MDedge Endocrinology

Dr Marconi Abreu, endocrinologist and associate professor at the University of Texas Southwestern Medical Center in Dallas, summarizes the results of four key studies related to diabetes and heart disease that were presented at the American Heart Association 2022 annual meeting.

First, he reports primary outcome data from the EMPA-KIDNEY trial, which show that the SGLT2 inhibitor empagliflozin has protective effects on renal function and cardiovascular mortality among patients with chronic kidney disease, regardless of diabetes status.

Next, Dr Abreu discusses the PROMINENT trial, which examined whether a reduction in triglyceride levels improved cardiovascular outcomes. Trial participants with type 2 diabetes, elevated triglycerides, and low HDL did not experience cardiovascular benefit from taking pemafibrate, compared with the group taking placebo.

He also covers a study from Japan that looks at the potential cardiovascular benefit of prescribing highly purified eicosapentaenoic acid for patients with chronic coronary artery disease who take statins.

Finally, Dr Abreu reviews findings from the Diuretic Comparison Project of a study comparing the safety and efficacy of hydrochlorothiazide with that of chlorthalidone in patients with hypertension.

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Associate Professor, Department of Internal Medicine, University of Texas Southwestern Medical Center; Medical Director, Parkland General Endocrinology Clinic, Dallas, Texas

Marconi Abreu, MD, has disclosed no relevant financial relationships.

Dr Marconi Abreu, endocrinologist and associate professor at the University of Texas Southwestern Medical Center in Dallas, summarizes the results of four key studies related to diabetes and heart disease that were presented at the American Heart Association 2022 annual meeting.

First, he reports primary outcome data from the EMPA-KIDNEY trial, which show that the SGLT2 inhibitor empagliflozin has protective effects on renal function and cardiovascular mortality among patients with chronic kidney disease, regardless of diabetes status.

Next, Dr Abreu discusses the PROMINENT trial, which examined whether a reduction in triglyceride levels improved cardiovascular outcomes. Trial participants with type 2 diabetes, elevated triglycerides, and low HDL did not experience cardiovascular benefit from taking pemafibrate, compared with the group taking placebo.

He also covers a study from Japan that looks at the potential cardiovascular benefit of prescribing highly purified eicosapentaenoic acid for patients with chronic coronary artery disease who take statins.

Finally, Dr Abreu reviews findings from the Diuretic Comparison Project of a study comparing the safety and efficacy of hydrochlorothiazide with that of chlorthalidone in patients with hypertension.

---

Associate Professor, Department of Internal Medicine, University of Texas Southwestern Medical Center; Medical Director, Parkland General Endocrinology Clinic, Dallas, Texas

Marconi Abreu, MD, has disclosed no relevant financial relationships.

Dr Marconi Abreu, endocrinologist and associate professor at the University of Texas Southwestern Medical Center in Dallas, summarizes the results of four key studies related to diabetes and heart disease that were presented at the American Heart Association 2022 annual meeting.

First, he reports primary outcome data from the EMPA-KIDNEY trial, which show that the SGLT2 inhibitor empagliflozin has protective effects on renal function and cardiovascular mortality among patients with chronic kidney disease, regardless of diabetes status.

Next, Dr Abreu discusses the PROMINENT trial, which examined whether a reduction in triglyceride levels improved cardiovascular outcomes. Trial participants with type 2 diabetes, elevated triglycerides, and low HDL did not experience cardiovascular benefit from taking pemafibrate, compared with the group taking placebo.

He also covers a study from Japan that looks at the potential cardiovascular benefit of prescribing highly purified eicosapentaenoic acid for patients with chronic coronary artery disease who take statins.

Finally, Dr Abreu reviews findings from the Diuretic Comparison Project of a study comparing the safety and efficacy of hydrochlorothiazide with that of chlorthalidone in patients with hypertension.

---

Associate Professor, Department of Internal Medicine, University of Texas Southwestern Medical Center; Medical Director, Parkland General Endocrinology Clinic, Dallas, Texas

Marconi Abreu, MD, has disclosed no relevant financial relationships.

When Mark Cucuzzella, MD, meets a new patient at the West Virginia Medical School clinic, he introduces himself as “Mark.” For one thing, says Dr. Cucuzzella, his last name is a mouthful. For another, the 56-year-old general practitioner asserts that getting on a first-name basis with his patients is integral to delivering the best care.

“I’m trying to break down the old paternalistic barriers of the doctor/patient relationship,” he says. “Titles create an environment where the doctors are making all the decisions and not involving the patient in any course of action.”

Aniruddh Setya, MD, has a different take on informality between patients and doctors: It’s not OK. “I am not your friend,” says the 35-year-old pediatrician from Florida-based KIDZ Medical Services. “There has to be a level of respect for the education and accomplishment of being a physician.”

The issue of “untitling” a doctor and failing to use their honorific is becoming increasingly common, according to a recent study published in JAMA Network Open. But that doesn’t mean most physicians support the practice. In fact, some doctors contend that it can be harmful, particularly to female physicians.

“My concern is that untitling (so termed by Amy Diehl, PhD, and Leanne Dzubinski, PhD) intrudes upon important professional boundaries and might be correlated with diminishing the value of someone’s time,” says Leah Witt, MD, a geriatrician at UCSF Health, San Francisco. Dr. Witt, along with colleague Lekshmi Santhosh, MD, a pulmonologist, offered commentary on the study results. “Studies have shown that women physicians get more patient portal messages, spend more time in the electronic health record, and have longer visits,” Dr. Witt said. “Dr. Santhosh and I wonder if untitling is a signifier of this diminished value of our time, and an assumption of increased ease of access leading to this higher workload.”

To compile the results reported in JAMA Network Open, Mayo Clinic researchers analyzed more than 90,000 emails from patients to doctors over the course of 3 years, beginning in 2018. Of those emails, more than 32% included the physician’s first name in greeting or salutation. For women physicians, the odds were twice as high that their titles would be omitted in the correspondence. The same holds true for doctors of osteopathic medicine (DOs) compared with MDs, and primary care physicians had similar odds for a title drop compared with specialists.

Dr. Witt says the findings are not surprising. “They match my experience as a woman in medicine, as Dr. Santhosh and I write in our commentary,” she says. “We think the findings could easily be replicated at other centers.”

Indeed, research on 321 speaker introductions at a medical rounds found that when female physicians introduced other physicians, they usually applied the doctor title. When the job of introducing colleagues fell to male physicians, however, the stats fell to 72.4% for male peers and only 49.2% when introducing female peers.

The Mayo Clinic study authors identified the pitfalls of patients who informally address their doctors. They wrote, “Untitling may have a negative impact on physicians, demonstrate lack of respect, and can lead to reduction in formality of the physician/patient relationship or workplace.”
 

Physician preferences vary

Although the results of the Mayo Clinic analysis didn’t and couldn’t address physician sentiments on patient informality, Dr. Setya observes that American culture is becoming less formal. “I’ve been practicing for over 10 years, and the number of people who consider doctors as equals is growing,” he says. “This has been particularly true over the last couple of years.”

This change was documented in 2015. Add in the pandemic and an entire society that is now accustomed to working from home in sweats, and it’s not a stretch to understand why some patients have become less formal in many settings. The 2015 article noted, however, that most physicians prefer to keep titles in the mix.

Perhaps most troublesome, says Dr. Setya, is that patients forgo asking whether it’s OK to use his first name and simply assume it’s acceptable. “It bothers me,” he says. “I became a doctor for more than the money.”

He suspects that his cultural background (Dr. Setya is of Indian descent) plays a role in how strongly he feels about patient-doctor informality. “As a British colony, Indian culture dictates that you pay respect to elders and to accomplishment,” he points out. “America is far looser when it comes to salutations.”

Dr. Cucuzzella largely agrees with Dr. Setya, but has a different view of the role culture plays in how physicians prefer to be addressed. “If your last name is difficult to pronounce, it can put the patient at ease if you give them an option,” he says. “I like my patients to feel comfortable and have a friendly conversation, so I don’t ask them to try to manage my last name.”

When patients revert to using Dr. Cucuzzella’s last name and title, this often breaks down along generational lines, Dr. Cucuzzella has found: Older patients might drop his title, whereas younger patients might keep it as a sign of respect. In some cases, Dr. Cucuzzella tries to bridge this gap, and offers the option of “Dr. Mark.” In his small West Virginia community, this is how people often refer to him.

Dr. Setya says that most of the older physicians he works with still prefer that patients and younger colleagues use their title, but he has witnessed exceptions to this. “My boss in residence hated to be called ‘Sir’ or ‘Doctor,’ ” he says. “In a situation like that, it is reasonable to ask, ‘How can I address you?’ But it has to be mutually agreed upon.”

Dr. Cucuzzella cites informality as the preferred mode for older patients. “If I have a 70-year-old patient, it seems natural they shouldn’t use my title,” he says. “They are worthy of equality in the community. If I’m talking to a retired CEO or state delegate, it’s uncomfortable if they call me doctor.”

Moreover, Dr. Cucuzzella maintains that establishing a less formal environment with patients leads to better outcomes. “Shared decision-making is a basic human right,” he says. “In 2022, doctors shouldn’t make decisions without patient input, unless it’s an emergency situation. Removing the title barriers makes that easier.”
 

How to handle informality

If you fall more in line with Dr. Setya, there are strategies you can use to try to keep formality in your doctor-patient relationships. Dr. Setya’s approach is indirect. “I don’t correct a patient if they use my first name, because that might seem hostile,” he says. “But I alert them in the way I address them back. A Sir, a Mrs., or a Mr. needs to go both ways.”

This particularly holds true in pediatrics, Dr. Setya has found. He has witnessed many colleagues addressing parents as “Mommy and Daddy,” something he says lacks respect and sets too informal a tone. “It’s almost universal that parents don’t like that, and we need to act accordingly.”

Dr. Witt also avoids directly correcting patients, but struggles when they drop her title. “The standard signature I use to sign every patient portal message I respond to includes my first and last name and credentials,” she says. “I maintain formality in most circumstances with that standard reply.”

Beneath the surface, however, Dr. Witt wishes it were easier. “I have struggled with answering the question, ‘Is it OK if I call you Leah?’ she says. “I want to keep our interaction anchored in professionalism without sacrificing the warmth I think is important to a productive patient-physician relationship. For this reason, I tend to say yes to this request, even though I’d rather patients didn’t make such requests.”

In the Fast Company article by Amy Diehl, PhD, and Leanne Dzubinski, PhD, on the topic of untitling professional women, the authors suggest several actions, beginning with leadership that sets expectations on the topic. They also suggest that physicians use polite corrections if patients untitle them. Supplying positive reinforcement when patients include your title can help, too. If all else fails, you can call out the offensive untitling. More often than not, especially with female physicians, the patient is demonstrating an unconscious bias rather than something deliberate.

Opinions vary on the topic of untitling, and ultimately each physician must make the decision for themselves. But creating informal cultures in an organization can have unintended consequences, especially for female peers.

Says Dr. Witt, “We all want to give our patients the best care we can, but professional boundaries are critical to time management, equitable care, and maintaining work-life balance. I would love to see a study that examines untitling by self-reported race and/or ethnicity of physicians, because we know that women of color experience higher rates of burnout and depression, and I wonder if untitling may be part of this.”

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

When Mark Cucuzzella, MD, meets a new patient at the West Virginia Medical School clinic, he introduces himself as “Mark.” For one thing, says Dr. Cucuzzella, his last name is a mouthful. For another, the 56-year-old general practitioner asserts that getting on a first-name basis with his patients is integral to delivering the best care.

“I’m trying to break down the old paternalistic barriers of the doctor/patient relationship,” he says. “Titles create an environment where the doctors are making all the decisions and not involving the patient in any course of action.”

Aniruddh Setya, MD, has a different take on informality between patients and doctors: It’s not OK. “I am not your friend,” says the 35-year-old pediatrician from Florida-based KIDZ Medical Services. “There has to be a level of respect for the education and accomplishment of being a physician.”

The issue of “untitling” a doctor and failing to use their honorific is becoming increasingly common, according to a recent study published in JAMA Network Open. But that doesn’t mean most physicians support the practice. In fact, some doctors contend that it can be harmful, particularly to female physicians.

“My concern is that untitling (so termed by Amy Diehl, PhD, and Leanne Dzubinski, PhD) intrudes upon important professional boundaries and might be correlated with diminishing the value of someone’s time,” says Leah Witt, MD, a geriatrician at UCSF Health, San Francisco. Dr. Witt, along with colleague Lekshmi Santhosh, MD, a pulmonologist, offered commentary on the study results. “Studies have shown that women physicians get more patient portal messages, spend more time in the electronic health record, and have longer visits,” Dr. Witt said. “Dr. Santhosh and I wonder if untitling is a signifier of this diminished value of our time, and an assumption of increased ease of access leading to this higher workload.”

To compile the results reported in JAMA Network Open, Mayo Clinic researchers analyzed more than 90,000 emails from patients to doctors over the course of 3 years, beginning in 2018. Of those emails, more than 32% included the physician’s first name in greeting or salutation. For women physicians, the odds were twice as high that their titles would be omitted in the correspondence. The same holds true for doctors of osteopathic medicine (DOs) compared with MDs, and primary care physicians had similar odds for a title drop compared with specialists.

Dr. Witt says the findings are not surprising. “They match my experience as a woman in medicine, as Dr. Santhosh and I write in our commentary,” she says. “We think the findings could easily be replicated at other centers.”

Indeed, research on 321 speaker introductions at a medical rounds found that when female physicians introduced other physicians, they usually applied the doctor title. When the job of introducing colleagues fell to male physicians, however, the stats fell to 72.4% for male peers and only 49.2% when introducing female peers.

The Mayo Clinic study authors identified the pitfalls of patients who informally address their doctors. They wrote, “Untitling may have a negative impact on physicians, demonstrate lack of respect, and can lead to reduction in formality of the physician/patient relationship or workplace.”
 

Physician preferences vary

Although the results of the Mayo Clinic analysis didn’t and couldn’t address physician sentiments on patient informality, Dr. Setya observes that American culture is becoming less formal. “I’ve been practicing for over 10 years, and the number of people who consider doctors as equals is growing,” he says. “This has been particularly true over the last couple of years.”

This change was documented in 2015. Add in the pandemic and an entire society that is now accustomed to working from home in sweats, and it’s not a stretch to understand why some patients have become less formal in many settings. The 2015 article noted, however, that most physicians prefer to keep titles in the mix.

Perhaps most troublesome, says Dr. Setya, is that patients forgo asking whether it’s OK to use his first name and simply assume it’s acceptable. “It bothers me,” he says. “I became a doctor for more than the money.”

He suspects that his cultural background (Dr. Setya is of Indian descent) plays a role in how strongly he feels about patient-doctor informality. “As a British colony, Indian culture dictates that you pay respect to elders and to accomplishment,” he points out. “America is far looser when it comes to salutations.”

Dr. Cucuzzella largely agrees with Dr. Setya, but has a different view of the role culture plays in how physicians prefer to be addressed. “If your last name is difficult to pronounce, it can put the patient at ease if you give them an option,” he says. “I like my patients to feel comfortable and have a friendly conversation, so I don’t ask them to try to manage my last name.”

When patients revert to using Dr. Cucuzzella’s last name and title, this often breaks down along generational lines, Dr. Cucuzzella has found: Older patients might drop his title, whereas younger patients might keep it as a sign of respect. In some cases, Dr. Cucuzzella tries to bridge this gap, and offers the option of “Dr. Mark.” In his small West Virginia community, this is how people often refer to him.

Dr. Setya says that most of the older physicians he works with still prefer that patients and younger colleagues use their title, but he has witnessed exceptions to this. “My boss in residence hated to be called ‘Sir’ or ‘Doctor,’ ” he says. “In a situation like that, it is reasonable to ask, ‘How can I address you?’ But it has to be mutually agreed upon.”

Dr. Cucuzzella cites informality as the preferred mode for older patients. “If I have a 70-year-old patient, it seems natural they shouldn’t use my title,” he says. “They are worthy of equality in the community. If I’m talking to a retired CEO or state delegate, it’s uncomfortable if they call me doctor.”

Moreover, Dr. Cucuzzella maintains that establishing a less formal environment with patients leads to better outcomes. “Shared decision-making is a basic human right,” he says. “In 2022, doctors shouldn’t make decisions without patient input, unless it’s an emergency situation. Removing the title barriers makes that easier.”
 

How to handle informality

If you fall more in line with Dr. Setya, there are strategies you can use to try to keep formality in your doctor-patient relationships. Dr. Setya’s approach is indirect. “I don’t correct a patient if they use my first name, because that might seem hostile,” he says. “But I alert them in the way I address them back. A Sir, a Mrs., or a Mr. needs to go both ways.”

This particularly holds true in pediatrics, Dr. Setya has found. He has witnessed many colleagues addressing parents as “Mommy and Daddy,” something he says lacks respect and sets too informal a tone. “It’s almost universal that parents don’t like that, and we need to act accordingly.”

Dr. Witt also avoids directly correcting patients, but struggles when they drop her title. “The standard signature I use to sign every patient portal message I respond to includes my first and last name and credentials,” she says. “I maintain formality in most circumstances with that standard reply.”

Beneath the surface, however, Dr. Witt wishes it were easier. “I have struggled with answering the question, ‘Is it OK if I call you Leah?’ she says. “I want to keep our interaction anchored in professionalism without sacrificing the warmth I think is important to a productive patient-physician relationship. For this reason, I tend to say yes to this request, even though I’d rather patients didn’t make such requests.”

In the Fast Company article by Amy Diehl, PhD, and Leanne Dzubinski, PhD, on the topic of untitling professional women, the authors suggest several actions, beginning with leadership that sets expectations on the topic. They also suggest that physicians use polite corrections if patients untitle them. Supplying positive reinforcement when patients include your title can help, too. If all else fails, you can call out the offensive untitling. More often than not, especially with female physicians, the patient is demonstrating an unconscious bias rather than something deliberate.

Opinions vary on the topic of untitling, and ultimately each physician must make the decision for themselves. But creating informal cultures in an organization can have unintended consequences, especially for female peers.

Says Dr. Witt, “We all want to give our patients the best care we can, but professional boundaries are critical to time management, equitable care, and maintaining work-life balance. I would love to see a study that examines untitling by self-reported race and/or ethnicity of physicians, because we know that women of color experience higher rates of burnout and depression, and I wonder if untitling may be part of this.”

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

When Mark Cucuzzella, MD, meets a new patient at the West Virginia Medical School clinic, he introduces himself as “Mark.” For one thing, says Dr. Cucuzzella, his last name is a mouthful. For another, the 56-year-old general practitioner asserts that getting on a first-name basis with his patients is integral to delivering the best care.

“I’m trying to break down the old paternalistic barriers of the doctor/patient relationship,” he says. “Titles create an environment where the doctors are making all the decisions and not involving the patient in any course of action.”

Aniruddh Setya, MD, has a different take on informality between patients and doctors: It’s not OK. “I am not your friend,” says the 35-year-old pediatrician from Florida-based KIDZ Medical Services. “There has to be a level of respect for the education and accomplishment of being a physician.”

The issue of “untitling” a doctor and failing to use their honorific is becoming increasingly common, according to a recent study published in JAMA Network Open. But that doesn’t mean most physicians support the practice. In fact, some doctors contend that it can be harmful, particularly to female physicians.

“My concern is that untitling (so termed by Amy Diehl, PhD, and Leanne Dzubinski, PhD) intrudes upon important professional boundaries and might be correlated with diminishing the value of someone’s time,” says Leah Witt, MD, a geriatrician at UCSF Health, San Francisco. Dr. Witt, along with colleague Lekshmi Santhosh, MD, a pulmonologist, offered commentary on the study results. “Studies have shown that women physicians get more patient portal messages, spend more time in the electronic health record, and have longer visits,” Dr. Witt said. “Dr. Santhosh and I wonder if untitling is a signifier of this diminished value of our time, and an assumption of increased ease of access leading to this higher workload.”

To compile the results reported in JAMA Network Open, Mayo Clinic researchers analyzed more than 90,000 emails from patients to doctors over the course of 3 years, beginning in 2018. Of those emails, more than 32% included the physician’s first name in greeting or salutation. For women physicians, the odds were twice as high that their titles would be omitted in the correspondence. The same holds true for doctors of osteopathic medicine (DOs) compared with MDs, and primary care physicians had similar odds for a title drop compared with specialists.

Dr. Witt says the findings are not surprising. “They match my experience as a woman in medicine, as Dr. Santhosh and I write in our commentary,” she says. “We think the findings could easily be replicated at other centers.”

Indeed, research on 321 speaker introductions at a medical rounds found that when female physicians introduced other physicians, they usually applied the doctor title. When the job of introducing colleagues fell to male physicians, however, the stats fell to 72.4% for male peers and only 49.2% when introducing female peers.

The Mayo Clinic study authors identified the pitfalls of patients who informally address their doctors. They wrote, “Untitling may have a negative impact on physicians, demonstrate lack of respect, and can lead to reduction in formality of the physician/patient relationship or workplace.”
 

Physician preferences vary

Although the results of the Mayo Clinic analysis didn’t and couldn’t address physician sentiments on patient informality, Dr. Setya observes that American culture is becoming less formal. “I’ve been practicing for over 10 years, and the number of people who consider doctors as equals is growing,” he says. “This has been particularly true over the last couple of years.”

This change was documented in 2015. Add in the pandemic and an entire society that is now accustomed to working from home in sweats, and it’s not a stretch to understand why some patients have become less formal in many settings. The 2015 article noted, however, that most physicians prefer to keep titles in the mix.

Perhaps most troublesome, says Dr. Setya, is that patients forgo asking whether it’s OK to use his first name and simply assume it’s acceptable. “It bothers me,” he says. “I became a doctor for more than the money.”

He suspects that his cultural background (Dr. Setya is of Indian descent) plays a role in how strongly he feels about patient-doctor informality. “As a British colony, Indian culture dictates that you pay respect to elders and to accomplishment,” he points out. “America is far looser when it comes to salutations.”

Dr. Cucuzzella largely agrees with Dr. Setya, but has a different view of the role culture plays in how physicians prefer to be addressed. “If your last name is difficult to pronounce, it can put the patient at ease if you give them an option,” he says. “I like my patients to feel comfortable and have a friendly conversation, so I don’t ask them to try to manage my last name.”

When patients revert to using Dr. Cucuzzella’s last name and title, this often breaks down along generational lines, Dr. Cucuzzella has found: Older patients might drop his title, whereas younger patients might keep it as a sign of respect. In some cases, Dr. Cucuzzella tries to bridge this gap, and offers the option of “Dr. Mark.” In his small West Virginia community, this is how people often refer to him.

Dr. Setya says that most of the older physicians he works with still prefer that patients and younger colleagues use their title, but he has witnessed exceptions to this. “My boss in residence hated to be called ‘Sir’ or ‘Doctor,’ ” he says. “In a situation like that, it is reasonable to ask, ‘How can I address you?’ But it has to be mutually agreed upon.”

Dr. Cucuzzella cites informality as the preferred mode for older patients. “If I have a 70-year-old patient, it seems natural they shouldn’t use my title,” he says. “They are worthy of equality in the community. If I’m talking to a retired CEO or state delegate, it’s uncomfortable if they call me doctor.”

Moreover, Dr. Cucuzzella maintains that establishing a less formal environment with patients leads to better outcomes. “Shared decision-making is a basic human right,” he says. “In 2022, doctors shouldn’t make decisions without patient input, unless it’s an emergency situation. Removing the title barriers makes that easier.”
 

How to handle informality

If you fall more in line with Dr. Setya, there are strategies you can use to try to keep formality in your doctor-patient relationships. Dr. Setya’s approach is indirect. “I don’t correct a patient if they use my first name, because that might seem hostile,” he says. “But I alert them in the way I address them back. A Sir, a Mrs., or a Mr. needs to go both ways.”

This particularly holds true in pediatrics, Dr. Setya has found. He has witnessed many colleagues addressing parents as “Mommy and Daddy,” something he says lacks respect and sets too informal a tone. “It’s almost universal that parents don’t like that, and we need to act accordingly.”

Dr. Witt also avoids directly correcting patients, but struggles when they drop her title. “The standard signature I use to sign every patient portal message I respond to includes my first and last name and credentials,” she says. “I maintain formality in most circumstances with that standard reply.”

Beneath the surface, however, Dr. Witt wishes it were easier. “I have struggled with answering the question, ‘Is it OK if I call you Leah?’ she says. “I want to keep our interaction anchored in professionalism without sacrificing the warmth I think is important to a productive patient-physician relationship. For this reason, I tend to say yes to this request, even though I’d rather patients didn’t make such requests.”

In the Fast Company article by Amy Diehl, PhD, and Leanne Dzubinski, PhD, on the topic of untitling professional women, the authors suggest several actions, beginning with leadership that sets expectations on the topic. They also suggest that physicians use polite corrections if patients untitle them. Supplying positive reinforcement when patients include your title can help, too. If all else fails, you can call out the offensive untitling. More often than not, especially with female physicians, the patient is demonstrating an unconscious bias rather than something deliberate.

Opinions vary on the topic of untitling, and ultimately each physician must make the decision for themselves. But creating informal cultures in an organization can have unintended consequences, especially for female peers.

Says Dr. Witt, “We all want to give our patients the best care we can, but professional boundaries are critical to time management, equitable care, and maintaining work-life balance. I would love to see a study that examines untitling by self-reported race and/or ethnicity of physicians, because we know that women of color experience higher rates of burnout and depression, and I wonder if untitling may be part of this.”

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

Highly processed foods meet the same criteria as tobacco for addiction, and labeling them as such might benefit public health, according to a new U.S. study that proposes a set of criteria to assess the addictive potential of some foods.

The research suggests that health care professionals are taking steps toward framing food addiction as a clinical entity in its own right; it currently lacks validated treatment protocols and recognition as a clinical diagnosis.

Meanwhile, other data, reported by researchers at the 2022 Diabetes Professional Care conference in London also add support to the clinical recognition of food addiction.

Clinical psychologist Jen Unwin, PhD, from Southport, England, showed that a 3-month online program of low-carbohydrate diet together with psychoeducational support significantly reduced food addiction symptoms among a varied group of individuals, not all of whom were overweight or had obesity.

Dr. Unwin said her new data represent the first wide-scale clinical audit of its kind, other than a prior report of three patients with food addiction who were successfully treated with a ketogenic diet. 

“Food addiction explains so much of what we see in clinical practice, where intelligent people understand what we tell them about the physiology associated with a low-carb diet, and they follow it for a while, but then they relapse,” said Dr. Unwin, explaining the difficulties faced by around 20% of her patients who are considered to have food addiction.

Meanwhile, the authors of the U.S. study, led by Ashley N. Gearhardt, PhD, a psychologist from the University of Michigan, Ann Arbor, wrote that the ability of highly processed foods (HPFs) “to rapidly deliver high doses of refined carbohydrates and/or fat appear key to their addictive potential. Thus, we conclude that HPFs can be considered addictive substances based on scientifically established criteria.”

They asserted that the contribution to preventable deaths by a diet dominated by highly processed foods is comparable with that of tobacco products, and as such, like Dr. Unwin, the authors sought clinical recognition and a more formalized protocol to manage food addiction.

“Understanding whether addiction contributes to HPF intake may lead to new treatments, as preliminary research finds that behavioral and pharmacological interventions that target addictive mechanisms may reduce compulsive HPF intake,” they stated.

The study led by Dr. Gearhardt was published in the journal Addiction, and the study led by Unwin was also recently published in Frontiers in Psychiatry.
 

Addiction criteria similar to tobacco

HPFs can be associated with an eating phenotype “that reflects the hallmarks of addiction,” said Dr. Gearhardt and coauthors; typically, loss of control over intake, intense cravings, inability to cut down, and continued use despite negative consequences.

Acknowledging the lack of a single addictive agent, they explain that food addiction reflects mechanisms implicated in other addictive disorders such as smoking.

As such, in their study, Dr. Gearhardt and colleagues proposed a set of scientifically based criteria for the evaluation of whether certain foods are addictive. “Specifically, we propose the primary criteria used to resolve one of the last major controversies over whether a substance, tobacco products, was addictive.”

They consider certain foods according to the primary criteria that have stood the test of time after being proposed in 1988 by the U.S. Surgeon General to establish the addictive potential of tobacco: they trigger compulsive use, they have psychoactive effects, and they are reinforcing.

They have updated these criteria to include the ability to trigger urges and cravings, and added that “both these products [tobacco and HPFs] are legal, easily accessible, inexpensive, lack an intoxication syndrome, and are major causes of preventable death.”

For example, with compulsive use, tobacco meets this criterion because evidence suggests that most smokers would like to quit but are unable to do so.

Likewise, wrote Dr. Gearhardt and colleagues, even “in the face of significant diet-related health consequences (e.g., diabetes and cardiovascular disease), the majority of patients are unable to adhere to medically recommended dietary plans that require a reduction in HPF intake.”

Reinforcement, through tobacco use, is demonstrated by its ‘being sufficiently rewarding to maintain self-administration” because of its ability to deliver nicotine, they said, quoting the Surgeon General’s report, and likewise, with food addiction, “both adults and children will self-administer HPFs (e.g., potato chips, candy, and cookies) even when satiated.”
 

Online group food addiction intervention study

Dr. Unwin and coauthors want people with food addiction to be able to access a validated treatment protocol. Their study aimed to evaluate an online group intervention across multiple sites in the United States, Canada, and the United Kingdom, involving an abstinent, low-carbohydrate diet and biopsychosocial education focused on addiction and recovery in people self-identifying as having food addiction.

“Lots of people with food addiction go to GPs who don’t clinically recognize this, or if they attend addiction services and psychiatry, then they tend to only specialize in drugs, alcohol, and gambling. Eating disorder services are linked but their programs mostly don’t work for a food addict,” Dr. Unwin remarked in an interview.

“We feel running groups, as well as training professionals to run groups, is the best way to manage food addiction,” she said, reflecting on the scale of the problem, with around 10% of adults in the U.K. general population considered to have food addiction. In Dr. Unwin’s study, some people had type 2 diabetes and some overweight/obesity, but she added that some participants were underweight or of normal weight.

Initially, the 103 participants received weekly group (8-24 people) sessions for 10-14 weeks, and then monthly maintenance comprising follow-up that involved coaching participants on how to cope with relapse and get back on track.

Food addiction symptoms were assessed pre- and post program using the modified Yale Food Addiction Scale (mYFAS) 2.0; ICD-10 symptoms of food-related substance use disorder (CRAVED); and mental health well-being measured using the short version of the Warwick Edinburgh Mental Wellbeing scale and body weight.

“The program eliminates processed foods with a personalized, abstinence food plan that involves education around mechanisms involved,” said Dr. Unwin, who explained that processed foods deliver a dopamine high, and in response to this, the brain lowers the number of dopamine receptors to effectively counteract the increase in dopamine. This drop in dopamine receptors explains the depression often associated with food addiction.

Dr. Unwin reported that food addiction symptoms were significantly reduced, with the mYFAS dropping by 1.52, the CRAVED score by 1.53, and body weight by 2.34 kg (5.2 lb). Mental health, as measured by the Warwick Edinburgh Mental Wellbeing scale, improved by 2.37 points.

“We were very interested in mental health and well-being because it impacts so much across our lives, and we saw significant improvements here, but we were less interested in weight because food addicts come in all shapes and sizes with some people underweight,” said Dr. Unwin. “Food addiction symptoms were significantly improved in the group, but we now need to look at the longer-term outcomes.”

Dr. Unwin runs a low-carbohydrate program for type 2 diabetes with her husband David Unwin, MD, who is a GP in Southport, England. She said that they ask patients if they think they have food addiction, and most say they do.

“I always try to explain to patients about the dopamine high, and how this starts the craving which makes people wonder when and where they can find the next sugar hit. Just thinking about the next chocolate bar gets the dopamine running for many people, and the more they tread this path then the worse it gets because the dopamine receptors keep reducing.”

Lorraine Avery, RN, a diabetes nurse specialist for Solent NHS Trust, who attended the DPC conference, welcomed Dr. Unwin’s presentation.

“My concern as a diabetes nurse specialist is that I’m unsure all our patients recognize their food addiction, and there are often more drivers to eating than just the food in front of them,” she said in an interview. “I think there’s an emotional element, too. These people are often ‘yo-yo’ dieters, and they join lots of expert companies to help them lose weight, but these companies want them to regain and re-join their programs,” she said.

“I think there is something about helping patients recognize they have a food addiction and they need to consider that other approaches might be helpful.”

Dr. Unwin reported no relevant financial relationships; some other authors have fee-paying clients with food addiction. Dr. Gearhardt and Ms. Avery reported no relevant financial relationships.

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

Highly processed foods meet the same criteria as tobacco for addiction, and labeling them as such might benefit public health, according to a new U.S. study that proposes a set of criteria to assess the addictive potential of some foods.

The research suggests that health care professionals are taking steps toward framing food addiction as a clinical entity in its own right; it currently lacks validated treatment protocols and recognition as a clinical diagnosis.

Meanwhile, other data, reported by researchers at the 2022 Diabetes Professional Care conference in London also add support to the clinical recognition of food addiction.

Clinical psychologist Jen Unwin, PhD, from Southport, England, showed that a 3-month online program of low-carbohydrate diet together with psychoeducational support significantly reduced food addiction symptoms among a varied group of individuals, not all of whom were overweight or had obesity.

Dr. Unwin said her new data represent the first wide-scale clinical audit of its kind, other than a prior report of three patients with food addiction who were successfully treated with a ketogenic diet. 

“Food addiction explains so much of what we see in clinical practice, where intelligent people understand what we tell them about the physiology associated with a low-carb diet, and they follow it for a while, but then they relapse,” said Dr. Unwin, explaining the difficulties faced by around 20% of her patients who are considered to have food addiction.

Meanwhile, the authors of the U.S. study, led by Ashley N. Gearhardt, PhD, a psychologist from the University of Michigan, Ann Arbor, wrote that the ability of highly processed foods (HPFs) “to rapidly deliver high doses of refined carbohydrates and/or fat appear key to their addictive potential. Thus, we conclude that HPFs can be considered addictive substances based on scientifically established criteria.”

They asserted that the contribution to preventable deaths by a diet dominated by highly processed foods is comparable with that of tobacco products, and as such, like Dr. Unwin, the authors sought clinical recognition and a more formalized protocol to manage food addiction.

“Understanding whether addiction contributes to HPF intake may lead to new treatments, as preliminary research finds that behavioral and pharmacological interventions that target addictive mechanisms may reduce compulsive HPF intake,” they stated.

The study led by Dr. Gearhardt was published in the journal Addiction, and the study led by Unwin was also recently published in Frontiers in Psychiatry.
 

Addiction criteria similar to tobacco

HPFs can be associated with an eating phenotype “that reflects the hallmarks of addiction,” said Dr. Gearhardt and coauthors; typically, loss of control over intake, intense cravings, inability to cut down, and continued use despite negative consequences.

Acknowledging the lack of a single addictive agent, they explain that food addiction reflects mechanisms implicated in other addictive disorders such as smoking.

As such, in their study, Dr. Gearhardt and colleagues proposed a set of scientifically based criteria for the evaluation of whether certain foods are addictive. “Specifically, we propose the primary criteria used to resolve one of the last major controversies over whether a substance, tobacco products, was addictive.”

They consider certain foods according to the primary criteria that have stood the test of time after being proposed in 1988 by the U.S. Surgeon General to establish the addictive potential of tobacco: they trigger compulsive use, they have psychoactive effects, and they are reinforcing.

They have updated these criteria to include the ability to trigger urges and cravings, and added that “both these products [tobacco and HPFs] are legal, easily accessible, inexpensive, lack an intoxication syndrome, and are major causes of preventable death.”

For example, with compulsive use, tobacco meets this criterion because evidence suggests that most smokers would like to quit but are unable to do so.

Likewise, wrote Dr. Gearhardt and colleagues, even “in the face of significant diet-related health consequences (e.g., diabetes and cardiovascular disease), the majority of patients are unable to adhere to medically recommended dietary plans that require a reduction in HPF intake.”

Reinforcement, through tobacco use, is demonstrated by its ‘being sufficiently rewarding to maintain self-administration” because of its ability to deliver nicotine, they said, quoting the Surgeon General’s report, and likewise, with food addiction, “both adults and children will self-administer HPFs (e.g., potato chips, candy, and cookies) even when satiated.”
 

Online group food addiction intervention study

Dr. Unwin and coauthors want people with food addiction to be able to access a validated treatment protocol. Their study aimed to evaluate an online group intervention across multiple sites in the United States, Canada, and the United Kingdom, involving an abstinent, low-carbohydrate diet and biopsychosocial education focused on addiction and recovery in people self-identifying as having food addiction.

“Lots of people with food addiction go to GPs who don’t clinically recognize this, or if they attend addiction services and psychiatry, then they tend to only specialize in drugs, alcohol, and gambling. Eating disorder services are linked but their programs mostly don’t work for a food addict,” Dr. Unwin remarked in an interview.

“We feel running groups, as well as training professionals to run groups, is the best way to manage food addiction,” she said, reflecting on the scale of the problem, with around 10% of adults in the U.K. general population considered to have food addiction. In Dr. Unwin’s study, some people had type 2 diabetes and some overweight/obesity, but she added that some participants were underweight or of normal weight.

Initially, the 103 participants received weekly group (8-24 people) sessions for 10-14 weeks, and then monthly maintenance comprising follow-up that involved coaching participants on how to cope with relapse and get back on track.

Food addiction symptoms were assessed pre- and post program using the modified Yale Food Addiction Scale (mYFAS) 2.0; ICD-10 symptoms of food-related substance use disorder (CRAVED); and mental health well-being measured using the short version of the Warwick Edinburgh Mental Wellbeing scale and body weight.

“The program eliminates processed foods with a personalized, abstinence food plan that involves education around mechanisms involved,” said Dr. Unwin, who explained that processed foods deliver a dopamine high, and in response to this, the brain lowers the number of dopamine receptors to effectively counteract the increase in dopamine. This drop in dopamine receptors explains the depression often associated with food addiction.

Dr. Unwin reported that food addiction symptoms were significantly reduced, with the mYFAS dropping by 1.52, the CRAVED score by 1.53, and body weight by 2.34 kg (5.2 lb). Mental health, as measured by the Warwick Edinburgh Mental Wellbeing scale, improved by 2.37 points.

“We were very interested in mental health and well-being because it impacts so much across our lives, and we saw significant improvements here, but we were less interested in weight because food addicts come in all shapes and sizes with some people underweight,” said Dr. Unwin. “Food addiction symptoms were significantly improved in the group, but we now need to look at the longer-term outcomes.”

Dr. Unwin runs a low-carbohydrate program for type 2 diabetes with her husband David Unwin, MD, who is a GP in Southport, England. She said that they ask patients if they think they have food addiction, and most say they do.

“I always try to explain to patients about the dopamine high, and how this starts the craving which makes people wonder when and where they can find the next sugar hit. Just thinking about the next chocolate bar gets the dopamine running for many people, and the more they tread this path then the worse it gets because the dopamine receptors keep reducing.”

Lorraine Avery, RN, a diabetes nurse specialist for Solent NHS Trust, who attended the DPC conference, welcomed Dr. Unwin’s presentation.

“My concern as a diabetes nurse specialist is that I’m unsure all our patients recognize their food addiction, and there are often more drivers to eating than just the food in front of them,” she said in an interview. “I think there’s an emotional element, too. These people are often ‘yo-yo’ dieters, and they join lots of expert companies to help them lose weight, but these companies want them to regain and re-join their programs,” she said.

“I think there is something about helping patients recognize they have a food addiction and they need to consider that other approaches might be helpful.”

Dr. Unwin reported no relevant financial relationships; some other authors have fee-paying clients with food addiction. Dr. Gearhardt and Ms. Avery reported no relevant financial relationships.

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

Highly processed foods meet the same criteria as tobacco for addiction, and labeling them as such might benefit public health, according to a new U.S. study that proposes a set of criteria to assess the addictive potential of some foods.

The research suggests that health care professionals are taking steps toward framing food addiction as a clinical entity in its own right; it currently lacks validated treatment protocols and recognition as a clinical diagnosis.

Meanwhile, other data, reported by researchers at the 2022 Diabetes Professional Care conference in London also add support to the clinical recognition of food addiction.

Clinical psychologist Jen Unwin, PhD, from Southport, England, showed that a 3-month online program of low-carbohydrate diet together with psychoeducational support significantly reduced food addiction symptoms among a varied group of individuals, not all of whom were overweight or had obesity.

Dr. Unwin said her new data represent the first wide-scale clinical audit of its kind, other than a prior report of three patients with food addiction who were successfully treated with a ketogenic diet. 

“Food addiction explains so much of what we see in clinical practice, where intelligent people understand what we tell them about the physiology associated with a low-carb diet, and they follow it for a while, but then they relapse,” said Dr. Unwin, explaining the difficulties faced by around 20% of her patients who are considered to have food addiction.

Meanwhile, the authors of the U.S. study, led by Ashley N. Gearhardt, PhD, a psychologist from the University of Michigan, Ann Arbor, wrote that the ability of highly processed foods (HPFs) “to rapidly deliver high doses of refined carbohydrates and/or fat appear key to their addictive potential. Thus, we conclude that HPFs can be considered addictive substances based on scientifically established criteria.”

They asserted that the contribution to preventable deaths by a diet dominated by highly processed foods is comparable with that of tobacco products, and as such, like Dr. Unwin, the authors sought clinical recognition and a more formalized protocol to manage food addiction.

“Understanding whether addiction contributes to HPF intake may lead to new treatments, as preliminary research finds that behavioral and pharmacological interventions that target addictive mechanisms may reduce compulsive HPF intake,” they stated.

The study led by Dr. Gearhardt was published in the journal Addiction, and the study led by Unwin was also recently published in Frontiers in Psychiatry.
 

Addiction criteria similar to tobacco

HPFs can be associated with an eating phenotype “that reflects the hallmarks of addiction,” said Dr. Gearhardt and coauthors; typically, loss of control over intake, intense cravings, inability to cut down, and continued use despite negative consequences.

Acknowledging the lack of a single addictive agent, they explain that food addiction reflects mechanisms implicated in other addictive disorders such as smoking.

As such, in their study, Dr. Gearhardt and colleagues proposed a set of scientifically based criteria for the evaluation of whether certain foods are addictive. “Specifically, we propose the primary criteria used to resolve one of the last major controversies over whether a substance, tobacco products, was addictive.”

They consider certain foods according to the primary criteria that have stood the test of time after being proposed in 1988 by the U.S. Surgeon General to establish the addictive potential of tobacco: they trigger compulsive use, they have psychoactive effects, and they are reinforcing.

They have updated these criteria to include the ability to trigger urges and cravings, and added that “both these products [tobacco and HPFs] are legal, easily accessible, inexpensive, lack an intoxication syndrome, and are major causes of preventable death.”

For example, with compulsive use, tobacco meets this criterion because evidence suggests that most smokers would like to quit but are unable to do so.

Likewise, wrote Dr. Gearhardt and colleagues, even “in the face of significant diet-related health consequences (e.g., diabetes and cardiovascular disease), the majority of patients are unable to adhere to medically recommended dietary plans that require a reduction in HPF intake.”

Reinforcement, through tobacco use, is demonstrated by its ‘being sufficiently rewarding to maintain self-administration” because of its ability to deliver nicotine, they said, quoting the Surgeon General’s report, and likewise, with food addiction, “both adults and children will self-administer HPFs (e.g., potato chips, candy, and cookies) even when satiated.”
 

Online group food addiction intervention study

Dr. Unwin and coauthors want people with food addiction to be able to access a validated treatment protocol. Their study aimed to evaluate an online group intervention across multiple sites in the United States, Canada, and the United Kingdom, involving an abstinent, low-carbohydrate diet and biopsychosocial education focused on addiction and recovery in people self-identifying as having food addiction.

“Lots of people with food addiction go to GPs who don’t clinically recognize this, or if they attend addiction services and psychiatry, then they tend to only specialize in drugs, alcohol, and gambling. Eating disorder services are linked but their programs mostly don’t work for a food addict,” Dr. Unwin remarked in an interview.

“We feel running groups, as well as training professionals to run groups, is the best way to manage food addiction,” she said, reflecting on the scale of the problem, with around 10% of adults in the U.K. general population considered to have food addiction. In Dr. Unwin’s study, some people had type 2 diabetes and some overweight/obesity, but she added that some participants were underweight or of normal weight.

Initially, the 103 participants received weekly group (8-24 people) sessions for 10-14 weeks, and then monthly maintenance comprising follow-up that involved coaching participants on how to cope with relapse and get back on track.

Food addiction symptoms were assessed pre- and post program using the modified Yale Food Addiction Scale (mYFAS) 2.0; ICD-10 symptoms of food-related substance use disorder (CRAVED); and mental health well-being measured using the short version of the Warwick Edinburgh Mental Wellbeing scale and body weight.

“The program eliminates processed foods with a personalized, abstinence food plan that involves education around mechanisms involved,” said Dr. Unwin, who explained that processed foods deliver a dopamine high, and in response to this, the brain lowers the number of dopamine receptors to effectively counteract the increase in dopamine. This drop in dopamine receptors explains the depression often associated with food addiction.

Dr. Unwin reported that food addiction symptoms were significantly reduced, with the mYFAS dropping by 1.52, the CRAVED score by 1.53, and body weight by 2.34 kg (5.2 lb). Mental health, as measured by the Warwick Edinburgh Mental Wellbeing scale, improved by 2.37 points.

“We were very interested in mental health and well-being because it impacts so much across our lives, and we saw significant improvements here, but we were less interested in weight because food addicts come in all shapes and sizes with some people underweight,” said Dr. Unwin. “Food addiction symptoms were significantly improved in the group, but we now need to look at the longer-term outcomes.”

Dr. Unwin runs a low-carbohydrate program for type 2 diabetes with her husband David Unwin, MD, who is a GP in Southport, England. She said that they ask patients if they think they have food addiction, and most say they do.

“I always try to explain to patients about the dopamine high, and how this starts the craving which makes people wonder when and where they can find the next sugar hit. Just thinking about the next chocolate bar gets the dopamine running for many people, and the more they tread this path then the worse it gets because the dopamine receptors keep reducing.”

Lorraine Avery, RN, a diabetes nurse specialist for Solent NHS Trust, who attended the DPC conference, welcomed Dr. Unwin’s presentation.

“My concern as a diabetes nurse specialist is that I’m unsure all our patients recognize their food addiction, and there are often more drivers to eating than just the food in front of them,” she said in an interview. “I think there’s an emotional element, too. These people are often ‘yo-yo’ dieters, and they join lots of expert companies to help them lose weight, but these companies want them to regain and re-join their programs,” she said.

“I think there is something about helping patients recognize they have a food addiction and they need to consider that other approaches might be helpful.”

Dr. Unwin reported no relevant financial relationships; some other authors have fee-paying clients with food addiction. Dr. Gearhardt and Ms. Avery reported no relevant financial relationships.

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

Dr Carol Wysham, of the University of Washington School of Medicine in Spokane, reports on key studies looking at glucose-lowering therapies in adults with type 2 diabetes, as presented at the 2022 annual meeting of the American Society of Nephrology. 

Dr Wysham first highlights a real-world study evaluating the long-term use of empagliflozin compared with dipeptidyl peptidase-4 (DPP-4) inhibitors. The researchers used the estimated glomerular filtration rate (eGFR) slope as their predictive value for clinical kidney benefit. They found that long-term use of empagliflozin was associated with less impairment of kidney function than DPP-4 inhibitors.  

Next, Dr Wysham discusses a study testing the safety of SGLT2 inhibitors in patients with both chronic kidney disease and type 2 diabetes. Researchers found that in this patient population undergoing routine care, use of SGLT2 inhibitors was associated with an increased risk for nonvertebral fractures, lower-limb amputations, and genital infections. 

Next, Dr Wysham examines a report pooling data from the SUSTAIN 6 and PIONEER 6 studies to determine whether semaglutide improves the eGFR slope. Researchers found that across the A1c and blood pressure subgroups, semaglutide reduced eGFR compared with placebo.  

Finally, Dr Wysham discusses an analysis using data from the Framingham Heart Study to determine whether a demonstrable link could be established between kidney disease and mild cognitive impairment. Researchers reported that patients with albuminuria had an increased risk for brain infarctions.  

--

Carol Wysham, MD, Clinical Professor of Medicine, Department of Medicine, University of Washington School of Medicine; Clinical Endocrinologist, Rockwood Center for Diabetes and Endocrinology, MultiCare Health Systems, Spokane, Washington 

Carol Wysham, MD, has disclosed the following relevant financial relationships: 

Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: Endocrine Society; MultiCare Health Systems 

Received research grant from: Allergan; Abbott; Corcept; Eli Lilly; Mylan; Novo Nordisk; Regeneron 

Dr Carol Wysham, of the University of Washington School of Medicine in Spokane, reports on key studies looking at glucose-lowering therapies in adults with type 2 diabetes, as presented at the 2022 annual meeting of the American Society of Nephrology. 

Dr Wysham first highlights a real-world study evaluating the long-term use of empagliflozin compared with dipeptidyl peptidase-4 (DPP-4) inhibitors. The researchers used the estimated glomerular filtration rate (eGFR) slope as their predictive value for clinical kidney benefit. They found that long-term use of empagliflozin was associated with less impairment of kidney function than DPP-4 inhibitors.  

Next, Dr Wysham discusses a study testing the safety of SGLT2 inhibitors in patients with both chronic kidney disease and type 2 diabetes. Researchers found that in this patient population undergoing routine care, use of SGLT2 inhibitors was associated with an increased risk for nonvertebral fractures, lower-limb amputations, and genital infections. 

Next, Dr Wysham examines a report pooling data from the SUSTAIN 6 and PIONEER 6 studies to determine whether semaglutide improves the eGFR slope. Researchers found that across the A1c and blood pressure subgroups, semaglutide reduced eGFR compared with placebo.  

Finally, Dr Wysham discusses an analysis using data from the Framingham Heart Study to determine whether a demonstrable link could be established between kidney disease and mild cognitive impairment. Researchers reported that patients with albuminuria had an increased risk for brain infarctions.  

--

Carol Wysham, MD, Clinical Professor of Medicine, Department of Medicine, University of Washington School of Medicine; Clinical Endocrinologist, Rockwood Center for Diabetes and Endocrinology, MultiCare Health Systems, Spokane, Washington 

Carol Wysham, MD, has disclosed the following relevant financial relationships: 

Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: Endocrine Society; MultiCare Health Systems 

Received research grant from: Allergan; Abbott; Corcept; Eli Lilly; Mylan; Novo Nordisk; Regeneron 

Dr Carol Wysham, of the University of Washington School of Medicine in Spokane, reports on key studies looking at glucose-lowering therapies in adults with type 2 diabetes, as presented at the 2022 annual meeting of the American Society of Nephrology. 

Dr Wysham first highlights a real-world study evaluating the long-term use of empagliflozin compared with dipeptidyl peptidase-4 (DPP-4) inhibitors. The researchers used the estimated glomerular filtration rate (eGFR) slope as their predictive value for clinical kidney benefit. They found that long-term use of empagliflozin was associated with less impairment of kidney function than DPP-4 inhibitors.  

Next, Dr Wysham discusses a study testing the safety of SGLT2 inhibitors in patients with both chronic kidney disease and type 2 diabetes. Researchers found that in this patient population undergoing routine care, use of SGLT2 inhibitors was associated with an increased risk for nonvertebral fractures, lower-limb amputations, and genital infections. 

Next, Dr Wysham examines a report pooling data from the SUSTAIN 6 and PIONEER 6 studies to determine whether semaglutide improves the eGFR slope. Researchers found that across the A1c and blood pressure subgroups, semaglutide reduced eGFR compared with placebo.  

Finally, Dr Wysham discusses an analysis using data from the Framingham Heart Study to determine whether a demonstrable link could be established between kidney disease and mild cognitive impairment. Researchers reported that patients with albuminuria had an increased risk for brain infarctions.  

--

Carol Wysham, MD, Clinical Professor of Medicine, Department of Medicine, University of Washington School of Medicine; Clinical Endocrinologist, Rockwood Center for Diabetes and Endocrinology, MultiCare Health Systems, Spokane, Washington 

Carol Wysham, MD, has disclosed the following relevant financial relationships: 

Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: Endocrine Society; MultiCare Health Systems 

Received research grant from: Allergan; Abbott; Corcept; Eli Lilly; Mylan; Novo Nordisk; Regeneron 

The Food and Drug Administration issued an alert on Nov. 22 that cited preliminary evidence for a “substantial risk” for severe and symptomatic hypocalcemia and serious outcomes related to abnormally low calcium levels in people being treated with dialysis and receiving the osteoporosis medication denosumab (Prolia), including hospitalization and death.

In its alert, the FDA advised clinicians to make sure that people on dialysis who receive Prolia ingest adequate calcium and vitamin D supplementation and undergo frequent blood calcium monitoring, “possibly more often than is already being conducted,” which “may help decrease the likelihood or severity of these risks.”

The agency also called on clinicians to “advise patients on dialysis to immediately seek help if they experience symptoms of hypocalcemia,” such as unusual tingling or numbness in the hands, arms, legs, or feet; painful muscle spasms or cramps; voice box or lung spasms causing difficulty breathing; vomiting; seizures; or irregular heart rhythm.

The FDA had a similar message for people being treated with dialysis who are also receiving Prolia. The alert advised patients to watch for these symptoms and to tell their health care provider if they occur. The agency also advised patients who are undergoing dialysis and receiving Prolia to not stop the agent on their own, without first discussing this step with their care provider.

The FDA also advised providers and patients to contact the agency about episodes of side effects from Prolia (or other medications) via the FDA’s MedWatch program.
 

Frequent and serious

The FDA explained it issued the alert because of “the frequency and seriousness” of the risk for hypocalcemia and resulting complications. The agency noted that the risk seems most acute for people on dialysis who also receive Prolia, but the risk may also extend to people with advanced kidney disease who are not being treated with hemodialysis.

The alert stemmed from “interim results” in an ongoing safety study of Prolia that the FDA required the agent’s manufacturer, Amgen, to run when the agency first approved denosumab for U.S. marketing in 2010. The FDA said its review of these interim results suggested an increased risk of hypocalcemia with Prolia in patients with advanced kidney disease.

In addition, adverse event reports submitted to the FDA suggested in a separate, internal study that patients on dialysis treated with Prolia are at “substantial risk for severe and symptomatic hypocalcemia, including hospitalization and death.”

The alert explained that “because of the frequency and seriousness of these risks, we are alerting healthcare professionals and patients about them and that we are continuing to evaluate this potential safety issue with Prolia use in patients with advanced kidney disease, particularly those on dialysis.” The FDA added that “we will communicate our final conclusions and recommendations when we have completed our review or have more information to share.”

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

The Food and Drug Administration issued an alert on Nov. 22 that cited preliminary evidence for a “substantial risk” for severe and symptomatic hypocalcemia and serious outcomes related to abnormally low calcium levels in people being treated with dialysis and receiving the osteoporosis medication denosumab (Prolia), including hospitalization and death.

In its alert, the FDA advised clinicians to make sure that people on dialysis who receive Prolia ingest adequate calcium and vitamin D supplementation and undergo frequent blood calcium monitoring, “possibly more often than is already being conducted,” which “may help decrease the likelihood or severity of these risks.”

The agency also called on clinicians to “advise patients on dialysis to immediately seek help if they experience symptoms of hypocalcemia,” such as unusual tingling or numbness in the hands, arms, legs, or feet; painful muscle spasms or cramps; voice box or lung spasms causing difficulty breathing; vomiting; seizures; or irregular heart rhythm.

The FDA had a similar message for people being treated with dialysis who are also receiving Prolia. The alert advised patients to watch for these symptoms and to tell their health care provider if they occur. The agency also advised patients who are undergoing dialysis and receiving Prolia to not stop the agent on their own, without first discussing this step with their care provider.

The FDA also advised providers and patients to contact the agency about episodes of side effects from Prolia (or other medications) via the FDA’s MedWatch program.
 

Frequent and serious

The FDA explained it issued the alert because of “the frequency and seriousness” of the risk for hypocalcemia and resulting complications. The agency noted that the risk seems most acute for people on dialysis who also receive Prolia, but the risk may also extend to people with advanced kidney disease who are not being treated with hemodialysis.

The alert stemmed from “interim results” in an ongoing safety study of Prolia that the FDA required the agent’s manufacturer, Amgen, to run when the agency first approved denosumab for U.S. marketing in 2010. The FDA said its review of these interim results suggested an increased risk of hypocalcemia with Prolia in patients with advanced kidney disease.

In addition, adverse event reports submitted to the FDA suggested in a separate, internal study that patients on dialysis treated with Prolia are at “substantial risk for severe and symptomatic hypocalcemia, including hospitalization and death.”

The alert explained that “because of the frequency and seriousness of these risks, we are alerting healthcare professionals and patients about them and that we are continuing to evaluate this potential safety issue with Prolia use in patients with advanced kidney disease, particularly those on dialysis.” The FDA added that “we will communicate our final conclusions and recommendations when we have completed our review or have more information to share.”

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

The Food and Drug Administration issued an alert on Nov. 22 that cited preliminary evidence for a “substantial risk” for severe and symptomatic hypocalcemia and serious outcomes related to abnormally low calcium levels in people being treated with dialysis and receiving the osteoporosis medication denosumab (Prolia), including hospitalization and death.

In its alert, the FDA advised clinicians to make sure that people on dialysis who receive Prolia ingest adequate calcium and vitamin D supplementation and undergo frequent blood calcium monitoring, “possibly more often than is already being conducted,” which “may help decrease the likelihood or severity of these risks.”

The agency also called on clinicians to “advise patients on dialysis to immediately seek help if they experience symptoms of hypocalcemia,” such as unusual tingling or numbness in the hands, arms, legs, or feet; painful muscle spasms or cramps; voice box or lung spasms causing difficulty breathing; vomiting; seizures; or irregular heart rhythm.

The FDA had a similar message for people being treated with dialysis who are also receiving Prolia. The alert advised patients to watch for these symptoms and to tell their health care provider if they occur. The agency also advised patients who are undergoing dialysis and receiving Prolia to not stop the agent on their own, without first discussing this step with their care provider.

The FDA also advised providers and patients to contact the agency about episodes of side effects from Prolia (or other medications) via the FDA’s MedWatch program.
 

Frequent and serious

The FDA explained it issued the alert because of “the frequency and seriousness” of the risk for hypocalcemia and resulting complications. The agency noted that the risk seems most acute for people on dialysis who also receive Prolia, but the risk may also extend to people with advanced kidney disease who are not being treated with hemodialysis.

The alert stemmed from “interim results” in an ongoing safety study of Prolia that the FDA required the agent’s manufacturer, Amgen, to run when the agency first approved denosumab for U.S. marketing in 2010. The FDA said its review of these interim results suggested an increased risk of hypocalcemia with Prolia in patients with advanced kidney disease.

In addition, adverse event reports submitted to the FDA suggested in a separate, internal study that patients on dialysis treated with Prolia are at “substantial risk for severe and symptomatic hypocalcemia, including hospitalization and death.”

The alert explained that “because of the frequency and seriousness of these risks, we are alerting healthcare professionals and patients about them and that we are continuing to evaluate this potential safety issue with Prolia use in patients with advanced kidney disease, particularly those on dialysis.” The FDA added that “we will communicate our final conclusions and recommendations when we have completed our review or have more information to share.”

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

While having proper indoor ventilation is recognized as a way to reduce the spread of COVID-19, a new study from MIT says maintaining the proper relative humidity in indoor spaces like your residence might help keep you healthy.

The “sweet spot” associated with reduced COVID-19 cases and deaths is 40%-60% indoor relative humidity, an MIT news release said. People who maintained indoor relative humidity outside those parameters had higher rates of catching COVID-19. 

Most people are comfortable with 30%-50% relative humidity, researchers said. An airplane cabin has about 20% relative humidity.

Relative humidity is the amount of moisture in the air, compared with the total moisture the air can hold at a given temperature before saturating and forming condensation.

The study was published in The Journal of the Royal Society Interface. Researchers examined COVID-19 data and meteorological measurements from 121 countries from January 2020 through August 2020, before vaccines became available to the public. 

“When outdoor temperatures were below the typical human comfort range, they assumed indoor spaces were heated to reach that comfort range. Based on the added heating, they calculated the associated drop in indoor relative humidity,” the MIT news release said.

The research teams found that when a region reported a rise in COVID-19 cases and deaths, the region’s estimated indoor relative humidity was either lower than 40% or higher than 60%, the release said. 

“There’s potentially a protective effect of this intermediate indoor relative humidity,” said Connor Verheyen, the lead author and a PhD student in medical engineering and medical physics in the Harvard-MIT Program in Health Sciences and Technology.

Widespread use of the 40%-60% indoor humidity range could reduce the need for lockdowns and other widespread restrictions, the study concluded.

“Unlike measures that depend on individual compliance (for example, masking or hand-washing), indoor RH optimization would achieve high compliance because all occupants of a common indoor space would be exposed to similar ambient conditions,” the study said. “Compared to the long timelines and high costs of vaccine production and distribution, humidity control systems could potentially be implemented more quickly and cheaply in certain indoor settings.”

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

While having proper indoor ventilation is recognized as a way to reduce the spread of COVID-19, a new study from MIT says maintaining the proper relative humidity in indoor spaces like your residence might help keep you healthy.

The “sweet spot” associated with reduced COVID-19 cases and deaths is 40%-60% indoor relative humidity, an MIT news release said. People who maintained indoor relative humidity outside those parameters had higher rates of catching COVID-19. 

Most people are comfortable with 30%-50% relative humidity, researchers said. An airplane cabin has about 20% relative humidity.

Relative humidity is the amount of moisture in the air, compared with the total moisture the air can hold at a given temperature before saturating and forming condensation.

The study was published in The Journal of the Royal Society Interface. Researchers examined COVID-19 data and meteorological measurements from 121 countries from January 2020 through August 2020, before vaccines became available to the public. 

“When outdoor temperatures were below the typical human comfort range, they assumed indoor spaces were heated to reach that comfort range. Based on the added heating, they calculated the associated drop in indoor relative humidity,” the MIT news release said.

The research teams found that when a region reported a rise in COVID-19 cases and deaths, the region’s estimated indoor relative humidity was either lower than 40% or higher than 60%, the release said. 

“There’s potentially a protective effect of this intermediate indoor relative humidity,” said Connor Verheyen, the lead author and a PhD student in medical engineering and medical physics in the Harvard-MIT Program in Health Sciences and Technology.

Widespread use of the 40%-60% indoor humidity range could reduce the need for lockdowns and other widespread restrictions, the study concluded.

“Unlike measures that depend on individual compliance (for example, masking or hand-washing), indoor RH optimization would achieve high compliance because all occupants of a common indoor space would be exposed to similar ambient conditions,” the study said. “Compared to the long timelines and high costs of vaccine production and distribution, humidity control systems could potentially be implemented more quickly and cheaply in certain indoor settings.”

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

While having proper indoor ventilation is recognized as a way to reduce the spread of COVID-19, a new study from MIT says maintaining the proper relative humidity in indoor spaces like your residence might help keep you healthy.

The “sweet spot” associated with reduced COVID-19 cases and deaths is 40%-60% indoor relative humidity, an MIT news release said. People who maintained indoor relative humidity outside those parameters had higher rates of catching COVID-19. 

Most people are comfortable with 30%-50% relative humidity, researchers said. An airplane cabin has about 20% relative humidity.

Relative humidity is the amount of moisture in the air, compared with the total moisture the air can hold at a given temperature before saturating and forming condensation.

The study was published in The Journal of the Royal Society Interface. Researchers examined COVID-19 data and meteorological measurements from 121 countries from January 2020 through August 2020, before vaccines became available to the public. 

“When outdoor temperatures were below the typical human comfort range, they assumed indoor spaces were heated to reach that comfort range. Based on the added heating, they calculated the associated drop in indoor relative humidity,” the MIT news release said.

The research teams found that when a region reported a rise in COVID-19 cases and deaths, the region’s estimated indoor relative humidity was either lower than 40% or higher than 60%, the release said. 

“There’s potentially a protective effect of this intermediate indoor relative humidity,” said Connor Verheyen, the lead author and a PhD student in medical engineering and medical physics in the Harvard-MIT Program in Health Sciences and Technology.

Widespread use of the 40%-60% indoor humidity range could reduce the need for lockdowns and other widespread restrictions, the study concluded.

“Unlike measures that depend on individual compliance (for example, masking or hand-washing), indoor RH optimization would achieve high compliance because all occupants of a common indoor space would be exposed to similar ambient conditions,” the study said. “Compared to the long timelines and high costs of vaccine production and distribution, humidity control systems could potentially be implemented more quickly and cheaply in certain indoor settings.”

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

High-density lipoprotein cholesterol may not be as effective a biomarker of cardiovascular disease risk as once thought, particularly in Black adults, according to results from a large biracial cohort study that also raised questions about the validity of high HDL cholesterol as a potentially protective factor in White and Black adults alike.

“I think this opens the door to suggest that every biomarker we use might have a race-specific association with disease outcome,” Nathalie Pamir, PhD, an associate professor at Oregon Health & Science University in Portland, said in an interview. “So, something as basic as HDL cholesterol – we’ve known about it since 1970 – has a race signature.”

Dr. Pamir and colleagues reported their findings from the REGARDS (Reasons for Geographic and Racial Differences in Stroke) cohort study that recruited 30,239 Black and White individuals aged 45 years and older from the contiguous United States from 2003 to 2007.

The study found that LDL cholesterol “modestly” predicted coronary heart disease (CHD) risk in Black and White adults. However, low HDL cholesterol, while associated with an increased risk in White patients (hazard ratio, 1.22; 95% confidence interval, 1.05-1.43), did not have a similar association in Blacks (HR, 0.94; 95% CI: 0.78-1.14). And high HDL cholesterol wasn’t found to be predictive in either group (HR, 0.96; 95% CI, 0.79-1.16 for White participants: HR, 0.91; 95% CI, 0.74-1.12 for Black participants).

Among 23,901 study participants who were CHD-risk free over a 10-year follow-up, 664 and 951 CHD events occurred in Black and White participants, respectively. The study cohort was 57.8% White and 58.4% women, with a mean age of 65 years.

The study noted that LDL cholesterol and triglycerides conferred similar risks for CHD in both White and Black participants.

Acknowledging that this study focused on Blacks, Dr. Pamir added that “we need to know about Asian Americans; we need to know about Hispanic Americans.”
 

Change of approach to lipid management called for

Dr. Pamir noted that the current understanding about HDL cholesterol and CHD risk comes from the Framingham heart study in the 1970s, whose population was 100% White.

Care algorithms derived from the Framingham study as well as the Multi-Ethnic Study of Atherosclerosis incorporate that association between HDL cholesterol and CHD risk, she noted, but these findings from REGARDS should change how cardiologists approach lipid management in Black and White patients.

“The conversation would go something like: High HDL cholesterol levels put you in a higher risk [bracket] but HDL cholesterol levels are not something we treat; we have no drugs for that,” Dr. Pamir said.

“The conversation would continue along the lines that: ‘You need to do more exercise, you need to change your diet, incorporate healthy fats, walnuts, and omega 3s.’

“But what might the conversation be for Black patients? ‘We don’t see the association that we see for White patients. Do adopt the good habits to exercise and dietary changes, but don’t get too worried about it.’ ”

The study report raises “caution” about using the Framingham, MESA, and other algorithms for evaluating CHD risk. Dr. Pamir explained what that means. “We might be underestimating risk, because what our study showed was that, when we looked at clinically high HDL cholesterol, about 60 mg/dL, it has no benefit for White and Black patients.”

She added, “So that pat on the back we get for patients that have high HDL-C levels? Maybe that pat on the back shouldn’t be there.”

In an invited commentary, Keith C. Ferdinand, MD, of Tulane University in New Orleans, wrote that using HDL cholesterol in risk calculations could inaccurately assess atherosclerotic cardiovascular risk in Black adults “and become a barrier to optimal care.”

In an interview, he said the REGARDS findings call for consideration of other biomarkers for evaluating CHD risk and point to the importance of socioeconomic factors in health outcomes.

“Physicians and other clinicians need to recognize the powerful impact of the social determinants of health and to also recognize the limits of HDL itself as either protective if it’s high or a definitive predictor of risk if it’s low, and focus on some more modern approaches, including coronary artery calcium scoring.”

He also said risk evaluation should include lipoprotein(a), which, he noted in the editorial, the European Atherosclerosis Society recommends measuring. “One of the reasons it’s underutilized is that we really don’t have a specific treatment for it,” he said of Lp(a) in the United States.

In his editorial comment, Dr. Ferdinand called for future research aimed at eliminating health disparities. “Regardless of the development of better tools for the assessment of risk, newer drugs to treat CVD, the use of coronary artery calcium, if we don’t apply evidence-based medicine equally across the population based on race, ethnicity, sex, gender, socioeconomic status, or geography, then the disparities are going to persist,” he said.

The National Institute of Neurological Disorders and Stroke and the National Institute on Aging provided funding for the study. Dr. Pamir has no relevant relationships to disclose. Dr. Ferdinand disclosed relationships with Boehringer Ingelheim, Novartis, Janssen, and Lilly.

High-density lipoprotein cholesterol may not be as effective a biomarker of cardiovascular disease risk as once thought, particularly in Black adults, according to results from a large biracial cohort study that also raised questions about the validity of high HDL cholesterol as a potentially protective factor in White and Black adults alike.

“I think this opens the door to suggest that every biomarker we use might have a race-specific association with disease outcome,” Nathalie Pamir, PhD, an associate professor at Oregon Health & Science University in Portland, said in an interview. “So, something as basic as HDL cholesterol – we’ve known about it since 1970 – has a race signature.”

Dr. Pamir and colleagues reported their findings from the REGARDS (Reasons for Geographic and Racial Differences in Stroke) cohort study that recruited 30,239 Black and White individuals aged 45 years and older from the contiguous United States from 2003 to 2007.

The study found that LDL cholesterol “modestly” predicted coronary heart disease (CHD) risk in Black and White adults. However, low HDL cholesterol, while associated with an increased risk in White patients (hazard ratio, 1.22; 95% confidence interval, 1.05-1.43), did not have a similar association in Blacks (HR, 0.94; 95% CI: 0.78-1.14). And high HDL cholesterol wasn’t found to be predictive in either group (HR, 0.96; 95% CI, 0.79-1.16 for White participants: HR, 0.91; 95% CI, 0.74-1.12 for Black participants).

Among 23,901 study participants who were CHD-risk free over a 10-year follow-up, 664 and 951 CHD events occurred in Black and White participants, respectively. The study cohort was 57.8% White and 58.4% women, with a mean age of 65 years.

The study noted that LDL cholesterol and triglycerides conferred similar risks for CHD in both White and Black participants.

Acknowledging that this study focused on Blacks, Dr. Pamir added that “we need to know about Asian Americans; we need to know about Hispanic Americans.”
 

Change of approach to lipid management called for

Dr. Pamir noted that the current understanding about HDL cholesterol and CHD risk comes from the Framingham heart study in the 1970s, whose population was 100% White.

Care algorithms derived from the Framingham study as well as the Multi-Ethnic Study of Atherosclerosis incorporate that association between HDL cholesterol and CHD risk, she noted, but these findings from REGARDS should change how cardiologists approach lipid management in Black and White patients.

“The conversation would go something like: High HDL cholesterol levels put you in a higher risk [bracket] but HDL cholesterol levels are not something we treat; we have no drugs for that,” Dr. Pamir said.

“The conversation would continue along the lines that: ‘You need to do more exercise, you need to change your diet, incorporate healthy fats, walnuts, and omega 3s.’

“But what might the conversation be for Black patients? ‘We don’t see the association that we see for White patients. Do adopt the good habits to exercise and dietary changes, but don’t get too worried about it.’ ”

The study report raises “caution” about using the Framingham, MESA, and other algorithms for evaluating CHD risk. Dr. Pamir explained what that means. “We might be underestimating risk, because what our study showed was that, when we looked at clinically high HDL cholesterol, about 60 mg/dL, it has no benefit for White and Black patients.”

She added, “So that pat on the back we get for patients that have high HDL-C levels? Maybe that pat on the back shouldn’t be there.”

In an invited commentary, Keith C. Ferdinand, MD, of Tulane University in New Orleans, wrote that using HDL cholesterol in risk calculations could inaccurately assess atherosclerotic cardiovascular risk in Black adults “and become a barrier to optimal care.”

In an interview, he said the REGARDS findings call for consideration of other biomarkers for evaluating CHD risk and point to the importance of socioeconomic factors in health outcomes.

“Physicians and other clinicians need to recognize the powerful impact of the social determinants of health and to also recognize the limits of HDL itself as either protective if it’s high or a definitive predictor of risk if it’s low, and focus on some more modern approaches, including coronary artery calcium scoring.”

He also said risk evaluation should include lipoprotein(a), which, he noted in the editorial, the European Atherosclerosis Society recommends measuring. “One of the reasons it’s underutilized is that we really don’t have a specific treatment for it,” he said of Lp(a) in the United States.

In his editorial comment, Dr. Ferdinand called for future research aimed at eliminating health disparities. “Regardless of the development of better tools for the assessment of risk, newer drugs to treat CVD, the use of coronary artery calcium, if we don’t apply evidence-based medicine equally across the population based on race, ethnicity, sex, gender, socioeconomic status, or geography, then the disparities are going to persist,” he said.

The National Institute of Neurological Disorders and Stroke and the National Institute on Aging provided funding for the study. Dr. Pamir has no relevant relationships to disclose. Dr. Ferdinand disclosed relationships with Boehringer Ingelheim, Novartis, Janssen, and Lilly.

High-density lipoprotein cholesterol may not be as effective a biomarker of cardiovascular disease risk as once thought, particularly in Black adults, according to results from a large biracial cohort study that also raised questions about the validity of high HDL cholesterol as a potentially protective factor in White and Black adults alike.

“I think this opens the door to suggest that every biomarker we use might have a race-specific association with disease outcome,” Nathalie Pamir, PhD, an associate professor at Oregon Health & Science University in Portland, said in an interview. “So, something as basic as HDL cholesterol – we’ve known about it since 1970 – has a race signature.”

Dr. Pamir and colleagues reported their findings from the REGARDS (Reasons for Geographic and Racial Differences in Stroke) cohort study that recruited 30,239 Black and White individuals aged 45 years and older from the contiguous United States from 2003 to 2007.

The study found that LDL cholesterol “modestly” predicted coronary heart disease (CHD) risk in Black and White adults. However, low HDL cholesterol, while associated with an increased risk in White patients (hazard ratio, 1.22; 95% confidence interval, 1.05-1.43), did not have a similar association in Blacks (HR, 0.94; 95% CI: 0.78-1.14). And high HDL cholesterol wasn’t found to be predictive in either group (HR, 0.96; 95% CI, 0.79-1.16 for White participants: HR, 0.91; 95% CI, 0.74-1.12 for Black participants).

Among 23,901 study participants who were CHD-risk free over a 10-year follow-up, 664 and 951 CHD events occurred in Black and White participants, respectively. The study cohort was 57.8% White and 58.4% women, with a mean age of 65 years.

The study noted that LDL cholesterol and triglycerides conferred similar risks for CHD in both White and Black participants.

Acknowledging that this study focused on Blacks, Dr. Pamir added that “we need to know about Asian Americans; we need to know about Hispanic Americans.”
 

Change of approach to lipid management called for

Dr. Pamir noted that the current understanding about HDL cholesterol and CHD risk comes from the Framingham heart study in the 1970s, whose population was 100% White.

Care algorithms derived from the Framingham study as well as the Multi-Ethnic Study of Atherosclerosis incorporate that association between HDL cholesterol and CHD risk, she noted, but these findings from REGARDS should change how cardiologists approach lipid management in Black and White patients.

“The conversation would go something like: High HDL cholesterol levels put you in a higher risk [bracket] but HDL cholesterol levels are not something we treat; we have no drugs for that,” Dr. Pamir said.

“The conversation would continue along the lines that: ‘You need to do more exercise, you need to change your diet, incorporate healthy fats, walnuts, and omega 3s.’

“But what might the conversation be for Black patients? ‘We don’t see the association that we see for White patients. Do adopt the good habits to exercise and dietary changes, but don’t get too worried about it.’ ”

The study report raises “caution” about using the Framingham, MESA, and other algorithms for evaluating CHD risk. Dr. Pamir explained what that means. “We might be underestimating risk, because what our study showed was that, when we looked at clinically high HDL cholesterol, about 60 mg/dL, it has no benefit for White and Black patients.”

She added, “So that pat on the back we get for patients that have high HDL-C levels? Maybe that pat on the back shouldn’t be there.”

In an invited commentary, Keith C. Ferdinand, MD, of Tulane University in New Orleans, wrote that using HDL cholesterol in risk calculations could inaccurately assess atherosclerotic cardiovascular risk in Black adults “and become a barrier to optimal care.”

In an interview, he said the REGARDS findings call for consideration of other biomarkers for evaluating CHD risk and point to the importance of socioeconomic factors in health outcomes.

“Physicians and other clinicians need to recognize the powerful impact of the social determinants of health and to also recognize the limits of HDL itself as either protective if it’s high or a definitive predictor of risk if it’s low, and focus on some more modern approaches, including coronary artery calcium scoring.”

He also said risk evaluation should include lipoprotein(a), which, he noted in the editorial, the European Atherosclerosis Society recommends measuring. “One of the reasons it’s underutilized is that we really don’t have a specific treatment for it,” he said of Lp(a) in the United States.

In his editorial comment, Dr. Ferdinand called for future research aimed at eliminating health disparities. “Regardless of the development of better tools for the assessment of risk, newer drugs to treat CVD, the use of coronary artery calcium, if we don’t apply evidence-based medicine equally across the population based on race, ethnicity, sex, gender, socioeconomic status, or geography, then the disparities are going to persist,” he said.

The National Institute of Neurological Disorders and Stroke and the National Institute on Aging provided funding for the study. Dr. Pamir has no relevant relationships to disclose. Dr. Ferdinand disclosed relationships with Boehringer Ingelheim, Novartis, Janssen, and Lilly.

A report from a well-respected nonprofit group may bolster efforts to have Medicare, the largest U.S. purchaser of prescription drugs, cover obesity medicines, for which there has been accumulating evidence of significant benefit.

The Institute for Clinical and Economic Review (ICER) released a report last month on obesity medicines, based on extensive review of research done to date and input from clinicians, drug-makers, and members of the public.

Of the treatments reviewed, the ICER report gave the best ratings to two Novo Nordisk products, a B+ for semaglutide (Wegovy) and a B for liraglutide (Saxenda), while also making the case for price cuts. At an annual U.S. net price estimated at $13,618, semaglutide exceeds what ICER considers typical cost-effectiveness thresholds. ICER suggested a benchmark annual price range for semaglutide of between $7,500 and $9,800.

The ICER report also directs insurers in general to provide more generous coverage of obesity medicines, with a specific recommendation for the U.S. Congress to pass a pending bill known as the Treat and Reduce Obesity Act of 2021. The bill would undo a restriction on weight-loss drugs in the Medicare Part D plans, which covered about 49 million people last year. Sen. Tom Carper (D-Del.) and Sen. Bill Cassidy, MD, (R-La.) have repeatedly introduced versions of the bill since 2013.

“In both chambers of Congress and with bipartisan support, we’ve pushed to expand Medicare coverage of additional therapies and medications to treat obesity,” Sen. Cassidy said in an email. “This report confirms what we’ve worked on for nearly a decade – our legislation will help improve lives.”

The current House version of the bill has the backing of more than a third of the members of that chamber, with 113 Democratic and 40 Republican cosponsors. The Senate version has 22 sponsors.
 

Changing views

The ICER report comes amid a broader change in how clinicians view obesity. 

The American Academy of Pediatrics is readying a new Clinical Practice Guideline for the Evaluation and Treatment of Pediatric Obesity that will mark a major shift in approach. Aaron S. Kelly, PhD, a professor of pediatrics at the University of Minnesota, Minneapolis, described it as a “sea change,” with obesity now seen as “a chronic, refractory, relapsing disease,” for which watchful waiting is no longer appropriate.

But the field of obesity treatment looked quite different in the early 2000s when Congress worked on a plan to add a pharmacy benefit to Medicare.

The deliberate omission of obesity medicine in the Medicare Part D benefit reflected both the state of science at the time and U.S. experience with a dangerous weight-loss drug combo in the late 1990s.

Initial expectations for weight-loss pills were high after the Food and Drug Administration cleared dexfenfluramine HCl (Redux) in 1996, which was part of the popular fen-phen combination. “Newly Approved Diet Drug Promises to Help Millions of Obese Americans – But Is No Magic Bullet,” read a headline about the Redux approval in The Washington Post

When work began in the 2000s to create a Medicare pharmacy benefit, lawmakers and congressional staff had a pool of about $400 billion available to establish what became the Part D program, Joel White, a former House staffer who helped draft the law, told this news organization in an email exchange.

Given the state of obesity research at the time, it seemed to make sense to exclude weight-loss medications, wrote Mr. White. Mr. White is now chief executive of the consulting firm Horizon, which has clients in the drug industry including the Pharmaceutical Research and Manufacturers of America.

“Now we know that obesity is a chronic disease of epidemic proportions. Decades of research have produced a series of advances in the way we understand and treat obesity. While scientists and many who work directly with those impacted by this epidemic understand how treatments have advanced, the law lags behind,” Mr. White said.

XXXCurrent payment policies for obesity treatments are based on “outdated information and ongoing misperception,” he noted. “While Part D has been a resounding success, our Medicare approach to obesity is not.”

“In addition, it makes no sense that Medicare covers the most drastic procedure (bariatric surgery) but not less-invasive, effective treatments,” he added. “We should have long ago lifted restrictions based on advances in science and medicine.”
 

Overcoming the stigma

Scott Kahan, MD, MPH, agreed and hopes that the new ICER report will help more patients secure needed medications, raising a “call to arms” about the need for better coverage of obesity drugs.

Dr. Kahan is director of the National Center for Weight and Wellness, a private clinic in Washington, and chair of the clinical committee for The Obesity Society. He also served as a member of a policy roundtable that ICER convened as part of research on the report on obesity drugs. Dr. Kahan, who also serves on the faculty at the Johns Hopkins Bloomberg School of Public Health, Baltimore, has received fees from drug makers such as Eli Lilly.

The ICER report may help what Dr. Kahan described as well-founded caution about obesity treatments in general.

“When it comes to weight loss, there are all of these magical treatments that are sold on social media and traditional media. There are a lot of bad actors in terms of people calling themselves experts and gurus and promising all kinds of crazy stuff,” said Dr. Kahan.

And there are long-standing stigmas about obesity, he stressed.

“That underlies a lot of the backward policies, including poor coverage for medications and the noncoverage by Medicare,” Dr. Kahan said. “There’s a societal ingrained set of beliefs and misperceptions and biases. That takes time to unwind, and I think we’re on the way, but we’re not quite there yet.”
 

Lifestyle changes not enough to tackle obesity

AHIP (formerly America’s Health Insurance Plans) told this news organization its members consider ICER reports when making decisions about which products to cover. “And health plans already cover obesity treatments that they consider medically necessary,” said David Allen, an AHIP spokesperson.

“It is important to note that every treatment does not work for every patient, and many patients experience adverse events and may discontinue treatment,” he added in an email. “Health insurance providers play an important role in helping [health care] providers and patients identify the treatment options that are most likely to be effective as well as affordable.”

Separately, the nonprofit watchdog group Public Citizen cautioned against liraglutide on its Worst Pills, Best Pills website. In its view, the drug is minimally effective and has many dangerous adverse effects, which are even more frequent with the higher-dose weight-loss version (a lower-dose version is approved for type 2 diabetes).

“There is currently no medication that can be used safely to achieve weight loss effortlessly and without dangerous adverse effects,” the group said. “Rather than focus on losing weight by turning to risky drugs, overweight and obese adults seeking to achieve better health should make reasonable and sustainable changes to their lifestyle, such as eating a healthy diet and getting regular exercise.”

Yet, many people find there is little help available for making lifestyle changes, and some patients and physicians say these modifications by themselves are not enough.

“The vast majority of people with obesity cannot achieve sustained weight loss through diet and exercise alone,” said David Rind, MD, chief medical officer of ICER, in an Oct. 20 statement. “As such, obesity, and its resulting physical health, mental health, and social burdens, is not a choice or failing, but a medical condition.”

The focus should now be on assuring that effective medications “are priced in alignment with their benefits so that they are accessible and affordable across U.S. society,” Dr. Rind urges.
 

‘My own demise with a fork and knife’

ICER sought public feedback on a draft version of the report before finalizing it.

In their comments on ICER’s work, several pharmaceutical researchers and Novo Nordisk questioned the calculations used in making judgments about the value of obesity drugs. In a statement, Novo Nordisk told this news organization that the company’s view is that ICER’s modeling “does not adequately address the real-world complexities of obesity, and consequently underestimates the health and societal impact medical treatments can have.”

Commenters also dug into aspects of ICER’s calculations, including ones that consider quality-adjusted life-years (QALYs). ICER describes QALY as an academic standard for measuring how well all different types of medical treatments can extend or improve patients’ lives. In an explainer on its website, ICER says this metric has served as a fundamental component of cost-effectiveness analyses in the United States and around the world for more than 30 years.

ICER and drug makers have been at odds for some time, with PhRMA having criticized the nonprofit group. A 2020 Reuters article detailed public relations strategies used by firms paid by drug makers to raise questions about ICER’s work. Critics accuse it of allying with insurers.

ICER’s list of its recent financial supporters includes Blue Cross Blue Shield of Massachusetts and the Kaiser Foundation Health Plan, but also many other groups, such as the U.S. Department of Veterans Affairs, the American Academy of Neurology, and the American College of Rheumatology.

The public comments on the ICER report also include one from an unidentified woman who wrote of her past struggles to lose weight.

She said her health plan wouldn’t cover behavioral programs or semaglutide as a weight-loss drug but did cover it eventually because of signs that she had developed insulin resistance. The patient said the drug worked for her, whereas other approaches to control weight had failed.

“To put it simply, I now experience hunger and satiety in a way that I can only assume people with normal metabolism do. I am 49 years old and approaching the age where serious comorbidities associated with obesity begin to manifest,” the patient wrote.

“I no longer worry about bringing about my own demise with a fork and knife because of misfiring hunger cues.”

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

A report from a well-respected nonprofit group may bolster efforts to have Medicare, the largest U.S. purchaser of prescription drugs, cover obesity medicines, for which there has been accumulating evidence of significant benefit.

The Institute for Clinical and Economic Review (ICER) released a report last month on obesity medicines, based on extensive review of research done to date and input from clinicians, drug-makers, and members of the public.

Of the treatments reviewed, the ICER report gave the best ratings to two Novo Nordisk products, a B+ for semaglutide (Wegovy) and a B for liraglutide (Saxenda), while also making the case for price cuts. At an annual U.S. net price estimated at $13,618, semaglutide exceeds what ICER considers typical cost-effectiveness thresholds. ICER suggested a benchmark annual price range for semaglutide of between $7,500 and $9,800.

The ICER report also directs insurers in general to provide more generous coverage of obesity medicines, with a specific recommendation for the U.S. Congress to pass a pending bill known as the Treat and Reduce Obesity Act of 2021. The bill would undo a restriction on weight-loss drugs in the Medicare Part D plans, which covered about 49 million people last year. Sen. Tom Carper (D-Del.) and Sen. Bill Cassidy, MD, (R-La.) have repeatedly introduced versions of the bill since 2013.

“In both chambers of Congress and with bipartisan support, we’ve pushed to expand Medicare coverage of additional therapies and medications to treat obesity,” Sen. Cassidy said in an email. “This report confirms what we’ve worked on for nearly a decade – our legislation will help improve lives.”

The current House version of the bill has the backing of more than a third of the members of that chamber, with 113 Democratic and 40 Republican cosponsors. The Senate version has 22 sponsors.
 

Changing views

The ICER report comes amid a broader change in how clinicians view obesity. 

The American Academy of Pediatrics is readying a new Clinical Practice Guideline for the Evaluation and Treatment of Pediatric Obesity that will mark a major shift in approach. Aaron S. Kelly, PhD, a professor of pediatrics at the University of Minnesota, Minneapolis, described it as a “sea change,” with obesity now seen as “a chronic, refractory, relapsing disease,” for which watchful waiting is no longer appropriate.

But the field of obesity treatment looked quite different in the early 2000s when Congress worked on a plan to add a pharmacy benefit to Medicare.

The deliberate omission of obesity medicine in the Medicare Part D benefit reflected both the state of science at the time and U.S. experience with a dangerous weight-loss drug combo in the late 1990s.

Initial expectations for weight-loss pills were high after the Food and Drug Administration cleared dexfenfluramine HCl (Redux) in 1996, which was part of the popular fen-phen combination. “Newly Approved Diet Drug Promises to Help Millions of Obese Americans – But Is No Magic Bullet,” read a headline about the Redux approval in The Washington Post

When work began in the 2000s to create a Medicare pharmacy benefit, lawmakers and congressional staff had a pool of about $400 billion available to establish what became the Part D program, Joel White, a former House staffer who helped draft the law, told this news organization in an email exchange.

Given the state of obesity research at the time, it seemed to make sense to exclude weight-loss medications, wrote Mr. White. Mr. White is now chief executive of the consulting firm Horizon, which has clients in the drug industry including the Pharmaceutical Research and Manufacturers of America.

“Now we know that obesity is a chronic disease of epidemic proportions. Decades of research have produced a series of advances in the way we understand and treat obesity. While scientists and many who work directly with those impacted by this epidemic understand how treatments have advanced, the law lags behind,” Mr. White said.

XXXCurrent payment policies for obesity treatments are based on “outdated information and ongoing misperception,” he noted. “While Part D has been a resounding success, our Medicare approach to obesity is not.”

“In addition, it makes no sense that Medicare covers the most drastic procedure (bariatric surgery) but not less-invasive, effective treatments,” he added. “We should have long ago lifted restrictions based on advances in science and medicine.”
 

Overcoming the stigma

Scott Kahan, MD, MPH, agreed and hopes that the new ICER report will help more patients secure needed medications, raising a “call to arms” about the need for better coverage of obesity drugs.

Dr. Kahan is director of the National Center for Weight and Wellness, a private clinic in Washington, and chair of the clinical committee for The Obesity Society. He also served as a member of a policy roundtable that ICER convened as part of research on the report on obesity drugs. Dr. Kahan, who also serves on the faculty at the Johns Hopkins Bloomberg School of Public Health, Baltimore, has received fees from drug makers such as Eli Lilly.

The ICER report may help what Dr. Kahan described as well-founded caution about obesity treatments in general.

“When it comes to weight loss, there are all of these magical treatments that are sold on social media and traditional media. There are a lot of bad actors in terms of people calling themselves experts and gurus and promising all kinds of crazy stuff,” said Dr. Kahan.

And there are long-standing stigmas about obesity, he stressed.

“That underlies a lot of the backward policies, including poor coverage for medications and the noncoverage by Medicare,” Dr. Kahan said. “There’s a societal ingrained set of beliefs and misperceptions and biases. That takes time to unwind, and I think we’re on the way, but we’re not quite there yet.”
 

Lifestyle changes not enough to tackle obesity

AHIP (formerly America’s Health Insurance Plans) told this news organization its members consider ICER reports when making decisions about which products to cover. “And health plans already cover obesity treatments that they consider medically necessary,” said David Allen, an AHIP spokesperson.

“It is important to note that every treatment does not work for every patient, and many patients experience adverse events and may discontinue treatment,” he added in an email. “Health insurance providers play an important role in helping [health care] providers and patients identify the treatment options that are most likely to be effective as well as affordable.”

Separately, the nonprofit watchdog group Public Citizen cautioned against liraglutide on its Worst Pills, Best Pills website. In its view, the drug is minimally effective and has many dangerous adverse effects, which are even more frequent with the higher-dose weight-loss version (a lower-dose version is approved for type 2 diabetes).

“There is currently no medication that can be used safely to achieve weight loss effortlessly and without dangerous adverse effects,” the group said. “Rather than focus on losing weight by turning to risky drugs, overweight and obese adults seeking to achieve better health should make reasonable and sustainable changes to their lifestyle, such as eating a healthy diet and getting regular exercise.”

Yet, many people find there is little help available for making lifestyle changes, and some patients and physicians say these modifications by themselves are not enough.

“The vast majority of people with obesity cannot achieve sustained weight loss through diet and exercise alone,” said David Rind, MD, chief medical officer of ICER, in an Oct. 20 statement. “As such, obesity, and its resulting physical health, mental health, and social burdens, is not a choice or failing, but a medical condition.”

The focus should now be on assuring that effective medications “are priced in alignment with their benefits so that they are accessible and affordable across U.S. society,” Dr. Rind urges.
 

‘My own demise with a fork and knife’

ICER sought public feedback on a draft version of the report before finalizing it.

In their comments on ICER’s work, several pharmaceutical researchers and Novo Nordisk questioned the calculations used in making judgments about the value of obesity drugs. In a statement, Novo Nordisk told this news organization that the company’s view is that ICER’s modeling “does not adequately address the real-world complexities of obesity, and consequently underestimates the health and societal impact medical treatments can have.”

Commenters also dug into aspects of ICER’s calculations, including ones that consider quality-adjusted life-years (QALYs). ICER describes QALY as an academic standard for measuring how well all different types of medical treatments can extend or improve patients’ lives. In an explainer on its website, ICER says this metric has served as a fundamental component of cost-effectiveness analyses in the United States and around the world for more than 30 years.

ICER and drug makers have been at odds for some time, with PhRMA having criticized the nonprofit group. A 2020 Reuters article detailed public relations strategies used by firms paid by drug makers to raise questions about ICER’s work. Critics accuse it of allying with insurers.

ICER’s list of its recent financial supporters includes Blue Cross Blue Shield of Massachusetts and the Kaiser Foundation Health Plan, but also many other groups, such as the U.S. Department of Veterans Affairs, the American Academy of Neurology, and the American College of Rheumatology.

The public comments on the ICER report also include one from an unidentified woman who wrote of her past struggles to lose weight.

She said her health plan wouldn’t cover behavioral programs or semaglutide as a weight-loss drug but did cover it eventually because of signs that she had developed insulin resistance. The patient said the drug worked for her, whereas other approaches to control weight had failed.

“To put it simply, I now experience hunger and satiety in a way that I can only assume people with normal metabolism do. I am 49 years old and approaching the age where serious comorbidities associated with obesity begin to manifest,” the patient wrote.

“I no longer worry about bringing about my own demise with a fork and knife because of misfiring hunger cues.”

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

A report from a well-respected nonprofit group may bolster efforts to have Medicare, the largest U.S. purchaser of prescription drugs, cover obesity medicines, for which there has been accumulating evidence of significant benefit.

The Institute for Clinical and Economic Review (ICER) released a report last month on obesity medicines, based on extensive review of research done to date and input from clinicians, drug-makers, and members of the public.

Of the treatments reviewed, the ICER report gave the best ratings to two Novo Nordisk products, a B+ for semaglutide (Wegovy) and a B for liraglutide (Saxenda), while also making the case for price cuts. At an annual U.S. net price estimated at $13,618, semaglutide exceeds what ICER considers typical cost-effectiveness thresholds. ICER suggested a benchmark annual price range for semaglutide of between $7,500 and $9,800.

The ICER report also directs insurers in general to provide more generous coverage of obesity medicines, with a specific recommendation for the U.S. Congress to pass a pending bill known as the Treat and Reduce Obesity Act of 2021. The bill would undo a restriction on weight-loss drugs in the Medicare Part D plans, which covered about 49 million people last year. Sen. Tom Carper (D-Del.) and Sen. Bill Cassidy, MD, (R-La.) have repeatedly introduced versions of the bill since 2013.

“In both chambers of Congress and with bipartisan support, we’ve pushed to expand Medicare coverage of additional therapies and medications to treat obesity,” Sen. Cassidy said in an email. “This report confirms what we’ve worked on for nearly a decade – our legislation will help improve lives.”

The current House version of the bill has the backing of more than a third of the members of that chamber, with 113 Democratic and 40 Republican cosponsors. The Senate version has 22 sponsors.
 

Changing views

The ICER report comes amid a broader change in how clinicians view obesity. 

The American Academy of Pediatrics is readying a new Clinical Practice Guideline for the Evaluation and Treatment of Pediatric Obesity that will mark a major shift in approach. Aaron S. Kelly, PhD, a professor of pediatrics at the University of Minnesota, Minneapolis, described it as a “sea change,” with obesity now seen as “a chronic, refractory, relapsing disease,” for which watchful waiting is no longer appropriate.

But the field of obesity treatment looked quite different in the early 2000s when Congress worked on a plan to add a pharmacy benefit to Medicare.

The deliberate omission of obesity medicine in the Medicare Part D benefit reflected both the state of science at the time and U.S. experience with a dangerous weight-loss drug combo in the late 1990s.

Initial expectations for weight-loss pills were high after the Food and Drug Administration cleared dexfenfluramine HCl (Redux) in 1996, which was part of the popular fen-phen combination. “Newly Approved Diet Drug Promises to Help Millions of Obese Americans – But Is No Magic Bullet,” read a headline about the Redux approval in The Washington Post

When work began in the 2000s to create a Medicare pharmacy benefit, lawmakers and congressional staff had a pool of about $400 billion available to establish what became the Part D program, Joel White, a former House staffer who helped draft the law, told this news organization in an email exchange.

Given the state of obesity research at the time, it seemed to make sense to exclude weight-loss medications, wrote Mr. White. Mr. White is now chief executive of the consulting firm Horizon, which has clients in the drug industry including the Pharmaceutical Research and Manufacturers of America.

“Now we know that obesity is a chronic disease of epidemic proportions. Decades of research have produced a series of advances in the way we understand and treat obesity. While scientists and many who work directly with those impacted by this epidemic understand how treatments have advanced, the law lags behind,” Mr. White said.

XXXCurrent payment policies for obesity treatments are based on “outdated information and ongoing misperception,” he noted. “While Part D has been a resounding success, our Medicare approach to obesity is not.”

“In addition, it makes no sense that Medicare covers the most drastic procedure (bariatric surgery) but not less-invasive, effective treatments,” he added. “We should have long ago lifted restrictions based on advances in science and medicine.”
 

Overcoming the stigma

Scott Kahan, MD, MPH, agreed and hopes that the new ICER report will help more patients secure needed medications, raising a “call to arms” about the need for better coverage of obesity drugs.

Dr. Kahan is director of the National Center for Weight and Wellness, a private clinic in Washington, and chair of the clinical committee for The Obesity Society. He also served as a member of a policy roundtable that ICER convened as part of research on the report on obesity drugs. Dr. Kahan, who also serves on the faculty at the Johns Hopkins Bloomberg School of Public Health, Baltimore, has received fees from drug makers such as Eli Lilly.

The ICER report may help what Dr. Kahan described as well-founded caution about obesity treatments in general.

“When it comes to weight loss, there are all of these magical treatments that are sold on social media and traditional media. There are a lot of bad actors in terms of people calling themselves experts and gurus and promising all kinds of crazy stuff,” said Dr. Kahan.

And there are long-standing stigmas about obesity, he stressed.

“That underlies a lot of the backward policies, including poor coverage for medications and the noncoverage by Medicare,” Dr. Kahan said. “There’s a societal ingrained set of beliefs and misperceptions and biases. That takes time to unwind, and I think we’re on the way, but we’re not quite there yet.”
 

Lifestyle changes not enough to tackle obesity

AHIP (formerly America’s Health Insurance Plans) told this news organization its members consider ICER reports when making decisions about which products to cover. “And health plans already cover obesity treatments that they consider medically necessary,” said David Allen, an AHIP spokesperson.

“It is important to note that every treatment does not work for every patient, and many patients experience adverse events and may discontinue treatment,” he added in an email. “Health insurance providers play an important role in helping [health care] providers and patients identify the treatment options that are most likely to be effective as well as affordable.”

Separately, the nonprofit watchdog group Public Citizen cautioned against liraglutide on its Worst Pills, Best Pills website. In its view, the drug is minimally effective and has many dangerous adverse effects, which are even more frequent with the higher-dose weight-loss version (a lower-dose version is approved for type 2 diabetes).

“There is currently no medication that can be used safely to achieve weight loss effortlessly and without dangerous adverse effects,” the group said. “Rather than focus on losing weight by turning to risky drugs, overweight and obese adults seeking to achieve better health should make reasonable and sustainable changes to their lifestyle, such as eating a healthy diet and getting regular exercise.”

Yet, many people find there is little help available for making lifestyle changes, and some patients and physicians say these modifications by themselves are not enough.

“The vast majority of people with obesity cannot achieve sustained weight loss through diet and exercise alone,” said David Rind, MD, chief medical officer of ICER, in an Oct. 20 statement. “As such, obesity, and its resulting physical health, mental health, and social burdens, is not a choice or failing, but a medical condition.”

The focus should now be on assuring that effective medications “are priced in alignment with their benefits so that they are accessible and affordable across U.S. society,” Dr. Rind urges.
 

‘My own demise with a fork and knife’

ICER sought public feedback on a draft version of the report before finalizing it.

In their comments on ICER’s work, several pharmaceutical researchers and Novo Nordisk questioned the calculations used in making judgments about the value of obesity drugs. In a statement, Novo Nordisk told this news organization that the company’s view is that ICER’s modeling “does not adequately address the real-world complexities of obesity, and consequently underestimates the health and societal impact medical treatments can have.”

Commenters also dug into aspects of ICER’s calculations, including ones that consider quality-adjusted life-years (QALYs). ICER describes QALY as an academic standard for measuring how well all different types of medical treatments can extend or improve patients’ lives. In an explainer on its website, ICER says this metric has served as a fundamental component of cost-effectiveness analyses in the United States and around the world for more than 30 years.

ICER and drug makers have been at odds for some time, with PhRMA having criticized the nonprofit group. A 2020 Reuters article detailed public relations strategies used by firms paid by drug makers to raise questions about ICER’s work. Critics accuse it of allying with insurers.

ICER’s list of its recent financial supporters includes Blue Cross Blue Shield of Massachusetts and the Kaiser Foundation Health Plan, but also many other groups, such as the U.S. Department of Veterans Affairs, the American Academy of Neurology, and the American College of Rheumatology.

The public comments on the ICER report also include one from an unidentified woman who wrote of her past struggles to lose weight.

She said her health plan wouldn’t cover behavioral programs or semaglutide as a weight-loss drug but did cover it eventually because of signs that she had developed insulin resistance. The patient said the drug worked for her, whereas other approaches to control weight had failed.

“To put it simply, I now experience hunger and satiety in a way that I can only assume people with normal metabolism do. I am 49 years old and approaching the age where serious comorbidities associated with obesity begin to manifest,” the patient wrote.

“I no longer worry about bringing about my own demise with a fork and knife because of misfiring hunger cues.”

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

A California nurse practitioner was fined nearly $20,000 for false advertising and fraud after referring to herself as “Dr. Sarah” and failing to file necessary business paperwork, according to a settlement announced on Nov. 14.  

Last month, the San Luis Obispo County, California, District Attorney Dan Dow filed a complaint against Sarah Erny, RN, NP, citing unfair business practices and unprofessional conduct.

According to court documents, California’s Medical Practice Act does not permit individuals to refer to themselves as “doctor, physician, or any other terms or letters indicating or implying that he or she is a physician and surgeon ... without having ... a certificate as a physician and surgeon.”

Individuals who misrepresent themselves are subject to misdemeanor charges and civil penalties. 

In addition to the fine, Ms. Erny agreed to refrain from referring to herself as a doctor in her practice and on social media. She has already deleted her Twitter account.

The case underscores tensions between physicians fighting to preserve their scope of practice and the allied professionals that U.S. lawmakers increasingly see as a less expensive way to improve access to health care.

The American Medical Association and specialty groups strongly oppose a new bill, the Improving Care and Access to Nurses Act, that would expand the scope of practice for nurse practitioners and physician assistants.

Court records show that Ms. Erny earned a doctor of nursing practice (DNP) degree from Vanderbilt University, Nashville, Tenn., and that she met the state requirements to obtain licensure as a registered nurse and nurse practitioner. In 2018, she opened a practice in Arroyo Grande, California, called Holistic Women’s Healing, where she provided medical services and drug supplements to patients.

She also entered a collaborative agreement with ob.gyn. Anika Moore, MD, for approximately 3 years. Dr. Moore’s medical practice was in another county and state, and the physician returned every 2 to 3 months to review a portion of Ms. Erny’s patient files.

Ms. Erny and Dr. Moore terminated the collaborative agreement in March, according to court documents.

However, Mr. Dow alleged that Ms. Erny regularly referred to herself as “Dr. Sarah” or “Dr. Sarah Erny” in her online advertising and social media accounts. Her patients “were so proud of her” that they called her doctor, and her supervising physician instructed staff to do the same.

Mr. Dow said Ms. Erny did not clearly advise the public that she was not a medical doctor and failed to identify her supervising physician. “Simply put, there is a great need for health care providers to state their level of training and licensing clearly and honestly in all of their advertising and marketing materials,” he said in a press release.

In California, nurse practitioners who have been certified by the Board of Registered Nursing may use the following titles: Advanced Practice Registered Nurse; Certified Nurse Practitioner; APRN-CNP; RN and NP; or a combination of other letters or words to identify specialization, such as adult nurse practitioner, pediatric nurse practitioner, obstetrical-gynecological nurse practitioner, and family nurse practitioner.

As educational requirements shift for advanced practice clinicians, similar cases will likely emerge, said Grant Martsolf, PhD, MPH, RN, FAAN, professor at the University of Pittsburgh School of Nursing.

“Scope of practice is governed by states, [so they] will have to figure [it] out as more professional disciplines move to clinical doctorates as the entry to practice. Pharma, [physical therapy], and [occupational therapy] have already done this, and advanced practice nursing is on its way. [Certified registered nurse anesthetists] are already required to get a DNP to sit for certification,” he said.

More guidance is needed, especially when considering other professions like dentists, clinical psychologists, and individuals with clinical or research doctorates who often call themselves doctors, Dr. Martsolf said.

“It seems that the honorific of ‘Dr.’ emerges from the degree, not from being a physician or surgeon,” he said.

Beyond the false advertising, Mr. Dow alleged that Ms. Erny did not file a fictitious business name statement for 2020 and 2021 – a requirement under the California Business and Professions Code to identify who is operating the business.

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

A California nurse practitioner was fined nearly $20,000 for false advertising and fraud after referring to herself as “Dr. Sarah” and failing to file necessary business paperwork, according to a settlement announced on Nov. 14.  

Last month, the San Luis Obispo County, California, District Attorney Dan Dow filed a complaint against Sarah Erny, RN, NP, citing unfair business practices and unprofessional conduct.

According to court documents, California’s Medical Practice Act does not permit individuals to refer to themselves as “doctor, physician, or any other terms or letters indicating or implying that he or she is a physician and surgeon ... without having ... a certificate as a physician and surgeon.”

Individuals who misrepresent themselves are subject to misdemeanor charges and civil penalties. 

In addition to the fine, Ms. Erny agreed to refrain from referring to herself as a doctor in her practice and on social media. She has already deleted her Twitter account.

The case underscores tensions between physicians fighting to preserve their scope of practice and the allied professionals that U.S. lawmakers increasingly see as a less expensive way to improve access to health care.

The American Medical Association and specialty groups strongly oppose a new bill, the Improving Care and Access to Nurses Act, that would expand the scope of practice for nurse practitioners and physician assistants.

Court records show that Ms. Erny earned a doctor of nursing practice (DNP) degree from Vanderbilt University, Nashville, Tenn., and that she met the state requirements to obtain licensure as a registered nurse and nurse practitioner. In 2018, she opened a practice in Arroyo Grande, California, called Holistic Women’s Healing, where she provided medical services and drug supplements to patients.

She also entered a collaborative agreement with ob.gyn. Anika Moore, MD, for approximately 3 years. Dr. Moore’s medical practice was in another county and state, and the physician returned every 2 to 3 months to review a portion of Ms. Erny’s patient files.

Ms. Erny and Dr. Moore terminated the collaborative agreement in March, according to court documents.

However, Mr. Dow alleged that Ms. Erny regularly referred to herself as “Dr. Sarah” or “Dr. Sarah Erny” in her online advertising and social media accounts. Her patients “were so proud of her” that they called her doctor, and her supervising physician instructed staff to do the same.

Mr. Dow said Ms. Erny did not clearly advise the public that she was not a medical doctor and failed to identify her supervising physician. “Simply put, there is a great need for health care providers to state their level of training and licensing clearly and honestly in all of their advertising and marketing materials,” he said in a press release.

In California, nurse practitioners who have been certified by the Board of Registered Nursing may use the following titles: Advanced Practice Registered Nurse; Certified Nurse Practitioner; APRN-CNP; RN and NP; or a combination of other letters or words to identify specialization, such as adult nurse practitioner, pediatric nurse practitioner, obstetrical-gynecological nurse practitioner, and family nurse practitioner.

As educational requirements shift for advanced practice clinicians, similar cases will likely emerge, said Grant Martsolf, PhD, MPH, RN, FAAN, professor at the University of Pittsburgh School of Nursing.

“Scope of practice is governed by states, [so they] will have to figure [it] out as more professional disciplines move to clinical doctorates as the entry to practice. Pharma, [physical therapy], and [occupational therapy] have already done this, and advanced practice nursing is on its way. [Certified registered nurse anesthetists] are already required to get a DNP to sit for certification,” he said.

More guidance is needed, especially when considering other professions like dentists, clinical psychologists, and individuals with clinical or research doctorates who often call themselves doctors, Dr. Martsolf said.

“It seems that the honorific of ‘Dr.’ emerges from the degree, not from being a physician or surgeon,” he said.

Beyond the false advertising, Mr. Dow alleged that Ms. Erny did not file a fictitious business name statement for 2020 and 2021 – a requirement under the California Business and Professions Code to identify who is operating the business.

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

A California nurse practitioner was fined nearly $20,000 for false advertising and fraud after referring to herself as “Dr. Sarah” and failing to file necessary business paperwork, according to a settlement announced on Nov. 14.  

Last month, the San Luis Obispo County, California, District Attorney Dan Dow filed a complaint against Sarah Erny, RN, NP, citing unfair business practices and unprofessional conduct.

According to court documents, California’s Medical Practice Act does not permit individuals to refer to themselves as “doctor, physician, or any other terms or letters indicating or implying that he or she is a physician and surgeon ... without having ... a certificate as a physician and surgeon.”

Individuals who misrepresent themselves are subject to misdemeanor charges and civil penalties. 

In addition to the fine, Ms. Erny agreed to refrain from referring to herself as a doctor in her practice and on social media. She has already deleted her Twitter account.

The case underscores tensions between physicians fighting to preserve their scope of practice and the allied professionals that U.S. lawmakers increasingly see as a less expensive way to improve access to health care.

The American Medical Association and specialty groups strongly oppose a new bill, the Improving Care and Access to Nurses Act, that would expand the scope of practice for nurse practitioners and physician assistants.

Court records show that Ms. Erny earned a doctor of nursing practice (DNP) degree from Vanderbilt University, Nashville, Tenn., and that she met the state requirements to obtain licensure as a registered nurse and nurse practitioner. In 2018, she opened a practice in Arroyo Grande, California, called Holistic Women’s Healing, where she provided medical services and drug supplements to patients.

She also entered a collaborative agreement with ob.gyn. Anika Moore, MD, for approximately 3 years. Dr. Moore’s medical practice was in another county and state, and the physician returned every 2 to 3 months to review a portion of Ms. Erny’s patient files.

Ms. Erny and Dr. Moore terminated the collaborative agreement in March, according to court documents.

However, Mr. Dow alleged that Ms. Erny regularly referred to herself as “Dr. Sarah” or “Dr. Sarah Erny” in her online advertising and social media accounts. Her patients “were so proud of her” that they called her doctor, and her supervising physician instructed staff to do the same.

Mr. Dow said Ms. Erny did not clearly advise the public that she was not a medical doctor and failed to identify her supervising physician. “Simply put, there is a great need for health care providers to state their level of training and licensing clearly and honestly in all of their advertising and marketing materials,” he said in a press release.

In California, nurse practitioners who have been certified by the Board of Registered Nursing may use the following titles: Advanced Practice Registered Nurse; Certified Nurse Practitioner; APRN-CNP; RN and NP; or a combination of other letters or words to identify specialization, such as adult nurse practitioner, pediatric nurse practitioner, obstetrical-gynecological nurse practitioner, and family nurse practitioner.

As educational requirements shift for advanced practice clinicians, similar cases will likely emerge, said Grant Martsolf, PhD, MPH, RN, FAAN, professor at the University of Pittsburgh School of Nursing.

“Scope of practice is governed by states, [so they] will have to figure [it] out as more professional disciplines move to clinical doctorates as the entry to practice. Pharma, [physical therapy], and [occupational therapy] have already done this, and advanced practice nursing is on its way. [Certified registered nurse anesthetists] are already required to get a DNP to sit for certification,” he said.

More guidance is needed, especially when considering other professions like dentists, clinical psychologists, and individuals with clinical or research doctorates who often call themselves doctors, Dr. Martsolf said.

“It seems that the honorific of ‘Dr.’ emerges from the degree, not from being a physician or surgeon,” he said.

Beyond the false advertising, Mr. Dow alleged that Ms. Erny did not file a fictitious business name statement for 2020 and 2021 – a requirement under the California Business and Professions Code to identify who is operating the business.

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

There was a wide gap between patients’ perceptions of their diet quality and the reality in the SMARTER weight-loss trial of lifestyle changes, researchers report.

Only 28% of the participants had good agreement – defined as a difference of 6 points or less – between their perceived diet quality and its actual quality based on Healthy Eating Index–2015 (HEI) scores at the end of the 12-month intervention.

Even fewer – only 13% – had good agreement with their perceived and actual improvement in diet quality.

Jessica Cheng, PhD, Harvard School of Public Health, Boston, presented the findings in an oral session at the American Heart Association scientific sessions.

The study suggests that “patients can benefit from concrete advice on aspects of their diet that could most benefit by being changed,” Dr. Cheng said in an interview.

“But once they know what to change, they may need additional advice on how to make and sustain those changes. Providers may direct their patients to resources such as dietitians, medically tailored meals, MyPlate, healthy recipes, etc.,” she advised.

“The findings are not surprising given that dietary recalls are subject to recall bias and depend on the person’s baseline nutrition knowledge or literacy,” Deepika Laddu, PhD, who was not involved with this research, said in an interview.

Misperception of diet intake is common in individuals with overweight or obesity, and one 90-minute session with a dietitian is not enough, according to Dr. Laddu, assistant professor at the University of Illinois at Chicago.

“The Dietary Guidelines for Americans does a really nice job at presenting all of the options,” she said. However, “understanding what a healthy diet pattern is, or how to adopt it, is confusing, due to a lot of ‘noise’, that is, the mixed messaging and unproven health claims, which add to inadequacies in health or nutrition literacy.”

“It is important to recognize that changing dietary practices is behaviorally challenging and complex,” she emphasized.

People who are interested in making dietary changes need to have ongoing conversations with a qualified health care professional, which most often starts with their primary care clinician.

“Given the well-known time constraints during a typical clinical visit, beyond that initial conversation, it is absolutely critical that patients be referred to qualified healthcare professionals such as a registered dietitian, nurse practitioner, health coach/educator or diabetes educator, etc, for ongoing support.”

These providers can assess the patient’s initial diet, perceptions of a healthy diet, and diet goals, and address any gaps in health literacy, to enable the patient to develop long-lasting, realistic, and healthy eating behaviors.
 

Perceived vs. actual diet quality

Healthy eating is essential for heart and general health and longevity, but it is unclear if people who make lifestyle (diet and physical activity) changes to lose weight have an accurate perception of diet quality.

The researchers analyzed data from the SMARTER trial of 502 adults aged 35-58 living in the greater Pittsburgh area who were trying to lose weight.

Participants received a 90-minute weight loss counseling session addressing behavioral strategies and establishing dietary and physical activity goals. They all received instructions on how to monitor their diet, physical activity, and weight daily, using a smartphone app, a wristband tracker (Fitbit Charge 2), and a smart wireless scale. Half of the participants also received real-time personalized feedback on those behaviors, up to three times a day, via the study app.

The participants replied to two 24-hour dietary recall questionnaires at study entry and two questionnaires at 12 months.

Researchers analyzed data from the 116 participants who provided information about diet quality. At 1 year, they were asked to rate their diet quality, but also rate their diet quality 12 months earlier at baseline, on a scale of 0-100, where 100 is best.

The average weight loss at 12 months was similar in the groups with and without feedback from the app (roughly 3.2% of baseline weight), so the two study arms were combined. The participants had a mean age of 52 years; 80% were women and 87% were White. They had an average body mass index of 33 kg/m².

Based on the information from the food recall questionnaires, the researchers calculated the patients’ HEI scores at the start and end of the study. The HEI score is a measure of how well a person’s diet adheres to the 2015-2020 Dietary Guidelines for Americans. It is based on an adequate consumption of nine types of foods – total fruits, whole fruits, total vegetables, greens and beans, total protein foods, seafood, and plant proteins (up to 5 points each), and whole grains, dairy, and fatty acids (up to 10 points each) – and reduced consumption of four dietary components – refined grains, sodium, added sugars, and saturated fats (up to 10 points each).

The healthiest diet has an HEI score of 100, and the Healthy People 2020 goal was an HEI score of 74, Dr. Cheng noted.

At 12 months, on average, the participants rated their diet quality at 70.5 points, whereas the researchers calculated that their average HEI score was only 56.

Participants thought they had improved their diet quality by about 20 points, Dr. Cheng reported. “However, the HEI would suggest they’ve improved it by 1.5 points, which is not a lot out of 100.”

“Future studies should examine the effects of helping people close the gap between their perceptions and objective diet quality measurements,” Dr. Cheng said in a press release from the AHA.

The study was funded by the National Heart, Lung, and Blood Institute, a division of the National Institutes of Health. Dr. Cheng and Dr. Laddu reported no relevant financial relationships.

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

There was a wide gap between patients’ perceptions of their diet quality and the reality in the SMARTER weight-loss trial of lifestyle changes, researchers report.

Only 28% of the participants had good agreement – defined as a difference of 6 points or less – between their perceived diet quality and its actual quality based on Healthy Eating Index–2015 (HEI) scores at the end of the 12-month intervention.

Even fewer – only 13% – had good agreement with their perceived and actual improvement in diet quality.

Jessica Cheng, PhD, Harvard School of Public Health, Boston, presented the findings in an oral session at the American Heart Association scientific sessions.

The study suggests that “patients can benefit from concrete advice on aspects of their diet that could most benefit by being changed,” Dr. Cheng said in an interview.

“But once they know what to change, they may need additional advice on how to make and sustain those changes. Providers may direct their patients to resources such as dietitians, medically tailored meals, MyPlate, healthy recipes, etc.,” she advised.

“The findings are not surprising given that dietary recalls are subject to recall bias and depend on the person’s baseline nutrition knowledge or literacy,” Deepika Laddu, PhD, who was not involved with this research, said in an interview.

Misperception of diet intake is common in individuals with overweight or obesity, and one 90-minute session with a dietitian is not enough, according to Dr. Laddu, assistant professor at the University of Illinois at Chicago.

“The Dietary Guidelines for Americans does a really nice job at presenting all of the options,” she said. However, “understanding what a healthy diet pattern is, or how to adopt it, is confusing, due to a lot of ‘noise’, that is, the mixed messaging and unproven health claims, which add to inadequacies in health or nutrition literacy.”

“It is important to recognize that changing dietary practices is behaviorally challenging and complex,” she emphasized.

People who are interested in making dietary changes need to have ongoing conversations with a qualified health care professional, which most often starts with their primary care clinician.

“Given the well-known time constraints during a typical clinical visit, beyond that initial conversation, it is absolutely critical that patients be referred to qualified healthcare professionals such as a registered dietitian, nurse practitioner, health coach/educator or diabetes educator, etc, for ongoing support.”

These providers can assess the patient’s initial diet, perceptions of a healthy diet, and diet goals, and address any gaps in health literacy, to enable the patient to develop long-lasting, realistic, and healthy eating behaviors.
 

Perceived vs. actual diet quality

Healthy eating is essential for heart and general health and longevity, but it is unclear if people who make lifestyle (diet and physical activity) changes to lose weight have an accurate perception of diet quality.

The researchers analyzed data from the SMARTER trial of 502 adults aged 35-58 living in the greater Pittsburgh area who were trying to lose weight.

Participants received a 90-minute weight loss counseling session addressing behavioral strategies and establishing dietary and physical activity goals. They all received instructions on how to monitor their diet, physical activity, and weight daily, using a smartphone app, a wristband tracker (Fitbit Charge 2), and a smart wireless scale. Half of the participants also received real-time personalized feedback on those behaviors, up to three times a day, via the study app.

The participants replied to two 24-hour dietary recall questionnaires at study entry and two questionnaires at 12 months.

Researchers analyzed data from the 116 participants who provided information about diet quality. At 1 year, they were asked to rate their diet quality, but also rate their diet quality 12 months earlier at baseline, on a scale of 0-100, where 100 is best.

The average weight loss at 12 months was similar in the groups with and without feedback from the app (roughly 3.2% of baseline weight), so the two study arms were combined. The participants had a mean age of 52 years; 80% were women and 87% were White. They had an average body mass index of 33 kg/m².

Based on the information from the food recall questionnaires, the researchers calculated the patients’ HEI scores at the start and end of the study. The HEI score is a measure of how well a person’s diet adheres to the 2015-2020 Dietary Guidelines for Americans. It is based on an adequate consumption of nine types of foods – total fruits, whole fruits, total vegetables, greens and beans, total protein foods, seafood, and plant proteins (up to 5 points each), and whole grains, dairy, and fatty acids (up to 10 points each) – and reduced consumption of four dietary components – refined grains, sodium, added sugars, and saturated fats (up to 10 points each).

The healthiest diet has an HEI score of 100, and the Healthy People 2020 goal was an HEI score of 74, Dr. Cheng noted.

At 12 months, on average, the participants rated their diet quality at 70.5 points, whereas the researchers calculated that their average HEI score was only 56.

Participants thought they had improved their diet quality by about 20 points, Dr. Cheng reported. “However, the HEI would suggest they’ve improved it by 1.5 points, which is not a lot out of 100.”

“Future studies should examine the effects of helping people close the gap between their perceptions and objective diet quality measurements,” Dr. Cheng said in a press release from the AHA.

The study was funded by the National Heart, Lung, and Blood Institute, a division of the National Institutes of Health. Dr. Cheng and Dr. Laddu reported no relevant financial relationships.

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

There was a wide gap between patients’ perceptions of their diet quality and the reality in the SMARTER weight-loss trial of lifestyle changes, researchers report.

Only 28% of the participants had good agreement – defined as a difference of 6 points or less – between their perceived diet quality and its actual quality based on Healthy Eating Index–2015 (HEI) scores at the end of the 12-month intervention.

Even fewer – only 13% – had good agreement with their perceived and actual improvement in diet quality.

Jessica Cheng, PhD, Harvard School of Public Health, Boston, presented the findings in an oral session at the American Heart Association scientific sessions.

The study suggests that “patients can benefit from concrete advice on aspects of their diet that could most benefit by being changed,” Dr. Cheng said in an interview.

“But once they know what to change, they may need additional advice on how to make and sustain those changes. Providers may direct their patients to resources such as dietitians, medically tailored meals, MyPlate, healthy recipes, etc.,” she advised.

“The findings are not surprising given that dietary recalls are subject to recall bias and depend on the person’s baseline nutrition knowledge or literacy,” Deepika Laddu, PhD, who was not involved with this research, said in an interview.

Misperception of diet intake is common in individuals with overweight or obesity, and one 90-minute session with a dietitian is not enough, according to Dr. Laddu, assistant professor at the University of Illinois at Chicago.

“The Dietary Guidelines for Americans does a really nice job at presenting all of the options,” she said. However, “understanding what a healthy diet pattern is, or how to adopt it, is confusing, due to a lot of ‘noise’, that is, the mixed messaging and unproven health claims, which add to inadequacies in health or nutrition literacy.”

“It is important to recognize that changing dietary practices is behaviorally challenging and complex,” she emphasized.

People who are interested in making dietary changes need to have ongoing conversations with a qualified health care professional, which most often starts with their primary care clinician.

“Given the well-known time constraints during a typical clinical visit, beyond that initial conversation, it is absolutely critical that patients be referred to qualified healthcare professionals such as a registered dietitian, nurse practitioner, health coach/educator or diabetes educator, etc, for ongoing support.”

These providers can assess the patient’s initial diet, perceptions of a healthy diet, and diet goals, and address any gaps in health literacy, to enable the patient to develop long-lasting, realistic, and healthy eating behaviors.
 

Perceived vs. actual diet quality

Healthy eating is essential for heart and general health and longevity, but it is unclear if people who make lifestyle (diet and physical activity) changes to lose weight have an accurate perception of diet quality.

The researchers analyzed data from the SMARTER trial of 502 adults aged 35-58 living in the greater Pittsburgh area who were trying to lose weight.

Participants received a 90-minute weight loss counseling session addressing behavioral strategies and establishing dietary and physical activity goals. They all received instructions on how to monitor their diet, physical activity, and weight daily, using a smartphone app, a wristband tracker (Fitbit Charge 2), and a smart wireless scale. Half of the participants also received real-time personalized feedback on those behaviors, up to three times a day, via the study app.

The participants replied to two 24-hour dietary recall questionnaires at study entry and two questionnaires at 12 months.

Researchers analyzed data from the 116 participants who provided information about diet quality. At 1 year, they were asked to rate their diet quality, but also rate their diet quality 12 months earlier at baseline, on a scale of 0-100, where 100 is best.

The average weight loss at 12 months was similar in the groups with and without feedback from the app (roughly 3.2% of baseline weight), so the two study arms were combined. The participants had a mean age of 52 years; 80% were women and 87% were White. They had an average body mass index of 33 kg/m².

Based on the information from the food recall questionnaires, the researchers calculated the patients’ HEI scores at the start and end of the study. The HEI score is a measure of how well a person’s diet adheres to the 2015-2020 Dietary Guidelines for Americans. It is based on an adequate consumption of nine types of foods – total fruits, whole fruits, total vegetables, greens and beans, total protein foods, seafood, and plant proteins (up to 5 points each), and whole grains, dairy, and fatty acids (up to 10 points each) – and reduced consumption of four dietary components – refined grains, sodium, added sugars, and saturated fats (up to 10 points each).

The healthiest diet has an HEI score of 100, and the Healthy People 2020 goal was an HEI score of 74, Dr. Cheng noted.

At 12 months, on average, the participants rated their diet quality at 70.5 points, whereas the researchers calculated that their average HEI score was only 56.

Participants thought they had improved their diet quality by about 20 points, Dr. Cheng reported. “However, the HEI would suggest they’ve improved it by 1.5 points, which is not a lot out of 100.”

“Future studies should examine the effects of helping people close the gap between their perceptions and objective diet quality measurements,” Dr. Cheng said in a press release from the AHA.

The study was funded by the National Heart, Lung, and Blood Institute, a division of the National Institutes of Health. Dr. Cheng and Dr. Laddu reported no relevant financial relationships.

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