Clinician Reviews

SAN DIEGO – Soon after Brett M. Coldiron, MD, launched his Cincinnati-based dermatology and Mohs surgery practice more than 20 years ago, he reported his first three cases of thin melanomas to the Ohio Department of Health, as mandated by state law.

“I got sent reams of paperwork to fill out that I did not understand,” Dr. Coldiron, a past president of the American College of Mohs Surgery and the American Academy of Dermatology, recalled at the annual Cutaneous Malignancy Update. “Then, I got chewed out for not reporting sooner and threatened with thousands of dollars in fines if I did not promptly report the forms in the future. It was an obnoxious experience.”

About 15 years later, while testifying at the Ohio Legislature on medical reasons to restrict the use of tanning beds, a lobbyist for the tanning bed industry told him that the melanoma rates had been stable in Ohio for the previous 5 years. “It turns out they were cherry picking certain segments of data to fit their narrative,” Dr. Coldiron said. “I was stunned and it kind of deflated me. I thought about this for a long time, and thought, ‘how do we solve this issue of reporting melanoma cases without adding work to existing staff if you’re a small practice and without spending significant amounts of money? Let’s make this easier.’ ”

In addition to reducing the use of tanning beds, proper reporting of melanoma cases is important for reasons that include efforts to increase sunscreen use and to be counted in ongoing research efforts to obtain a realistic snapshot of melanoma prevalence and incidence, he said.

Quality of melanoma case reporting relies on the Centers for Disease Control and Prevention’s National Program of Cancer Registries (NPCR), and the National Cancer Institute’s Surveillance Epidemiology and End Results (SEER) Program, which collects data on the incidence, treatment, staging, and survival for 28% of the US population. All 50 states and US territories require melanoma to be reported to the NPCR, but while most hospital systems have reporting protocols and dedicated data registrars, private practices may not.

Also, many dermatopathology practices operate independently and do not have dedicated registrars and may not report cases. “Melanoma is unique in that it is often completely managed in outpatient settings and these melanomas may never be reported,” said Dr. Coldiron, current president of the Ohio Dermatological Foundation. “That’s the practice gap.” One study published in 2018 found that only 49% of dermatologists knew that melanoma was a reportable disease and only 34% routinely reported newly diagnosed cases to their state’s cancer registry. He characterized melanoma reporting as an unfunded mandate.

“Hospitals are doing the most of them, because they have a registrar,” he said. “Small practices have to assign someone to do this, and it can be difficult to train that person. It’s time consuming. The first time we did it, it took an hour,” but, he said, taking a 2-hour tutorial from the Ohio Department of Health helped.

He noted that there is a lack of awareness and clinicians think it’s the dermatopathologist’s job to report cases, “while the dermatopathologist thinks it’s the clinician’s job,” and many of the entry fields are not applicable to thinner melanomas.

There is also a “patchwork” of ways that state departments of health accept the information, not all electronically, he continued. For example, those in Arizona, Montana, West Virginia, Delaware, Vermont, and Maine accept paper copies only, “meaning you have to download a PDF, fill it out, and fax it back to them,” Dr. Coldiron said at the meeting, which was hosted by Scripps Cancer Center.

To facilitate reporting in Ohio, Dr. Coldiron and two of his dermatology fellows, Matthew DaCunha, MD, and Michael Tassavor, MD, partnered with a local melanoma support group – Melanoma Know More — to assist with collection data in the reporting of thin melanomas, training volunteers from the group for the task. “We have them sign a HIPAA form and take the two-hour online tutorial,” he said. They download data that Ohio dermatologists have faxed to a dedicated secure HIPAA-compliant cloud-based fax line that Dr. Coldiron has set up, and the cases are then sent to the Ohio Department of Health.

Dr. Coldiron and colleagues have also partnered with the University of Cincinnati Clermont, which offers a National Cancer Registries Association–accredited certificate program — one of several nationwide. Students in this program are trained to become cancer registrars. “The university staff are gung-ho about it because they are looking for easy cases to train the students on. Also, the Ohio Department of Health staff are keen to help train the students and even help them find jobs or hire them after they complete the degree. Staff from the department of health and college faculty are fully engaged and supervising. It’s a win-win for all.”

According to Dr. Coldiron, in 2023, 8 Ohio dermatology practices were sending their reports to the fax line he set up and 7 more have signed up in recent months, making 15 practices to date. “It’s self-perpetuating at this point,” he said. “The Ohio Department of Health and the University of Cincinnati are invested in this program long-term.” The fax service costs Dr. Coldiron $42 per month — a small price to pay, he said, for being a clearinghouse for private Ohio dermatology practices looking for a practical way to report their melanoma cases. The model has increased melanoma reporting in Ohio by 2.8% in the last 2 years, “which doesn’t seem like that many, but if there are 6500 cases of melanoma, and you can increase reporting by a couple hundred cases, that’s a lot,” he said.

His goal is to expand this model to more states. “Dermatologists, surgical oncologists, and cancer center administrators should embrace this opportunity to make their practices a clearinghouse for their state,” he said. “This is an opportunity to improve state health, quality improvement projects, help providers, and gain recognition as a center of excellence. The increase in incidence of melanoma will lend great clout to public and legislative requests for prevention, treatment, and research dollars.”

In an interview, Hugh Greenway, MD, the head of Mohs and dermatologic surgery at Scripps Clinic in San Diego, also noted that cutaneous melanoma is significantly underreported in spite of individual state requirements. “As Dr. Coldiron reminds us, the main reason is that in many cases the pathology diagnosis and report come from the dermatologist’s/dermatopathologist’s office,” Dr. Greenway said. “With no hospital or large multispecialty laboratory involved, the reporting may be incomplete or not done. This is not the case with almost all other cancers where a hospital laboratory is involved.”

If widespread adoption of Dr. Coldiron’s model can occur, he added, “then we will have much better melanoma reporting data on which to both help our patients and specialty. He is to be applauded for producing a workable solution to the problem of underreporting.”

Dr. Coldiron reported having no relevant disclosures. Dr. Greenway reported that he conducts research for Castle Biosciences. He is also course director of the annual Cutaneous Malignancy Update.

SAN DIEGO – Soon after Brett M. Coldiron, MD, launched his Cincinnati-based dermatology and Mohs surgery practice more than 20 years ago, he reported his first three cases of thin melanomas to the Ohio Department of Health, as mandated by state law.

“I got sent reams of paperwork to fill out that I did not understand,” Dr. Coldiron, a past president of the American College of Mohs Surgery and the American Academy of Dermatology, recalled at the annual Cutaneous Malignancy Update. “Then, I got chewed out for not reporting sooner and threatened with thousands of dollars in fines if I did not promptly report the forms in the future. It was an obnoxious experience.”

About 15 years later, while testifying at the Ohio Legislature on medical reasons to restrict the use of tanning beds, a lobbyist for the tanning bed industry told him that the melanoma rates had been stable in Ohio for the previous 5 years. “It turns out they were cherry picking certain segments of data to fit their narrative,” Dr. Coldiron said. “I was stunned and it kind of deflated me. I thought about this for a long time, and thought, ‘how do we solve this issue of reporting melanoma cases without adding work to existing staff if you’re a small practice and without spending significant amounts of money? Let’s make this easier.’ ”

In addition to reducing the use of tanning beds, proper reporting of melanoma cases is important for reasons that include efforts to increase sunscreen use and to be counted in ongoing research efforts to obtain a realistic snapshot of melanoma prevalence and incidence, he said.

Quality of melanoma case reporting relies on the Centers for Disease Control and Prevention’s National Program of Cancer Registries (NPCR), and the National Cancer Institute’s Surveillance Epidemiology and End Results (SEER) Program, which collects data on the incidence, treatment, staging, and survival for 28% of the US population. All 50 states and US territories require melanoma to be reported to the NPCR, but while most hospital systems have reporting protocols and dedicated data registrars, private practices may not.

Also, many dermatopathology practices operate independently and do not have dedicated registrars and may not report cases. “Melanoma is unique in that it is often completely managed in outpatient settings and these melanomas may never be reported,” said Dr. Coldiron, current president of the Ohio Dermatological Foundation. “That’s the practice gap.” One study published in 2018 found that only 49% of dermatologists knew that melanoma was a reportable disease and only 34% routinely reported newly diagnosed cases to their state’s cancer registry. He characterized melanoma reporting as an unfunded mandate.

“Hospitals are doing the most of them, because they have a registrar,” he said. “Small practices have to assign someone to do this, and it can be difficult to train that person. It’s time consuming. The first time we did it, it took an hour,” but, he said, taking a 2-hour tutorial from the Ohio Department of Health helped.

He noted that there is a lack of awareness and clinicians think it’s the dermatopathologist’s job to report cases, “while the dermatopathologist thinks it’s the clinician’s job,” and many of the entry fields are not applicable to thinner melanomas.

There is also a “patchwork” of ways that state departments of health accept the information, not all electronically, he continued. For example, those in Arizona, Montana, West Virginia, Delaware, Vermont, and Maine accept paper copies only, “meaning you have to download a PDF, fill it out, and fax it back to them,” Dr. Coldiron said at the meeting, which was hosted by Scripps Cancer Center.

To facilitate reporting in Ohio, Dr. Coldiron and two of his dermatology fellows, Matthew DaCunha, MD, and Michael Tassavor, MD, partnered with a local melanoma support group – Melanoma Know More — to assist with collection data in the reporting of thin melanomas, training volunteers from the group for the task. “We have them sign a HIPAA form and take the two-hour online tutorial,” he said. They download data that Ohio dermatologists have faxed to a dedicated secure HIPAA-compliant cloud-based fax line that Dr. Coldiron has set up, and the cases are then sent to the Ohio Department of Health.

Dr. Coldiron and colleagues have also partnered with the University of Cincinnati Clermont, which offers a National Cancer Registries Association–accredited certificate program — one of several nationwide. Students in this program are trained to become cancer registrars. “The university staff are gung-ho about it because they are looking for easy cases to train the students on. Also, the Ohio Department of Health staff are keen to help train the students and even help them find jobs or hire them after they complete the degree. Staff from the department of health and college faculty are fully engaged and supervising. It’s a win-win for all.”

According to Dr. Coldiron, in 2023, 8 Ohio dermatology practices were sending their reports to the fax line he set up and 7 more have signed up in recent months, making 15 practices to date. “It’s self-perpetuating at this point,” he said. “The Ohio Department of Health and the University of Cincinnati are invested in this program long-term.” The fax service costs Dr. Coldiron $42 per month — a small price to pay, he said, for being a clearinghouse for private Ohio dermatology practices looking for a practical way to report their melanoma cases. The model has increased melanoma reporting in Ohio by 2.8% in the last 2 years, “which doesn’t seem like that many, but if there are 6500 cases of melanoma, and you can increase reporting by a couple hundred cases, that’s a lot,” he said.

His goal is to expand this model to more states. “Dermatologists, surgical oncologists, and cancer center administrators should embrace this opportunity to make their practices a clearinghouse for their state,” he said. “This is an opportunity to improve state health, quality improvement projects, help providers, and gain recognition as a center of excellence. The increase in incidence of melanoma will lend great clout to public and legislative requests for prevention, treatment, and research dollars.”

In an interview, Hugh Greenway, MD, the head of Mohs and dermatologic surgery at Scripps Clinic in San Diego, also noted that cutaneous melanoma is significantly underreported in spite of individual state requirements. “As Dr. Coldiron reminds us, the main reason is that in many cases the pathology diagnosis and report come from the dermatologist’s/dermatopathologist’s office,” Dr. Greenway said. “With no hospital or large multispecialty laboratory involved, the reporting may be incomplete or not done. This is not the case with almost all other cancers where a hospital laboratory is involved.”

If widespread adoption of Dr. Coldiron’s model can occur, he added, “then we will have much better melanoma reporting data on which to both help our patients and specialty. He is to be applauded for producing a workable solution to the problem of underreporting.”

Dr. Coldiron reported having no relevant disclosures. Dr. Greenway reported that he conducts research for Castle Biosciences. He is also course director of the annual Cutaneous Malignancy Update.

SAN DIEGO – Soon after Brett M. Coldiron, MD, launched his Cincinnati-based dermatology and Mohs surgery practice more than 20 years ago, he reported his first three cases of thin melanomas to the Ohio Department of Health, as mandated by state law.

“I got sent reams of paperwork to fill out that I did not understand,” Dr. Coldiron, a past president of the American College of Mohs Surgery and the American Academy of Dermatology, recalled at the annual Cutaneous Malignancy Update. “Then, I got chewed out for not reporting sooner and threatened with thousands of dollars in fines if I did not promptly report the forms in the future. It was an obnoxious experience.”

About 15 years later, while testifying at the Ohio Legislature on medical reasons to restrict the use of tanning beds, a lobbyist for the tanning bed industry told him that the melanoma rates had been stable in Ohio for the previous 5 years. “It turns out they were cherry picking certain segments of data to fit their narrative,” Dr. Coldiron said. “I was stunned and it kind of deflated me. I thought about this for a long time, and thought, ‘how do we solve this issue of reporting melanoma cases without adding work to existing staff if you’re a small practice and without spending significant amounts of money? Let’s make this easier.’ ”

In addition to reducing the use of tanning beds, proper reporting of melanoma cases is important for reasons that include efforts to increase sunscreen use and to be counted in ongoing research efforts to obtain a realistic snapshot of melanoma prevalence and incidence, he said.

Quality of melanoma case reporting relies on the Centers for Disease Control and Prevention’s National Program of Cancer Registries (NPCR), and the National Cancer Institute’s Surveillance Epidemiology and End Results (SEER) Program, which collects data on the incidence, treatment, staging, and survival for 28% of the US population. All 50 states and US territories require melanoma to be reported to the NPCR, but while most hospital systems have reporting protocols and dedicated data registrars, private practices may not.

Also, many dermatopathology practices operate independently and do not have dedicated registrars and may not report cases. “Melanoma is unique in that it is often completely managed in outpatient settings and these melanomas may never be reported,” said Dr. Coldiron, current president of the Ohio Dermatological Foundation. “That’s the practice gap.” One study published in 2018 found that only 49% of dermatologists knew that melanoma was a reportable disease and only 34% routinely reported newly diagnosed cases to their state’s cancer registry. He characterized melanoma reporting as an unfunded mandate.

“Hospitals are doing the most of them, because they have a registrar,” he said. “Small practices have to assign someone to do this, and it can be difficult to train that person. It’s time consuming. The first time we did it, it took an hour,” but, he said, taking a 2-hour tutorial from the Ohio Department of Health helped.

He noted that there is a lack of awareness and clinicians think it’s the dermatopathologist’s job to report cases, “while the dermatopathologist thinks it’s the clinician’s job,” and many of the entry fields are not applicable to thinner melanomas.

There is also a “patchwork” of ways that state departments of health accept the information, not all electronically, he continued. For example, those in Arizona, Montana, West Virginia, Delaware, Vermont, and Maine accept paper copies only, “meaning you have to download a PDF, fill it out, and fax it back to them,” Dr. Coldiron said at the meeting, which was hosted by Scripps Cancer Center.

To facilitate reporting in Ohio, Dr. Coldiron and two of his dermatology fellows, Matthew DaCunha, MD, and Michael Tassavor, MD, partnered with a local melanoma support group – Melanoma Know More — to assist with collection data in the reporting of thin melanomas, training volunteers from the group for the task. “We have them sign a HIPAA form and take the two-hour online tutorial,” he said. They download data that Ohio dermatologists have faxed to a dedicated secure HIPAA-compliant cloud-based fax line that Dr. Coldiron has set up, and the cases are then sent to the Ohio Department of Health.

Dr. Coldiron and colleagues have also partnered with the University of Cincinnati Clermont, which offers a National Cancer Registries Association–accredited certificate program — one of several nationwide. Students in this program are trained to become cancer registrars. “The university staff are gung-ho about it because they are looking for easy cases to train the students on. Also, the Ohio Department of Health staff are keen to help train the students and even help them find jobs or hire them after they complete the degree. Staff from the department of health and college faculty are fully engaged and supervising. It’s a win-win for all.”

According to Dr. Coldiron, in 2023, 8 Ohio dermatology practices were sending their reports to the fax line he set up and 7 more have signed up in recent months, making 15 practices to date. “It’s self-perpetuating at this point,” he said. “The Ohio Department of Health and the University of Cincinnati are invested in this program long-term.” The fax service costs Dr. Coldiron $42 per month — a small price to pay, he said, for being a clearinghouse for private Ohio dermatology practices looking for a practical way to report their melanoma cases. The model has increased melanoma reporting in Ohio by 2.8% in the last 2 years, “which doesn’t seem like that many, but if there are 6500 cases of melanoma, and you can increase reporting by a couple hundred cases, that’s a lot,” he said.

His goal is to expand this model to more states. “Dermatologists, surgical oncologists, and cancer center administrators should embrace this opportunity to make their practices a clearinghouse for their state,” he said. “This is an opportunity to improve state health, quality improvement projects, help providers, and gain recognition as a center of excellence. The increase in incidence of melanoma will lend great clout to public and legislative requests for prevention, treatment, and research dollars.”

In an interview, Hugh Greenway, MD, the head of Mohs and dermatologic surgery at Scripps Clinic in San Diego, also noted that cutaneous melanoma is significantly underreported in spite of individual state requirements. “As Dr. Coldiron reminds us, the main reason is that in many cases the pathology diagnosis and report come from the dermatologist’s/dermatopathologist’s office,” Dr. Greenway said. “With no hospital or large multispecialty laboratory involved, the reporting may be incomplete or not done. This is not the case with almost all other cancers where a hospital laboratory is involved.”

If widespread adoption of Dr. Coldiron’s model can occur, he added, “then we will have much better melanoma reporting data on which to both help our patients and specialty. He is to be applauded for producing a workable solution to the problem of underreporting.”

Dr. Coldiron reported having no relevant disclosures. Dr. Greenway reported that he conducts research for Castle Biosciences. He is also course director of the annual Cutaneous Malignancy Update.

TOPLINE:

Despite diabetes technology, many with type 1 diabetes (T1D) miss glycemic targets and experience severe hypoglycemia and impaired awareness of hypoglycemia (IAH). 

METHODOLOGY:

• The clinical management of T1D through technology is now recognized as the standard of care, but its real-world impact on glycemic targets and severe hypoglycemic events and IAH is unclear.
• Researchers assessed the self-reported prevalence of glycemic metrics, severe hypoglycemia, and hypoglycemia awareness according to the use of continuous glucose monitoring (CGM) and automated insulin delivery (AID) systems.
• They enrolled 2044 individuals diagnosed with T1D for at least 2 years (mean age, 43.0 years; 72.1% women; 95.4% White) from the T1D Exchange Registry and online communities who filled an online survey.
• Participants were stratified on the basis of the presence or absence of CGM and different insulin delivery methods (multiple daily injections, conventional pumps, or AID systems).
• The primary outcome was the proportion of participants who achieved glycemic targets (self-reported A1c), had severe hypoglycemia (any low glucose incidence in 12 months), and/or IAH (a modified Gold score on a seven-point Likert scale).

TAKEAWAY:

• Most participants (91.7%) used CGM, and 50.8% of CGM users used an AID system.
• Despite advanced interventions, only 59.6% (95% CI, 57.3%-61.8%) of CGM users met the glycemic target (A1c < 7%), while nearly 40% of CGM users and 35.6% of AID users didn’t reach the target.
• At least one event of severe hypoglycemia in the previous 12 months was reported in 10.8% of CGM users and 16.6% of those using an AID system.
• IAH prevalence was seen in 31.1% (95% CI, 29.0%-33.2%) and 30.3% (95% CI, 17.5%-33.3%) of participants using CGM and CGM + AID, respectively.

IN PRACTICE:

“Educational initiatives continue to be important for all individuals with type 1 diabetes, and the development of novel therapeutic options and strategies, including bihormonal AID systems and beta-cell replacement, will be required to enable more of these individuals to meet treatment goals,” the authors wrote.

SOURCE:

The study, published online in Diabetes Care, was led by Jennifer L. Sherr, MD, PhD, Yale School of Medicine, New Haven, Connecticut.

LIMITATIONS:

The survey participants in this study were from the T1D Exchange online community, who tend to be highly involved, have technology experience, and are more likely to achieve glycemic targets. The data reported as part of the survey were based on self-reports by participants and may be subject to recall bias. Notably, severe hypoglycemic events may be overreported by individuals using CGM and AID systems due to sensor alarms.

DISCLOSURES:

The study was funded by Vertex Pharmaceuticals. Several authors disclosed financial relationships, including grants, consulting fees, honoraria, stock ownership, and employment with pharmaceutical and device companies and other entities.

A version of this article appeared on Medscape.com.

TOPLINE:

Despite diabetes technology, many with type 1 diabetes (T1D) miss glycemic targets and experience severe hypoglycemia and impaired awareness of hypoglycemia (IAH). 

METHODOLOGY:

• The clinical management of T1D through technology is now recognized as the standard of care, but its real-world impact on glycemic targets and severe hypoglycemic events and IAH is unclear.
• Researchers assessed the self-reported prevalence of glycemic metrics, severe hypoglycemia, and hypoglycemia awareness according to the use of continuous glucose monitoring (CGM) and automated insulin delivery (AID) systems.
• They enrolled 2044 individuals diagnosed with T1D for at least 2 years (mean age, 43.0 years; 72.1% women; 95.4% White) from the T1D Exchange Registry and online communities who filled an online survey.
• Participants were stratified on the basis of the presence or absence of CGM and different insulin delivery methods (multiple daily injections, conventional pumps, or AID systems).
• The primary outcome was the proportion of participants who achieved glycemic targets (self-reported A1c), had severe hypoglycemia (any low glucose incidence in 12 months), and/or IAH (a modified Gold score on a seven-point Likert scale).

TAKEAWAY:

• Most participants (91.7%) used CGM, and 50.8% of CGM users used an AID system.
• Despite advanced interventions, only 59.6% (95% CI, 57.3%-61.8%) of CGM users met the glycemic target (A1c < 7%), while nearly 40% of CGM users and 35.6% of AID users didn’t reach the target.
• At least one event of severe hypoglycemia in the previous 12 months was reported in 10.8% of CGM users and 16.6% of those using an AID system.
• IAH prevalence was seen in 31.1% (95% CI, 29.0%-33.2%) and 30.3% (95% CI, 17.5%-33.3%) of participants using CGM and CGM + AID, respectively.

IN PRACTICE:

“Educational initiatives continue to be important for all individuals with type 1 diabetes, and the development of novel therapeutic options and strategies, including bihormonal AID systems and beta-cell replacement, will be required to enable more of these individuals to meet treatment goals,” the authors wrote.

SOURCE:

The study, published online in Diabetes Care, was led by Jennifer L. Sherr, MD, PhD, Yale School of Medicine, New Haven, Connecticut.

LIMITATIONS:

The survey participants in this study were from the T1D Exchange online community, who tend to be highly involved, have technology experience, and are more likely to achieve glycemic targets. The data reported as part of the survey were based on self-reports by participants and may be subject to recall bias. Notably, severe hypoglycemic events may be overreported by individuals using CGM and AID systems due to sensor alarms.

DISCLOSURES:

The study was funded by Vertex Pharmaceuticals. Several authors disclosed financial relationships, including grants, consulting fees, honoraria, stock ownership, and employment with pharmaceutical and device companies and other entities.

A version of this article appeared on Medscape.com.

TOPLINE:

Despite diabetes technology, many with type 1 diabetes (T1D) miss glycemic targets and experience severe hypoglycemia and impaired awareness of hypoglycemia (IAH). 

METHODOLOGY:

• The clinical management of T1D through technology is now recognized as the standard of care, but its real-world impact on glycemic targets and severe hypoglycemic events and IAH is unclear.
• Researchers assessed the self-reported prevalence of glycemic metrics, severe hypoglycemia, and hypoglycemia awareness according to the use of continuous glucose monitoring (CGM) and automated insulin delivery (AID) systems.
• They enrolled 2044 individuals diagnosed with T1D for at least 2 years (mean age, 43.0 years; 72.1% women; 95.4% White) from the T1D Exchange Registry and online communities who filled an online survey.
• Participants were stratified on the basis of the presence or absence of CGM and different insulin delivery methods (multiple daily injections, conventional pumps, or AID systems).
• The primary outcome was the proportion of participants who achieved glycemic targets (self-reported A1c), had severe hypoglycemia (any low glucose incidence in 12 months), and/or IAH (a modified Gold score on a seven-point Likert scale).

TAKEAWAY:

• Most participants (91.7%) used CGM, and 50.8% of CGM users used an AID system.
• Despite advanced interventions, only 59.6% (95% CI, 57.3%-61.8%) of CGM users met the glycemic target (A1c < 7%), while nearly 40% of CGM users and 35.6% of AID users didn’t reach the target.
• At least one event of severe hypoglycemia in the previous 12 months was reported in 10.8% of CGM users and 16.6% of those using an AID system.
• IAH prevalence was seen in 31.1% (95% CI, 29.0%-33.2%) and 30.3% (95% CI, 17.5%-33.3%) of participants using CGM and CGM + AID, respectively.

IN PRACTICE:

“Educational initiatives continue to be important for all individuals with type 1 diabetes, and the development of novel therapeutic options and strategies, including bihormonal AID systems and beta-cell replacement, will be required to enable more of these individuals to meet treatment goals,” the authors wrote.

SOURCE:

The study, published online in Diabetes Care, was led by Jennifer L. Sherr, MD, PhD, Yale School of Medicine, New Haven, Connecticut.

LIMITATIONS:

The survey participants in this study were from the T1D Exchange online community, who tend to be highly involved, have technology experience, and are more likely to achieve glycemic targets. The data reported as part of the survey were based on self-reports by participants and may be subject to recall bias. Notably, severe hypoglycemic events may be overreported by individuals using CGM and AID systems due to sensor alarms.

DISCLOSURES:

The study was funded by Vertex Pharmaceuticals. Several authors disclosed financial relationships, including grants, consulting fees, honoraria, stock ownership, and employment with pharmaceutical and device companies and other entities.

A version of this article appeared on Medscape.com.

TOPLINE:

Oral intragastric expandable capsules taken twice daily before meals reduce body weight in adults with overweight or obesity compared with placebo, with mild gastrointestinal adverse events.

METHODOLOGY:

• Numerous anti-obesity pharmacotherapies have demonstrated effectiveness in reducing weight, but they may lead to side effects.
• This 24-week phase 3 randomized placebo-controlled study evaluated 2.24 g oral intragastric expandable capsules for weight loss in 280 adults (ages 18-60 years) with overweight or obesity (body mass index ≥ 24 kg/m2).
• One capsule, taken before lunch and dinner with water, expands to fill about one quarter of average stomach volume and then passes through the body, similar to the US Food and Drug Administration–cleared device Plenity.
• Primary endpoints were the percentage change in body weight from baseline and the weight loss response rate (weight loss of at least 5% of baseline body weight) at week 24.
• Researchers analyzed efficacy outcomes in two ways: Intention to treat (a full analysis based on groups to which they were randomly assigned) and per protocol (based on data from participants who follow the protocol).

TAKEAWAY:

• At 24 weeks, the change in mean body weight was higher with intragastric expandable capsules than with placebo using the per protocol set (estimated treatment difference [ETD], −3.6%; P < .001), with similar results using the full analysis set.
• The weight loss response rate at 24 weeks was higher with intragastric expandable capsules than with placebo using the per protocol set (ETD, 29.6%; P < .001), with similar results using the full analysis set.
• Reduction in fasting insulin levels was higher with intragastric expandable capsules than with placebo (P = .008), while improvements in the lipid profile, fasting plasma glucose levels, and heart rate were similar between the groups.
• Gastrointestinal disorders were reported in 25.0% of participants in the intragastric expandable capsule group compared with 21.9% in the placebo group, with most being transient and mild in severity.

IN PRACTICE:

“As a mild and safe anti-obesity medication, intragastric expandable capsules provide a new therapeutic choice for individuals with overweight or obesity, helping them to enhance and maintain the effect of diet restriction,” wrote the authors.

SOURCE:

Difei Lu, MD, Department of Endocrinology, Peking University First Hospital, Beijing, China, led the study, which was published online in Diabetes, Obesity and Metabolism.

LIMITATIONS:

The study included individuals who were overweight or obese, who might have been more willing to lose weight than the general population. Moreover, only 3.25% of the participants had type 2 diabetes, and participants were relatively young. This may have reduced the potential to discover metabolic or cardiovascular improvement by the product.

DISCLOSURES:

This study was funded by Xiamen Junde Pharmaceutical Technology. The authors disclosed no conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

Oral intragastric expandable capsules taken twice daily before meals reduce body weight in adults with overweight or obesity compared with placebo, with mild gastrointestinal adverse events.

METHODOLOGY:

• Numerous anti-obesity pharmacotherapies have demonstrated effectiveness in reducing weight, but they may lead to side effects.
• This 24-week phase 3 randomized placebo-controlled study evaluated 2.24 g oral intragastric expandable capsules for weight loss in 280 adults (ages 18-60 years) with overweight or obesity (body mass index ≥ 24 kg/m2).
• One capsule, taken before lunch and dinner with water, expands to fill about one quarter of average stomach volume and then passes through the body, similar to the US Food and Drug Administration–cleared device Plenity.
• Primary endpoints were the percentage change in body weight from baseline and the weight loss response rate (weight loss of at least 5% of baseline body weight) at week 24.
• Researchers analyzed efficacy outcomes in two ways: Intention to treat (a full analysis based on groups to which they were randomly assigned) and per protocol (based on data from participants who follow the protocol).

TAKEAWAY:

• At 24 weeks, the change in mean body weight was higher with intragastric expandable capsules than with placebo using the per protocol set (estimated treatment difference [ETD], −3.6%; P < .001), with similar results using the full analysis set.
• The weight loss response rate at 24 weeks was higher with intragastric expandable capsules than with placebo using the per protocol set (ETD, 29.6%; P < .001), with similar results using the full analysis set.
• Reduction in fasting insulin levels was higher with intragastric expandable capsules than with placebo (P = .008), while improvements in the lipid profile, fasting plasma glucose levels, and heart rate were similar between the groups.
• Gastrointestinal disorders were reported in 25.0% of participants in the intragastric expandable capsule group compared with 21.9% in the placebo group, with most being transient and mild in severity.

IN PRACTICE:

“As a mild and safe anti-obesity medication, intragastric expandable capsules provide a new therapeutic choice for individuals with overweight or obesity, helping them to enhance and maintain the effect of diet restriction,” wrote the authors.

SOURCE:

Difei Lu, MD, Department of Endocrinology, Peking University First Hospital, Beijing, China, led the study, which was published online in Diabetes, Obesity and Metabolism.

LIMITATIONS:

The study included individuals who were overweight or obese, who might have been more willing to lose weight than the general population. Moreover, only 3.25% of the participants had type 2 diabetes, and participants were relatively young. This may have reduced the potential to discover metabolic or cardiovascular improvement by the product.

DISCLOSURES:

This study was funded by Xiamen Junde Pharmaceutical Technology. The authors disclosed no conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

Oral intragastric expandable capsules taken twice daily before meals reduce body weight in adults with overweight or obesity compared with placebo, with mild gastrointestinal adverse events.

METHODOLOGY:

• Numerous anti-obesity pharmacotherapies have demonstrated effectiveness in reducing weight, but they may lead to side effects.
• This 24-week phase 3 randomized placebo-controlled study evaluated 2.24 g oral intragastric expandable capsules for weight loss in 280 adults (ages 18-60 years) with overweight or obesity (body mass index ≥ 24 kg/m2).
• One capsule, taken before lunch and dinner with water, expands to fill about one quarter of average stomach volume and then passes through the body, similar to the US Food and Drug Administration–cleared device Plenity.
• Primary endpoints were the percentage change in body weight from baseline and the weight loss response rate (weight loss of at least 5% of baseline body weight) at week 24.
• Researchers analyzed efficacy outcomes in two ways: Intention to treat (a full analysis based on groups to which they were randomly assigned) and per protocol (based on data from participants who follow the protocol).

TAKEAWAY:

• At 24 weeks, the change in mean body weight was higher with intragastric expandable capsules than with placebo using the per protocol set (estimated treatment difference [ETD], −3.6%; P < .001), with similar results using the full analysis set.
• The weight loss response rate at 24 weeks was higher with intragastric expandable capsules than with placebo using the per protocol set (ETD, 29.6%; P < .001), with similar results using the full analysis set.
• Reduction in fasting insulin levels was higher with intragastric expandable capsules than with placebo (P = .008), while improvements in the lipid profile, fasting plasma glucose levels, and heart rate were similar between the groups.
• Gastrointestinal disorders were reported in 25.0% of participants in the intragastric expandable capsule group compared with 21.9% in the placebo group, with most being transient and mild in severity.

IN PRACTICE:

“As a mild and safe anti-obesity medication, intragastric expandable capsules provide a new therapeutic choice for individuals with overweight or obesity, helping them to enhance and maintain the effect of diet restriction,” wrote the authors.

SOURCE:

Difei Lu, MD, Department of Endocrinology, Peking University First Hospital, Beijing, China, led the study, which was published online in Diabetes, Obesity and Metabolism.

LIMITATIONS:

The study included individuals who were overweight or obese, who might have been more willing to lose weight than the general population. Moreover, only 3.25% of the participants had type 2 diabetes, and participants were relatively young. This may have reduced the potential to discover metabolic or cardiovascular improvement by the product.

DISCLOSURES:

This study was funded by Xiamen Junde Pharmaceutical Technology. The authors disclosed no conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

Persistent hypertriglyceridemia is linked to an increased risk for type 2 diabetes (T2D) in young adults, independent of lifestyle factors.

METHODOLOGY:

• This prospective study analyzed the data of 1,840,251 individuals aged 20-39 years from the South Korean National Health Insurance Service database (mean age 34 years, 71% male).
• The individuals had undergone four consecutive annual health checkups between 2009 and 2012 and had no history of T2D.
• The individuals were sorted into five groups indicating the number of hypertriglyceridemia diagnoses over four consecutive years: 0, 1, 2, 3, and 4, defined as serum fasting triglyceride levels of 150 mg/dL or higher.
• Data on lifestyle-related risk factors, such as smoking status and heavy alcohol consumption, were collected through self-reported questionnaires.
• The primary outcome was newly diagnosed cases of T2D. Over a mean follow-up of 6.53 years, a total of 40,286 individuals developed T2D.

TAKEAWAY:

• The cumulative incidence of T2D increased with an increase in exposure scores for hypertriglyceridemia (log-rank test, P < .001), independent of lifestyle-related factors.
• The incidence rate per 1000 person-years was 1.25 for participants with an exposure score of 0 and 11.55 for those with a score of 4.
• For individuals with exposure scores of 1, 2, 3, and 4, the adjusted hazard ratios for incident diabetes were 1.674 (95% CI, 1.619-1.732), 2.192 (2.117-2.269), 2.637 (2.548-2.73), and 3.715 (3.6-3.834), respectively, vs those with an exposure score of 0.
• Exploratory subgroup analyses suggested the risk for T2D in persistent hypertriglyceridemia were more pronounced among people in their 20s than in their 30s and in women.

IN PRACTICE:

“Identification of individuals at higher risk based on triglyceride levels and management strategies for persistent hypertriglyceridemia in young adults could potentially reduce the burden of young-onset type 2 diabetes and enhance long-term health outcomes,” the authors wrote.

SOURCE:

The study, led by Min-Kyung Lee, Division of Endocrinology and Metabolism, Department of Internal Medicine, Myongji Hospital, Hanyang University College of Medicine, Seoul, Republic of Korea, was published online in Diabetes Research and Clinical Practice.

LIMITATIONS:

The scoring system based on fasting triglyceride levels of ≥ 150 mg/dL may have limitations, as the cumulative incidence of T2D also varied significantly for mean triglyceride levels. Moreover, relying on a single annual health checkup for hypertriglyceridemia diagnosis might not capture short-term fluctuations. Despite sufficient cases and a high follow-up rate, the study might have underestimated the incidence of T2D.

DISCLOSURES:

This work was supported by the National Research Foundation of Korea grant funded by the Korean Government and the faculty grant of Myongji Hospital. The authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

Persistent hypertriglyceridemia is linked to an increased risk for type 2 diabetes (T2D) in young adults, independent of lifestyle factors.

METHODOLOGY:

• This prospective study analyzed the data of 1,840,251 individuals aged 20-39 years from the South Korean National Health Insurance Service database (mean age 34 years, 71% male).
• The individuals had undergone four consecutive annual health checkups between 2009 and 2012 and had no history of T2D.
• The individuals were sorted into five groups indicating the number of hypertriglyceridemia diagnoses over four consecutive years: 0, 1, 2, 3, and 4, defined as serum fasting triglyceride levels of 150 mg/dL or higher.
• Data on lifestyle-related risk factors, such as smoking status and heavy alcohol consumption, were collected through self-reported questionnaires.
• The primary outcome was newly diagnosed cases of T2D. Over a mean follow-up of 6.53 years, a total of 40,286 individuals developed T2D.

TAKEAWAY:

• The cumulative incidence of T2D increased with an increase in exposure scores for hypertriglyceridemia (log-rank test, P < .001), independent of lifestyle-related factors.
• The incidence rate per 1000 person-years was 1.25 for participants with an exposure score of 0 and 11.55 for those with a score of 4.
• For individuals with exposure scores of 1, 2, 3, and 4, the adjusted hazard ratios for incident diabetes were 1.674 (95% CI, 1.619-1.732), 2.192 (2.117-2.269), 2.637 (2.548-2.73), and 3.715 (3.6-3.834), respectively, vs those with an exposure score of 0.
• Exploratory subgroup analyses suggested the risk for T2D in persistent hypertriglyceridemia were more pronounced among people in their 20s than in their 30s and in women.

IN PRACTICE:

“Identification of individuals at higher risk based on triglyceride levels and management strategies for persistent hypertriglyceridemia in young adults could potentially reduce the burden of young-onset type 2 diabetes and enhance long-term health outcomes,” the authors wrote.

SOURCE:

The study, led by Min-Kyung Lee, Division of Endocrinology and Metabolism, Department of Internal Medicine, Myongji Hospital, Hanyang University College of Medicine, Seoul, Republic of Korea, was published online in Diabetes Research and Clinical Practice.

LIMITATIONS:

The scoring system based on fasting triglyceride levels of ≥ 150 mg/dL may have limitations, as the cumulative incidence of T2D also varied significantly for mean triglyceride levels. Moreover, relying on a single annual health checkup for hypertriglyceridemia diagnosis might not capture short-term fluctuations. Despite sufficient cases and a high follow-up rate, the study might have underestimated the incidence of T2D.

DISCLOSURES:

This work was supported by the National Research Foundation of Korea grant funded by the Korean Government and the faculty grant of Myongji Hospital. The authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

Persistent hypertriglyceridemia is linked to an increased risk for type 2 diabetes (T2D) in young adults, independent of lifestyle factors.

METHODOLOGY:

• This prospective study analyzed the data of 1,840,251 individuals aged 20-39 years from the South Korean National Health Insurance Service database (mean age 34 years, 71% male).
• The individuals had undergone four consecutive annual health checkups between 2009 and 2012 and had no history of T2D.
• The individuals were sorted into five groups indicating the number of hypertriglyceridemia diagnoses over four consecutive years: 0, 1, 2, 3, and 4, defined as serum fasting triglyceride levels of 150 mg/dL or higher.
• Data on lifestyle-related risk factors, such as smoking status and heavy alcohol consumption, were collected through self-reported questionnaires.
• The primary outcome was newly diagnosed cases of T2D. Over a mean follow-up of 6.53 years, a total of 40,286 individuals developed T2D.

TAKEAWAY:

• The cumulative incidence of T2D increased with an increase in exposure scores for hypertriglyceridemia (log-rank test, P < .001), independent of lifestyle-related factors.
• The incidence rate per 1000 person-years was 1.25 for participants with an exposure score of 0 and 11.55 for those with a score of 4.
• For individuals with exposure scores of 1, 2, 3, and 4, the adjusted hazard ratios for incident diabetes were 1.674 (95% CI, 1.619-1.732), 2.192 (2.117-2.269), 2.637 (2.548-2.73), and 3.715 (3.6-3.834), respectively, vs those with an exposure score of 0.
• Exploratory subgroup analyses suggested the risk for T2D in persistent hypertriglyceridemia were more pronounced among people in their 20s than in their 30s and in women.

IN PRACTICE:

“Identification of individuals at higher risk based on triglyceride levels and management strategies for persistent hypertriglyceridemia in young adults could potentially reduce the burden of young-onset type 2 diabetes and enhance long-term health outcomes,” the authors wrote.

SOURCE:

The study, led by Min-Kyung Lee, Division of Endocrinology and Metabolism, Department of Internal Medicine, Myongji Hospital, Hanyang University College of Medicine, Seoul, Republic of Korea, was published online in Diabetes Research and Clinical Practice.

LIMITATIONS:

The scoring system based on fasting triglyceride levels of ≥ 150 mg/dL may have limitations, as the cumulative incidence of T2D also varied significantly for mean triglyceride levels. Moreover, relying on a single annual health checkup for hypertriglyceridemia diagnosis might not capture short-term fluctuations. Despite sufficient cases and a high follow-up rate, the study might have underestimated the incidence of T2D.

DISCLOSURES:

This work was supported by the National Research Foundation of Korea grant funded by the Korean Government and the faculty grant of Myongji Hospital. The authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

A universal cardiovascular disease (CVD) prediction tool performs well in patients with and without atherosclerotic CVD (ASCVD), a new study showed, suggesting this model could facilitate transition from primary to secondary prevention by streamlining risk classification.

METHODOLOGY:

• Researchers used different models to evaluate whether established CVD predictors, including age, sex, race, diabetes, systolic blood pressure, or smoking, are associated with major adverse cardiovascular events (MACEs), including myocardial infarction (MI), stroke, and heart failure (HF), among 9138 patients, mean age 63.8 years, in the Atherosclerosis Risk in Communities (ARIC) study.
• Of these, 609 had ASCVD (history of MI, ischemic stroke, or symptomatic peripheral artery disease) and 8529 did not.
• They extended their exploration to other predictors available in clinical practice, including family history of premature ASCVD, high-sensitivity C-reactive protein, lipoprotein(a), triglycerides, and apolipoprotein B, as well as predictors of HF such as body mass index and heart rate and blood-based cardiac biomarkers.
• An external validation analysis included 5322 participants in the Multi-Ethnic Study of Atherosclerosis (MESA).
• Over a median follow-up of 18.9 years, 3209 ARIC participants (35%) developed MACE for an incidence rate per 1000 person-years of 21.3 for MACE, 12.6 for MI/stroke, and 13.8 for HF.

TAKEAWAY:

• Of all candidate predictors, 10 variables (including established predictors and cardiac biomarkers) were included in the universal prediction model, which demonstrated good calibration in both those with ASCVD (hazard ratio [HR] C-statistic, 0.692; 95% CI, 0.650-0.735) and without ASCVD (HR C-statistic, 0.748; 95% CI, 0.726-0.770).
• As anticipated, the risk for MACE was generally lower in those with no prior ASCVD, but the 5-year risk in the highest quintile of predicted risk in those without ASCVD was higher than that in the lowest two quintiles of the ASCVD group.
• The universal risk prediction model was validated in the MESA community–based cohort; over a median follow-up of 13.7 years, 12% of participants with and without prior ASCVD developed MACE for an incidence rate per 1000 person-years of 10.2 for MACE, 7.4 for MI/stroke, and 4.3 for HF.
• The results were generally similar when examining individual outcomes (MI/stroke and HF) and for both no ASCVD and ASCVD groups across demographic subgroups by age, sex, and race.

IN PRACTICE:

The findings “support the importance of established predictors for classifying long-term CVD risk in both primary and secondary prevention settings,” the authors wrote, adding an advantage to this risk prediction approach could be to help providers and patients “further personalize secondary prevention.”

In an accompanying editorial, Pier Sergio Saba, MD, PhD, Clinical and Interventional Cardiology, Sassari University Hospital, Sassari, Italy, and others said the universal risk assessment approach “is conceptually promising” but noted patients with ASCVD represented only 7% of the study population, and this population was relatively young, potentially limiting the applicability of this risk model in older individuals. Before the risk model can be used in clinical settings, results need to be validated and given incorporation of cardiac biomarkers, “careful cost-benefit analyses may also be needed,” the editorial writers added.

SOURCE:

The study was conducted by Yejin Mok, PHD, MPH, Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, and colleagues. It was published online on January 29, 2024, in the Journal of the American College of Cardiology (JACC).

LIMITATIONS:

The somewhat limited number of study participants with prior ASCVD precluded researchers from quantifying the prognostic impact of ASCVD subtypes (eg, history of MI vs stroke vs peripheral artery disease). The study didn’t have data on some predictors recognized in guidelines (eg, coronary artery calcium and left ventricular ejection fraction). The ARIC analysis included only Black and White participants, and although models were validated in MESA, which included Chinese and Hispanic adults, extrapolation of results to more racially/ethnically diverse populations should be done with care.

DISCLOSURES:

The ARIC study received funding from the National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health, and Department of Health and Human Services. The MESA study was supported by the NHLBI and National Center for Advancing Translational Sciences. The study authors and editorial writers had no relevant conflicts of interest.

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

TOPLINE:

A universal cardiovascular disease (CVD) prediction tool performs well in patients with and without atherosclerotic CVD (ASCVD), a new study showed, suggesting this model could facilitate transition from primary to secondary prevention by streamlining risk classification.

METHODOLOGY:

• Researchers used different models to evaluate whether established CVD predictors, including age, sex, race, diabetes, systolic blood pressure, or smoking, are associated with major adverse cardiovascular events (MACEs), including myocardial infarction (MI), stroke, and heart failure (HF), among 9138 patients, mean age 63.8 years, in the Atherosclerosis Risk in Communities (ARIC) study.
• Of these, 609 had ASCVD (history of MI, ischemic stroke, or symptomatic peripheral artery disease) and 8529 did not.
• They extended their exploration to other predictors available in clinical practice, including family history of premature ASCVD, high-sensitivity C-reactive protein, lipoprotein(a), triglycerides, and apolipoprotein B, as well as predictors of HF such as body mass index and heart rate and blood-based cardiac biomarkers.
• An external validation analysis included 5322 participants in the Multi-Ethnic Study of Atherosclerosis (MESA).
• Over a median follow-up of 18.9 years, 3209 ARIC participants (35%) developed MACE for an incidence rate per 1000 person-years of 21.3 for MACE, 12.6 for MI/stroke, and 13.8 for HF.

TAKEAWAY:

• Of all candidate predictors, 10 variables (including established predictors and cardiac biomarkers) were included in the universal prediction model, which demonstrated good calibration in both those with ASCVD (hazard ratio [HR] C-statistic, 0.692; 95% CI, 0.650-0.735) and without ASCVD (HR C-statistic, 0.748; 95% CI, 0.726-0.770).
• As anticipated, the risk for MACE was generally lower in those with no prior ASCVD, but the 5-year risk in the highest quintile of predicted risk in those without ASCVD was higher than that in the lowest two quintiles of the ASCVD group.
• The universal risk prediction model was validated in the MESA community–based cohort; over a median follow-up of 13.7 years, 12% of participants with and without prior ASCVD developed MACE for an incidence rate per 1000 person-years of 10.2 for MACE, 7.4 for MI/stroke, and 4.3 for HF.
• The results were generally similar when examining individual outcomes (MI/stroke and HF) and for both no ASCVD and ASCVD groups across demographic subgroups by age, sex, and race.

IN PRACTICE:

The findings “support the importance of established predictors for classifying long-term CVD risk in both primary and secondary prevention settings,” the authors wrote, adding an advantage to this risk prediction approach could be to help providers and patients “further personalize secondary prevention.”

In an accompanying editorial, Pier Sergio Saba, MD, PhD, Clinical and Interventional Cardiology, Sassari University Hospital, Sassari, Italy, and others said the universal risk assessment approach “is conceptually promising” but noted patients with ASCVD represented only 7% of the study population, and this population was relatively young, potentially limiting the applicability of this risk model in older individuals. Before the risk model can be used in clinical settings, results need to be validated and given incorporation of cardiac biomarkers, “careful cost-benefit analyses may also be needed,” the editorial writers added.

SOURCE:

The study was conducted by Yejin Mok, PHD, MPH, Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, and colleagues. It was published online on January 29, 2024, in the Journal of the American College of Cardiology (JACC).

LIMITATIONS:

The somewhat limited number of study participants with prior ASCVD precluded researchers from quantifying the prognostic impact of ASCVD subtypes (eg, history of MI vs stroke vs peripheral artery disease). The study didn’t have data on some predictors recognized in guidelines (eg, coronary artery calcium and left ventricular ejection fraction). The ARIC analysis included only Black and White participants, and although models were validated in MESA, which included Chinese and Hispanic adults, extrapolation of results to more racially/ethnically diverse populations should be done with care.

DISCLOSURES:

The ARIC study received funding from the National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health, and Department of Health and Human Services. The MESA study was supported by the NHLBI and National Center for Advancing Translational Sciences. The study authors and editorial writers had no relevant conflicts of interest.

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

TOPLINE:

A universal cardiovascular disease (CVD) prediction tool performs well in patients with and without atherosclerotic CVD (ASCVD), a new study showed, suggesting this model could facilitate transition from primary to secondary prevention by streamlining risk classification.

METHODOLOGY:

• Researchers used different models to evaluate whether established CVD predictors, including age, sex, race, diabetes, systolic blood pressure, or smoking, are associated with major adverse cardiovascular events (MACEs), including myocardial infarction (MI), stroke, and heart failure (HF), among 9138 patients, mean age 63.8 years, in the Atherosclerosis Risk in Communities (ARIC) study.
• Of these, 609 had ASCVD (history of MI, ischemic stroke, or symptomatic peripheral artery disease) and 8529 did not.
• They extended their exploration to other predictors available in clinical practice, including family history of premature ASCVD, high-sensitivity C-reactive protein, lipoprotein(a), triglycerides, and apolipoprotein B, as well as predictors of HF such as body mass index and heart rate and blood-based cardiac biomarkers.
• An external validation analysis included 5322 participants in the Multi-Ethnic Study of Atherosclerosis (MESA).
• Over a median follow-up of 18.9 years, 3209 ARIC participants (35%) developed MACE for an incidence rate per 1000 person-years of 21.3 for MACE, 12.6 for MI/stroke, and 13.8 for HF.

TAKEAWAY:

• Of all candidate predictors, 10 variables (including established predictors and cardiac biomarkers) were included in the universal prediction model, which demonstrated good calibration in both those with ASCVD (hazard ratio [HR] C-statistic, 0.692; 95% CI, 0.650-0.735) and without ASCVD (HR C-statistic, 0.748; 95% CI, 0.726-0.770).
• As anticipated, the risk for MACE was generally lower in those with no prior ASCVD, but the 5-year risk in the highest quintile of predicted risk in those without ASCVD was higher than that in the lowest two quintiles of the ASCVD group.
• The universal risk prediction model was validated in the MESA community–based cohort; over a median follow-up of 13.7 years, 12% of participants with and without prior ASCVD developed MACE for an incidence rate per 1000 person-years of 10.2 for MACE, 7.4 for MI/stroke, and 4.3 for HF.
• The results were generally similar when examining individual outcomes (MI/stroke and HF) and for both no ASCVD and ASCVD groups across demographic subgroups by age, sex, and race.

IN PRACTICE:

The findings “support the importance of established predictors for classifying long-term CVD risk in both primary and secondary prevention settings,” the authors wrote, adding an advantage to this risk prediction approach could be to help providers and patients “further personalize secondary prevention.”

In an accompanying editorial, Pier Sergio Saba, MD, PhD, Clinical and Interventional Cardiology, Sassari University Hospital, Sassari, Italy, and others said the universal risk assessment approach “is conceptually promising” but noted patients with ASCVD represented only 7% of the study population, and this population was relatively young, potentially limiting the applicability of this risk model in older individuals. Before the risk model can be used in clinical settings, results need to be validated and given incorporation of cardiac biomarkers, “careful cost-benefit analyses may also be needed,” the editorial writers added.

SOURCE:

The study was conducted by Yejin Mok, PHD, MPH, Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, and colleagues. It was published online on January 29, 2024, in the Journal of the American College of Cardiology (JACC).

LIMITATIONS:

The somewhat limited number of study participants with prior ASCVD precluded researchers from quantifying the prognostic impact of ASCVD subtypes (eg, history of MI vs stroke vs peripheral artery disease). The study didn’t have data on some predictors recognized in guidelines (eg, coronary artery calcium and left ventricular ejection fraction). The ARIC analysis included only Black and White participants, and although models were validated in MESA, which included Chinese and Hispanic adults, extrapolation of results to more racially/ethnically diverse populations should be done with care.

DISCLOSURES:

The ARIC study received funding from the National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health, and Department of Health and Human Services. The MESA study was supported by the NHLBI and National Center for Advancing Translational Sciences. The study authors and editorial writers had no relevant conflicts of interest.

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

Replacing regular salt with a salt substitute reduced the incidence of new hypertension compared with a usual salt group, without provoking hypotension, new data showed.

Among a group of older adults with normal blood pressure (BP), those who swapped table salt for a salt substitute — consisting of 62.5% sodium chloride, 25% potassium chloride, and 12.5% flavorings — were 40% less apt to develop hypertension over 2 years than were peers who continued with regular salt.

“From a public health perspective, our study results indicate that everyone in the whole population, either hypertensive or normotensive, can benefit from replacing regular salt with potassium-enriched salt substitute,” lead author Yangfeng Wu, MD, PhD, professor and executive associate director, Peking University Clinical Research Institute, Beijing, China, told this news organization.

“Thus, salt substitution should be considered and promoted as a whole-population strategy for prevention and control of hypertension and cardiovascular disease,” Dr. Wu said.

The study was published online on February 12 in the Journal of the American College of Cardiology.

“Considering the failing strategy to reduce the intake of salt worldwide, salt substitution is an attractive alternative. The food industry and authorities should prepare strategies for wide-scale implementation of salt substitutes,” Rik Olde Engberink, MD, PhD, with Amsterdam University Medical Center, wrote in a linked editorial.

Population Strategy for Hypertension Prevention

The DECIDE-Salt clinical trial was a cluster-randomized trial conducted in 48 residential elderly care facilities in China with 1612 participants (1230 men and 382 women) aged 55 years or older. The trial assessed the effect of two sodium reduction strategies in lowering BP — replacing salt with a salt substitute and progressive restriction of the salt supply.

In the original study, the salt substitute intervention lowered systolic/diastolic BP significantly by 7.1/1.9 mm Hg vs the usual salt group. The progressive restriction of salt had no impact on BP vs usual salt or salt substitute groups.

This post hoc analysis of DECIDE-Salt focused on 609 participants (mean age, 71 years; 74% men) who were normotensive at baseline (mean BP, 122/74 mm Hg), with 298 in the usual salt group and 313 in the salt substitute group.

Compared with the usual salt group, the salt substitute group had a lower incidence of hypertension over 2 years (adjusted hazard ratio [HR], 0.60; 95% CI, 0.39-0.92; P = .02), with no increase in episodes of hypotension (P = .76).

From baseline to 2 years, there was no change in mean systolic/diastolic BP in the salt substitution group, whereas the usual salt group experienced a significant increase in systolic/diastolic BP (mean, 7.0/2.1 mm Hg).

The post hoc results from DECIDE-Salt are in line with a previous study from Peru, which also investigated mostly normotensive participants and reported a 51% lower risk of developing hypertension in the salt substitute group, as reported previously by this news organization.

“Although the study involved only participants aged 55 years and above, the epidemic of hypertension and its relations with sodium and potassium intake are not limited to older adults. Thus, we believe the salt substitution should also be beneficial to younger adults,” Dr. Wu said.

Notable Analysis

Reached for comment, Ankur Shah, MD, Division of Kidney Disease and Hypertension, Warren Alpert Medical School of Brown University, Providence, Rhode Island, said the study is “notable due to the limited and conflicting reports on the effects of salt substitution in individuals with normal blood pressure.”

“There is a growing body of literature on the impact of salt substitution in controlling hypertension, but less is known about prevention,” Dr. Shah, who was not involved in the study, told this news organization.

“The study certainly has population-level implications, as the design of a cluster-randomized trial at the facility level makes for a clear path to implementation — sodium substitution in elderly care facilities. That said, this is also the greatest limitation — extrapolating to the general population may not be accurate,” Dr. Shah noted.

There is also a potential concern with salt substitutes in patients with kidney disease, who typically are advised to lower potassium intake.

“Supplementing potassium could result in hyperkalemia, which can be life-threatening if severe, and patients taking medications that interfere with the kidney’s ability to excrete potassium should be cautious as well,” Dr. Shah said.

This research was supported by a grant from the National Key Research and Development Program, Ministry of Science and Technology of China. China Salt General Company at Yulin provided the usual salt and salt substitute used in the study free of charge. Dr. Wu, Dr. Engberink, and Dr. Shah had no relevant conflicts of interest.

A version of this article appeared on Medscape.com.

Replacing regular salt with a salt substitute reduced the incidence of new hypertension compared with a usual salt group, without provoking hypotension, new data showed.

Among a group of older adults with normal blood pressure (BP), those who swapped table salt for a salt substitute — consisting of 62.5% sodium chloride, 25% potassium chloride, and 12.5% flavorings — were 40% less apt to develop hypertension over 2 years than were peers who continued with regular salt.

“From a public health perspective, our study results indicate that everyone in the whole population, either hypertensive or normotensive, can benefit from replacing regular salt with potassium-enriched salt substitute,” lead author Yangfeng Wu, MD, PhD, professor and executive associate director, Peking University Clinical Research Institute, Beijing, China, told this news organization.

“Thus, salt substitution should be considered and promoted as a whole-population strategy for prevention and control of hypertension and cardiovascular disease,” Dr. Wu said.

The study was published online on February 12 in the Journal of the American College of Cardiology.

“Considering the failing strategy to reduce the intake of salt worldwide, salt substitution is an attractive alternative. The food industry and authorities should prepare strategies for wide-scale implementation of salt substitutes,” Rik Olde Engberink, MD, PhD, with Amsterdam University Medical Center, wrote in a linked editorial.

Population Strategy for Hypertension Prevention

The DECIDE-Salt clinical trial was a cluster-randomized trial conducted in 48 residential elderly care facilities in China with 1612 participants (1230 men and 382 women) aged 55 years or older. The trial assessed the effect of two sodium reduction strategies in lowering BP — replacing salt with a salt substitute and progressive restriction of the salt supply.

In the original study, the salt substitute intervention lowered systolic/diastolic BP significantly by 7.1/1.9 mm Hg vs the usual salt group. The progressive restriction of salt had no impact on BP vs usual salt or salt substitute groups.

This post hoc analysis of DECIDE-Salt focused on 609 participants (mean age, 71 years; 74% men) who were normotensive at baseline (mean BP, 122/74 mm Hg), with 298 in the usual salt group and 313 in the salt substitute group.

Compared with the usual salt group, the salt substitute group had a lower incidence of hypertension over 2 years (adjusted hazard ratio [HR], 0.60; 95% CI, 0.39-0.92; P = .02), with no increase in episodes of hypotension (P = .76).

From baseline to 2 years, there was no change in mean systolic/diastolic BP in the salt substitution group, whereas the usual salt group experienced a significant increase in systolic/diastolic BP (mean, 7.0/2.1 mm Hg).

The post hoc results from DECIDE-Salt are in line with a previous study from Peru, which also investigated mostly normotensive participants and reported a 51% lower risk of developing hypertension in the salt substitute group, as reported previously by this news organization.

“Although the study involved only participants aged 55 years and above, the epidemic of hypertension and its relations with sodium and potassium intake are not limited to older adults. Thus, we believe the salt substitution should also be beneficial to younger adults,” Dr. Wu said.

Notable Analysis

Reached for comment, Ankur Shah, MD, Division of Kidney Disease and Hypertension, Warren Alpert Medical School of Brown University, Providence, Rhode Island, said the study is “notable due to the limited and conflicting reports on the effects of salt substitution in individuals with normal blood pressure.”

“There is a growing body of literature on the impact of salt substitution in controlling hypertension, but less is known about prevention,” Dr. Shah, who was not involved in the study, told this news organization.

“The study certainly has population-level implications, as the design of a cluster-randomized trial at the facility level makes for a clear path to implementation — sodium substitution in elderly care facilities. That said, this is also the greatest limitation — extrapolating to the general population may not be accurate,” Dr. Shah noted.

There is also a potential concern with salt substitutes in patients with kidney disease, who typically are advised to lower potassium intake.

“Supplementing potassium could result in hyperkalemia, which can be life-threatening if severe, and patients taking medications that interfere with the kidney’s ability to excrete potassium should be cautious as well,” Dr. Shah said.

This research was supported by a grant from the National Key Research and Development Program, Ministry of Science and Technology of China. China Salt General Company at Yulin provided the usual salt and salt substitute used in the study free of charge. Dr. Wu, Dr. Engberink, and Dr. Shah had no relevant conflicts of interest.

A version of this article appeared on Medscape.com.

Replacing regular salt with a salt substitute reduced the incidence of new hypertension compared with a usual salt group, without provoking hypotension, new data showed.

Among a group of older adults with normal blood pressure (BP), those who swapped table salt for a salt substitute — consisting of 62.5% sodium chloride, 25% potassium chloride, and 12.5% flavorings — were 40% less apt to develop hypertension over 2 years than were peers who continued with regular salt.

“From a public health perspective, our study results indicate that everyone in the whole population, either hypertensive or normotensive, can benefit from replacing regular salt with potassium-enriched salt substitute,” lead author Yangfeng Wu, MD, PhD, professor and executive associate director, Peking University Clinical Research Institute, Beijing, China, told this news organization.

“Thus, salt substitution should be considered and promoted as a whole-population strategy for prevention and control of hypertension and cardiovascular disease,” Dr. Wu said.

The study was published online on February 12 in the Journal of the American College of Cardiology.

“Considering the failing strategy to reduce the intake of salt worldwide, salt substitution is an attractive alternative. The food industry and authorities should prepare strategies for wide-scale implementation of salt substitutes,” Rik Olde Engberink, MD, PhD, with Amsterdam University Medical Center, wrote in a linked editorial.

Population Strategy for Hypertension Prevention

The DECIDE-Salt clinical trial was a cluster-randomized trial conducted in 48 residential elderly care facilities in China with 1612 participants (1230 men and 382 women) aged 55 years or older. The trial assessed the effect of two sodium reduction strategies in lowering BP — replacing salt with a salt substitute and progressive restriction of the salt supply.

In the original study, the salt substitute intervention lowered systolic/diastolic BP significantly by 7.1/1.9 mm Hg vs the usual salt group. The progressive restriction of salt had no impact on BP vs usual salt or salt substitute groups.

This post hoc analysis of DECIDE-Salt focused on 609 participants (mean age, 71 years; 74% men) who were normotensive at baseline (mean BP, 122/74 mm Hg), with 298 in the usual salt group and 313 in the salt substitute group.

Compared with the usual salt group, the salt substitute group had a lower incidence of hypertension over 2 years (adjusted hazard ratio [HR], 0.60; 95% CI, 0.39-0.92; P = .02), with no increase in episodes of hypotension (P = .76).

From baseline to 2 years, there was no change in mean systolic/diastolic BP in the salt substitution group, whereas the usual salt group experienced a significant increase in systolic/diastolic BP (mean, 7.0/2.1 mm Hg).

The post hoc results from DECIDE-Salt are in line with a previous study from Peru, which also investigated mostly normotensive participants and reported a 51% lower risk of developing hypertension in the salt substitute group, as reported previously by this news organization.

“Although the study involved only participants aged 55 years and above, the epidemic of hypertension and its relations with sodium and potassium intake are not limited to older adults. Thus, we believe the salt substitution should also be beneficial to younger adults,” Dr. Wu said.

Notable Analysis

Reached for comment, Ankur Shah, MD, Division of Kidney Disease and Hypertension, Warren Alpert Medical School of Brown University, Providence, Rhode Island, said the study is “notable due to the limited and conflicting reports on the effects of salt substitution in individuals with normal blood pressure.”

“There is a growing body of literature on the impact of salt substitution in controlling hypertension, but less is known about prevention,” Dr. Shah, who was not involved in the study, told this news organization.

“The study certainly has population-level implications, as the design of a cluster-randomized trial at the facility level makes for a clear path to implementation — sodium substitution in elderly care facilities. That said, this is also the greatest limitation — extrapolating to the general population may not be accurate,” Dr. Shah noted.

There is also a potential concern with salt substitutes in patients with kidney disease, who typically are advised to lower potassium intake.

“Supplementing potassium could result in hyperkalemia, which can be life-threatening if severe, and patients taking medications that interfere with the kidney’s ability to excrete potassium should be cautious as well,” Dr. Shah said.

This research was supported by a grant from the National Key Research and Development Program, Ministry of Science and Technology of China. China Salt General Company at Yulin provided the usual salt and salt substitute used in the study free of charge. Dr. Wu, Dr. Engberink, and Dr. Shah had no relevant conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

Spinal cord injury (SCI) is associated with a significantly greater risk for heart disease than that of the general non-SCI population, especially among those with severe disability, new observational data suggest.

METHODOLOGY:

• Researchers analyzed data from Korea’s National Health Insurance Service on 5083 patients with cervical, thoracic, or lumbar SCI (mean age, 58; 75% men) and 1:3 age- and sex-matched non-SCI controls.
• The study endpoint was new-onset myocardial infarction (MI), heart failure (HF), or atrial fibrillation (AF) during a mean follow-up of 4.3 years.
• Covariates included low income, living in an urban or rural area, alcohol consumption, smoking status, physical activity engagement, body mass index, and blood pressure; comorbidities included hypertension, type 2 diabetes, and dyslipidemia.

TAKEAWAY:

• A total of 169 MI events (7.3 per 1000 person-years), 426 HF events (18.8 per 1000 person-years), and 158 AF events (6.8 per 1000 person-years) occurred among SCI survivors.
• After adjustment, SCI survivors had a higher risk for MI (adjusted hazard ratio [aHR], 2.41), HF (aHR, 2.24), and AF (aHR, 1.84) than that of controls.
• Among SCI survivors with a disability, the risks increased with disability severity, and those with severe disability had the highest risks for MI (aHR, 3.74), HF (aHR, 3.96), and AF (aHR, 3.32).
• Cervical and lumbar SCI survivors had an increased risk for heart disease compared with controls regardless of disability, and the risk was slightly higher for those with a disability; for cervical SCI survivors with a disability, aHRs for MI, HF, and AF, respectively, were 2.30, 2.05, and 1.73; for lumbar SCI survivors with a disability, aHRs were 2.79, 2.35, and 2.47.
• Thoracic SCI survivors with disability had a higher risk for MI (aHR, 5.62) and HF (aHR, 3.31) than controls.

IN PRACTICE:

“[T]he recognition and treatment of modifiable cardiovascular risk factors must be reinforced in the SCI population, [and] proper rehabilitation and education should be considered to prevent autonomic dysreflexia or orthostatic hypotension,” the authors wrote.

In an accompanying editorial, Christopher R. West, PhD, and Jacquelyn J. Cragg, PhD, both of the University of British Columbia, Vancouver, Canada, noted that clinical guidelines for cardiovascular and cardiometabolic disease after SCI don’t include approaches to help mitigate the risk for cardiac events such as those reported in the study; therefore, they wrote, the findings “should act as ‘call-to-arms’ to researchers and clinicians to shift gears from tradition and begin studying the clinical efficacy of neuraxial therapies that could help restore autonomic balance [in SCI], such as targeted neuromodulation.”

SOURCE:

The study was led by Jung Eun Yoo, MD, PhD of Seoul National University College of Medicine, Seoul, South Korea, and published online on February 12 in the Journal of the American College of Cardiology.

LIMITATIONS:

The database was not designed for the SCI population, so data are incomplete. The incidence of thoracic SCI was particularly low. Because SCI survivors may have impaired perception of chest pain in ischemic heart disease, those with asymptomatic or silent heart disease may not have been captured during follow-up. All study participants were Korean, so the findings may not be generalizable to other ethnicities.

DISCLOSURES:

This research was partially supported by a grant from the Korea Health Technology R&D Project through the Korea Health Industry Development Institute, funded by the Ministry of Health and Welfare, South Korea. The study authors and the editorialists had no relevant relationships to disclose.

A version of this article appeared on Medscape.com.

TOPLINE:

Spinal cord injury (SCI) is associated with a significantly greater risk for heart disease than that of the general non-SCI population, especially among those with severe disability, new observational data suggest.

METHODOLOGY:

• Researchers analyzed data from Korea’s National Health Insurance Service on 5083 patients with cervical, thoracic, or lumbar SCI (mean age, 58; 75% men) and 1:3 age- and sex-matched non-SCI controls.
• The study endpoint was new-onset myocardial infarction (MI), heart failure (HF), or atrial fibrillation (AF) during a mean follow-up of 4.3 years.
• Covariates included low income, living in an urban or rural area, alcohol consumption, smoking status, physical activity engagement, body mass index, and blood pressure; comorbidities included hypertension, type 2 diabetes, and dyslipidemia.

TAKEAWAY:

• A total of 169 MI events (7.3 per 1000 person-years), 426 HF events (18.8 per 1000 person-years), and 158 AF events (6.8 per 1000 person-years) occurred among SCI survivors.
• After adjustment, SCI survivors had a higher risk for MI (adjusted hazard ratio [aHR], 2.41), HF (aHR, 2.24), and AF (aHR, 1.84) than that of controls.
• Among SCI survivors with a disability, the risks increased with disability severity, and those with severe disability had the highest risks for MI (aHR, 3.74), HF (aHR, 3.96), and AF (aHR, 3.32).
• Cervical and lumbar SCI survivors had an increased risk for heart disease compared with controls regardless of disability, and the risk was slightly higher for those with a disability; for cervical SCI survivors with a disability, aHRs for MI, HF, and AF, respectively, were 2.30, 2.05, and 1.73; for lumbar SCI survivors with a disability, aHRs were 2.79, 2.35, and 2.47.
• Thoracic SCI survivors with disability had a higher risk for MI (aHR, 5.62) and HF (aHR, 3.31) than controls.

IN PRACTICE:

“[T]he recognition and treatment of modifiable cardiovascular risk factors must be reinforced in the SCI population, [and] proper rehabilitation and education should be considered to prevent autonomic dysreflexia or orthostatic hypotension,” the authors wrote.

In an accompanying editorial, Christopher R. West, PhD, and Jacquelyn J. Cragg, PhD, both of the University of British Columbia, Vancouver, Canada, noted that clinical guidelines for cardiovascular and cardiometabolic disease after SCI don’t include approaches to help mitigate the risk for cardiac events such as those reported in the study; therefore, they wrote, the findings “should act as ‘call-to-arms’ to researchers and clinicians to shift gears from tradition and begin studying the clinical efficacy of neuraxial therapies that could help restore autonomic balance [in SCI], such as targeted neuromodulation.”

SOURCE:

The study was led by Jung Eun Yoo, MD, PhD of Seoul National University College of Medicine, Seoul, South Korea, and published online on February 12 in the Journal of the American College of Cardiology.

LIMITATIONS:

The database was not designed for the SCI population, so data are incomplete. The incidence of thoracic SCI was particularly low. Because SCI survivors may have impaired perception of chest pain in ischemic heart disease, those with asymptomatic or silent heart disease may not have been captured during follow-up. All study participants were Korean, so the findings may not be generalizable to other ethnicities.

DISCLOSURES:

This research was partially supported by a grant from the Korea Health Technology R&D Project through the Korea Health Industry Development Institute, funded by the Ministry of Health and Welfare, South Korea. The study authors and the editorialists had no relevant relationships to disclose.

A version of this article appeared on Medscape.com.

TOPLINE:

Spinal cord injury (SCI) is associated with a significantly greater risk for heart disease than that of the general non-SCI population, especially among those with severe disability, new observational data suggest.

METHODOLOGY:

• Researchers analyzed data from Korea’s National Health Insurance Service on 5083 patients with cervical, thoracic, or lumbar SCI (mean age, 58; 75% men) and 1:3 age- and sex-matched non-SCI controls.
• The study endpoint was new-onset myocardial infarction (MI), heart failure (HF), or atrial fibrillation (AF) during a mean follow-up of 4.3 years.
• Covariates included low income, living in an urban or rural area, alcohol consumption, smoking status, physical activity engagement, body mass index, and blood pressure; comorbidities included hypertension, type 2 diabetes, and dyslipidemia.

TAKEAWAY:

• A total of 169 MI events (7.3 per 1000 person-years), 426 HF events (18.8 per 1000 person-years), and 158 AF events (6.8 per 1000 person-years) occurred among SCI survivors.
• After adjustment, SCI survivors had a higher risk for MI (adjusted hazard ratio [aHR], 2.41), HF (aHR, 2.24), and AF (aHR, 1.84) than that of controls.
• Among SCI survivors with a disability, the risks increased with disability severity, and those with severe disability had the highest risks for MI (aHR, 3.74), HF (aHR, 3.96), and AF (aHR, 3.32).
• Cervical and lumbar SCI survivors had an increased risk for heart disease compared with controls regardless of disability, and the risk was slightly higher for those with a disability; for cervical SCI survivors with a disability, aHRs for MI, HF, and AF, respectively, were 2.30, 2.05, and 1.73; for lumbar SCI survivors with a disability, aHRs were 2.79, 2.35, and 2.47.
• Thoracic SCI survivors with disability had a higher risk for MI (aHR, 5.62) and HF (aHR, 3.31) than controls.

IN PRACTICE:

“[T]he recognition and treatment of modifiable cardiovascular risk factors must be reinforced in the SCI population, [and] proper rehabilitation and education should be considered to prevent autonomic dysreflexia or orthostatic hypotension,” the authors wrote.

In an accompanying editorial, Christopher R. West, PhD, and Jacquelyn J. Cragg, PhD, both of the University of British Columbia, Vancouver, Canada, noted that clinical guidelines for cardiovascular and cardiometabolic disease after SCI don’t include approaches to help mitigate the risk for cardiac events such as those reported in the study; therefore, they wrote, the findings “should act as ‘call-to-arms’ to researchers and clinicians to shift gears from tradition and begin studying the clinical efficacy of neuraxial therapies that could help restore autonomic balance [in SCI], such as targeted neuromodulation.”

SOURCE:

The study was led by Jung Eun Yoo, MD, PhD of Seoul National University College of Medicine, Seoul, South Korea, and published online on February 12 in the Journal of the American College of Cardiology.

LIMITATIONS:

The database was not designed for the SCI population, so data are incomplete. The incidence of thoracic SCI was particularly low. Because SCI survivors may have impaired perception of chest pain in ischemic heart disease, those with asymptomatic or silent heart disease may not have been captured during follow-up. All study participants were Korean, so the findings may not be generalizable to other ethnicities.

DISCLOSURES:

This research was partially supported by a grant from the Korea Health Technology R&D Project through the Korea Health Industry Development Institute, funded by the Ministry of Health and Welfare, South Korea. The study authors and the editorialists had no relevant relationships to disclose.

A version of this article appeared on Medscape.com.

TOPLINE:

Allergens were present in more than half of evaluable over-the-counter (OTC) topical scar products, study finds. 

METHODOLOGY:

• OTC topical scar treatments have the potential to cause an allergic reaction, but the prevalence of North American Contact Dermatitis Group (NACDG) core allergens in these products is unclear.
• Researchers used the word scar in a query of Amazon.com and four other retail websites to identify topical scar products for consumers and noted the list of ingredients.
• The investigators also surveyed the American Contact Dermatitis Society’s Contact Allergen Management Program (CAMP), a resource that helps patients with allergies find personal care products that are safe to use, for pertinent products.

TAKEAWAY: 

• The search query identified 156 products. Of these, 119 (76.2%) were gels, creams, or oils and 37 (23.7%) were sheets, strips, or tape.
• Of the 125 products that had a list of ingredients, 69 (55.2%) contained at least one NACDG allergen and 45 (36%) contained more than one.
• The top six most common allergens listed in the ingredients were fragrance (16.8%), phenoxyethanol (16.8%), parabens (14.4%), panthenol (12.8%), sodium benzoate (9.60%), and ethylhexylglycerin (8%).
• Analysis of CAMP revealed that the program only had five unique scar products in its list, suggesting that CAMP might not be a reliable source of scar product information for patients with known allergies to pertinent NACDG allergens.

IN PRACTICE:

“Patients can consider trying a ‘use test’ on the inner forearm before applying to the surgical site,” the authors wrote. “It may reveal they are sensitive or sensitized by a product. 

SOURCE:

First author Meera Kattapuram, MD, of the Department of Internal Medicine at Mount Sinai Hospital, New York, led the study, published in the February issue of Dermatologic Surgery.  

LIMITATIONS:

Limitations include the selection of five retailers and the top 100 products from each website and the potential for ingredient list inaccuracies. 

DISCLOSURES:

The authors reported having no financial conflicts of interest. The research was supported by a grant from the National Institutes of Health/National Cancer Institute. 

A version of this article appeared on Medscape.com.

TOPLINE:

Allergens were present in more than half of evaluable over-the-counter (OTC) topical scar products, study finds. 

METHODOLOGY:

• OTC topical scar treatments have the potential to cause an allergic reaction, but the prevalence of North American Contact Dermatitis Group (NACDG) core allergens in these products is unclear.
• Researchers used the word scar in a query of Amazon.com and four other retail websites to identify topical scar products for consumers and noted the list of ingredients.
• The investigators also surveyed the American Contact Dermatitis Society’s Contact Allergen Management Program (CAMP), a resource that helps patients with allergies find personal care products that are safe to use, for pertinent products.

TAKEAWAY: 

• The search query identified 156 products. Of these, 119 (76.2%) were gels, creams, or oils and 37 (23.7%) were sheets, strips, or tape.
• Of the 125 products that had a list of ingredients, 69 (55.2%) contained at least one NACDG allergen and 45 (36%) contained more than one.
• The top six most common allergens listed in the ingredients were fragrance (16.8%), phenoxyethanol (16.8%), parabens (14.4%), panthenol (12.8%), sodium benzoate (9.60%), and ethylhexylglycerin (8%).
• Analysis of CAMP revealed that the program only had five unique scar products in its list, suggesting that CAMP might not be a reliable source of scar product information for patients with known allergies to pertinent NACDG allergens.

IN PRACTICE:

“Patients can consider trying a ‘use test’ on the inner forearm before applying to the surgical site,” the authors wrote. “It may reveal they are sensitive or sensitized by a product. 

SOURCE:

First author Meera Kattapuram, MD, of the Department of Internal Medicine at Mount Sinai Hospital, New York, led the study, published in the February issue of Dermatologic Surgery.  

LIMITATIONS:

Limitations include the selection of five retailers and the top 100 products from each website and the potential for ingredient list inaccuracies. 

DISCLOSURES:

The authors reported having no financial conflicts of interest. The research was supported by a grant from the National Institutes of Health/National Cancer Institute. 

A version of this article appeared on Medscape.com.

TOPLINE:

Allergens were present in more than half of evaluable over-the-counter (OTC) topical scar products, study finds. 

METHODOLOGY:

• OTC topical scar treatments have the potential to cause an allergic reaction, but the prevalence of North American Contact Dermatitis Group (NACDG) core allergens in these products is unclear.
• Researchers used the word scar in a query of Amazon.com and four other retail websites to identify topical scar products for consumers and noted the list of ingredients.
• The investigators also surveyed the American Contact Dermatitis Society’s Contact Allergen Management Program (CAMP), a resource that helps patients with allergies find personal care products that are safe to use, for pertinent products.

TAKEAWAY: 

• The search query identified 156 products. Of these, 119 (76.2%) were gels, creams, or oils and 37 (23.7%) were sheets, strips, or tape.
• Of the 125 products that had a list of ingredients, 69 (55.2%) contained at least one NACDG allergen and 45 (36%) contained more than one.
• The top six most common allergens listed in the ingredients were fragrance (16.8%), phenoxyethanol (16.8%), parabens (14.4%), panthenol (12.8%), sodium benzoate (9.60%), and ethylhexylglycerin (8%).
• Analysis of CAMP revealed that the program only had five unique scar products in its list, suggesting that CAMP might not be a reliable source of scar product information for patients with known allergies to pertinent NACDG allergens.

IN PRACTICE:

“Patients can consider trying a ‘use test’ on the inner forearm before applying to the surgical site,” the authors wrote. “It may reveal they are sensitive or sensitized by a product. 

SOURCE:

First author Meera Kattapuram, MD, of the Department of Internal Medicine at Mount Sinai Hospital, New York, led the study, published in the February issue of Dermatologic Surgery.  

LIMITATIONS:

Limitations include the selection of five retailers and the top 100 products from each website and the potential for ingredient list inaccuracies. 

DISCLOSURES:

The authors reported having no financial conflicts of interest. The research was supported by a grant from the National Institutes of Health/National Cancer Institute. 

A version of this article appeared on Medscape.com.

People taking a popular type of drug for weight loss or to manage diabetes have a lower likelihood of being newly diagnosed with depression or anxiety, according to an analysis of millions of people’s health records.

The findings were published this week by researchers from the electronic health record company Epic. Researchers looked for new diagnoses of depression or anxiety among people who started taking drugs from a class called GLP-1 agonists that can help manage blood sugar or treat obesity by mimicking hormone levels in the body that can affect appetite and blood sugar. Many people who take the drugs experience significant weight loss.

The researchers found that people with diabetes who started taking most versions of GLP-1 agonists were between 11% and 65% less likely to be newly diagnosed with depression than people with diabetes who didn’t take one of the drugs. The greatest reduction in likelihood of a new depression diagnosis was observed among people taking tirzepatide, which is sold under the brand names Mounjaro and Zepbound. 

A reduced likelihood of being diagnosed with anxiety was also observed among people with diabetes after they started taking a GLP-1 agonist, compared to people with diabetes who didn’t take one of the drugs. Again, tirzepatide showed the greatest reduction in odds, with people taking that drug experiencing a 60% reduced likelihood of being newly diagnosed with anxiety.

Similar reductions in the likelihood of new depression or anxiety diagnoses were observed among people who didn’t have diabetes but were taking GLP-1 agonists, such as for weight loss.

The mind-body connection has been well established by research.

“Thoughts, feelings, beliefs, and attitudes can affect how healthy your body is,” according to a summary from the CDC about the connection between diabetes and depression. “Untreated mental health issues can make diabetes worse, and problems with diabetes can make mental health issues worse. But fortunately if one gets better, the other tends to get better, too.”

This latest analysis included the drugs dulaglutide, exenatide, liraglutide, semaglutide, and tirzepatide. The medicines, used for weight loss or to manage diabetes, include the brand names Byetta, Ozempic, Mounjaro, Trulicity, Wegovy, and Zepbound. The researchers also looked for links between depression or anxiety diagnoses among people taking liraglutide (sold under brand names Saxenda and Victoza), but found that there was little to no change in the likelihood of being diagnosed with depression or anxiety after starting liraglutide.

The findings are timely as regulators in the U.S. and Europe are investigating reports of suicidal thoughts among people using the drugs. In January, the FDA announced that a preliminary investigation showed no increased risk of suicidal thoughts or actions, but the agency could not “definitively rule out that a small risk may exist; therefore, FDA is continuing to look into this issue.”

This latest analysis from Epic Research only looked at health records, was not published in a peer-reviewed journal, nor could it establish a definitive role the medications may have played in whether or not someone was diagnosed with depression or anxiety. It’s unknown whether people in the study had symptoms of depression or anxiety before starting the medications.

“These results show that these medications may serve a dual purpose for patients, but we do not understand them well enough yet to say these medications should be given as a treatment for anxiety or depression outside of diabetes or weight management,” Kersten Bartelt, a researcher employed by Epic, told ABC News.

A version of this article appeared on WebMD.com.

People taking a popular type of drug for weight loss or to manage diabetes have a lower likelihood of being newly diagnosed with depression or anxiety, according to an analysis of millions of people’s health records.

The findings were published this week by researchers from the electronic health record company Epic. Researchers looked for new diagnoses of depression or anxiety among people who started taking drugs from a class called GLP-1 agonists that can help manage blood sugar or treat obesity by mimicking hormone levels in the body that can affect appetite and blood sugar. Many people who take the drugs experience significant weight loss.

The researchers found that people with diabetes who started taking most versions of GLP-1 agonists were between 11% and 65% less likely to be newly diagnosed with depression than people with diabetes who didn’t take one of the drugs. The greatest reduction in likelihood of a new depression diagnosis was observed among people taking tirzepatide, which is sold under the brand names Mounjaro and Zepbound. 

A reduced likelihood of being diagnosed with anxiety was also observed among people with diabetes after they started taking a GLP-1 agonist, compared to people with diabetes who didn’t take one of the drugs. Again, tirzepatide showed the greatest reduction in odds, with people taking that drug experiencing a 60% reduced likelihood of being newly diagnosed with anxiety.

Similar reductions in the likelihood of new depression or anxiety diagnoses were observed among people who didn’t have diabetes but were taking GLP-1 agonists, such as for weight loss.

The mind-body connection has been well established by research.

“Thoughts, feelings, beliefs, and attitudes can affect how healthy your body is,” according to a summary from the CDC about the connection between diabetes and depression. “Untreated mental health issues can make diabetes worse, and problems with diabetes can make mental health issues worse. But fortunately if one gets better, the other tends to get better, too.”

This latest analysis included the drugs dulaglutide, exenatide, liraglutide, semaglutide, and tirzepatide. The medicines, used for weight loss or to manage diabetes, include the brand names Byetta, Ozempic, Mounjaro, Trulicity, Wegovy, and Zepbound. The researchers also looked for links between depression or anxiety diagnoses among people taking liraglutide (sold under brand names Saxenda and Victoza), but found that there was little to no change in the likelihood of being diagnosed with depression or anxiety after starting liraglutide.

The findings are timely as regulators in the U.S. and Europe are investigating reports of suicidal thoughts among people using the drugs. In January, the FDA announced that a preliminary investigation showed no increased risk of suicidal thoughts or actions, but the agency could not “definitively rule out that a small risk may exist; therefore, FDA is continuing to look into this issue.”

This latest analysis from Epic Research only looked at health records, was not published in a peer-reviewed journal, nor could it establish a definitive role the medications may have played in whether or not someone was diagnosed with depression or anxiety. It’s unknown whether people in the study had symptoms of depression or anxiety before starting the medications.

“These results show that these medications may serve a dual purpose for patients, but we do not understand them well enough yet to say these medications should be given as a treatment for anxiety or depression outside of diabetes or weight management,” Kersten Bartelt, a researcher employed by Epic, told ABC News.

A version of this article appeared on WebMD.com.

People taking a popular type of drug for weight loss or to manage diabetes have a lower likelihood of being newly diagnosed with depression or anxiety, according to an analysis of millions of people’s health records.

The findings were published this week by researchers from the electronic health record company Epic. Researchers looked for new diagnoses of depression or anxiety among people who started taking drugs from a class called GLP-1 agonists that can help manage blood sugar or treat obesity by mimicking hormone levels in the body that can affect appetite and blood sugar. Many people who take the drugs experience significant weight loss.

The researchers found that people with diabetes who started taking most versions of GLP-1 agonists were between 11% and 65% less likely to be newly diagnosed with depression than people with diabetes who didn’t take one of the drugs. The greatest reduction in likelihood of a new depression diagnosis was observed among people taking tirzepatide, which is sold under the brand names Mounjaro and Zepbound. 

A reduced likelihood of being diagnosed with anxiety was also observed among people with diabetes after they started taking a GLP-1 agonist, compared to people with diabetes who didn’t take one of the drugs. Again, tirzepatide showed the greatest reduction in odds, with people taking that drug experiencing a 60% reduced likelihood of being newly diagnosed with anxiety.

Similar reductions in the likelihood of new depression or anxiety diagnoses were observed among people who didn’t have diabetes but were taking GLP-1 agonists, such as for weight loss.

The mind-body connection has been well established by research.

“Thoughts, feelings, beliefs, and attitudes can affect how healthy your body is,” according to a summary from the CDC about the connection between diabetes and depression. “Untreated mental health issues can make diabetes worse, and problems with diabetes can make mental health issues worse. But fortunately if one gets better, the other tends to get better, too.”

This latest analysis included the drugs dulaglutide, exenatide, liraglutide, semaglutide, and tirzepatide. The medicines, used for weight loss or to manage diabetes, include the brand names Byetta, Ozempic, Mounjaro, Trulicity, Wegovy, and Zepbound. The researchers also looked for links between depression or anxiety diagnoses among people taking liraglutide (sold under brand names Saxenda and Victoza), but found that there was little to no change in the likelihood of being diagnosed with depression or anxiety after starting liraglutide.

The findings are timely as regulators in the U.S. and Europe are investigating reports of suicidal thoughts among people using the drugs. In January, the FDA announced that a preliminary investigation showed no increased risk of suicidal thoughts or actions, but the agency could not “definitively rule out that a small risk may exist; therefore, FDA is continuing to look into this issue.”

This latest analysis from Epic Research only looked at health records, was not published in a peer-reviewed journal, nor could it establish a definitive role the medications may have played in whether or not someone was diagnosed with depression or anxiety. It’s unknown whether people in the study had symptoms of depression or anxiety before starting the medications.

“These results show that these medications may serve a dual purpose for patients, but we do not understand them well enough yet to say these medications should be given as a treatment for anxiety or depression outside of diabetes or weight management,” Kersten Bartelt, a researcher employed by Epic, told ABC News.

A version of this article appeared on WebMD.com.

This transcript has been edited for clarity.

Hi. I’m Art Caplan. I’m at the Division of Medical Ethics at the New York University Grossman School of Medicine in New York City.

I think we had a breakthrough on a very controversial subject over the past month. Over and over again, debates have been breaking out, cases have been going to court, and fights have been coming to ethics committees about brain death. How do we know what brain death is, how do we diagnose it, and what rights do families have with respect to the diagnosis?

The American Academy of Neurology decided to form a task force, and they just issued guidelines on the definition, tests to use it, and the rights of families. Whether you›re a neurologist, someone involved in actually diagnosing brain death, or you›re dealing with very ill people whose families are trying to direct the kinds of things that you or the nurses can do, these guidelines, I think, are excellent. They did a wonderful job, in my view. They›ve achieved clarity.

First, they tried to handle both adults and children. Children are, if you will, more difficult — and that’s been known — to test for brain death. Their brains are smaller. You get more interference and false signals coming from muscle or nerve activity that might be going on elsewhere in their bodies.

The guidelines say we’re going to try to see whether a person can breathe without support. If it’s an adult, one test over a 24-hour period would be sufficient. If you had them off the ventilator and they can’t breathe and show no signs of being able to do that, that’s a very fundamental test for brain death. For children, you’re going to have to do it twice. The guidelines are saying to be cautious.

Second, they say it’s very important to know the cause of the suspected brain death condition. If someone has a massive head injury, that’s different from a situation in which someone overdoses from drugs or drowns. Those conditions can be a little deceptive. In the case of drowning, sometimes the brain has protective mechanisms to protect circulation to the brain naturally for a little bit of time. I’m talking about minutes, not hours.

You want to be careful to make sure that you know the cause of the massive brain injury or insult that makes someone believe that the patient is brain-dead, whether it’s a stroke, an embolism, a bleed, a gunshot wound, or trauma to the head. Those factors really drive the certainty with which brain death should be pronounced. I think that’s very, very important.

They also said that brain death means the permanent loss of brain function. You may get a few cells still firing or you may be in a situation, because the life support is still there, where the body looks pink and perhaps might appear to still be alive to someone. When you know that the damage to the brain is so severe that there’s nothing that can be done to bring back the support of heart function, breathing, and most likely any ability to sense or feel anything, that is death.

I believe it’s very important, when talking to families, to say there are two ways that we pronounce people dead, and they’re equal: One is to say their heart has stopped, their breathing has stopped, and there’s nothing we can do to resuscitate them, which is cardiac death. The other is to say their brain has permanently ceased to function in any kind of integrated way. That means no heartbeat, no breathing, and no mental sensations. That is death.

In approaching families, it is critical that doctors and nurses don’t say, “Your relative is brain-dead.” That gives the family a sense that maybe they’re only “partially dead” or maybe there’s one key organ that has stopped working but maybe you can bring it back. Death is death. The law recognizes both cardiac death and brain death as death.

When you approach a family, if you believe that death has occurred, you say, “I’m very sorry. With regret, I have to tell you, your loved one is dead.” If they ask how you know, you can say, “We’ve determined it through brain death or through cardiac death.” You don’t give them a sense that people could be kind of dead, sort of dead, or nearly dead. Those states are comas or permanent vegetative states; they’re not the same as death.

What if the family says, “I don’t want you to do any testing. I don’t want to find out whether my relative is dead”? The American Academy of Neurology looked at this carefully and said that any test for death can be done without the permission or consent of the family. They said that because doctors need to know what steps to take to treat someone.

If a person is dead, then treatment is going to stop. It may not stop immediately. There may be issues about organ donation. There may be issues about gathering the family to come to the bedside to say goodbye, because many people think that’s more humane than saying goodbye at the morgue or in another setting.

This is all well and good, but patients cannot protect against bad news when it comes to death. We don’t want to be doing things to the dead that cost money or are futile because of death and using resources that might go to others.

We’ve got much more clarity than we have ever had with respect to the issue of brain death and how it works in any hospital. We have certain tests, including being off the ventilator and some other tests, that the guidelines supply. We know we have to be more careful with children. We want to know the etiology of the cause of the brain trauma, the devastating brain injury, to be sure that this is something that really is permanent cessation of integrated brain function.

We know that if you believe the person has died, you don’t need the consent of the family in order to do a brain-death test. You have to do it because there is no point in continuing treatment in expensive ICU settings and denying resources to others who might want to use those resources. The family can’t hold the medical team hostage.

We do know that when we approach someone with the determination, whatever it is, we should lead by saying that the person has died and then explain how that was determined, whether it be by cardiac death pronouncement — where you tried to resuscitate and the heart’s not beating — or brain-death analysis.

I’m Art Caplan at the Division of Medical Ethics at the NYU Grossman School of Medicine. Thanks for watching.

Dr. Caplan has disclosed the following relevant financial relationships: Served as a director, officer, partner, employee, advisor, consultant, or trustee for: Johnson & Johnson’s Panel for Compassionate Drug Use (unpaid position); serves as a contributing author and adviser for this news organization.

A version of this article appeared on Medscape.com.

This transcript has been edited for clarity.

Hi. I’m Art Caplan. I’m at the Division of Medical Ethics at the New York University Grossman School of Medicine in New York City.

I think we had a breakthrough on a very controversial subject over the past month. Over and over again, debates have been breaking out, cases have been going to court, and fights have been coming to ethics committees about brain death. How do we know what brain death is, how do we diagnose it, and what rights do families have with respect to the diagnosis?

The American Academy of Neurology decided to form a task force, and they just issued guidelines on the definition, tests to use it, and the rights of families. Whether you›re a neurologist, someone involved in actually diagnosing brain death, or you›re dealing with very ill people whose families are trying to direct the kinds of things that you or the nurses can do, these guidelines, I think, are excellent. They did a wonderful job, in my view. They›ve achieved clarity.

First, they tried to handle both adults and children. Children are, if you will, more difficult — and that’s been known — to test for brain death. Their brains are smaller. You get more interference and false signals coming from muscle or nerve activity that might be going on elsewhere in their bodies.

The guidelines say we’re going to try to see whether a person can breathe without support. If it’s an adult, one test over a 24-hour period would be sufficient. If you had them off the ventilator and they can’t breathe and show no signs of being able to do that, that’s a very fundamental test for brain death. For children, you’re going to have to do it twice. The guidelines are saying to be cautious.

Second, they say it’s very important to know the cause of the suspected brain death condition. If someone has a massive head injury, that’s different from a situation in which someone overdoses from drugs or drowns. Those conditions can be a little deceptive. In the case of drowning, sometimes the brain has protective mechanisms to protect circulation to the brain naturally for a little bit of time. I’m talking about minutes, not hours.

You want to be careful to make sure that you know the cause of the massive brain injury or insult that makes someone believe that the patient is brain-dead, whether it’s a stroke, an embolism, a bleed, a gunshot wound, or trauma to the head. Those factors really drive the certainty with which brain death should be pronounced. I think that’s very, very important.

They also said that brain death means the permanent loss of brain function. You may get a few cells still firing or you may be in a situation, because the life support is still there, where the body looks pink and perhaps might appear to still be alive to someone. When you know that the damage to the brain is so severe that there’s nothing that can be done to bring back the support of heart function, breathing, and most likely any ability to sense or feel anything, that is death.

I believe it’s very important, when talking to families, to say there are two ways that we pronounce people dead, and they’re equal: One is to say their heart has stopped, their breathing has stopped, and there’s nothing we can do to resuscitate them, which is cardiac death. The other is to say their brain has permanently ceased to function in any kind of integrated way. That means no heartbeat, no breathing, and no mental sensations. That is death.

In approaching families, it is critical that doctors and nurses don’t say, “Your relative is brain-dead.” That gives the family a sense that maybe they’re only “partially dead” or maybe there’s one key organ that has stopped working but maybe you can bring it back. Death is death. The law recognizes both cardiac death and brain death as death.

When you approach a family, if you believe that death has occurred, you say, “I’m very sorry. With regret, I have to tell you, your loved one is dead.” If they ask how you know, you can say, “We’ve determined it through brain death or through cardiac death.” You don’t give them a sense that people could be kind of dead, sort of dead, or nearly dead. Those states are comas or permanent vegetative states; they’re not the same as death.

What if the family says, “I don’t want you to do any testing. I don’t want to find out whether my relative is dead”? The American Academy of Neurology looked at this carefully and said that any test for death can be done without the permission or consent of the family. They said that because doctors need to know what steps to take to treat someone.

If a person is dead, then treatment is going to stop. It may not stop immediately. There may be issues about organ donation. There may be issues about gathering the family to come to the bedside to say goodbye, because many people think that’s more humane than saying goodbye at the morgue or in another setting.

This is all well and good, but patients cannot protect against bad news when it comes to death. We don’t want to be doing things to the dead that cost money or are futile because of death and using resources that might go to others.

We’ve got much more clarity than we have ever had with respect to the issue of brain death and how it works in any hospital. We have certain tests, including being off the ventilator and some other tests, that the guidelines supply. We know we have to be more careful with children. We want to know the etiology of the cause of the brain trauma, the devastating brain injury, to be sure that this is something that really is permanent cessation of integrated brain function.

We know that if you believe the person has died, you don’t need the consent of the family in order to do a brain-death test. You have to do it because there is no point in continuing treatment in expensive ICU settings and denying resources to others who might want to use those resources. The family can’t hold the medical team hostage.

We do know that when we approach someone with the determination, whatever it is, we should lead by saying that the person has died and then explain how that was determined, whether it be by cardiac death pronouncement — where you tried to resuscitate and the heart’s not beating — or brain-death analysis.

I’m Art Caplan at the Division of Medical Ethics at the NYU Grossman School of Medicine. Thanks for watching.

Dr. Caplan has disclosed the following relevant financial relationships: Served as a director, officer, partner, employee, advisor, consultant, or trustee for: Johnson & Johnson’s Panel for Compassionate Drug Use (unpaid position); serves as a contributing author and adviser for this news organization.

A version of this article appeared on Medscape.com.

This transcript has been edited for clarity.

Hi. I’m Art Caplan. I’m at the Division of Medical Ethics at the New York University Grossman School of Medicine in New York City.

I think we had a breakthrough on a very controversial subject over the past month. Over and over again, debates have been breaking out, cases have been going to court, and fights have been coming to ethics committees about brain death. How do we know what brain death is, how do we diagnose it, and what rights do families have with respect to the diagnosis?

The American Academy of Neurology decided to form a task force, and they just issued guidelines on the definition, tests to use it, and the rights of families. Whether you›re a neurologist, someone involved in actually diagnosing brain death, or you›re dealing with very ill people whose families are trying to direct the kinds of things that you or the nurses can do, these guidelines, I think, are excellent. They did a wonderful job, in my view. They›ve achieved clarity.

First, they tried to handle both adults and children. Children are, if you will, more difficult — and that’s been known — to test for brain death. Their brains are smaller. You get more interference and false signals coming from muscle or nerve activity that might be going on elsewhere in their bodies.

The guidelines say we’re going to try to see whether a person can breathe without support. If it’s an adult, one test over a 24-hour period would be sufficient. If you had them off the ventilator and they can’t breathe and show no signs of being able to do that, that’s a very fundamental test for brain death. For children, you’re going to have to do it twice. The guidelines are saying to be cautious.

Second, they say it’s very important to know the cause of the suspected brain death condition. If someone has a massive head injury, that’s different from a situation in which someone overdoses from drugs or drowns. Those conditions can be a little deceptive. In the case of drowning, sometimes the brain has protective mechanisms to protect circulation to the brain naturally for a little bit of time. I’m talking about minutes, not hours.

You want to be careful to make sure that you know the cause of the massive brain injury or insult that makes someone believe that the patient is brain-dead, whether it’s a stroke, an embolism, a bleed, a gunshot wound, or trauma to the head. Those factors really drive the certainty with which brain death should be pronounced. I think that’s very, very important.

They also said that brain death means the permanent loss of brain function. You may get a few cells still firing or you may be in a situation, because the life support is still there, where the body looks pink and perhaps might appear to still be alive to someone. When you know that the damage to the brain is so severe that there’s nothing that can be done to bring back the support of heart function, breathing, and most likely any ability to sense or feel anything, that is death.

I believe it’s very important, when talking to families, to say there are two ways that we pronounce people dead, and they’re equal: One is to say their heart has stopped, their breathing has stopped, and there’s nothing we can do to resuscitate them, which is cardiac death. The other is to say their brain has permanently ceased to function in any kind of integrated way. That means no heartbeat, no breathing, and no mental sensations. That is death.

In approaching families, it is critical that doctors and nurses don’t say, “Your relative is brain-dead.” That gives the family a sense that maybe they’re only “partially dead” or maybe there’s one key organ that has stopped working but maybe you can bring it back. Death is death. The law recognizes both cardiac death and brain death as death.

When you approach a family, if you believe that death has occurred, you say, “I’m very sorry. With regret, I have to tell you, your loved one is dead.” If they ask how you know, you can say, “We’ve determined it through brain death or through cardiac death.” You don’t give them a sense that people could be kind of dead, sort of dead, or nearly dead. Those states are comas or permanent vegetative states; they’re not the same as death.

What if the family says, “I don’t want you to do any testing. I don’t want to find out whether my relative is dead”? The American Academy of Neurology looked at this carefully and said that any test for death can be done without the permission or consent of the family. They said that because doctors need to know what steps to take to treat someone.

If a person is dead, then treatment is going to stop. It may not stop immediately. There may be issues about organ donation. There may be issues about gathering the family to come to the bedside to say goodbye, because many people think that’s more humane than saying goodbye at the morgue or in another setting.

This is all well and good, but patients cannot protect against bad news when it comes to death. We don’t want to be doing things to the dead that cost money or are futile because of death and using resources that might go to others.

We’ve got much more clarity than we have ever had with respect to the issue of brain death and how it works in any hospital. We have certain tests, including being off the ventilator and some other tests, that the guidelines supply. We know we have to be more careful with children. We want to know the etiology of the cause of the brain trauma, the devastating brain injury, to be sure that this is something that really is permanent cessation of integrated brain function.

We know that if you believe the person has died, you don’t need the consent of the family in order to do a brain-death test. You have to do it because there is no point in continuing treatment in expensive ICU settings and denying resources to others who might want to use those resources. The family can’t hold the medical team hostage.

We do know that when we approach someone with the determination, whatever it is, we should lead by saying that the person has died and then explain how that was determined, whether it be by cardiac death pronouncement — where you tried to resuscitate and the heart’s not beating — or brain-death analysis.

I’m Art Caplan at the Division of Medical Ethics at the NYU Grossman School of Medicine. Thanks for watching.

Dr. Caplan has disclosed the following relevant financial relationships: Served as a director, officer, partner, employee, advisor, consultant, or trustee for: Johnson & Johnson’s Panel for Compassionate Drug Use (unpaid position); serves as a contributing author and adviser for this news organization.

A version of this article appeared on Medscape.com.