Qualified Health Center. She is also the medical director of the Vermont Child Psychiatry Access Program and a clinical assistant professor in the department of psychiatry at the University of Vermont.
References
1. Raffoul A et al. Social media platforms generate billions of dollars in revenue from U.S. youth: Findings from a simulated revenue model. PLoS One. 2023 Dec 27;18(12):e0295337. doi: 10.1371/journal.pone.0295337.
2. Telzer EH et al. Sleep variability in adolescence is associated with altered brain development. Dev Cogn Neurosci. 2015 Aug:14:16-22. doi: 10.1016/j.dcn.2015.05.007.
3. Common Sense Family Media Agreement. https://www.commonsensemedia.org/sites/default/files/featured-content/files/common_sense_family_media_agreement.pdf.
4. Healthy Children Family Media Plan. https://www.healthychildren.org/English/fmp/Pages/MediaPlan.aspx.
5. Getz L, Prinstein M. Like Ability: The Truth About Popularity. Washington: Magination Press, 2022. https://www.apa.org/pubs/magination/like-ability.
An Effective Nondrug Approach to Improve Sleep in Dementia, Phase 3 Data Show
A multicomponent nonpharmaceutical intervention improves sleep in people with dementia living at home, early results of a new phase 3 randomized controlled trial (RCT) show.
The benefits of the intervention — called DREAMS-START — were sustained at 8 months and extended to caregivers, the study found.
“We’re pleased with our results. We think that we were able to deliver it successfully and to a high rate of fidelity,” said study investigator Penny Rapaport, PhD, Division of Psychiatry, University College London, England.
The findings were presented at the Alzheimer’s Association International Conference (AAIC) 2024.
Sustained, Long-Term Effect
Sleep disturbances are very common in dementia. About 26% of people with all types of dementia will experience sleep disturbances, and that rate is higher in certain dementia subtypes, such as dementia with Lewy bodies, said Dr. Rapaport.
Such disturbances are distressing for people living with dementia as well as for those supporting them, she added. They’re “often the thing that will lead to people transitioning and moving into a care home.”
Dr. Rapaport noted there has not been full RCT evidence that any nonpharmacologic interventions or light-based treatments are effective in improving sleep disturbances.
Medications such as antipsychotics and benzodiazepines aren’t recommended as first-line treatment in people with dementia “because often these can be harmful,” she said.
The study recruited 377 dyads of people living with dementia (mean age, 79.4 years) and their caregivers from 12 national health service sites across England. “We were able to recruit an ethnically diverse sample from a broad socioeconomic background,” said Dr. Rapaport.
Researchers allocated the dyads to the intervention or to a treatment as usual group.
About 92% of participants were included in the intention-to-treat analysis at 8 months, which was the primary time point.
The intervention consists of six 1-hour interactive sessions that are “personalized and tailored to individual goals and needs,” said Dr. Rapaport. It was delivered by supervised, trained graduates, not clinicians.
The sessions focused on components of sleep hygiene (healthy habits, behaviors, and environments); activity and exercise; a tailored sleep routine; strategies to manage distress; natural and artificial light; and relaxation. A whole session was devoted to supporting sleep of caregivers.
The trial included masked outcome assessments, “so the people collecting the data were blinded to the intervention group,” said Dr. Rapaport.
The primary outcome was the Sleep Disorders Inventory (SDI) score. The SDI is a questionnaire about frequency and severity of sleep-disturbed behaviors completed by caregivers; a higher score indicates a worse outcome. The study adjusted for baseline SDI score and study site.
The adjusted mean difference between groups on the SDI was −4.7 points (95% confidence interval [CI], −7.65 to −1.74; P = .002) at 8 months.
The minimal clinically important difference on the SDI is a 4-point change, noted Dr. Rapaport.
The adjusted mean difference on the SDI at 4 months (a secondary outcome) was −4.4 points (95% CI, −7.3 to −1.5; P = .003).
Referring to illustrative graphs, Dr. Rapaport said that SDI scores decreased at both 4 and 8 months. “You can see statistically, there’s a significant difference between groups at both time points,” she said.
As for other secondary outcomes, the study found a significant reduction in neuropsychiatric symptoms among people with dementia at 8 months in the intervention arm relative to the control arm.
In addition, sleep and anxiety significantly improved among caregivers after 8 months. This shows “a picture of things getting better for the person with dementia, and the person who’s caring for them,” said Dr. Rapaport.
She noted the good adherence rate, with almost 83% of people in the intervention arm completing four or more sessions.
Fidelity to the intervention (ie, the extent to which it is implemented as intended) was also high, “so we feel it was delivered well,” said Dr. Rapaport.
Researchers also carried out a health economics analysis and looked at strategies for implementation of the program, but Dr. Rapaport did not discuss those results.
Encouraging Findings
Commenting for this news organization, Alex Bahar-Fuchs, PhD, Faculty of Health, School of Psychology, Deakin University, Victoria, Australia, who co-chaired the session featuring the research, said the findings of this “well-powered” RCT are “encouraging,” both for the primary outcome of sleep quality and for some of the secondary outcomes for the care-partner.
“The study adds to the growing evidence behind several nonpharmacological treatment approaches for cognitive and neuropsychiatric symptoms of people with dementia,” he said.
The results “offer some hope for the treatment of a common disturbance in people with dementia which is associated with poorer outcomes and increased caregiver burden,” he added.
An important area for further work would be to incorporate more objective measures of sleep quality, said Dr. Bahar-Fuchs.
Because the primary outcome was measured using a self-report questionnaire (the SDI) completed by care-partners, and because the intervention arm could not be blinded, “it remains possible that some detection bias may have affected the study findings,” said Dr. Bahar-Fuchs.
He said he would like to see the research extended to include an active control condition “to be able to better ascertain treatment mechanisms.”
The study was supported by the National Institute of Health and Care Research. Dr. Rapaport and Dr. Bahar-Fuchs reported no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
A multicomponent nonpharmaceutical intervention improves sleep in people with dementia living at home, early results of a new phase 3 randomized controlled trial (RCT) show.
The benefits of the intervention — called DREAMS-START — were sustained at 8 months and extended to caregivers, the study found.
“We’re pleased with our results. We think that we were able to deliver it successfully and to a high rate of fidelity,” said study investigator Penny Rapaport, PhD, Division of Psychiatry, University College London, England.
The findings were presented at the Alzheimer’s Association International Conference (AAIC) 2024.
Sustained, Long-Term Effect
Sleep disturbances are very common in dementia. About 26% of people with all types of dementia will experience sleep disturbances, and that rate is higher in certain dementia subtypes, such as dementia with Lewy bodies, said Dr. Rapaport.
Such disturbances are distressing for people living with dementia as well as for those supporting them, she added. They’re “often the thing that will lead to people transitioning and moving into a care home.”
Dr. Rapaport noted there has not been full RCT evidence that any nonpharmacologic interventions or light-based treatments are effective in improving sleep disturbances.
Medications such as antipsychotics and benzodiazepines aren’t recommended as first-line treatment in people with dementia “because often these can be harmful,” she said.
The study recruited 377 dyads of people living with dementia (mean age, 79.4 years) and their caregivers from 12 national health service sites across England. “We were able to recruit an ethnically diverse sample from a broad socioeconomic background,” said Dr. Rapaport.
Researchers allocated the dyads to the intervention or to a treatment as usual group.
About 92% of participants were included in the intention-to-treat analysis at 8 months, which was the primary time point.
The intervention consists of six 1-hour interactive sessions that are “personalized and tailored to individual goals and needs,” said Dr. Rapaport. It was delivered by supervised, trained graduates, not clinicians.
The sessions focused on components of sleep hygiene (healthy habits, behaviors, and environments); activity and exercise; a tailored sleep routine; strategies to manage distress; natural and artificial light; and relaxation. A whole session was devoted to supporting sleep of caregivers.
The trial included masked outcome assessments, “so the people collecting the data were blinded to the intervention group,” said Dr. Rapaport.
The primary outcome was the Sleep Disorders Inventory (SDI) score. The SDI is a questionnaire about frequency and severity of sleep-disturbed behaviors completed by caregivers; a higher score indicates a worse outcome. The study adjusted for baseline SDI score and study site.
The adjusted mean difference between groups on the SDI was −4.7 points (95% confidence interval [CI], −7.65 to −1.74; P = .002) at 8 months.
The minimal clinically important difference on the SDI is a 4-point change, noted Dr. Rapaport.
The adjusted mean difference on the SDI at 4 months (a secondary outcome) was −4.4 points (95% CI, −7.3 to −1.5; P = .003).
Referring to illustrative graphs, Dr. Rapaport said that SDI scores decreased at both 4 and 8 months. “You can see statistically, there’s a significant difference between groups at both time points,” she said.
As for other secondary outcomes, the study found a significant reduction in neuropsychiatric symptoms among people with dementia at 8 months in the intervention arm relative to the control arm.
In addition, sleep and anxiety significantly improved among caregivers after 8 months. This shows “a picture of things getting better for the person with dementia, and the person who’s caring for them,” said Dr. Rapaport.
She noted the good adherence rate, with almost 83% of people in the intervention arm completing four or more sessions.
Fidelity to the intervention (ie, the extent to which it is implemented as intended) was also high, “so we feel it was delivered well,” said Dr. Rapaport.
Researchers also carried out a health economics analysis and looked at strategies for implementation of the program, but Dr. Rapaport did not discuss those results.
Encouraging Findings
Commenting for this news organization, Alex Bahar-Fuchs, PhD, Faculty of Health, School of Psychology, Deakin University, Victoria, Australia, who co-chaired the session featuring the research, said the findings of this “well-powered” RCT are “encouraging,” both for the primary outcome of sleep quality and for some of the secondary outcomes for the care-partner.
“The study adds to the growing evidence behind several nonpharmacological treatment approaches for cognitive and neuropsychiatric symptoms of people with dementia,” he said.
The results “offer some hope for the treatment of a common disturbance in people with dementia which is associated with poorer outcomes and increased caregiver burden,” he added.
An important area for further work would be to incorporate more objective measures of sleep quality, said Dr. Bahar-Fuchs.
Because the primary outcome was measured using a self-report questionnaire (the SDI) completed by care-partners, and because the intervention arm could not be blinded, “it remains possible that some detection bias may have affected the study findings,” said Dr. Bahar-Fuchs.
He said he would like to see the research extended to include an active control condition “to be able to better ascertain treatment mechanisms.”
The study was supported by the National Institute of Health and Care Research. Dr. Rapaport and Dr. Bahar-Fuchs reported no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
A multicomponent nonpharmaceutical intervention improves sleep in people with dementia living at home, early results of a new phase 3 randomized controlled trial (RCT) show.
The benefits of the intervention — called DREAMS-START — were sustained at 8 months and extended to caregivers, the study found.
“We’re pleased with our results. We think that we were able to deliver it successfully and to a high rate of fidelity,” said study investigator Penny Rapaport, PhD, Division of Psychiatry, University College London, England.
The findings were presented at the Alzheimer’s Association International Conference (AAIC) 2024.
Sustained, Long-Term Effect
Sleep disturbances are very common in dementia. About 26% of people with all types of dementia will experience sleep disturbances, and that rate is higher in certain dementia subtypes, such as dementia with Lewy bodies, said Dr. Rapaport.
Such disturbances are distressing for people living with dementia as well as for those supporting them, she added. They’re “often the thing that will lead to people transitioning and moving into a care home.”
Dr. Rapaport noted there has not been full RCT evidence that any nonpharmacologic interventions or light-based treatments are effective in improving sleep disturbances.
Medications such as antipsychotics and benzodiazepines aren’t recommended as first-line treatment in people with dementia “because often these can be harmful,” she said.
The study recruited 377 dyads of people living with dementia (mean age, 79.4 years) and their caregivers from 12 national health service sites across England. “We were able to recruit an ethnically diverse sample from a broad socioeconomic background,” said Dr. Rapaport.
Researchers allocated the dyads to the intervention or to a treatment as usual group.
About 92% of participants were included in the intention-to-treat analysis at 8 months, which was the primary time point.
The intervention consists of six 1-hour interactive sessions that are “personalized and tailored to individual goals and needs,” said Dr. Rapaport. It was delivered by supervised, trained graduates, not clinicians.
The sessions focused on components of sleep hygiene (healthy habits, behaviors, and environments); activity and exercise; a tailored sleep routine; strategies to manage distress; natural and artificial light; and relaxation. A whole session was devoted to supporting sleep of caregivers.
The trial included masked outcome assessments, “so the people collecting the data were blinded to the intervention group,” said Dr. Rapaport.
The primary outcome was the Sleep Disorders Inventory (SDI) score. The SDI is a questionnaire about frequency and severity of sleep-disturbed behaviors completed by caregivers; a higher score indicates a worse outcome. The study adjusted for baseline SDI score and study site.
The adjusted mean difference between groups on the SDI was −4.7 points (95% confidence interval [CI], −7.65 to −1.74; P = .002) at 8 months.
The minimal clinically important difference on the SDI is a 4-point change, noted Dr. Rapaport.
The adjusted mean difference on the SDI at 4 months (a secondary outcome) was −4.4 points (95% CI, −7.3 to −1.5; P = .003).
Referring to illustrative graphs, Dr. Rapaport said that SDI scores decreased at both 4 and 8 months. “You can see statistically, there’s a significant difference between groups at both time points,” she said.
As for other secondary outcomes, the study found a significant reduction in neuropsychiatric symptoms among people with dementia at 8 months in the intervention arm relative to the control arm.
In addition, sleep and anxiety significantly improved among caregivers after 8 months. This shows “a picture of things getting better for the person with dementia, and the person who’s caring for them,” said Dr. Rapaport.
She noted the good adherence rate, with almost 83% of people in the intervention arm completing four or more sessions.
Fidelity to the intervention (ie, the extent to which it is implemented as intended) was also high, “so we feel it was delivered well,” said Dr. Rapaport.
Researchers also carried out a health economics analysis and looked at strategies for implementation of the program, but Dr. Rapaport did not discuss those results.
Encouraging Findings
Commenting for this news organization, Alex Bahar-Fuchs, PhD, Faculty of Health, School of Psychology, Deakin University, Victoria, Australia, who co-chaired the session featuring the research, said the findings of this “well-powered” RCT are “encouraging,” both for the primary outcome of sleep quality and for some of the secondary outcomes for the care-partner.
“The study adds to the growing evidence behind several nonpharmacological treatment approaches for cognitive and neuropsychiatric symptoms of people with dementia,” he said.
The results “offer some hope for the treatment of a common disturbance in people with dementia which is associated with poorer outcomes and increased caregiver burden,” he added.
An important area for further work would be to incorporate more objective measures of sleep quality, said Dr. Bahar-Fuchs.
Because the primary outcome was measured using a self-report questionnaire (the SDI) completed by care-partners, and because the intervention arm could not be blinded, “it remains possible that some detection bias may have affected the study findings,” said Dr. Bahar-Fuchs.
He said he would like to see the research extended to include an active control condition “to be able to better ascertain treatment mechanisms.”
The study was supported by the National Institute of Health and Care Research. Dr. Rapaport and Dr. Bahar-Fuchs reported no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
FROM AAIC 2024
Most Youths Who Die by Suicide Had No Mental Health Diagnosis
, according to a large analysis of Centers for Disease Control and Prevention data.
Sofia Chaudhary, MD, with the Department of Pediatrics and Emergency Medicine at Emory University School of Medicine in Atlanta, Georgia, and colleagues, analyzed data from the National Violent Death Reporting System and found in the cross-sectional study of 40, 618 youths that 24,192 (59.6%) had no such diagnosis previously. Findings were published online in JAMA Network Open.
Gaps by Race, Sex and Age
The odds of having a mental health diagnosis before death by suicide differed by race and sex. Compared with White youths, the odds were lower among youths who were American Indian or Alaska Native (adjusted odds ratio [aOR], 0.45; Asian, Native Hawaiian, or Other Pacific Islander (aOR, 0.58); and Black youths (aOR, 0.62). And more than half of female youths who died by suicide had a mental health diagnosis (4429 youths [52.4%]), compared with 11,994 male youths (37.3%).
The researchers also found wide gaps by age, specifically lower odds of having a mental health diagnosis before suicide in children ages 10-14 compared with those 20-24.
“This finding is particularly notable because suicide rates have risen to become the second leading cause of death in youths aged 10 to 14 years,” the authors wrote. “Suicide prevention strategies for young children in primary care and community settings should focus on fostering resilience, promoting peer and family connectedness, and empowering children with strategies to cope with stress and adversity.”
Youths who died by firearm suicide, the most common mechanism, had the lowest rate of diagnosis. “Similar to a prior study, we found that decedents without a documented mental health diagnosis were far more likely to utilize a firearm than those with a documented mental health diagnosis,” the authors wrote.
In an invited commentary, Lisa M. Horowitz, PhD, MPH, with the Office of the Clinical Director, Intramural Research Program, National Institute of Mental Health, in Bethesda, Maryland, and colleagues wrote that the data show that identifying youth early who have mental disorders or are at-risk for suicide “is more the exception than the rule” in the United States.
The editorialists highlight that the study showed that about one-quarter of youths who have attempted suicide and nearly one-half of youths with depressed mood had no documented mental health diagnosis. Decedents were categorized with depressed mood if they were perceived by themselves or others as depressed at the time of death.
Intervention Recommendations
The study authors point to the high number of youth firearm suicide (the method used by nearly half of those who died — 19,027 (46.8%) and recommended interventions. “Suicide prevention strategies are needed for the estimated 22.6 million US children living in households with firearms, of whom 4.5 million are exposed to firearms stored loaded and unlocked,” they wrote.
A mental health diagnosis was documented for only 6308 of 19,027 youths who died by firearms (33.2%).
They noted that research has shown that more than 75% of guns used in youth suicide are owned by a family member, most commonly parents, and the presence of a firearm in the home is linked with a higher risk of youth suicide.
They wrote that the risk can be mitigated by storing all guns locked and unloaded, with ammunition stored and locked in a separate location.
The editorialists said the study highlights the need for action in several primary areas. “Suicide prevention strategies should not solely rely on a history of mental illness to identify at-risk youths, and universal suicide risk screening in healthcare settings deserves greater consideration,” they wrote.
Equitable access to care is essential to youth suicide risk detection. Interventions such as lethal means safety counseling, safety planning, and a helpline number, such as 988, should be accessible to every family and healthcare clinician.
Community-level interventions are critical, including school-based suicide prevention programs, as well as population-based training for families on the safe storage of lethal means at home.
“Every trusted adult working with children and adolescents can and should be trained to recognize the warning signs of suicide risk and help young people develop the coping strategies needed to manage difficult life experiences so that suicide is never an option,” Dr. Horowitz and colleagues wrote.
A coauthor of the study, Jennifer A. Hoffmann, MD, reports receiving grants from Children’s Research Fund Junior Board outside the submitted work. Another coauthor, Joel Fein, MD, reports fees for a patent owned by Children’s Hospital of Philadelphia licensed to Potential for the Behavioral Health Screen-Emergency Department. Among the editorialists, Jeffrey A. Bridge, PhD, reported grants from the National Institute of Mental Health, Patient Centered Outcomes Research Institute, and Centers for Disease Control and Prevention; and being a member of the Scientific Advisory Board of Clarigent Health and the Scientific Council of the American Foundation for Suicide Prevention outside the submitted work.
, according to a large analysis of Centers for Disease Control and Prevention data.
Sofia Chaudhary, MD, with the Department of Pediatrics and Emergency Medicine at Emory University School of Medicine in Atlanta, Georgia, and colleagues, analyzed data from the National Violent Death Reporting System and found in the cross-sectional study of 40, 618 youths that 24,192 (59.6%) had no such diagnosis previously. Findings were published online in JAMA Network Open.
Gaps by Race, Sex and Age
The odds of having a mental health diagnosis before death by suicide differed by race and sex. Compared with White youths, the odds were lower among youths who were American Indian or Alaska Native (adjusted odds ratio [aOR], 0.45; Asian, Native Hawaiian, or Other Pacific Islander (aOR, 0.58); and Black youths (aOR, 0.62). And more than half of female youths who died by suicide had a mental health diagnosis (4429 youths [52.4%]), compared with 11,994 male youths (37.3%).
The researchers also found wide gaps by age, specifically lower odds of having a mental health diagnosis before suicide in children ages 10-14 compared with those 20-24.
“This finding is particularly notable because suicide rates have risen to become the second leading cause of death in youths aged 10 to 14 years,” the authors wrote. “Suicide prevention strategies for young children in primary care and community settings should focus on fostering resilience, promoting peer and family connectedness, and empowering children with strategies to cope with stress and adversity.”
Youths who died by firearm suicide, the most common mechanism, had the lowest rate of diagnosis. “Similar to a prior study, we found that decedents without a documented mental health diagnosis were far more likely to utilize a firearm than those with a documented mental health diagnosis,” the authors wrote.
In an invited commentary, Lisa M. Horowitz, PhD, MPH, with the Office of the Clinical Director, Intramural Research Program, National Institute of Mental Health, in Bethesda, Maryland, and colleagues wrote that the data show that identifying youth early who have mental disorders or are at-risk for suicide “is more the exception than the rule” in the United States.
The editorialists highlight that the study showed that about one-quarter of youths who have attempted suicide and nearly one-half of youths with depressed mood had no documented mental health diagnosis. Decedents were categorized with depressed mood if they were perceived by themselves or others as depressed at the time of death.
Intervention Recommendations
The study authors point to the high number of youth firearm suicide (the method used by nearly half of those who died — 19,027 (46.8%) and recommended interventions. “Suicide prevention strategies are needed for the estimated 22.6 million US children living in households with firearms, of whom 4.5 million are exposed to firearms stored loaded and unlocked,” they wrote.
A mental health diagnosis was documented for only 6308 of 19,027 youths who died by firearms (33.2%).
They noted that research has shown that more than 75% of guns used in youth suicide are owned by a family member, most commonly parents, and the presence of a firearm in the home is linked with a higher risk of youth suicide.
They wrote that the risk can be mitigated by storing all guns locked and unloaded, with ammunition stored and locked in a separate location.
The editorialists said the study highlights the need for action in several primary areas. “Suicide prevention strategies should not solely rely on a history of mental illness to identify at-risk youths, and universal suicide risk screening in healthcare settings deserves greater consideration,” they wrote.
Equitable access to care is essential to youth suicide risk detection. Interventions such as lethal means safety counseling, safety planning, and a helpline number, such as 988, should be accessible to every family and healthcare clinician.
Community-level interventions are critical, including school-based suicide prevention programs, as well as population-based training for families on the safe storage of lethal means at home.
“Every trusted adult working with children and adolescents can and should be trained to recognize the warning signs of suicide risk and help young people develop the coping strategies needed to manage difficult life experiences so that suicide is never an option,” Dr. Horowitz and colleagues wrote.
A coauthor of the study, Jennifer A. Hoffmann, MD, reports receiving grants from Children’s Research Fund Junior Board outside the submitted work. Another coauthor, Joel Fein, MD, reports fees for a patent owned by Children’s Hospital of Philadelphia licensed to Potential for the Behavioral Health Screen-Emergency Department. Among the editorialists, Jeffrey A. Bridge, PhD, reported grants from the National Institute of Mental Health, Patient Centered Outcomes Research Institute, and Centers for Disease Control and Prevention; and being a member of the Scientific Advisory Board of Clarigent Health and the Scientific Council of the American Foundation for Suicide Prevention outside the submitted work.
, according to a large analysis of Centers for Disease Control and Prevention data.
Sofia Chaudhary, MD, with the Department of Pediatrics and Emergency Medicine at Emory University School of Medicine in Atlanta, Georgia, and colleagues, analyzed data from the National Violent Death Reporting System and found in the cross-sectional study of 40, 618 youths that 24,192 (59.6%) had no such diagnosis previously. Findings were published online in JAMA Network Open.
Gaps by Race, Sex and Age
The odds of having a mental health diagnosis before death by suicide differed by race and sex. Compared with White youths, the odds were lower among youths who were American Indian or Alaska Native (adjusted odds ratio [aOR], 0.45; Asian, Native Hawaiian, or Other Pacific Islander (aOR, 0.58); and Black youths (aOR, 0.62). And more than half of female youths who died by suicide had a mental health diagnosis (4429 youths [52.4%]), compared with 11,994 male youths (37.3%).
The researchers also found wide gaps by age, specifically lower odds of having a mental health diagnosis before suicide in children ages 10-14 compared with those 20-24.
“This finding is particularly notable because suicide rates have risen to become the second leading cause of death in youths aged 10 to 14 years,” the authors wrote. “Suicide prevention strategies for young children in primary care and community settings should focus on fostering resilience, promoting peer and family connectedness, and empowering children with strategies to cope with stress and adversity.”
Youths who died by firearm suicide, the most common mechanism, had the lowest rate of diagnosis. “Similar to a prior study, we found that decedents without a documented mental health diagnosis were far more likely to utilize a firearm than those with a documented mental health diagnosis,” the authors wrote.
In an invited commentary, Lisa M. Horowitz, PhD, MPH, with the Office of the Clinical Director, Intramural Research Program, National Institute of Mental Health, in Bethesda, Maryland, and colleagues wrote that the data show that identifying youth early who have mental disorders or are at-risk for suicide “is more the exception than the rule” in the United States.
The editorialists highlight that the study showed that about one-quarter of youths who have attempted suicide and nearly one-half of youths with depressed mood had no documented mental health diagnosis. Decedents were categorized with depressed mood if they were perceived by themselves or others as depressed at the time of death.
Intervention Recommendations
The study authors point to the high number of youth firearm suicide (the method used by nearly half of those who died — 19,027 (46.8%) and recommended interventions. “Suicide prevention strategies are needed for the estimated 22.6 million US children living in households with firearms, of whom 4.5 million are exposed to firearms stored loaded and unlocked,” they wrote.
A mental health diagnosis was documented for only 6308 of 19,027 youths who died by firearms (33.2%).
They noted that research has shown that more than 75% of guns used in youth suicide are owned by a family member, most commonly parents, and the presence of a firearm in the home is linked with a higher risk of youth suicide.
They wrote that the risk can be mitigated by storing all guns locked and unloaded, with ammunition stored and locked in a separate location.
The editorialists said the study highlights the need for action in several primary areas. “Suicide prevention strategies should not solely rely on a history of mental illness to identify at-risk youths, and universal suicide risk screening in healthcare settings deserves greater consideration,” they wrote.
Equitable access to care is essential to youth suicide risk detection. Interventions such as lethal means safety counseling, safety planning, and a helpline number, such as 988, should be accessible to every family and healthcare clinician.
Community-level interventions are critical, including school-based suicide prevention programs, as well as population-based training for families on the safe storage of lethal means at home.
“Every trusted adult working with children and adolescents can and should be trained to recognize the warning signs of suicide risk and help young people develop the coping strategies needed to manage difficult life experiences so that suicide is never an option,” Dr. Horowitz and colleagues wrote.
A coauthor of the study, Jennifer A. Hoffmann, MD, reports receiving grants from Children’s Research Fund Junior Board outside the submitted work. Another coauthor, Joel Fein, MD, reports fees for a patent owned by Children’s Hospital of Philadelphia licensed to Potential for the Behavioral Health Screen-Emergency Department. Among the editorialists, Jeffrey A. Bridge, PhD, reported grants from the National Institute of Mental Health, Patient Centered Outcomes Research Institute, and Centers for Disease Control and Prevention; and being a member of the Scientific Advisory Board of Clarigent Health and the Scientific Council of the American Foundation for Suicide Prevention outside the submitted work.
FROM JAMA NETWORK OPEN
Psychiatric, Autoimmune Comorbidities Increased in Patients with Alopecia Areata
TOPLINE:
and were at greater risk of developing those comorbidities after diagnosis.
METHODOLOGY:
- Researchers evaluated 63,384 patients with AA and 3,309,107 individuals without AA (aged 12-64 years) from the Merative MarketScan Research Databases.
- The matched cohorts included 16,512 patients with AA and 66,048 control individuals.
- Outcomes were the prevalence of psychiatric and autoimmune diseases at baseline and the incidence of new-onset psychiatric and autoimmune diseases during the year after diagnosis.
TAKEAWAY:
- Overall, patients with AA showed a greater prevalence of any psychiatric disease (30.9% vs 26.8%; P < .001) and any immune-mediated or autoimmune disease (16.1% vs 8.9%; P < .0001) than those with controls.
- In matched cohorts, patients with AA also showed a higher incidence of any new-onset psychiatric diseases (10.2% vs 6.8%; P < .001) or immune-mediated or autoimmune disease (6.2% vs 1.5%; P <.001) within the first 12 months of AA diagnosis than those with controls.
- Among patients with AA, the risk of developing a psychiatric comorbidity was higher (adjusted hazard ratio [aHR], 1.3; 95% CI, 1.3-1.4). The highest risks were seen for adjustment disorder (aHR, 1.5), panic disorder (aHR, 1.4), and sexual dysfunction (aHR, 1.4).
- Compared with controls, patients with AA were also at an increased risk of developing immune-mediated or autoimmune comorbidities (aHR, 2.7; 95% CI, 2.5-2.8), with the highest for systemic lupus (aHR, 5.7), atopic dermatitis (aHR, 4.3), and vitiligo (aHR, 3.8).
IN PRACTICE:
“Routine monitoring of patients with AA, especially those at risk of developing comorbidities, may permit earlier and more effective intervention,” the authors wrote.
SOURCE:
The study was led by Arash Mostaghimi, MD, MPA, MPH, Brigham and Women’s Hospital and Harvard University, Boston. It was published online on July 31, 2024, in JAMA Dermatology.
LIMITATIONS:
Causality could not be inferred because of the retrospective nature of the study. Comorbidities were solely diagnosed on the basis of diagnostic codes, and researchers did not have access to characteristics such as lab values that could have indicated any underlying comorbidity before the AA diagnosis. This study also did not account for the varying levels of severity of the disease, which may have led to an underestimation of disease burden and the risk for comorbidities.
DISCLOSURES:
AbbVie provided funding for this study. Mostaghimi disclosed receiving personal fees from Abbvie and several other companies outside of this work. The other four authors were current or former employees of Abbvie and have or may have stock and/or stock options in AbbVie.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
and were at greater risk of developing those comorbidities after diagnosis.
METHODOLOGY:
- Researchers evaluated 63,384 patients with AA and 3,309,107 individuals without AA (aged 12-64 years) from the Merative MarketScan Research Databases.
- The matched cohorts included 16,512 patients with AA and 66,048 control individuals.
- Outcomes were the prevalence of psychiatric and autoimmune diseases at baseline and the incidence of new-onset psychiatric and autoimmune diseases during the year after diagnosis.
TAKEAWAY:
- Overall, patients with AA showed a greater prevalence of any psychiatric disease (30.9% vs 26.8%; P < .001) and any immune-mediated or autoimmune disease (16.1% vs 8.9%; P < .0001) than those with controls.
- In matched cohorts, patients with AA also showed a higher incidence of any new-onset psychiatric diseases (10.2% vs 6.8%; P < .001) or immune-mediated or autoimmune disease (6.2% vs 1.5%; P <.001) within the first 12 months of AA diagnosis than those with controls.
- Among patients with AA, the risk of developing a psychiatric comorbidity was higher (adjusted hazard ratio [aHR], 1.3; 95% CI, 1.3-1.4). The highest risks were seen for adjustment disorder (aHR, 1.5), panic disorder (aHR, 1.4), and sexual dysfunction (aHR, 1.4).
- Compared with controls, patients with AA were also at an increased risk of developing immune-mediated or autoimmune comorbidities (aHR, 2.7; 95% CI, 2.5-2.8), with the highest for systemic lupus (aHR, 5.7), atopic dermatitis (aHR, 4.3), and vitiligo (aHR, 3.8).
IN PRACTICE:
“Routine monitoring of patients with AA, especially those at risk of developing comorbidities, may permit earlier and more effective intervention,” the authors wrote.
SOURCE:
The study was led by Arash Mostaghimi, MD, MPA, MPH, Brigham and Women’s Hospital and Harvard University, Boston. It was published online on July 31, 2024, in JAMA Dermatology.
LIMITATIONS:
Causality could not be inferred because of the retrospective nature of the study. Comorbidities were solely diagnosed on the basis of diagnostic codes, and researchers did not have access to characteristics such as lab values that could have indicated any underlying comorbidity before the AA diagnosis. This study also did not account for the varying levels of severity of the disease, which may have led to an underestimation of disease burden and the risk for comorbidities.
DISCLOSURES:
AbbVie provided funding for this study. Mostaghimi disclosed receiving personal fees from Abbvie and several other companies outside of this work. The other four authors were current or former employees of Abbvie and have or may have stock and/or stock options in AbbVie.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
and were at greater risk of developing those comorbidities after diagnosis.
METHODOLOGY:
- Researchers evaluated 63,384 patients with AA and 3,309,107 individuals without AA (aged 12-64 years) from the Merative MarketScan Research Databases.
- The matched cohorts included 16,512 patients with AA and 66,048 control individuals.
- Outcomes were the prevalence of psychiatric and autoimmune diseases at baseline and the incidence of new-onset psychiatric and autoimmune diseases during the year after diagnosis.
TAKEAWAY:
- Overall, patients with AA showed a greater prevalence of any psychiatric disease (30.9% vs 26.8%; P < .001) and any immune-mediated or autoimmune disease (16.1% vs 8.9%; P < .0001) than those with controls.
- In matched cohorts, patients with AA also showed a higher incidence of any new-onset psychiatric diseases (10.2% vs 6.8%; P < .001) or immune-mediated or autoimmune disease (6.2% vs 1.5%; P <.001) within the first 12 months of AA diagnosis than those with controls.
- Among patients with AA, the risk of developing a psychiatric comorbidity was higher (adjusted hazard ratio [aHR], 1.3; 95% CI, 1.3-1.4). The highest risks were seen for adjustment disorder (aHR, 1.5), panic disorder (aHR, 1.4), and sexual dysfunction (aHR, 1.4).
- Compared with controls, patients with AA were also at an increased risk of developing immune-mediated or autoimmune comorbidities (aHR, 2.7; 95% CI, 2.5-2.8), with the highest for systemic lupus (aHR, 5.7), atopic dermatitis (aHR, 4.3), and vitiligo (aHR, 3.8).
IN PRACTICE:
“Routine monitoring of patients with AA, especially those at risk of developing comorbidities, may permit earlier and more effective intervention,” the authors wrote.
SOURCE:
The study was led by Arash Mostaghimi, MD, MPA, MPH, Brigham and Women’s Hospital and Harvard University, Boston. It was published online on July 31, 2024, in JAMA Dermatology.
LIMITATIONS:
Causality could not be inferred because of the retrospective nature of the study. Comorbidities were solely diagnosed on the basis of diagnostic codes, and researchers did not have access to characteristics such as lab values that could have indicated any underlying comorbidity before the AA diagnosis. This study also did not account for the varying levels of severity of the disease, which may have led to an underestimation of disease burden and the risk for comorbidities.
DISCLOSURES:
AbbVie provided funding for this study. Mostaghimi disclosed receiving personal fees from Abbvie and several other companies outside of this work. The other four authors were current or former employees of Abbvie and have or may have stock and/or stock options in AbbVie.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
Government Accuses Health System of Paying Docs Outrageous Salaries for Patient Referrals
Strapped for cash and searching for new profits, Tennessee-based Erlanger Health System illegally paid excessive salaries to physicians in exchange for patient referrals, the US government alleged in a federal lawsuit.
Erlanger changed its compensation model to entice revenue-generating doctors, paying some two to three times the median salary for their specialty, according to the complaint.
The physicians in turn referred numerous patients to Erlanger, and the health system submitted claims to Medicare for the referred services in violation of the Stark Law, according to the suit, filed in US District Court for the Western District of North Carolina.
The government’s complaint “serves as a warning” to healthcare providers who try to boost profits through improper financial arrangements with referring physicians, said Tamala E. Miles, Special Agent in Charge for the US Department of Health and Human Services (HHS) Office of Inspector General (OIG).
In a statement provided to this news organization, Erlanger denied the allegations and said it would “vigorously” defend the lawsuit.
“Erlanger paid physicians based on amounts that outside experts advised was fair market value,” Erlanger officials said in the statement. “Erlanger did not pay for referrals. A complete picture of the facts will demonstrate that the allegations lack merit and tell a very different story than what the government now claims.”
The Erlanger case is a reminder to physicians to consult their own knowledgeable advisors when considering financial arrangements with hospitals, said William Sarraille, JD, adjunct professor for the University of Maryland Francis King Carey School of Law in Baltimore and a regulatory consultant.
“There is a tendency by physicians when contracting ... to rely on [hospitals’] perceived compliance and legal expertise,” Mr. Sarraille told this news organization. “This case illustrates the risks in doing so. Sometimes bigger doesn’t translate into more sophisticated or more effective from a compliance perspective.”
Stark Law Prohibits Kickbacks
The Stark Law prohibits hospitals from billing the Centers for Medicare & Medicaid Services (CMS) for services referred by a physician with whom the hospital has an improper financial relationship.
CMS paid Erlanger about $27.8 million for claims stemming from the improper financial arrangements, the government contends.
“HHS-OIG will continue to investigate such deals to prevent financial arrangements that could compromise impartial medical judgment, increase healthcare costs, and erode public trust in the healthcare system,” Ms. Miles said in a statement.
Suit: Health System’s Money Woes Led to Illegal Arrangements
Erlanger’s financial troubles allegedly started after a previous run-in with the US government over false claims.
In 2005, Erlanger Health System agreed to pay the government $40 million to resolve allegations that it knowingly submitted false claims to Medicare, according to the government’s complaint. At the time, Erlanger entered into a Corporate Integrity Agreement (CIA) with the OIG that required Erlanger to put controls in place to ensure its financial relationships did not violate the Stark Law.
Erlanger’s agreement with OIG ended in 2010. Over the next 3 years, the health system lost nearly $32 million and in fiscal year 2013, had only 65 days of cash on hand, according to the government’s lawsuit.
Beginning in 2013, Erlanger allegedly implemented a strategy to increase profits by employing more physicians, particularly specialists from competing hospitals whose patients would need costly hospital stays, according to the complaint.
Once hired, Erlanger’s physicians were expected to treat patients at Erlanger’s hospitals and refer them to other providers within the health system, the suit claims. Erlanger also relaxed or eliminated the oversight and controls on physician compensation put in place under the CIA. For example, Erlanger’s CEO signed some compensation contracts before its chief compliance officer could review them and no longer allowed the compliance officer to vote on whether to approve compensation arrangements, according to the complaint.
Erlanger also changed its compensation model to include large salaries for medical director and academic positions and allegedly paid such salaries to physicians without ensuring the required work was performed. As a result, Erlanger physicians with profitable referrals were among the highest paid in the nation for their specialties, the government claims. For example, according to the complaint:
- Erlanger paid an electrophysiologist an annual clinical salary of $816,701, a medical director salary of $101,080, an academic salary of $59,322, and a productivity incentive based on work relative value units (wRVUs). The medical director and academic salaries paid were near the 90th percentile of comparable salaries in the specialty.
- The health system paid a neurosurgeon a base salary of $654,735, a productivity incentive based on wRVUs, and payments for excess call coverage ranging from $400 to $1000 per 24-hour shift. In 2016, the neurosurgeon made $500,000 in excess call payments.
- Erlanger paid a cardiothoracic surgeon a base clinical salary of $1,070,000, a sign-on bonus of $150,000, a retention bonus of $100,000 (payable in the 4th year of the contract), and a program incentive of up to $150,000 per year.
In addition, Erlanger ignored patient safety concerns about some of its high revenue-generating physicians, the government claims.
For instance, Erlanger received multiple complaints that a cardiothoracic surgeon was misusing an expensive form of life support in which pumps and oxygenators take over heart and lung function. Overuse of the equipment prolonged patients’ hospital stays and increased the hospital fees generated by the surgeon, according to the complaint. Staff also raised concerns about the cardiothoracic surgeon’s patient outcomes.
But Erlanger disregarded the concerns and in 2018, increased the cardiothoracic surgeon’s retention bonus from $100,000 to $250,000, the suit alleges. A year later, the health system increased his base salary from $1,070,000 to $1,195,000.
Health care compensation and billing consultants alerted Erlanger that it was overpaying salaries and handing out bonuses based on measures that overstated the work physicians were performing, but Erlanger ignored the warnings, according to the complaint.
Administrators allegedly resisted efforts by the chief compliance officer to hire an outside consultant to review its compensation models. Erlanger fired the compliance officer in 2019.
The former chief compliance officer and another administrator filed a whistleblower lawsuit against Erlanger in 2021. The two administrators are relators in the government’s July 2024 lawsuit.
How to Protect Yourself From Illegal Hospital Deals
The Erlanger case is the latest in a series of recent complaints by the federal government involving financial arrangements between hospitals and physicians.
In December 2023, Indianapolis-based Community Health Network Inc. agreed to pay the government $345 million to resolve claims that it paid physicians above fair market value and awarded bonuses tied to referrals in violation of the Stark Law.
Also in 2023, Saginaw, Michigan–based Covenant HealthCare and two physicians paid the government $69 million to settle allegations that administrators engaged in improper financial arrangements with referring physicians and a physician-owned investment group. In another 2023 case, Massachusetts Eye and Ear in Boston agreed to pay $5.7 million to resolve claims that some of its physician compensation plans violated the Stark Law.
Before you enter into a financial arrangement with a hospital, it’s also important to examine what percentile the aggregate compensation would reflect, law professor Mr. Sarraille said. The Erlanger case highlights federal officials’ suspicion of compensation, in aggregate, that exceeds the 90th percentile and increased attention to compensation that exceeds the 75th percentile, he said.
To research compensation levels, doctors can review the Medical Group Management Association’s annual compensation report or search its compensation data.
Before signing any contracts, Mr. Sarraille suggests, physicians should also consider whether the hospital shares the same values. Ask physicians at the hospital what they have to say about the hospital’s culture, vision, and values. Have physicians left the hospital after their practices were acquired? Consider speaking with them to learn why.
Keep in mind that a doctor’s reputation could be impacted by a compliance complaint, regardless of whether it’s directed at the hospital and not the employed physician, Mr. Sarraille said.
“The [Erlanger] complaint focuses on the compensation of specific, named physicians saying they were wildly overcompensated,” he said. “The implication is that they sold their referral power in exchange for a pay day. It’s a bad look, no matter how the case evolves from here.”
Physicians could also face their own liability risk under the Stark Law and False Claims Act, depending on the circumstances. In the event of related quality-of-care issues, medical liability could come into play, Mr. Sarraille noted. In such cases, plaintiffs’ attorneys may see an opportunity to boost their claims with allegations that the patient harm was a function of “chasing compensation dollars,” Mr. Sarraille said.
“Where that happens, plaintiff lawyers see the potential for crippling punitive damages, which might not be covered by an insurer,” he said.
A version of this article appeared on Medscape.com.
Strapped for cash and searching for new profits, Tennessee-based Erlanger Health System illegally paid excessive salaries to physicians in exchange for patient referrals, the US government alleged in a federal lawsuit.
Erlanger changed its compensation model to entice revenue-generating doctors, paying some two to three times the median salary for their specialty, according to the complaint.
The physicians in turn referred numerous patients to Erlanger, and the health system submitted claims to Medicare for the referred services in violation of the Stark Law, according to the suit, filed in US District Court for the Western District of North Carolina.
The government’s complaint “serves as a warning” to healthcare providers who try to boost profits through improper financial arrangements with referring physicians, said Tamala E. Miles, Special Agent in Charge for the US Department of Health and Human Services (HHS) Office of Inspector General (OIG).
In a statement provided to this news organization, Erlanger denied the allegations and said it would “vigorously” defend the lawsuit.
“Erlanger paid physicians based on amounts that outside experts advised was fair market value,” Erlanger officials said in the statement. “Erlanger did not pay for referrals. A complete picture of the facts will demonstrate that the allegations lack merit and tell a very different story than what the government now claims.”
The Erlanger case is a reminder to physicians to consult their own knowledgeable advisors when considering financial arrangements with hospitals, said William Sarraille, JD, adjunct professor for the University of Maryland Francis King Carey School of Law in Baltimore and a regulatory consultant.
“There is a tendency by physicians when contracting ... to rely on [hospitals’] perceived compliance and legal expertise,” Mr. Sarraille told this news organization. “This case illustrates the risks in doing so. Sometimes bigger doesn’t translate into more sophisticated or more effective from a compliance perspective.”
Stark Law Prohibits Kickbacks
The Stark Law prohibits hospitals from billing the Centers for Medicare & Medicaid Services (CMS) for services referred by a physician with whom the hospital has an improper financial relationship.
CMS paid Erlanger about $27.8 million for claims stemming from the improper financial arrangements, the government contends.
“HHS-OIG will continue to investigate such deals to prevent financial arrangements that could compromise impartial medical judgment, increase healthcare costs, and erode public trust in the healthcare system,” Ms. Miles said in a statement.
Suit: Health System’s Money Woes Led to Illegal Arrangements
Erlanger’s financial troubles allegedly started after a previous run-in with the US government over false claims.
In 2005, Erlanger Health System agreed to pay the government $40 million to resolve allegations that it knowingly submitted false claims to Medicare, according to the government’s complaint. At the time, Erlanger entered into a Corporate Integrity Agreement (CIA) with the OIG that required Erlanger to put controls in place to ensure its financial relationships did not violate the Stark Law.
Erlanger’s agreement with OIG ended in 2010. Over the next 3 years, the health system lost nearly $32 million and in fiscal year 2013, had only 65 days of cash on hand, according to the government’s lawsuit.
Beginning in 2013, Erlanger allegedly implemented a strategy to increase profits by employing more physicians, particularly specialists from competing hospitals whose patients would need costly hospital stays, according to the complaint.
Once hired, Erlanger’s physicians were expected to treat patients at Erlanger’s hospitals and refer them to other providers within the health system, the suit claims. Erlanger also relaxed or eliminated the oversight and controls on physician compensation put in place under the CIA. For example, Erlanger’s CEO signed some compensation contracts before its chief compliance officer could review them and no longer allowed the compliance officer to vote on whether to approve compensation arrangements, according to the complaint.
Erlanger also changed its compensation model to include large salaries for medical director and academic positions and allegedly paid such salaries to physicians without ensuring the required work was performed. As a result, Erlanger physicians with profitable referrals were among the highest paid in the nation for their specialties, the government claims. For example, according to the complaint:
- Erlanger paid an electrophysiologist an annual clinical salary of $816,701, a medical director salary of $101,080, an academic salary of $59,322, and a productivity incentive based on work relative value units (wRVUs). The medical director and academic salaries paid were near the 90th percentile of comparable salaries in the specialty.
- The health system paid a neurosurgeon a base salary of $654,735, a productivity incentive based on wRVUs, and payments for excess call coverage ranging from $400 to $1000 per 24-hour shift. In 2016, the neurosurgeon made $500,000 in excess call payments.
- Erlanger paid a cardiothoracic surgeon a base clinical salary of $1,070,000, a sign-on bonus of $150,000, a retention bonus of $100,000 (payable in the 4th year of the contract), and a program incentive of up to $150,000 per year.
In addition, Erlanger ignored patient safety concerns about some of its high revenue-generating physicians, the government claims.
For instance, Erlanger received multiple complaints that a cardiothoracic surgeon was misusing an expensive form of life support in which pumps and oxygenators take over heart and lung function. Overuse of the equipment prolonged patients’ hospital stays and increased the hospital fees generated by the surgeon, according to the complaint. Staff also raised concerns about the cardiothoracic surgeon’s patient outcomes.
But Erlanger disregarded the concerns and in 2018, increased the cardiothoracic surgeon’s retention bonus from $100,000 to $250,000, the suit alleges. A year later, the health system increased his base salary from $1,070,000 to $1,195,000.
Health care compensation and billing consultants alerted Erlanger that it was overpaying salaries and handing out bonuses based on measures that overstated the work physicians were performing, but Erlanger ignored the warnings, according to the complaint.
Administrators allegedly resisted efforts by the chief compliance officer to hire an outside consultant to review its compensation models. Erlanger fired the compliance officer in 2019.
The former chief compliance officer and another administrator filed a whistleblower lawsuit against Erlanger in 2021. The two administrators are relators in the government’s July 2024 lawsuit.
How to Protect Yourself From Illegal Hospital Deals
The Erlanger case is the latest in a series of recent complaints by the federal government involving financial arrangements between hospitals and physicians.
In December 2023, Indianapolis-based Community Health Network Inc. agreed to pay the government $345 million to resolve claims that it paid physicians above fair market value and awarded bonuses tied to referrals in violation of the Stark Law.
Also in 2023, Saginaw, Michigan–based Covenant HealthCare and two physicians paid the government $69 million to settle allegations that administrators engaged in improper financial arrangements with referring physicians and a physician-owned investment group. In another 2023 case, Massachusetts Eye and Ear in Boston agreed to pay $5.7 million to resolve claims that some of its physician compensation plans violated the Stark Law.
Before you enter into a financial arrangement with a hospital, it’s also important to examine what percentile the aggregate compensation would reflect, law professor Mr. Sarraille said. The Erlanger case highlights federal officials’ suspicion of compensation, in aggregate, that exceeds the 90th percentile and increased attention to compensation that exceeds the 75th percentile, he said.
To research compensation levels, doctors can review the Medical Group Management Association’s annual compensation report or search its compensation data.
Before signing any contracts, Mr. Sarraille suggests, physicians should also consider whether the hospital shares the same values. Ask physicians at the hospital what they have to say about the hospital’s culture, vision, and values. Have physicians left the hospital after their practices were acquired? Consider speaking with them to learn why.
Keep in mind that a doctor’s reputation could be impacted by a compliance complaint, regardless of whether it’s directed at the hospital and not the employed physician, Mr. Sarraille said.
“The [Erlanger] complaint focuses on the compensation of specific, named physicians saying they were wildly overcompensated,” he said. “The implication is that they sold their referral power in exchange for a pay day. It’s a bad look, no matter how the case evolves from here.”
Physicians could also face their own liability risk under the Stark Law and False Claims Act, depending on the circumstances. In the event of related quality-of-care issues, medical liability could come into play, Mr. Sarraille noted. In such cases, plaintiffs’ attorneys may see an opportunity to boost their claims with allegations that the patient harm was a function of “chasing compensation dollars,” Mr. Sarraille said.
“Where that happens, plaintiff lawyers see the potential for crippling punitive damages, which might not be covered by an insurer,” he said.
A version of this article appeared on Medscape.com.
Strapped for cash and searching for new profits, Tennessee-based Erlanger Health System illegally paid excessive salaries to physicians in exchange for patient referrals, the US government alleged in a federal lawsuit.
Erlanger changed its compensation model to entice revenue-generating doctors, paying some two to three times the median salary for their specialty, according to the complaint.
The physicians in turn referred numerous patients to Erlanger, and the health system submitted claims to Medicare for the referred services in violation of the Stark Law, according to the suit, filed in US District Court for the Western District of North Carolina.
The government’s complaint “serves as a warning” to healthcare providers who try to boost profits through improper financial arrangements with referring physicians, said Tamala E. Miles, Special Agent in Charge for the US Department of Health and Human Services (HHS) Office of Inspector General (OIG).
In a statement provided to this news organization, Erlanger denied the allegations and said it would “vigorously” defend the lawsuit.
“Erlanger paid physicians based on amounts that outside experts advised was fair market value,” Erlanger officials said in the statement. “Erlanger did not pay for referrals. A complete picture of the facts will demonstrate that the allegations lack merit and tell a very different story than what the government now claims.”
The Erlanger case is a reminder to physicians to consult their own knowledgeable advisors when considering financial arrangements with hospitals, said William Sarraille, JD, adjunct professor for the University of Maryland Francis King Carey School of Law in Baltimore and a regulatory consultant.
“There is a tendency by physicians when contracting ... to rely on [hospitals’] perceived compliance and legal expertise,” Mr. Sarraille told this news organization. “This case illustrates the risks in doing so. Sometimes bigger doesn’t translate into more sophisticated or more effective from a compliance perspective.”
Stark Law Prohibits Kickbacks
The Stark Law prohibits hospitals from billing the Centers for Medicare & Medicaid Services (CMS) for services referred by a physician with whom the hospital has an improper financial relationship.
CMS paid Erlanger about $27.8 million for claims stemming from the improper financial arrangements, the government contends.
“HHS-OIG will continue to investigate such deals to prevent financial arrangements that could compromise impartial medical judgment, increase healthcare costs, and erode public trust in the healthcare system,” Ms. Miles said in a statement.
Suit: Health System’s Money Woes Led to Illegal Arrangements
Erlanger’s financial troubles allegedly started after a previous run-in with the US government over false claims.
In 2005, Erlanger Health System agreed to pay the government $40 million to resolve allegations that it knowingly submitted false claims to Medicare, according to the government’s complaint. At the time, Erlanger entered into a Corporate Integrity Agreement (CIA) with the OIG that required Erlanger to put controls in place to ensure its financial relationships did not violate the Stark Law.
Erlanger’s agreement with OIG ended in 2010. Over the next 3 years, the health system lost nearly $32 million and in fiscal year 2013, had only 65 days of cash on hand, according to the government’s lawsuit.
Beginning in 2013, Erlanger allegedly implemented a strategy to increase profits by employing more physicians, particularly specialists from competing hospitals whose patients would need costly hospital stays, according to the complaint.
Once hired, Erlanger’s physicians were expected to treat patients at Erlanger’s hospitals and refer them to other providers within the health system, the suit claims. Erlanger also relaxed or eliminated the oversight and controls on physician compensation put in place under the CIA. For example, Erlanger’s CEO signed some compensation contracts before its chief compliance officer could review them and no longer allowed the compliance officer to vote on whether to approve compensation arrangements, according to the complaint.
Erlanger also changed its compensation model to include large salaries for medical director and academic positions and allegedly paid such salaries to physicians without ensuring the required work was performed. As a result, Erlanger physicians with profitable referrals were among the highest paid in the nation for their specialties, the government claims. For example, according to the complaint:
- Erlanger paid an electrophysiologist an annual clinical salary of $816,701, a medical director salary of $101,080, an academic salary of $59,322, and a productivity incentive based on work relative value units (wRVUs). The medical director and academic salaries paid were near the 90th percentile of comparable salaries in the specialty.
- The health system paid a neurosurgeon a base salary of $654,735, a productivity incentive based on wRVUs, and payments for excess call coverage ranging from $400 to $1000 per 24-hour shift. In 2016, the neurosurgeon made $500,000 in excess call payments.
- Erlanger paid a cardiothoracic surgeon a base clinical salary of $1,070,000, a sign-on bonus of $150,000, a retention bonus of $100,000 (payable in the 4th year of the contract), and a program incentive of up to $150,000 per year.
In addition, Erlanger ignored patient safety concerns about some of its high revenue-generating physicians, the government claims.
For instance, Erlanger received multiple complaints that a cardiothoracic surgeon was misusing an expensive form of life support in which pumps and oxygenators take over heart and lung function. Overuse of the equipment prolonged patients’ hospital stays and increased the hospital fees generated by the surgeon, according to the complaint. Staff also raised concerns about the cardiothoracic surgeon’s patient outcomes.
But Erlanger disregarded the concerns and in 2018, increased the cardiothoracic surgeon’s retention bonus from $100,000 to $250,000, the suit alleges. A year later, the health system increased his base salary from $1,070,000 to $1,195,000.
Health care compensation and billing consultants alerted Erlanger that it was overpaying salaries and handing out bonuses based on measures that overstated the work physicians were performing, but Erlanger ignored the warnings, according to the complaint.
Administrators allegedly resisted efforts by the chief compliance officer to hire an outside consultant to review its compensation models. Erlanger fired the compliance officer in 2019.
The former chief compliance officer and another administrator filed a whistleblower lawsuit against Erlanger in 2021. The two administrators are relators in the government’s July 2024 lawsuit.
How to Protect Yourself From Illegal Hospital Deals
The Erlanger case is the latest in a series of recent complaints by the federal government involving financial arrangements between hospitals and physicians.
In December 2023, Indianapolis-based Community Health Network Inc. agreed to pay the government $345 million to resolve claims that it paid physicians above fair market value and awarded bonuses tied to referrals in violation of the Stark Law.
Also in 2023, Saginaw, Michigan–based Covenant HealthCare and two physicians paid the government $69 million to settle allegations that administrators engaged in improper financial arrangements with referring physicians and a physician-owned investment group. In another 2023 case, Massachusetts Eye and Ear in Boston agreed to pay $5.7 million to resolve claims that some of its physician compensation plans violated the Stark Law.
Before you enter into a financial arrangement with a hospital, it’s also important to examine what percentile the aggregate compensation would reflect, law professor Mr. Sarraille said. The Erlanger case highlights federal officials’ suspicion of compensation, in aggregate, that exceeds the 90th percentile and increased attention to compensation that exceeds the 75th percentile, he said.
To research compensation levels, doctors can review the Medical Group Management Association’s annual compensation report or search its compensation data.
Before signing any contracts, Mr. Sarraille suggests, physicians should also consider whether the hospital shares the same values. Ask physicians at the hospital what they have to say about the hospital’s culture, vision, and values. Have physicians left the hospital after their practices were acquired? Consider speaking with them to learn why.
Keep in mind that a doctor’s reputation could be impacted by a compliance complaint, regardless of whether it’s directed at the hospital and not the employed physician, Mr. Sarraille said.
“The [Erlanger] complaint focuses on the compensation of specific, named physicians saying they were wildly overcompensated,” he said. “The implication is that they sold their referral power in exchange for a pay day. It’s a bad look, no matter how the case evolves from here.”
Physicians could also face their own liability risk under the Stark Law and False Claims Act, depending on the circumstances. In the event of related quality-of-care issues, medical liability could come into play, Mr. Sarraille noted. In such cases, plaintiffs’ attorneys may see an opportunity to boost their claims with allegations that the patient harm was a function of “chasing compensation dollars,” Mr. Sarraille said.
“Where that happens, plaintiff lawyers see the potential for crippling punitive damages, which might not be covered by an insurer,” he said.
A version of this article appeared on Medscape.com.
SUNY Downstate Emergency Medicine Doc Charged With $1.5M Fraud
In a case that spotlights the importance of comprehensive financial controls in medical offices,
Michael Lucchesi, MD, who had served as chairman of Emergency Medicine at SUNY Downstate Medical Center in New York City, was arraigned on July 9 and pleaded not guilty. Dr. Lucchesi’s attorney, Earl Ward, did not respond to messages from this news organization, but he told the New York Post that “the funds he used were not stolen funds.”
Dr. Lucchesi, who’s in his late 60s, faces nine counts of first- and second-degree grand larceny, first-degree falsifying business records, and third-degree criminal tax fraud. According to a press statement from the district attorney of Kings County, which encompasses the borough of Brooklyn, Dr. Lucchesi is accused of using his clinical practice’s business card for cash advances (about $115,000), high-end pet care ($176,000), personal travel ($348,000), gym membership and personal training ($109,000), catering ($52,000), tuition payments for his children ($46,000), and other expenses such as online shopping, flowers, liquor, and electronics.
Most of the alleged pet care spending — $120,000 — went to the Green Leaf Pet Resort, which has two locations in New Jersey, including one with “56 acres of nature and lots of tail wagging.” Some of the alleged spending on gym membership was at the New York Sports Clubs chain, where monthly membership tops out at $139.99.
The alleged spending occurred between 2016 and 2023 and was discovered by SUNY Downstate during an audit. Dr. Lucchesi reportedly left his position at the hospital, where he made $399,712 in 2022 as a professor, according to public records.
“As a high-ranking doctor at this vital healthcare institution, this defendant was entrusted with access to significant funds, which he allegedly exploited, stealing more than 1 million dollars to pay for a lavish lifestyle,” District Attorney Eric Gonzalez said in a statement.
SUNY Downstate is in a fight for its life amid efforts by New York Governor Kathy Hochul to shut it down. According to The New York Times, it is the only state-run hospital in New York City.
Dr. Lucchesi, who had previously served as the hospital’s chief medical officer and acting head, was released without bail. His next court date is September 25, 2024.
Size of Alleged Theft Is ‘Very Unusual’
David P. Weber, JD, DBA, a professor and fraud specialist at Salisbury University, Salisbury, Maryland, told this news organization that the fraudulent use of a business or purchase credit card is a form of embezzlement and “one of the most frequently seen types of frauds against organizations.”
William J. Kresse, JD, MSA, CPA/CFF, who studies fraud at Governors State University in University Park, Illinois, noted in an interview with this news organization that the high amount of alleged fraud in this case is “very unusual,” as is the period it is said to have occurred (over 6 years).
Mr. Kresse highlighted a 2024 report by the Association of Certified Fraud Examiners, which found that the median fraud loss in healthcare, on the basis of 117 cases, is $100,000. The most common form of fraud in the industry is corruption (47%), followed by billing (38%), noncash theft such as inventory (22%), and expense reimbursement (21%).
The details of the current case suggest that “SUNY Downstate had weak or insufficient internal controls to prevent this type of fraud,” Salisbury University’s Mr. Weber said. “However, research also makes clear that the tenure and position of the perpetrator play a significant role in the size of the fraud. Internal controls are supposed to apply to all employees, but the higher in the organization the perpetrator is, the easier it can be to engage in fraud.”
Even Small Medical Offices Can Act to Prevent Fraud
What can be done to prevent this kind of fraud? “Each employee should be required to submit actual receipts or scanned copies, and the reimbursement requests should be reviewed and inputted by a separate department or office of the organization to ensure that the expenses are legitimate,” Mr. Weber said. “In addition, all credit card statements should be available for review by the organization either simultaneously with the bill going to the employee or available for audit or review at any time without notification to the employee. Expenses that are in certain categories should be prohibited automatically and coded to the card so such a charge is rejected by the credit card bank.”
Smaller businesses — like many medical practices — may not have the manpower to handle these roles. In that case, Mr. Weber said, “The key is segregation or separation of duties. The bookkeeper cannot be the person receiving the bank statements, the payments from patients, and the invoices from vendors. There needs to be at least one other person in the loop to have some level of control.”
One strategy, he said, “is that the practice should institute a policy that only the doctor or owner of the practice can receive the mail, not the bookkeeper. Even if the practice leader does not actually review the bank statements, simply opening them before handing them off to the bookkeeper can provide a level of deterrence [since] the employee may get caught if someone else is reviewing the bank statements.”
A version of this article first appeared on Medscape.com.
In a case that spotlights the importance of comprehensive financial controls in medical offices,
Michael Lucchesi, MD, who had served as chairman of Emergency Medicine at SUNY Downstate Medical Center in New York City, was arraigned on July 9 and pleaded not guilty. Dr. Lucchesi’s attorney, Earl Ward, did not respond to messages from this news organization, but he told the New York Post that “the funds he used were not stolen funds.”
Dr. Lucchesi, who’s in his late 60s, faces nine counts of first- and second-degree grand larceny, first-degree falsifying business records, and third-degree criminal tax fraud. According to a press statement from the district attorney of Kings County, which encompasses the borough of Brooklyn, Dr. Lucchesi is accused of using his clinical practice’s business card for cash advances (about $115,000), high-end pet care ($176,000), personal travel ($348,000), gym membership and personal training ($109,000), catering ($52,000), tuition payments for his children ($46,000), and other expenses such as online shopping, flowers, liquor, and electronics.
Most of the alleged pet care spending — $120,000 — went to the Green Leaf Pet Resort, which has two locations in New Jersey, including one with “56 acres of nature and lots of tail wagging.” Some of the alleged spending on gym membership was at the New York Sports Clubs chain, where monthly membership tops out at $139.99.
The alleged spending occurred between 2016 and 2023 and was discovered by SUNY Downstate during an audit. Dr. Lucchesi reportedly left his position at the hospital, where he made $399,712 in 2022 as a professor, according to public records.
“As a high-ranking doctor at this vital healthcare institution, this defendant was entrusted with access to significant funds, which he allegedly exploited, stealing more than 1 million dollars to pay for a lavish lifestyle,” District Attorney Eric Gonzalez said in a statement.
SUNY Downstate is in a fight for its life amid efforts by New York Governor Kathy Hochul to shut it down. According to The New York Times, it is the only state-run hospital in New York City.
Dr. Lucchesi, who had previously served as the hospital’s chief medical officer and acting head, was released without bail. His next court date is September 25, 2024.
Size of Alleged Theft Is ‘Very Unusual’
David P. Weber, JD, DBA, a professor and fraud specialist at Salisbury University, Salisbury, Maryland, told this news organization that the fraudulent use of a business or purchase credit card is a form of embezzlement and “one of the most frequently seen types of frauds against organizations.”
William J. Kresse, JD, MSA, CPA/CFF, who studies fraud at Governors State University in University Park, Illinois, noted in an interview with this news organization that the high amount of alleged fraud in this case is “very unusual,” as is the period it is said to have occurred (over 6 years).
Mr. Kresse highlighted a 2024 report by the Association of Certified Fraud Examiners, which found that the median fraud loss in healthcare, on the basis of 117 cases, is $100,000. The most common form of fraud in the industry is corruption (47%), followed by billing (38%), noncash theft such as inventory (22%), and expense reimbursement (21%).
The details of the current case suggest that “SUNY Downstate had weak or insufficient internal controls to prevent this type of fraud,” Salisbury University’s Mr. Weber said. “However, research also makes clear that the tenure and position of the perpetrator play a significant role in the size of the fraud. Internal controls are supposed to apply to all employees, but the higher in the organization the perpetrator is, the easier it can be to engage in fraud.”
Even Small Medical Offices Can Act to Prevent Fraud
What can be done to prevent this kind of fraud? “Each employee should be required to submit actual receipts or scanned copies, and the reimbursement requests should be reviewed and inputted by a separate department or office of the organization to ensure that the expenses are legitimate,” Mr. Weber said. “In addition, all credit card statements should be available for review by the organization either simultaneously with the bill going to the employee or available for audit or review at any time without notification to the employee. Expenses that are in certain categories should be prohibited automatically and coded to the card so such a charge is rejected by the credit card bank.”
Smaller businesses — like many medical practices — may not have the manpower to handle these roles. In that case, Mr. Weber said, “The key is segregation or separation of duties. The bookkeeper cannot be the person receiving the bank statements, the payments from patients, and the invoices from vendors. There needs to be at least one other person in the loop to have some level of control.”
One strategy, he said, “is that the practice should institute a policy that only the doctor or owner of the practice can receive the mail, not the bookkeeper. Even if the practice leader does not actually review the bank statements, simply opening them before handing them off to the bookkeeper can provide a level of deterrence [since] the employee may get caught if someone else is reviewing the bank statements.”
A version of this article first appeared on Medscape.com.
In a case that spotlights the importance of comprehensive financial controls in medical offices,
Michael Lucchesi, MD, who had served as chairman of Emergency Medicine at SUNY Downstate Medical Center in New York City, was arraigned on July 9 and pleaded not guilty. Dr. Lucchesi’s attorney, Earl Ward, did not respond to messages from this news organization, but he told the New York Post that “the funds he used were not stolen funds.”
Dr. Lucchesi, who’s in his late 60s, faces nine counts of first- and second-degree grand larceny, first-degree falsifying business records, and third-degree criminal tax fraud. According to a press statement from the district attorney of Kings County, which encompasses the borough of Brooklyn, Dr. Lucchesi is accused of using his clinical practice’s business card for cash advances (about $115,000), high-end pet care ($176,000), personal travel ($348,000), gym membership and personal training ($109,000), catering ($52,000), tuition payments for his children ($46,000), and other expenses such as online shopping, flowers, liquor, and electronics.
Most of the alleged pet care spending — $120,000 — went to the Green Leaf Pet Resort, which has two locations in New Jersey, including one with “56 acres of nature and lots of tail wagging.” Some of the alleged spending on gym membership was at the New York Sports Clubs chain, where monthly membership tops out at $139.99.
The alleged spending occurred between 2016 and 2023 and was discovered by SUNY Downstate during an audit. Dr. Lucchesi reportedly left his position at the hospital, where he made $399,712 in 2022 as a professor, according to public records.
“As a high-ranking doctor at this vital healthcare institution, this defendant was entrusted with access to significant funds, which he allegedly exploited, stealing more than 1 million dollars to pay for a lavish lifestyle,” District Attorney Eric Gonzalez said in a statement.
SUNY Downstate is in a fight for its life amid efforts by New York Governor Kathy Hochul to shut it down. According to The New York Times, it is the only state-run hospital in New York City.
Dr. Lucchesi, who had previously served as the hospital’s chief medical officer and acting head, was released without bail. His next court date is September 25, 2024.
Size of Alleged Theft Is ‘Very Unusual’
David P. Weber, JD, DBA, a professor and fraud specialist at Salisbury University, Salisbury, Maryland, told this news organization that the fraudulent use of a business or purchase credit card is a form of embezzlement and “one of the most frequently seen types of frauds against organizations.”
William J. Kresse, JD, MSA, CPA/CFF, who studies fraud at Governors State University in University Park, Illinois, noted in an interview with this news organization that the high amount of alleged fraud in this case is “very unusual,” as is the period it is said to have occurred (over 6 years).
Mr. Kresse highlighted a 2024 report by the Association of Certified Fraud Examiners, which found that the median fraud loss in healthcare, on the basis of 117 cases, is $100,000. The most common form of fraud in the industry is corruption (47%), followed by billing (38%), noncash theft such as inventory (22%), and expense reimbursement (21%).
The details of the current case suggest that “SUNY Downstate had weak or insufficient internal controls to prevent this type of fraud,” Salisbury University’s Mr. Weber said. “However, research also makes clear that the tenure and position of the perpetrator play a significant role in the size of the fraud. Internal controls are supposed to apply to all employees, but the higher in the organization the perpetrator is, the easier it can be to engage in fraud.”
Even Small Medical Offices Can Act to Prevent Fraud
What can be done to prevent this kind of fraud? “Each employee should be required to submit actual receipts or scanned copies, and the reimbursement requests should be reviewed and inputted by a separate department or office of the organization to ensure that the expenses are legitimate,” Mr. Weber said. “In addition, all credit card statements should be available for review by the organization either simultaneously with the bill going to the employee or available for audit or review at any time without notification to the employee. Expenses that are in certain categories should be prohibited automatically and coded to the card so such a charge is rejected by the credit card bank.”
Smaller businesses — like many medical practices — may not have the manpower to handle these roles. In that case, Mr. Weber said, “The key is segregation or separation of duties. The bookkeeper cannot be the person receiving the bank statements, the payments from patients, and the invoices from vendors. There needs to be at least one other person in the loop to have some level of control.”
One strategy, he said, “is that the practice should institute a policy that only the doctor or owner of the practice can receive the mail, not the bookkeeper. Even if the practice leader does not actually review the bank statements, simply opening them before handing them off to the bookkeeper can provide a level of deterrence [since] the employee may get caught if someone else is reviewing the bank statements.”
A version of this article first appeared on Medscape.com.
Wearables May Confirm Sleep Disruption Impact on Chronic Disease
Rapid eye movement (REM) sleep, deep sleep, and sleep irregularity were significantly associated with increased risk for a range of chronic diseases, based on a new study of > 6000 individuals.
“Most of what we think we know about sleep patterns in adults comes from either self-report surveys, which are widely used but have all sorts of problems with over- and under-estimating sleep duration and quality, or single-night sleep studies,” corresponding author Evan L. Brittain, MD, of Vanderbilt University, Nashville, Tennessee, said in an interview.
The single-night study yields the highest quality data but is limited by extrapolating a single night’s sleep to represent habitual sleep patterns, which is often not the case, he said. In the current study, published in Nature Medicine, “we had a unique opportunity to understand sleep using a large cohort of individuals using wearable devices that measure sleep duration, quality, and variability. The All of Us Research Program is the first to link wearables data to the electronic health record at scale and allowed us to study long-term, real-world sleep behavior,” Dr. Brittain said.
The timing of the study is important because the American Heart Association now recognizes sleep as a key component of heart health, and public awareness of the value of sleep is increasing, he added.
The researchers reviewed objectively measured, longitudinal sleep data from 6785 adults who used commercial wearable devices (Fitbit) linked to electronic health record data in the All of Us Research Program. The median age of the participants was 50.2 years, 71% were women, and 84% self-identified as White individuals. The median period of sleep monitoring was 4.5 years.
REM sleep and deep sleep were inversely associated with the odds of incident heart rhythm and heart rate abnormalities. A higher percentage of deep sleep was associated with reduced odds of atrial fibrillation (OR, 0.87), major depressive disorder (OR, 0.93), and anxiety disorder (OR, 0.94).
Increased irregular sleep was significantly associated with increased odds of incident obesity (OR, 1.49), hyperlipidemia (OR, 1.39), and hypertension (OR, 1.56), as well as major depressive disorder (OR, 1.75), anxiety disorder (OR, 1.55), and bipolar disorder (OR, 2.27).
The researchers also identified J-shaped associations between average daily sleep duration and hypertension (P for nonlinearity = .003), as well as major depressive disorder and generalized anxiety disorder (both P < .001).
The study was limited by several factors including the relatively young, White, and female study population. However, the results illustrate how sleep stages, duration, and regularity are associated with chronic disease development, and may inform evidence-based recommendations on healthy sleeping habits, the researchers wrote.
Findings Support Need for Sleep Consistency
“The biggest surprise for me was the impact of sleep variability of health,” Dr. Brittain told this news organization. “The more your sleep duration varies, the higher your risk of numerous chronic diseases across the entire spectrum of organ systems. Sleep duration and quality were also important but that was less surprising,” he said.
The clinical implications of the findings are that sleep duration, quality, and variability are all important, said Dr. Brittain. “To me, the easiest finding to translate into the clinic is the importance of reducing the variability of sleep duration as much as possible,” he said. For patients, that means explaining that they need to go to sleep and wake up at roughly the same time night to night, he said.
“Commercial wearable devices are not perfect compared with research grade devices, but our study showed that they nonetheless collect clinically relevant information,” Dr. Brittain added. “For patients who own a device, I have adopted the practice of reviewing my patients’ sleep and activity data which gives objective insight into behavior that is not always accurate through routine questioning,” he said.
As for other limitations, “Our cohort was limited to individuals who already owned a Fitbit; not surprisingly, these individuals differ from a random sample of the community in important ways, both demographic and behavioral, and our findings need to be validated in a more diverse population,” said Dr. Brittain.
Looking ahead, “we are interested in using commercial devices as a tool for sleep interventions to test the impact of improving sleep hygiene on chronic disease incidence, severity, and progression,” he said.
Device Data Will Evolve to Inform Patient Care
“With the increasing use of commercial wearable devices, it is crucial to identify and understand the data they can collect,” said Arianne K. Baldomero, MD, a pulmonologist and assistant professor of medicine at the University of Minnesota, Minneapolis, in an interview. “This study specifically analyzed sleep data from Fitbit devices among participants in the All of Us Research Program to assess sleep patterns and their association with chronic disease risk,” said Dr. Baldomero, who was not involved in the study.
The significant relationships between sleep patterns and risk for chronic diseases were not surprising, said Dr. Baldomero. The findings of an association between shorter sleep duration and greater sleep irregularity with obesity and sleep apnea validated previous studies in large-scale population surveys, she said. Findings from the current study also reflect data from the literature on sleep duration associated with hypertension, major depressive disorder, and generalized anxiety findings, she added.
“This study reinforces the importance of adequate sleep, typically around 7 hours per night, and suggests that insufficient or poor-quality sleep may be associated with chronic diseases,” Dr. Baldomero told this news organization. “Pulmonologists should remain vigilant about sleep-related issues, and consider further investigation and referrals to sleep specialty clinics for patients suspected of having sleep disturbances,” she said.
“What remains unclear is whether abnormal sleep patterns are a cause or an effect of chronic diseases,” Dr. Baldomero noted. “Additionally, it is essential to ensure that these devices accurately capture sleep patterns and continue to validate their data against gold standard measures of sleep disturbances,” she said.
The study was based on work that was partially funded by an unrestricted gift from Google, and the study itself was supported by National Institutes of Health. Dr. Brittain disclosed received research funds unrelated to this work from United Therapeutics. Dr. Baldomero had no financial conflicts to disclose.
A version of this article first appeared on Medscape.com.
Rapid eye movement (REM) sleep, deep sleep, and sleep irregularity were significantly associated with increased risk for a range of chronic diseases, based on a new study of > 6000 individuals.
“Most of what we think we know about sleep patterns in adults comes from either self-report surveys, which are widely used but have all sorts of problems with over- and under-estimating sleep duration and quality, or single-night sleep studies,” corresponding author Evan L. Brittain, MD, of Vanderbilt University, Nashville, Tennessee, said in an interview.
The single-night study yields the highest quality data but is limited by extrapolating a single night’s sleep to represent habitual sleep patterns, which is often not the case, he said. In the current study, published in Nature Medicine, “we had a unique opportunity to understand sleep using a large cohort of individuals using wearable devices that measure sleep duration, quality, and variability. The All of Us Research Program is the first to link wearables data to the electronic health record at scale and allowed us to study long-term, real-world sleep behavior,” Dr. Brittain said.
The timing of the study is important because the American Heart Association now recognizes sleep as a key component of heart health, and public awareness of the value of sleep is increasing, he added.
The researchers reviewed objectively measured, longitudinal sleep data from 6785 adults who used commercial wearable devices (Fitbit) linked to electronic health record data in the All of Us Research Program. The median age of the participants was 50.2 years, 71% were women, and 84% self-identified as White individuals. The median period of sleep monitoring was 4.5 years.
REM sleep and deep sleep were inversely associated with the odds of incident heart rhythm and heart rate abnormalities. A higher percentage of deep sleep was associated with reduced odds of atrial fibrillation (OR, 0.87), major depressive disorder (OR, 0.93), and anxiety disorder (OR, 0.94).
Increased irregular sleep was significantly associated with increased odds of incident obesity (OR, 1.49), hyperlipidemia (OR, 1.39), and hypertension (OR, 1.56), as well as major depressive disorder (OR, 1.75), anxiety disorder (OR, 1.55), and bipolar disorder (OR, 2.27).
The researchers also identified J-shaped associations between average daily sleep duration and hypertension (P for nonlinearity = .003), as well as major depressive disorder and generalized anxiety disorder (both P < .001).
The study was limited by several factors including the relatively young, White, and female study population. However, the results illustrate how sleep stages, duration, and regularity are associated with chronic disease development, and may inform evidence-based recommendations on healthy sleeping habits, the researchers wrote.
Findings Support Need for Sleep Consistency
“The biggest surprise for me was the impact of sleep variability of health,” Dr. Brittain told this news organization. “The more your sleep duration varies, the higher your risk of numerous chronic diseases across the entire spectrum of organ systems. Sleep duration and quality were also important but that was less surprising,” he said.
The clinical implications of the findings are that sleep duration, quality, and variability are all important, said Dr. Brittain. “To me, the easiest finding to translate into the clinic is the importance of reducing the variability of sleep duration as much as possible,” he said. For patients, that means explaining that they need to go to sleep and wake up at roughly the same time night to night, he said.
“Commercial wearable devices are not perfect compared with research grade devices, but our study showed that they nonetheless collect clinically relevant information,” Dr. Brittain added. “For patients who own a device, I have adopted the practice of reviewing my patients’ sleep and activity data which gives objective insight into behavior that is not always accurate through routine questioning,” he said.
As for other limitations, “Our cohort was limited to individuals who already owned a Fitbit; not surprisingly, these individuals differ from a random sample of the community in important ways, both demographic and behavioral, and our findings need to be validated in a more diverse population,” said Dr. Brittain.
Looking ahead, “we are interested in using commercial devices as a tool for sleep interventions to test the impact of improving sleep hygiene on chronic disease incidence, severity, and progression,” he said.
Device Data Will Evolve to Inform Patient Care
“With the increasing use of commercial wearable devices, it is crucial to identify and understand the data they can collect,” said Arianne K. Baldomero, MD, a pulmonologist and assistant professor of medicine at the University of Minnesota, Minneapolis, in an interview. “This study specifically analyzed sleep data from Fitbit devices among participants in the All of Us Research Program to assess sleep patterns and their association with chronic disease risk,” said Dr. Baldomero, who was not involved in the study.
The significant relationships between sleep patterns and risk for chronic diseases were not surprising, said Dr. Baldomero. The findings of an association between shorter sleep duration and greater sleep irregularity with obesity and sleep apnea validated previous studies in large-scale population surveys, she said. Findings from the current study also reflect data from the literature on sleep duration associated with hypertension, major depressive disorder, and generalized anxiety findings, she added.
“This study reinforces the importance of adequate sleep, typically around 7 hours per night, and suggests that insufficient or poor-quality sleep may be associated with chronic diseases,” Dr. Baldomero told this news organization. “Pulmonologists should remain vigilant about sleep-related issues, and consider further investigation and referrals to sleep specialty clinics for patients suspected of having sleep disturbances,” she said.
“What remains unclear is whether abnormal sleep patterns are a cause or an effect of chronic diseases,” Dr. Baldomero noted. “Additionally, it is essential to ensure that these devices accurately capture sleep patterns and continue to validate their data against gold standard measures of sleep disturbances,” she said.
The study was based on work that was partially funded by an unrestricted gift from Google, and the study itself was supported by National Institutes of Health. Dr. Brittain disclosed received research funds unrelated to this work from United Therapeutics. Dr. Baldomero had no financial conflicts to disclose.
A version of this article first appeared on Medscape.com.
Rapid eye movement (REM) sleep, deep sleep, and sleep irregularity were significantly associated with increased risk for a range of chronic diseases, based on a new study of > 6000 individuals.
“Most of what we think we know about sleep patterns in adults comes from either self-report surveys, which are widely used but have all sorts of problems with over- and under-estimating sleep duration and quality, or single-night sleep studies,” corresponding author Evan L. Brittain, MD, of Vanderbilt University, Nashville, Tennessee, said in an interview.
The single-night study yields the highest quality data but is limited by extrapolating a single night’s sleep to represent habitual sleep patterns, which is often not the case, he said. In the current study, published in Nature Medicine, “we had a unique opportunity to understand sleep using a large cohort of individuals using wearable devices that measure sleep duration, quality, and variability. The All of Us Research Program is the first to link wearables data to the electronic health record at scale and allowed us to study long-term, real-world sleep behavior,” Dr. Brittain said.
The timing of the study is important because the American Heart Association now recognizes sleep as a key component of heart health, and public awareness of the value of sleep is increasing, he added.
The researchers reviewed objectively measured, longitudinal sleep data from 6785 adults who used commercial wearable devices (Fitbit) linked to electronic health record data in the All of Us Research Program. The median age of the participants was 50.2 years, 71% were women, and 84% self-identified as White individuals. The median period of sleep monitoring was 4.5 years.
REM sleep and deep sleep were inversely associated with the odds of incident heart rhythm and heart rate abnormalities. A higher percentage of deep sleep was associated with reduced odds of atrial fibrillation (OR, 0.87), major depressive disorder (OR, 0.93), and anxiety disorder (OR, 0.94).
Increased irregular sleep was significantly associated with increased odds of incident obesity (OR, 1.49), hyperlipidemia (OR, 1.39), and hypertension (OR, 1.56), as well as major depressive disorder (OR, 1.75), anxiety disorder (OR, 1.55), and bipolar disorder (OR, 2.27).
The researchers also identified J-shaped associations between average daily sleep duration and hypertension (P for nonlinearity = .003), as well as major depressive disorder and generalized anxiety disorder (both P < .001).
The study was limited by several factors including the relatively young, White, and female study population. However, the results illustrate how sleep stages, duration, and regularity are associated with chronic disease development, and may inform evidence-based recommendations on healthy sleeping habits, the researchers wrote.
Findings Support Need for Sleep Consistency
“The biggest surprise for me was the impact of sleep variability of health,” Dr. Brittain told this news organization. “The more your sleep duration varies, the higher your risk of numerous chronic diseases across the entire spectrum of organ systems. Sleep duration and quality were also important but that was less surprising,” he said.
The clinical implications of the findings are that sleep duration, quality, and variability are all important, said Dr. Brittain. “To me, the easiest finding to translate into the clinic is the importance of reducing the variability of sleep duration as much as possible,” he said. For patients, that means explaining that they need to go to sleep and wake up at roughly the same time night to night, he said.
“Commercial wearable devices are not perfect compared with research grade devices, but our study showed that they nonetheless collect clinically relevant information,” Dr. Brittain added. “For patients who own a device, I have adopted the practice of reviewing my patients’ sleep and activity data which gives objective insight into behavior that is not always accurate through routine questioning,” he said.
As for other limitations, “Our cohort was limited to individuals who already owned a Fitbit; not surprisingly, these individuals differ from a random sample of the community in important ways, both demographic and behavioral, and our findings need to be validated in a more diverse population,” said Dr. Brittain.
Looking ahead, “we are interested in using commercial devices as a tool for sleep interventions to test the impact of improving sleep hygiene on chronic disease incidence, severity, and progression,” he said.
Device Data Will Evolve to Inform Patient Care
“With the increasing use of commercial wearable devices, it is crucial to identify and understand the data they can collect,” said Arianne K. Baldomero, MD, a pulmonologist and assistant professor of medicine at the University of Minnesota, Minneapolis, in an interview. “This study specifically analyzed sleep data from Fitbit devices among participants in the All of Us Research Program to assess sleep patterns and their association with chronic disease risk,” said Dr. Baldomero, who was not involved in the study.
The significant relationships between sleep patterns and risk for chronic diseases were not surprising, said Dr. Baldomero. The findings of an association between shorter sleep duration and greater sleep irregularity with obesity and sleep apnea validated previous studies in large-scale population surveys, she said. Findings from the current study also reflect data from the literature on sleep duration associated with hypertension, major depressive disorder, and generalized anxiety findings, she added.
“This study reinforces the importance of adequate sleep, typically around 7 hours per night, and suggests that insufficient or poor-quality sleep may be associated with chronic diseases,” Dr. Baldomero told this news organization. “Pulmonologists should remain vigilant about sleep-related issues, and consider further investigation and referrals to sleep specialty clinics for patients suspected of having sleep disturbances,” she said.
“What remains unclear is whether abnormal sleep patterns are a cause or an effect of chronic diseases,” Dr. Baldomero noted. “Additionally, it is essential to ensure that these devices accurately capture sleep patterns and continue to validate their data against gold standard measures of sleep disturbances,” she said.
The study was based on work that was partially funded by an unrestricted gift from Google, and the study itself was supported by National Institutes of Health. Dr. Brittain disclosed received research funds unrelated to this work from United Therapeutics. Dr. Baldomero had no financial conflicts to disclose.
A version of this article first appeared on Medscape.com.
When Is Sexual Behavior Out of Control?
A 25-year-old man comes in with a pulled muscle. You ask if he has anything else to discuss. Sheepishly, he says he is concerned about his use of pornography.
A 45-year-old woman struggling with depression finds herself persistently seeking sex outside the bounds of her long-term relationship. Her partner is threatening to leave. She is devastated and tells you she doesn’t understand her own behavior.
Do these patients have some form of sex addiction? How should a primary care clinician intervene? Is a referral to a 12-step program for sex addiction the right choice? What other options exist? Is a diagnosis — let alone treatment — possible or appropriate?
‘Who Are You Calling “Abnormal” ’?
Normal is not a meaningful concept in human sexual behavior. To quote the sex therapist Marty Klein, PhD: “Normal is just a setting on the dryer.”
The same goes among partners: What is “normal” for one person in a sexual relationship may discomfit another. In partnerships, we have differences around all sorts of issues, from finances to parenting to how to load the dishwasher. Why should sex, sexual desire, and sexual frequency be different?
Remember: Shame, fear, and secrecy often play a role in perpetuating behaviors that cause distress. Helping our patients accept and embrace their whole selves can provide important healing, relief from anxiety, and may even help them regulate their actions. Feeling less shame, fear, and secrecy may facilitate safer choices about sex, as well as testing and treatment for sexually transmitted infections.
The International Classification of Diseases-11 includes compulsive sexual behavior disorder (CSBD)as an attempt to create consensus around a complicated, and hotly debated, problem to facilitate diagnosis and research. Syndromes similar to CSBD have had many names: “hypersexual disorder,” “sexual addiction,” “sexual compulsivity,” and “out-of-control sexual behavior.” A sizable cohort of the sexuality research community casts doubt on whether CSBD is even a discrete diagnosis.
According to the ICD-11, CSBD is characterized by “intense, repetitive sexual impulses or urges that are experienced as irresistible or uncontrollable” and result in significant distress or functional impairment.
This diagnosis has several important rule-outs. First, paraphilias, defined as a set of nonconsensual sexual behaviors and interests, are excluded. Another is that distress exclusively related to moral judgment or social disapproval is not sufficient for a diagnosis of CSBD. Finally, the diagnosis hinges on distress and does not rely on frequency of any type of sexual behavior. Some people experience significant distress over behaviors in which they engage infrequently, whereas others may have no distress from activities in which they engage quite frequently.
In one study from Germany, 5% of men and 3% of women met criteria for CSBD. A small US study found the number to be 10% and 7%, respectively. The diagnosis is not simple. Compulsive sexual behavior can be secondary to other mental health or medical conditions. Behaviors sometimes confused with CSBD can result from neurologic diseases, such as frontal brain lesions or frontotemporal dementia, as well as the use of substances and medications that enhance dopaminergic activity.
Impaired control over sexual impulses occurs in manic and hypomanic episodes. Compulsive sexual behavior frequently co-occurs with mood disorders, obsessive-compulsive disorder, attention-deficit/hyperactivity disorder, and substance use disorders. Those meeting criteria for CSBD may engage in sexual behaviors as a way of coping with depression, anxiety, boredom, loneliness, or other negative affective states.
The diagnosis of CSBD may be useful for clinicians. However, many, perhaps most, patients who present with concerns about their sexual behavior will fail to meet most criteria for CSBD. Their problem is of shorter duration, related to morality, external disapproval, lack of sexual health information, and anxiety about diverse erotic interests. It may be helpful for them to understand that they are not in the grip of a lifelong disorder but are experiencing common life challenges.
Societal concerns about sexually explicit media, often called pornography, are complex, conflicting, and catastrophizing. Some studies indicate that sexually explicit media are positive for both individual and relational sexual satisfaction; other studies have found negative effects on sexual function. Concerns about pornography often are conflated with taboos about solo sexual activity. Ironically, use of pornography is associated with fear of addiction to pornography, creating a spiral of negative self-perception.
Consequences of sexual behavior may induce distress, even if a person doesn’t meet criteria for CSBD, such as potential dissolution of a marriage, loss of a job, excessive spending, sexually transmitted infections, other health concerns, and even legal problems. Sexual behavior might not be the central issue but rather an offshoot of relational distress, a mental health disorder, or a dysfunctional coping style.
Guilt and shame can act as potent contributors to maintaining the behaviors as well as promoting secrecy around them. Sexual medicine experts recommend avoiding interventions that increase the experience of discrimination and stigma and avoiding the pathologization of the behaviors of sexually diverse individuals. As in so many aspects of medical care, we must walk in our patients’ shoes and avoid imposing on them our own moral or religious values.
What Can a Primary Care Provider Do?
When a patient is concerned about sexual behavior that feels out of control, primary care providers have an important role in evaluating for neurologic disease or side effects related to the use of medication or other substances, and facilitating psychiatric assessment to evaluate for mental health comorbidities, past trauma, and associated attachment disorders.
Our patients need resources to tease out the individual and relational problems that may arise. Seek out well-trained sex therapy colleagues in your community. The American Association of Sexuality Educators, Counselors, and Therapists (AASECT) is one certifying body in the United States for sex therapy.
Because of the heterogeneity of those who present with out-of-control sexual behavior, no one treatment fits all. Twelve-step programs, especially those with a focus on sexual “abstinence,” may not be the best choice. Many psychotherapeutic modalities are effective and often focus on addressing underlying or unrecognized mental health concerns, provide training on self-regulation and urge management, and relationship skills. Most important, the therapist needs to be sexologically informed and aware of their own biases around sexuality. Medical treatments are not recommended without concurrent psychological intervention.
Relational sex therapy can help couples create clear relational agreements that work for both parties (or, in polyamorous relationships, everyone involved). Relational distress also may be a stimulus for individual psychotherapy.
Back to these two patients.
The 25-year-old could be counseled that use of sexually explicit media and solo sex are not inherently bad or damaging. When used for pleasure and enjoyment, they do not lead to problems with partnered sex or cause sexual dysfunction. Counseling him to move toward social engagement and life goals, rather than away from pornography, may be all that is necessary.
Our second patient probably will need more intensive treatment, including medication management for her mood and referral to a certified sex therapist who has expertise in working with out-of-control sexual behavior. When she returns to see you in follow-up, she ideally expresses reduced shame, more autonomy, and renewed connection to her values, and she is keeping her relational agreements without sacrificing her sexual needs.
Dr. Kranz is medical director, Rochester Center for Sexual Wellness; assistant professor of Clinical Family Medicine and Obstetrics and Gynecology, University of Rochester Medical Center, Rochester, New York. Dr. Kranz has disclosed no relevant financial relationships. Dr. Rosen is director of Behavioral Health, Rochester Center for Sexual Wellness, Rochester, New York. He has disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
A 25-year-old man comes in with a pulled muscle. You ask if he has anything else to discuss. Sheepishly, he says he is concerned about his use of pornography.
A 45-year-old woman struggling with depression finds herself persistently seeking sex outside the bounds of her long-term relationship. Her partner is threatening to leave. She is devastated and tells you she doesn’t understand her own behavior.
Do these patients have some form of sex addiction? How should a primary care clinician intervene? Is a referral to a 12-step program for sex addiction the right choice? What other options exist? Is a diagnosis — let alone treatment — possible or appropriate?
‘Who Are You Calling “Abnormal” ’?
Normal is not a meaningful concept in human sexual behavior. To quote the sex therapist Marty Klein, PhD: “Normal is just a setting on the dryer.”
The same goes among partners: What is “normal” for one person in a sexual relationship may discomfit another. In partnerships, we have differences around all sorts of issues, from finances to parenting to how to load the dishwasher. Why should sex, sexual desire, and sexual frequency be different?
Remember: Shame, fear, and secrecy often play a role in perpetuating behaviors that cause distress. Helping our patients accept and embrace their whole selves can provide important healing, relief from anxiety, and may even help them regulate their actions. Feeling less shame, fear, and secrecy may facilitate safer choices about sex, as well as testing and treatment for sexually transmitted infections.
The International Classification of Diseases-11 includes compulsive sexual behavior disorder (CSBD)as an attempt to create consensus around a complicated, and hotly debated, problem to facilitate diagnosis and research. Syndromes similar to CSBD have had many names: “hypersexual disorder,” “sexual addiction,” “sexual compulsivity,” and “out-of-control sexual behavior.” A sizable cohort of the sexuality research community casts doubt on whether CSBD is even a discrete diagnosis.
According to the ICD-11, CSBD is characterized by “intense, repetitive sexual impulses or urges that are experienced as irresistible or uncontrollable” and result in significant distress or functional impairment.
This diagnosis has several important rule-outs. First, paraphilias, defined as a set of nonconsensual sexual behaviors and interests, are excluded. Another is that distress exclusively related to moral judgment or social disapproval is not sufficient for a diagnosis of CSBD. Finally, the diagnosis hinges on distress and does not rely on frequency of any type of sexual behavior. Some people experience significant distress over behaviors in which they engage infrequently, whereas others may have no distress from activities in which they engage quite frequently.
In one study from Germany, 5% of men and 3% of women met criteria for CSBD. A small US study found the number to be 10% and 7%, respectively. The diagnosis is not simple. Compulsive sexual behavior can be secondary to other mental health or medical conditions. Behaviors sometimes confused with CSBD can result from neurologic diseases, such as frontal brain lesions or frontotemporal dementia, as well as the use of substances and medications that enhance dopaminergic activity.
Impaired control over sexual impulses occurs in manic and hypomanic episodes. Compulsive sexual behavior frequently co-occurs with mood disorders, obsessive-compulsive disorder, attention-deficit/hyperactivity disorder, and substance use disorders. Those meeting criteria for CSBD may engage in sexual behaviors as a way of coping with depression, anxiety, boredom, loneliness, or other negative affective states.
The diagnosis of CSBD may be useful for clinicians. However, many, perhaps most, patients who present with concerns about their sexual behavior will fail to meet most criteria for CSBD. Their problem is of shorter duration, related to morality, external disapproval, lack of sexual health information, and anxiety about diverse erotic interests. It may be helpful for them to understand that they are not in the grip of a lifelong disorder but are experiencing common life challenges.
Societal concerns about sexually explicit media, often called pornography, are complex, conflicting, and catastrophizing. Some studies indicate that sexually explicit media are positive for both individual and relational sexual satisfaction; other studies have found negative effects on sexual function. Concerns about pornography often are conflated with taboos about solo sexual activity. Ironically, use of pornography is associated with fear of addiction to pornography, creating a spiral of negative self-perception.
Consequences of sexual behavior may induce distress, even if a person doesn’t meet criteria for CSBD, such as potential dissolution of a marriage, loss of a job, excessive spending, sexually transmitted infections, other health concerns, and even legal problems. Sexual behavior might not be the central issue but rather an offshoot of relational distress, a mental health disorder, or a dysfunctional coping style.
Guilt and shame can act as potent contributors to maintaining the behaviors as well as promoting secrecy around them. Sexual medicine experts recommend avoiding interventions that increase the experience of discrimination and stigma and avoiding the pathologization of the behaviors of sexually diverse individuals. As in so many aspects of medical care, we must walk in our patients’ shoes and avoid imposing on them our own moral or religious values.
What Can a Primary Care Provider Do?
When a patient is concerned about sexual behavior that feels out of control, primary care providers have an important role in evaluating for neurologic disease or side effects related to the use of medication or other substances, and facilitating psychiatric assessment to evaluate for mental health comorbidities, past trauma, and associated attachment disorders.
Our patients need resources to tease out the individual and relational problems that may arise. Seek out well-trained sex therapy colleagues in your community. The American Association of Sexuality Educators, Counselors, and Therapists (AASECT) is one certifying body in the United States for sex therapy.
Because of the heterogeneity of those who present with out-of-control sexual behavior, no one treatment fits all. Twelve-step programs, especially those with a focus on sexual “abstinence,” may not be the best choice. Many psychotherapeutic modalities are effective and often focus on addressing underlying or unrecognized mental health concerns, provide training on self-regulation and urge management, and relationship skills. Most important, the therapist needs to be sexologically informed and aware of their own biases around sexuality. Medical treatments are not recommended without concurrent psychological intervention.
Relational sex therapy can help couples create clear relational agreements that work for both parties (or, in polyamorous relationships, everyone involved). Relational distress also may be a stimulus for individual psychotherapy.
Back to these two patients.
The 25-year-old could be counseled that use of sexually explicit media and solo sex are not inherently bad or damaging. When used for pleasure and enjoyment, they do not lead to problems with partnered sex or cause sexual dysfunction. Counseling him to move toward social engagement and life goals, rather than away from pornography, may be all that is necessary.
Our second patient probably will need more intensive treatment, including medication management for her mood and referral to a certified sex therapist who has expertise in working with out-of-control sexual behavior. When she returns to see you in follow-up, she ideally expresses reduced shame, more autonomy, and renewed connection to her values, and she is keeping her relational agreements without sacrificing her sexual needs.
Dr. Kranz is medical director, Rochester Center for Sexual Wellness; assistant professor of Clinical Family Medicine and Obstetrics and Gynecology, University of Rochester Medical Center, Rochester, New York. Dr. Kranz has disclosed no relevant financial relationships. Dr. Rosen is director of Behavioral Health, Rochester Center for Sexual Wellness, Rochester, New York. He has disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
A 25-year-old man comes in with a pulled muscle. You ask if he has anything else to discuss. Sheepishly, he says he is concerned about his use of pornography.
A 45-year-old woman struggling with depression finds herself persistently seeking sex outside the bounds of her long-term relationship. Her partner is threatening to leave. She is devastated and tells you she doesn’t understand her own behavior.
Do these patients have some form of sex addiction? How should a primary care clinician intervene? Is a referral to a 12-step program for sex addiction the right choice? What other options exist? Is a diagnosis — let alone treatment — possible or appropriate?
‘Who Are You Calling “Abnormal” ’?
Normal is not a meaningful concept in human sexual behavior. To quote the sex therapist Marty Klein, PhD: “Normal is just a setting on the dryer.”
The same goes among partners: What is “normal” for one person in a sexual relationship may discomfit another. In partnerships, we have differences around all sorts of issues, from finances to parenting to how to load the dishwasher. Why should sex, sexual desire, and sexual frequency be different?
Remember: Shame, fear, and secrecy often play a role in perpetuating behaviors that cause distress. Helping our patients accept and embrace their whole selves can provide important healing, relief from anxiety, and may even help them regulate their actions. Feeling less shame, fear, and secrecy may facilitate safer choices about sex, as well as testing and treatment for sexually transmitted infections.
The International Classification of Diseases-11 includes compulsive sexual behavior disorder (CSBD)as an attempt to create consensus around a complicated, and hotly debated, problem to facilitate diagnosis and research. Syndromes similar to CSBD have had many names: “hypersexual disorder,” “sexual addiction,” “sexual compulsivity,” and “out-of-control sexual behavior.” A sizable cohort of the sexuality research community casts doubt on whether CSBD is even a discrete diagnosis.
According to the ICD-11, CSBD is characterized by “intense, repetitive sexual impulses or urges that are experienced as irresistible or uncontrollable” and result in significant distress or functional impairment.
This diagnosis has several important rule-outs. First, paraphilias, defined as a set of nonconsensual sexual behaviors and interests, are excluded. Another is that distress exclusively related to moral judgment or social disapproval is not sufficient for a diagnosis of CSBD. Finally, the diagnosis hinges on distress and does not rely on frequency of any type of sexual behavior. Some people experience significant distress over behaviors in which they engage infrequently, whereas others may have no distress from activities in which they engage quite frequently.
In one study from Germany, 5% of men and 3% of women met criteria for CSBD. A small US study found the number to be 10% and 7%, respectively. The diagnosis is not simple. Compulsive sexual behavior can be secondary to other mental health or medical conditions. Behaviors sometimes confused with CSBD can result from neurologic diseases, such as frontal brain lesions or frontotemporal dementia, as well as the use of substances and medications that enhance dopaminergic activity.
Impaired control over sexual impulses occurs in manic and hypomanic episodes. Compulsive sexual behavior frequently co-occurs with mood disorders, obsessive-compulsive disorder, attention-deficit/hyperactivity disorder, and substance use disorders. Those meeting criteria for CSBD may engage in sexual behaviors as a way of coping with depression, anxiety, boredom, loneliness, or other negative affective states.
The diagnosis of CSBD may be useful for clinicians. However, many, perhaps most, patients who present with concerns about their sexual behavior will fail to meet most criteria for CSBD. Their problem is of shorter duration, related to morality, external disapproval, lack of sexual health information, and anxiety about diverse erotic interests. It may be helpful for them to understand that they are not in the grip of a lifelong disorder but are experiencing common life challenges.
Societal concerns about sexually explicit media, often called pornography, are complex, conflicting, and catastrophizing. Some studies indicate that sexually explicit media are positive for both individual and relational sexual satisfaction; other studies have found negative effects on sexual function. Concerns about pornography often are conflated with taboos about solo sexual activity. Ironically, use of pornography is associated with fear of addiction to pornography, creating a spiral of negative self-perception.
Consequences of sexual behavior may induce distress, even if a person doesn’t meet criteria for CSBD, such as potential dissolution of a marriage, loss of a job, excessive spending, sexually transmitted infections, other health concerns, and even legal problems. Sexual behavior might not be the central issue but rather an offshoot of relational distress, a mental health disorder, or a dysfunctional coping style.
Guilt and shame can act as potent contributors to maintaining the behaviors as well as promoting secrecy around them. Sexual medicine experts recommend avoiding interventions that increase the experience of discrimination and stigma and avoiding the pathologization of the behaviors of sexually diverse individuals. As in so many aspects of medical care, we must walk in our patients’ shoes and avoid imposing on them our own moral or religious values.
What Can a Primary Care Provider Do?
When a patient is concerned about sexual behavior that feels out of control, primary care providers have an important role in evaluating for neurologic disease or side effects related to the use of medication or other substances, and facilitating psychiatric assessment to evaluate for mental health comorbidities, past trauma, and associated attachment disorders.
Our patients need resources to tease out the individual and relational problems that may arise. Seek out well-trained sex therapy colleagues in your community. The American Association of Sexuality Educators, Counselors, and Therapists (AASECT) is one certifying body in the United States for sex therapy.
Because of the heterogeneity of those who present with out-of-control sexual behavior, no one treatment fits all. Twelve-step programs, especially those with a focus on sexual “abstinence,” may not be the best choice. Many psychotherapeutic modalities are effective and often focus on addressing underlying or unrecognized mental health concerns, provide training on self-regulation and urge management, and relationship skills. Most important, the therapist needs to be sexologically informed and aware of their own biases around sexuality. Medical treatments are not recommended without concurrent psychological intervention.
Relational sex therapy can help couples create clear relational agreements that work for both parties (or, in polyamorous relationships, everyone involved). Relational distress also may be a stimulus for individual psychotherapy.
Back to these two patients.
The 25-year-old could be counseled that use of sexually explicit media and solo sex are not inherently bad or damaging. When used for pleasure and enjoyment, they do not lead to problems with partnered sex or cause sexual dysfunction. Counseling him to move toward social engagement and life goals, rather than away from pornography, may be all that is necessary.
Our second patient probably will need more intensive treatment, including medication management for her mood and referral to a certified sex therapist who has expertise in working with out-of-control sexual behavior. When she returns to see you in follow-up, she ideally expresses reduced shame, more autonomy, and renewed connection to her values, and she is keeping her relational agreements without sacrificing her sexual needs.
Dr. Kranz is medical director, Rochester Center for Sexual Wellness; assistant professor of Clinical Family Medicine and Obstetrics and Gynecology, University of Rochester Medical Center, Rochester, New York. Dr. Kranz has disclosed no relevant financial relationships. Dr. Rosen is director of Behavioral Health, Rochester Center for Sexual Wellness, Rochester, New York. He has disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
Ozempic Curbs Hunger – And Not Just for Food
This transcript has been edited for clarity.
If you’ve been paying attention only to the headlines, when you think of “Ozempic” you’ll think of a few things: a blockbuster weight loss drug or the tip of the spear of a completely new industry — why not? A drug so popular that the people it was invented for (those with diabetes) can’t even get it.
Ozempic and other GLP-1 receptor agonists are undeniable game changers. Insofar as obesity is the number-one public health risk in the United States, antiobesity drugs hold immense promise even if all they do is reduce obesity.
In 2023, an article in Scientific Reports presented data suggesting that people on Ozempic might be reducing their alcohol intake, not just their total calories.
A 2024 article in Molecular Psychiatry found that the drug might positively impact cannabis use disorder. An article from Brain Sciences suggests that the drug reduces compulsive shopping.
A picture is starting to form, a picture that suggests these drugs curb hunger both literally and figuratively. That GLP-1 receptor agonists like Ozempic and Mounjaro are fundamentally anticonsumption drugs. In a society that — some would argue — is plagued by overconsumption, these drugs might be just what the doctor ordered.
If only they could stop people from smoking.
Oh, wait — they can.
At least it seems they can, based on a new study appearing in Annals of Internal Medicine.
Before we get too excited, this is not a randomized trial. There actually was a small randomized trial of exenatide (Byetta), which is in the same class as Ozempic but probably a bit less potent, with promising results for smoking cessation. 
But Byetta is the weaker drug in this class; the market leader is Ozempic. So how can you figure out whether Ozempic can reduce smoking without doing a huge and expensive randomized trial? You can do what Nora Volkow and colleagues from the National Institute on Drug Abuse did: a target trial emulation study.
A target trial emulation study is more or less what it sounds like. First, you decide what your dream randomized controlled trial would be and you plan it all out in great detail. You define the population you would recruit, with all the relevant inclusion and exclusion criteria. You define the intervention and the control, and you define the outcome.
But you don’t actually do the trial. You could if someone would lend you $10-$50 million, but assuming you don’t have that lying around, you do the next best thing, which is to dig into a medical record database to find all the people who would be eligible for your imaginary trial. And you analyze them.
The authors wanted to study the effect of Ozempic on smoking among people with diabetes; that’s why all the comparator agents are antidiabetes drugs. They figured out whether these folks were smoking on the basis of a medical record diagnosis of tobacco use disorder before they started one of the drugs of interest. This code is fairly specific: If a patient has it, you can be pretty sure they are smoking. But it’s not very sensitive; not every smoker has this diagnostic code. This is an age-old limitation of using EHR data instead of asking patients, but it’s part of the tradeoff for not having to spend $50 million.
After applying all those inclusion and exclusion criteria, they have a defined population who could be in their dream trial. And, as luck would have it, some of those people really were treated with Ozempic and some really were treated with those other agents. Although decisions about what to prescribe were not randomized, the authors account for this confounding-by-indication using propensity-score matching. You can find a little explainer on propensity-score matching in an earlier column here. 
It’s easy enough, using the EHR, to figure out who has diabetes and who got which drug. But how do you know who quit smoking? Remember, everyone had a diagnosis code for tobacco use disorder prior to starting Ozempic or a comparator drug. The authors decided that if the patient had a medical visit where someone again coded tobacco-use disorder, they were still smoking. If someone prescribed smoking cessation meds like a nicotine patch or varenicline, they were obviously still smoking. If someone billed for tobacco-cessation counseling, the patient is still smoking. We’ll get back to the implications of this outcome definition in a minute.
Let’s talk about the results, which are pretty intriguing. 
When Ozempic is compared with insulin among smokers with diabetes, those on Ozempic were about 30% more likely to quit smoking. They were about 18% more likely to quit smoking than those who took metformin. They were even slightly more likely to quit smoking than those on other GLP-1 receptor antagonists, though I should note that Mounjaro, which is probably the more potent GLP-1 drug in terms of weight loss, was not among the comparators.
This is pretty impressive for a drug that was not designed to be a smoking cessation drug. It speaks to this emerging idea that these drugs do more than curb appetite by slowing down gastric emptying or something. They work in the brain, modulating some of the reward circuitry that keeps us locked into our bad habits.
There are, of course, some caveats. As I pointed out, this study captured the idea of “still smoking” through the use of administrative codes in the EHR and prescription of smoking cessation aids. You could see similar results if taking Ozempic makes people less likely to address their smoking at all; maybe they shut down the doctor before they even talk about it, or there is too much to discuss during these visits to even get to the subject of smoking. You could also see results like this if people taking Ozempic had fewer visits overall, but the authors showed that that, at least, was not the case.
I’m inclined to believe that this effect is real, simply because we keep seeing signals from multiple sources. If that turns out to be the case, these new “weight loss” drugs may prove to be much more than that; they may turn out to be the drugs that can finally save us from ourselves.
Dr. Wilson is associate professor of medicine and public health and director of the Clinical and Translational Research Accelerator at Yale University, New Haven, Connecticut. He has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
If you’ve been paying attention only to the headlines, when you think of “Ozempic” you’ll think of a few things: a blockbuster weight loss drug or the tip of the spear of a completely new industry — why not? A drug so popular that the people it was invented for (those with diabetes) can’t even get it.
Ozempic and other GLP-1 receptor agonists are undeniable game changers. Insofar as obesity is the number-one public health risk in the United States, antiobesity drugs hold immense promise even if all they do is reduce obesity.
In 2023, an article in Scientific Reports presented data suggesting that people on Ozempic might be reducing their alcohol intake, not just their total calories.
A 2024 article in Molecular Psychiatry found that the drug might positively impact cannabis use disorder. An article from Brain Sciences suggests that the drug reduces compulsive shopping.
A picture is starting to form, a picture that suggests these drugs curb hunger both literally and figuratively. That GLP-1 receptor agonists like Ozempic and Mounjaro are fundamentally anticonsumption drugs. In a society that — some would argue — is plagued by overconsumption, these drugs might be just what the doctor ordered.
If only they could stop people from smoking.
Oh, wait — they can.
At least it seems they can, based on a new study appearing in Annals of Internal Medicine.
Before we get too excited, this is not a randomized trial. There actually was a small randomized trial of exenatide (Byetta), which is in the same class as Ozempic but probably a bit less potent, with promising results for smoking cessation.
But Byetta is the weaker drug in this class; the market leader is Ozempic. So how can you figure out whether Ozempic can reduce smoking without doing a huge and expensive randomized trial? You can do what Nora Volkow and colleagues from the National Institute on Drug Abuse did: a target trial emulation study.
A target trial emulation study is more or less what it sounds like. First, you decide what your dream randomized controlled trial would be and you plan it all out in great detail. You define the population you would recruit, with all the relevant inclusion and exclusion criteria. You define the intervention and the control, and you define the outcome.
But you don’t actually do the trial. You could if someone would lend you $10-$50 million, but assuming you don’t have that lying around, you do the next best thing, which is to dig into a medical record database to find all the people who would be eligible for your imaginary trial. And you analyze them.
The authors wanted to study the effect of Ozempic on smoking among people with diabetes; that’s why all the comparator agents are antidiabetes drugs. They figured out whether these folks were smoking on the basis of a medical record diagnosis of tobacco use disorder before they started one of the drugs of interest. This code is fairly specific: If a patient has it, you can be pretty sure they are smoking. But it’s not very sensitive; not every smoker has this diagnostic code. This is an age-old limitation of using EHR data instead of asking patients, but it’s part of the tradeoff for not having to spend $50 million.
After applying all those inclusion and exclusion criteria, they have a defined population who could be in their dream trial. And, as luck would have it, some of those people really were treated with Ozempic and some really were treated with those other agents. Although decisions about what to prescribe were not randomized, the authors account for this confounding-by-indication using propensity-score matching. You can find a little explainer on propensity-score matching in an earlier column here.
It’s easy enough, using the EHR, to figure out who has diabetes and who got which drug. But how do you know who quit smoking? Remember, everyone had a diagnosis code for tobacco use disorder prior to starting Ozempic or a comparator drug. The authors decided that if the patient had a medical visit where someone again coded tobacco-use disorder, they were still smoking. If someone prescribed smoking cessation meds like a nicotine patch or varenicline, they were obviously still smoking. If someone billed for tobacco-cessation counseling, the patient is still smoking. We’ll get back to the implications of this outcome definition in a minute.
Let’s talk about the results, which are pretty intriguing.
When Ozempic is compared with insulin among smokers with diabetes, those on Ozempic were about 30% more likely to quit smoking. They were about 18% more likely to quit smoking than those who took metformin. They were even slightly more likely to quit smoking than those on other GLP-1 receptor antagonists, though I should note that Mounjaro, which is probably the more potent GLP-1 drug in terms of weight loss, was not among the comparators.
This is pretty impressive for a drug that was not designed to be a smoking cessation drug. It speaks to this emerging idea that these drugs do more than curb appetite by slowing down gastric emptying or something. They work in the brain, modulating some of the reward circuitry that keeps us locked into our bad habits.
There are, of course, some caveats. As I pointed out, this study captured the idea of “still smoking” through the use of administrative codes in the EHR and prescription of smoking cessation aids. You could see similar results if taking Ozempic makes people less likely to address their smoking at all; maybe they shut down the doctor before they even talk about it, or there is too much to discuss during these visits to even get to the subject of smoking. You could also see results like this if people taking Ozempic had fewer visits overall, but the authors showed that that, at least, was not the case.
I’m inclined to believe that this effect is real, simply because we keep seeing signals from multiple sources. If that turns out to be the case, these new “weight loss” drugs may prove to be much more than that; they may turn out to be the drugs that can finally save us from ourselves.
Dr. Wilson is associate professor of medicine and public health and director of the Clinical and Translational Research Accelerator at Yale University, New Haven, Connecticut. He has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
If you’ve been paying attention only to the headlines, when you think of “Ozempic” you’ll think of a few things: a blockbuster weight loss drug or the tip of the spear of a completely new industry — why not? A drug so popular that the people it was invented for (those with diabetes) can’t even get it.
Ozempic and other GLP-1 receptor agonists are undeniable game changers. Insofar as obesity is the number-one public health risk in the United States, antiobesity drugs hold immense promise even if all they do is reduce obesity.
In 2023, an article in Scientific Reports presented data suggesting that people on Ozempic might be reducing their alcohol intake, not just their total calories.
A 2024 article in Molecular Psychiatry found that the drug might positively impact cannabis use disorder. An article from Brain Sciences suggests that the drug reduces compulsive shopping.
A picture is starting to form, a picture that suggests these drugs curb hunger both literally and figuratively. That GLP-1 receptor agonists like Ozempic and Mounjaro are fundamentally anticonsumption drugs. In a society that — some would argue — is plagued by overconsumption, these drugs might be just what the doctor ordered.
If only they could stop people from smoking.
Oh, wait — they can.
At least it seems they can, based on a new study appearing in Annals of Internal Medicine.
Before we get too excited, this is not a randomized trial. There actually was a small randomized trial of exenatide (Byetta), which is in the same class as Ozempic but probably a bit less potent, with promising results for smoking cessation.
But Byetta is the weaker drug in this class; the market leader is Ozempic. So how can you figure out whether Ozempic can reduce smoking without doing a huge and expensive randomized trial? You can do what Nora Volkow and colleagues from the National Institute on Drug Abuse did: a target trial emulation study.
A target trial emulation study is more or less what it sounds like. First, you decide what your dream randomized controlled trial would be and you plan it all out in great detail. You define the population you would recruit, with all the relevant inclusion and exclusion criteria. You define the intervention and the control, and you define the outcome.
But you don’t actually do the trial. You could if someone would lend you $10-$50 million, but assuming you don’t have that lying around, you do the next best thing, which is to dig into a medical record database to find all the people who would be eligible for your imaginary trial. And you analyze them.
The authors wanted to study the effect of Ozempic on smoking among people with diabetes; that’s why all the comparator agents are antidiabetes drugs. They figured out whether these folks were smoking on the basis of a medical record diagnosis of tobacco use disorder before they started one of the drugs of interest. This code is fairly specific: If a patient has it, you can be pretty sure they are smoking. But it’s not very sensitive; not every smoker has this diagnostic code. This is an age-old limitation of using EHR data instead of asking patients, but it’s part of the tradeoff for not having to spend $50 million.
After applying all those inclusion and exclusion criteria, they have a defined population who could be in their dream trial. And, as luck would have it, some of those people really were treated with Ozempic and some really were treated with those other agents. Although decisions about what to prescribe were not randomized, the authors account for this confounding-by-indication using propensity-score matching. You can find a little explainer on propensity-score matching in an earlier column here.
It’s easy enough, using the EHR, to figure out who has diabetes and who got which drug. But how do you know who quit smoking? Remember, everyone had a diagnosis code for tobacco use disorder prior to starting Ozempic or a comparator drug. The authors decided that if the patient had a medical visit where someone again coded tobacco-use disorder, they were still smoking. If someone prescribed smoking cessation meds like a nicotine patch or varenicline, they were obviously still smoking. If someone billed for tobacco-cessation counseling, the patient is still smoking. We’ll get back to the implications of this outcome definition in a minute.
Let’s talk about the results, which are pretty intriguing.
When Ozempic is compared with insulin among smokers with diabetes, those on Ozempic were about 30% more likely to quit smoking. They were about 18% more likely to quit smoking than those who took metformin. They were even slightly more likely to quit smoking than those on other GLP-1 receptor antagonists, though I should note that Mounjaro, which is probably the more potent GLP-1 drug in terms of weight loss, was not among the comparators.
This is pretty impressive for a drug that was not designed to be a smoking cessation drug. It speaks to this emerging idea that these drugs do more than curb appetite by slowing down gastric emptying or something. They work in the brain, modulating some of the reward circuitry that keeps us locked into our bad habits.
There are, of course, some caveats. As I pointed out, this study captured the idea of “still smoking” through the use of administrative codes in the EHR and prescription of smoking cessation aids. You could see similar results if taking Ozempic makes people less likely to address their smoking at all; maybe they shut down the doctor before they even talk about it, or there is too much to discuss during these visits to even get to the subject of smoking. You could also see results like this if people taking Ozempic had fewer visits overall, but the authors showed that that, at least, was not the case.
I’m inclined to believe that this effect is real, simply because we keep seeing signals from multiple sources. If that turns out to be the case, these new “weight loss” drugs may prove to be much more than that; they may turn out to be the drugs that can finally save us from ourselves.
Dr. Wilson is associate professor of medicine and public health and director of the Clinical and Translational Research Accelerator at Yale University, New Haven, Connecticut. He has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Too Much Coffee Linked to Accelerated Cognitive Decline
PHILADELPHIA – results from a large study suggest.
Investigators examined the impact of different amounts of coffee and tea on fluid intelligence — a measure of cognitive functions including abstract reasoning, pattern recognition, and logical thinking.
“It’s the old adage that too much of anything isn’t good. It’s all about balance, so moderate coffee consumption is okay but too much is probably not recommended,” said study investigator Kelsey R. Sewell, PhD, Advent Health Research Institute, Orlando, Florida.
The findings of the study were presented at the 2024 Alzheimer’s Association International Conference (AAIC).
One of the World’s Most Widely Consumed Beverages
Coffee is one of the most widely consumed beverages around the world. The beans contain a range of bioactive compounds, including caffeine, chlorogenic acid, and small amounts of vitamins and minerals.
Consistent evidence from observational and epidemiologic studies indicates that intake of both coffee and tea has beneficial effects on stroke, heart failure, cancers, diabetes, and Parkinson’s disease.
Several studies also suggest that coffee may reduce the risk for Alzheimer’s disease, said Dr. Sewell. However, there are limited longitudinal data on associations between coffee and tea intake and cognitive decline, particularly in distinct cognitive domains.
Dr. Sewell’s group previously published a study of cognitively unimpaired older adults that found greater coffee consumption was associated with slower cognitive decline and slower accumulation of brain beta-amyloid.
Their current study extends some of the prior findings and investigates the relationship between both coffee and tea intake and cognitive decline over time in a larger sample of older adults.
This new study included 8451 mostly female (60%) and White (97%) cognitively unimpaired adults older than 60 (mean age, 67.8 years) in the UK Biobank, a large-scale research resource containing in-depth, deidentified genetic and health information from half a million UK participants. Study subjects had a mean body mass index (BMI) of 26, and about 26% were apolipoprotein epsilon 4 (APOE e4) gene carriers.
Researchers divided coffee and tea consumption into tertiles: high, moderate, and no consumption.
For daily coffee consumption, 18% reported drinking four or more cups (high consumption), 58% reported drinking one to three cups (moderate consumption), and 25% reported that they never drink coffee. For daily tea consumption, 47% reported drinking four or more cups (high consumption), 38% reported drinking one to three cups (moderate consumption), and 15% reported that they never drink tea.
The study assessed cognitive function at baseline and at least two additional patient visits.
Researchers used linear mixed models to assess the relationships between coffee and tea intake and cognitive outcomes. The models adjusted for age, sex, Townsend deprivation index (reflecting socioeconomic status), ethnicity, APOE e4 status, and BMI.
Steeper Decline
Compared with high coffee consumption (four or more cups daily), people who never consumed coffee (beta, 0.06; standard error [SE], 0.02; P = .005) and those with moderate consumption (beta, 0.07; SE, 0.02; P = < .001) had slower decline in fluid intelligence after an average of 8.83 years of follow-up.
“We can see that those with high coffee consumption showed the steepest decline in fluid intelligence across the follow up, compared to those with moderate coffee consumption and those never consuming coffee,” said Dr. Sewell, referring to illustrative graphs.
At the same time, “our data suggest that across this time period, moderate coffee consumption can serve as some kind of protective factor against cognitive decline,” she added.
For tea, there was a somewhat different pattern. People who never drank tea had a greater decline in fluid intelligence, compared with those who had moderate consumption (beta, 0.06; SE, 0.02; P = .0090) or high consumption (beta, 0.06; SE, 0.02; P = .003).
Because this is an observational study, “we still need randomized controlled trials to better understand the neuroprotective mechanism of coffee and tea compounds,” said Dr. Sewell.
Responding later to a query from a meeting delegate about how moderate coffee drinking could be protective, Dr. Sewell said there are probably “different levels of mechanisms,” including at the molecular level (possibly involving amyloid toxicity) and the behavioral level (possibly involving sleep patterns).
Dr. Sewell said that she hopes this line of investigation will lead to new avenues of research in preventive strategies for Alzheimer’s disease.
“We hope that coffee and tea intake could contribute to the development of a safe and inexpensive strategy for delaying the onset and reducing the incidence for Alzheimer’s disease.”
A limitation of the study is possible recall bias, because coffee and tea consumption were self-reported. However, this may not be much of an issue because coffee and tea consumption “is usually quite a habitual behavior,” said Dr. Sewell.
The study also had no data on midlife coffee or tea consumption and did not compare the effect of different preparation methods or types of coffee and tea — for example, green tea versus black tea.
When asked if the study controlled for smoking, Dr. Sewell said it didn’t but added that it would be interesting to explore its impact on cognition.
Dr. Sewell reported no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
PHILADELPHIA – results from a large study suggest.
Investigators examined the impact of different amounts of coffee and tea on fluid intelligence — a measure of cognitive functions including abstract reasoning, pattern recognition, and logical thinking.
“It’s the old adage that too much of anything isn’t good. It’s all about balance, so moderate coffee consumption is okay but too much is probably not recommended,” said study investigator Kelsey R. Sewell, PhD, Advent Health Research Institute, Orlando, Florida.
The findings of the study were presented at the 2024 Alzheimer’s Association International Conference (AAIC).
One of the World’s Most Widely Consumed Beverages
Coffee is one of the most widely consumed beverages around the world. The beans contain a range of bioactive compounds, including caffeine, chlorogenic acid, and small amounts of vitamins and minerals.
Consistent evidence from observational and epidemiologic studies indicates that intake of both coffee and tea has beneficial effects on stroke, heart failure, cancers, diabetes, and Parkinson’s disease.
Several studies also suggest that coffee may reduce the risk for Alzheimer’s disease, said Dr. Sewell. However, there are limited longitudinal data on associations between coffee and tea intake and cognitive decline, particularly in distinct cognitive domains.
Dr. Sewell’s group previously published a study of cognitively unimpaired older adults that found greater coffee consumption was associated with slower cognitive decline and slower accumulation of brain beta-amyloid.
Their current study extends some of the prior findings and investigates the relationship between both coffee and tea intake and cognitive decline over time in a larger sample of older adults.
This new study included 8451 mostly female (60%) and White (97%) cognitively unimpaired adults older than 60 (mean age, 67.8 years) in the UK Biobank, a large-scale research resource containing in-depth, deidentified genetic and health information from half a million UK participants. Study subjects had a mean body mass index (BMI) of 26, and about 26% were apolipoprotein epsilon 4 (APOE e4) gene carriers.
Researchers divided coffee and tea consumption into tertiles: high, moderate, and no consumption.
For daily coffee consumption, 18% reported drinking four or more cups (high consumption), 58% reported drinking one to three cups (moderate consumption), and 25% reported that they never drink coffee. For daily tea consumption, 47% reported drinking four or more cups (high consumption), 38% reported drinking one to three cups (moderate consumption), and 15% reported that they never drink tea.
The study assessed cognitive function at baseline and at least two additional patient visits.
Researchers used linear mixed models to assess the relationships between coffee and tea intake and cognitive outcomes. The models adjusted for age, sex, Townsend deprivation index (reflecting socioeconomic status), ethnicity, APOE e4 status, and BMI.
Steeper Decline
Compared with high coffee consumption (four or more cups daily), people who never consumed coffee (beta, 0.06; standard error [SE], 0.02; P = .005) and those with moderate consumption (beta, 0.07; SE, 0.02; P = < .001) had slower decline in fluid intelligence after an average of 8.83 years of follow-up.
“We can see that those with high coffee consumption showed the steepest decline in fluid intelligence across the follow up, compared to those with moderate coffee consumption and those never consuming coffee,” said Dr. Sewell, referring to illustrative graphs.
At the same time, “our data suggest that across this time period, moderate coffee consumption can serve as some kind of protective factor against cognitive decline,” she added.
For tea, there was a somewhat different pattern. People who never drank tea had a greater decline in fluid intelligence, compared with those who had moderate consumption (beta, 0.06; SE, 0.02; P = .0090) or high consumption (beta, 0.06; SE, 0.02; P = .003).
Because this is an observational study, “we still need randomized controlled trials to better understand the neuroprotective mechanism of coffee and tea compounds,” said Dr. Sewell.
Responding later to a query from a meeting delegate about how moderate coffee drinking could be protective, Dr. Sewell said there are probably “different levels of mechanisms,” including at the molecular level (possibly involving amyloid toxicity) and the behavioral level (possibly involving sleep patterns).
Dr. Sewell said that she hopes this line of investigation will lead to new avenues of research in preventive strategies for Alzheimer’s disease.
“We hope that coffee and tea intake could contribute to the development of a safe and inexpensive strategy for delaying the onset and reducing the incidence for Alzheimer’s disease.”
A limitation of the study is possible recall bias, because coffee and tea consumption were self-reported. However, this may not be much of an issue because coffee and tea consumption “is usually quite a habitual behavior,” said Dr. Sewell.
The study also had no data on midlife coffee or tea consumption and did not compare the effect of different preparation methods or types of coffee and tea — for example, green tea versus black tea.
When asked if the study controlled for smoking, Dr. Sewell said it didn’t but added that it would be interesting to explore its impact on cognition.
Dr. Sewell reported no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
PHILADELPHIA – results from a large study suggest.
Investigators examined the impact of different amounts of coffee and tea on fluid intelligence — a measure of cognitive functions including abstract reasoning, pattern recognition, and logical thinking.
“It’s the old adage that too much of anything isn’t good. It’s all about balance, so moderate coffee consumption is okay but too much is probably not recommended,” said study investigator Kelsey R. Sewell, PhD, Advent Health Research Institute, Orlando, Florida.
The findings of the study were presented at the 2024 Alzheimer’s Association International Conference (AAIC).
One of the World’s Most Widely Consumed Beverages
Coffee is one of the most widely consumed beverages around the world. The beans contain a range of bioactive compounds, including caffeine, chlorogenic acid, and small amounts of vitamins and minerals.
Consistent evidence from observational and epidemiologic studies indicates that intake of both coffee and tea has beneficial effects on stroke, heart failure, cancers, diabetes, and Parkinson’s disease.
Several studies also suggest that coffee may reduce the risk for Alzheimer’s disease, said Dr. Sewell. However, there are limited longitudinal data on associations between coffee and tea intake and cognitive decline, particularly in distinct cognitive domains.
Dr. Sewell’s group previously published a study of cognitively unimpaired older adults that found greater coffee consumption was associated with slower cognitive decline and slower accumulation of brain beta-amyloid.
Their current study extends some of the prior findings and investigates the relationship between both coffee and tea intake and cognitive decline over time in a larger sample of older adults.
This new study included 8451 mostly female (60%) and White (97%) cognitively unimpaired adults older than 60 (mean age, 67.8 years) in the UK Biobank, a large-scale research resource containing in-depth, deidentified genetic and health information from half a million UK participants. Study subjects had a mean body mass index (BMI) of 26, and about 26% were apolipoprotein epsilon 4 (APOE e4) gene carriers.
Researchers divided coffee and tea consumption into tertiles: high, moderate, and no consumption.
For daily coffee consumption, 18% reported drinking four or more cups (high consumption), 58% reported drinking one to three cups (moderate consumption), and 25% reported that they never drink coffee. For daily tea consumption, 47% reported drinking four or more cups (high consumption), 38% reported drinking one to three cups (moderate consumption), and 15% reported that they never drink tea.
The study assessed cognitive function at baseline and at least two additional patient visits.
Researchers used linear mixed models to assess the relationships between coffee and tea intake and cognitive outcomes. The models adjusted for age, sex, Townsend deprivation index (reflecting socioeconomic status), ethnicity, APOE e4 status, and BMI.
Steeper Decline
Compared with high coffee consumption (four or more cups daily), people who never consumed coffee (beta, 0.06; standard error [SE], 0.02; P = .005) and those with moderate consumption (beta, 0.07; SE, 0.02; P = < .001) had slower decline in fluid intelligence after an average of 8.83 years of follow-up.
“We can see that those with high coffee consumption showed the steepest decline in fluid intelligence across the follow up, compared to those with moderate coffee consumption and those never consuming coffee,” said Dr. Sewell, referring to illustrative graphs.
At the same time, “our data suggest that across this time period, moderate coffee consumption can serve as some kind of protective factor against cognitive decline,” she added.
For tea, there was a somewhat different pattern. People who never drank tea had a greater decline in fluid intelligence, compared with those who had moderate consumption (beta, 0.06; SE, 0.02; P = .0090) or high consumption (beta, 0.06; SE, 0.02; P = .003).
Because this is an observational study, “we still need randomized controlled trials to better understand the neuroprotective mechanism of coffee and tea compounds,” said Dr. Sewell.
Responding later to a query from a meeting delegate about how moderate coffee drinking could be protective, Dr. Sewell said there are probably “different levels of mechanisms,” including at the molecular level (possibly involving amyloid toxicity) and the behavioral level (possibly involving sleep patterns).
Dr. Sewell said that she hopes this line of investigation will lead to new avenues of research in preventive strategies for Alzheimer’s disease.
“We hope that coffee and tea intake could contribute to the development of a safe and inexpensive strategy for delaying the onset and reducing the incidence for Alzheimer’s disease.”
A limitation of the study is possible recall bias, because coffee and tea consumption were self-reported. However, this may not be much of an issue because coffee and tea consumption “is usually quite a habitual behavior,” said Dr. Sewell.
The study also had no data on midlife coffee or tea consumption and did not compare the effect of different preparation methods or types of coffee and tea — for example, green tea versus black tea.
When asked if the study controlled for smoking, Dr. Sewell said it didn’t but added that it would be interesting to explore its impact on cognition.
Dr. Sewell reported no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
FROM AAIC 2024