BERLIN – Further findings from the PSORRO study suggest that oral roflumilast may be an option for treating patients with moderate to severe plaque psoriasis, particularly if they have a high body mass index (BMI).

Reporting secondary outcomes from the investigator-led trial at the annual congress of the European Academy of Dermatology and Venereology, Alexander Egeberg, MD, PhD, DMSc, noted that “clinically significant weight loss” was seen among patients who were treated with oral roflumilast, 500 mcg once daily, versus those receiving placebo.

Indeed, after 12 weeks of therapy, one in three patients treated with oral roflumilast experienced at least a 5% drop in their baseline body weight vs no patients who received placebo (35% vs. 0%; P < .05).

Additionally, a respective 17% versus 0% of patients lost 10% or more of their body weight, and 4% versus 0% lost 15% or more of their baseline body weight at 12 weeks.

After 24 weeks’ treatment, a substantial percentage of patients still had greater than or equal to 5%, greater than or equal to 10%, or greater than or equal to 15% weight loss, at 30%, 17%, and 13% for oral roflumilast, compared with 9%, 0%, and 0% for placebo, respectively.

“We saw that the higher baseline weight correlated with the proportion of weight loss, so that the more heavy patients at baseline also were the ones who experienced the greatest weight loss,” said Dr. Egeberg, who is professor of dermatology at the University of Copenhagen and a senior consultant at the department of dermatology at Bispebjerg Hospital, Copenhagen.
 

A beneficial side effect in psoriasis?

“You may have heard in psoriasis about topical roflumilast, but oral roflumilast is actually also shown to be effective in treating psoriasis,” said Egeberg.

Topical roflumilast is approved in the United States and Canada for treating plaque psoriasis.

Efficacy results from the PSORRO study were published earlier this year and showed a significantly greater improvement in Psoriasis Area and Severity Index (PASI) 75 with oral roflumilast vs. placebo at 12 weeks (35% vs. 0%), with a sustained effect seen at 24 weeks (44% vs. 40%).

Weight loss was among the most common side effects seen, leading Dr. Egeberg and fellow PSORRO investigators to wonder whether this may actually be a beneficial effect in patients with psoriasis.

“Oral roflumilast is actually a drug that has been on the market for quite a number of years,” Dr. Egeberg said.

Although only currently licensed for chronic obstructive pulmonary disease (COPD) in the United States, oral roflumilast, a phosphodiesterase (PDE) 4 inhibitor, is available as a generic, “which also means that it is extremely affordable,” suggested Dr. Edeberg.

Weight loss may be a problem in patients with COPD, he acknowledged; these patients tend to be underweight as a result of their poor state of health caused by the lung condition. Weight loss could be an advantage in patients with psoriasis who are overweight or living with obesity and have poor cardiometabolic parameters.

The psoriasis treatment with oral roflumilast study

The PSORRO study was a phase 2, multicenter, placebo-controlled, randomized trial performed between 2021 and 2022. A total of 46 adults with plaque psoriasis participated; half were initially treated with oral roflumilast and half with placebo.

Treatment was double-blind for the first 12 weeks, with all patients then receiving open-label treatment with roflumilast for 12 weeks.

The primary endpoint was the proportion of patients achieving at least 75% reduction from baseline PASI (PASI75). A host of secondary endpoints were studied, including weight and cardiometabolic parameters, which Dr. Egeberg reported at the EADV meeting.

Looking at the baseline characteristics of the oral roflumilast and placebo groups, the mean age was a respective 38 and 39 years, 65% and 83% were men, and the mean starting body weight was 102 kg and 105.1 kg.

After 12 weeks of treatment, body weight fell by a mean of 5.4 kg in the oral roflumilast group, with a further decrease of 1.4 kg by 24 weeks, bringing the total average weight loss to 6.8 kg. By comparison, weight loss among those in the placebo group was 0 kg at 12 weeks and around 2 kg at 24 weeks.

The majority of participants in both groups had high baseline BMIs; 70% of those who received oral roflumilast and 61% of those who received placebo had a BMI of 30 or higher.

“We wanted to investigate the impact of body weight, [so] we didn’t allow patients to be underweight when they were included,” Dr. Egeberg explained. Thus, for inclusion, patients had to have a BMI of 20 or higher.

An “extraordinary” finding was how some patients’ weight status based on their BMI changed throughout the study.

“We could see people that went from obese class 3, all the way to obese class 1. And we could see people going from being overweight to normal weight, which is really extraordinary for patients with psoriasis,” Dr. Egeberg said.

“But most importantly,” he added, “we didn’t have any patients who became underweight, suggesting that it actually is safe to use also in normal-weight patients.”
 

Reduced appetite behind benefit?

Trying to see why the weight loss occurred, Dr. Egeberg noted that it looked like it could be a result of a reduced appetite.

In common with other PDE-4 inhibitors, oral roflumilast treatment was associated with gastrointestinal symptoms – nausea, diarrhea, and abdominal pain – but all of these “decrease to placebo levels again, quite quickly,” he said.

“This really suggests that it’s not because of diarrhea, it’s not because of nausea and abdominal pain; it is because of a reduced appetite that patients actually lose weight when treated with roflumilast,” Dr. Egeberg said. It’s a potential bonus for the drug’s effects on the skin and could afford clinicians an opportunity to help motivate patients to eat well when they do eat, he observed.

Other cardiometabolic parameters assessed included blood pressure, glycated hemoglobin, total cholesterol and other key lipids, creatinine, alanine aminotransferase, and high-sensitivity C-reactive protein, but there were no noteworthy differences between the groups.

Roflumilast is an inexpensive drug because it is generic, Dr. Egeberg observed, but that also means that its use is likely to be off-label.

“It will be up to the treating physician to decide if this is an optimal therapy for their patients,” he suggested.
 

Cardiometabolic comorbidities important to target

Obesity is a cardiometabolic comorbidity that is important to consider when treating your patients with psoriasis, Paolo Gisondi, MD, of the University of Verona (Italy), said at a separate presentation at the EADV meeting.

While not directly commenting on the roflumilast study, he noted that moderate to severe psoriasis was “frequently associated” with metabolic disorders that put people at additional risk for cardiovascular and fatty liver diseases.

The PSORRO study was an investigator-initiated and investigator-led study and received no commercial funding. Research funding came from the Danish Psoriasis Foundation, Herlev and Gentofte Hospital, and several charitable and humanitarian organizations. Dr. Egeberg acknowledged acting as the principal investigator, speaker, and/or consultant to multiple pharma companies, all of which were unrelated to the study he presented. Dr. Gisondi’s comments were from a separate presentation, and he was not involved in the study.

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

BERLIN – Further findings from the PSORRO study suggest that oral roflumilast may be an option for treating patients with moderate to severe plaque psoriasis, particularly if they have a high body mass index (BMI).

Reporting secondary outcomes from the investigator-led trial at the annual congress of the European Academy of Dermatology and Venereology, Alexander Egeberg, MD, PhD, DMSc, noted that “clinically significant weight loss” was seen among patients who were treated with oral roflumilast, 500 mcg once daily, versus those receiving placebo.

Indeed, after 12 weeks of therapy, one in three patients treated with oral roflumilast experienced at least a 5% drop in their baseline body weight vs no patients who received placebo (35% vs. 0%; P < .05).

Additionally, a respective 17% versus 0% of patients lost 10% or more of their body weight, and 4% versus 0% lost 15% or more of their baseline body weight at 12 weeks.

After 24 weeks’ treatment, a substantial percentage of patients still had greater than or equal to 5%, greater than or equal to 10%, or greater than or equal to 15% weight loss, at 30%, 17%, and 13% for oral roflumilast, compared with 9%, 0%, and 0% for placebo, respectively.

“We saw that the higher baseline weight correlated with the proportion of weight loss, so that the more heavy patients at baseline also were the ones who experienced the greatest weight loss,” said Dr. Egeberg, who is professor of dermatology at the University of Copenhagen and a senior consultant at the department of dermatology at Bispebjerg Hospital, Copenhagen.
 

A beneficial side effect in psoriasis?

“You may have heard in psoriasis about topical roflumilast, but oral roflumilast is actually also shown to be effective in treating psoriasis,” said Egeberg.

Topical roflumilast is approved in the United States and Canada for treating plaque psoriasis.

Efficacy results from the PSORRO study were published earlier this year and showed a significantly greater improvement in Psoriasis Area and Severity Index (PASI) 75 with oral roflumilast vs. placebo at 12 weeks (35% vs. 0%), with a sustained effect seen at 24 weeks (44% vs. 40%).

Weight loss was among the most common side effects seen, leading Dr. Egeberg and fellow PSORRO investigators to wonder whether this may actually be a beneficial effect in patients with psoriasis.

“Oral roflumilast is actually a drug that has been on the market for quite a number of years,” Dr. Egeberg said.

Although only currently licensed for chronic obstructive pulmonary disease (COPD) in the United States, oral roflumilast, a phosphodiesterase (PDE) 4 inhibitor, is available as a generic, “which also means that it is extremely affordable,” suggested Dr. Edeberg.

Weight loss may be a problem in patients with COPD, he acknowledged; these patients tend to be underweight as a result of their poor state of health caused by the lung condition. Weight loss could be an advantage in patients with psoriasis who are overweight or living with obesity and have poor cardiometabolic parameters.

The psoriasis treatment with oral roflumilast study

The PSORRO study was a phase 2, multicenter, placebo-controlled, randomized trial performed between 2021 and 2022. A total of 46 adults with plaque psoriasis participated; half were initially treated with oral roflumilast and half with placebo.

Treatment was double-blind for the first 12 weeks, with all patients then receiving open-label treatment with roflumilast for 12 weeks.

The primary endpoint was the proportion of patients achieving at least 75% reduction from baseline PASI (PASI75). A host of secondary endpoints were studied, including weight and cardiometabolic parameters, which Dr. Egeberg reported at the EADV meeting.

Looking at the baseline characteristics of the oral roflumilast and placebo groups, the mean age was a respective 38 and 39 years, 65% and 83% were men, and the mean starting body weight was 102 kg and 105.1 kg.

After 12 weeks of treatment, body weight fell by a mean of 5.4 kg in the oral roflumilast group, with a further decrease of 1.4 kg by 24 weeks, bringing the total average weight loss to 6.8 kg. By comparison, weight loss among those in the placebo group was 0 kg at 12 weeks and around 2 kg at 24 weeks.

The majority of participants in both groups had high baseline BMIs; 70% of those who received oral roflumilast and 61% of those who received placebo had a BMI of 30 or higher.

“We wanted to investigate the impact of body weight, [so] we didn’t allow patients to be underweight when they were included,” Dr. Egeberg explained. Thus, for inclusion, patients had to have a BMI of 20 or higher.

An “extraordinary” finding was how some patients’ weight status based on their BMI changed throughout the study.

“We could see people that went from obese class 3, all the way to obese class 1. And we could see people going from being overweight to normal weight, which is really extraordinary for patients with psoriasis,” Dr. Egeberg said.

“But most importantly,” he added, “we didn’t have any patients who became underweight, suggesting that it actually is safe to use also in normal-weight patients.”
 

Reduced appetite behind benefit?

Trying to see why the weight loss occurred, Dr. Egeberg noted that it looked like it could be a result of a reduced appetite.

In common with other PDE-4 inhibitors, oral roflumilast treatment was associated with gastrointestinal symptoms – nausea, diarrhea, and abdominal pain – but all of these “decrease to placebo levels again, quite quickly,” he said.

“This really suggests that it’s not because of diarrhea, it’s not because of nausea and abdominal pain; it is because of a reduced appetite that patients actually lose weight when treated with roflumilast,” Dr. Egeberg said. It’s a potential bonus for the drug’s effects on the skin and could afford clinicians an opportunity to help motivate patients to eat well when they do eat, he observed.

Other cardiometabolic parameters assessed included blood pressure, glycated hemoglobin, total cholesterol and other key lipids, creatinine, alanine aminotransferase, and high-sensitivity C-reactive protein, but there were no noteworthy differences between the groups.

Roflumilast is an inexpensive drug because it is generic, Dr. Egeberg observed, but that also means that its use is likely to be off-label.

“It will be up to the treating physician to decide if this is an optimal therapy for their patients,” he suggested.
 

Cardiometabolic comorbidities important to target

Obesity is a cardiometabolic comorbidity that is important to consider when treating your patients with psoriasis, Paolo Gisondi, MD, of the University of Verona (Italy), said at a separate presentation at the EADV meeting.

While not directly commenting on the roflumilast study, he noted that moderate to severe psoriasis was “frequently associated” with metabolic disorders that put people at additional risk for cardiovascular and fatty liver diseases.

The PSORRO study was an investigator-initiated and investigator-led study and received no commercial funding. Research funding came from the Danish Psoriasis Foundation, Herlev and Gentofte Hospital, and several charitable and humanitarian organizations. Dr. Egeberg acknowledged acting as the principal investigator, speaker, and/or consultant to multiple pharma companies, all of which were unrelated to the study he presented. Dr. Gisondi’s comments were from a separate presentation, and he was not involved in the study.

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

BERLIN – Further findings from the PSORRO study suggest that oral roflumilast may be an option for treating patients with moderate to severe plaque psoriasis, particularly if they have a high body mass index (BMI).

Reporting secondary outcomes from the investigator-led trial at the annual congress of the European Academy of Dermatology and Venereology, Alexander Egeberg, MD, PhD, DMSc, noted that “clinically significant weight loss” was seen among patients who were treated with oral roflumilast, 500 mcg once daily, versus those receiving placebo.

Indeed, after 12 weeks of therapy, one in three patients treated with oral roflumilast experienced at least a 5% drop in their baseline body weight vs no patients who received placebo (35% vs. 0%; P < .05).

Additionally, a respective 17% versus 0% of patients lost 10% or more of their body weight, and 4% versus 0% lost 15% or more of their baseline body weight at 12 weeks.

After 24 weeks’ treatment, a substantial percentage of patients still had greater than or equal to 5%, greater than or equal to 10%, or greater than or equal to 15% weight loss, at 30%, 17%, and 13% for oral roflumilast, compared with 9%, 0%, and 0% for placebo, respectively.

“We saw that the higher baseline weight correlated with the proportion of weight loss, so that the more heavy patients at baseline also were the ones who experienced the greatest weight loss,” said Dr. Egeberg, who is professor of dermatology at the University of Copenhagen and a senior consultant at the department of dermatology at Bispebjerg Hospital, Copenhagen.
 

A beneficial side effect in psoriasis?

“You may have heard in psoriasis about topical roflumilast, but oral roflumilast is actually also shown to be effective in treating psoriasis,” said Egeberg.

Topical roflumilast is approved in the United States and Canada for treating plaque psoriasis.

Efficacy results from the PSORRO study were published earlier this year and showed a significantly greater improvement in Psoriasis Area and Severity Index (PASI) 75 with oral roflumilast vs. placebo at 12 weeks (35% vs. 0%), with a sustained effect seen at 24 weeks (44% vs. 40%).

Weight loss was among the most common side effects seen, leading Dr. Egeberg and fellow PSORRO investigators to wonder whether this may actually be a beneficial effect in patients with psoriasis.

“Oral roflumilast is actually a drug that has been on the market for quite a number of years,” Dr. Egeberg said.

Although only currently licensed for chronic obstructive pulmonary disease (COPD) in the United States, oral roflumilast, a phosphodiesterase (PDE) 4 inhibitor, is available as a generic, “which also means that it is extremely affordable,” suggested Dr. Edeberg.

Weight loss may be a problem in patients with COPD, he acknowledged; these patients tend to be underweight as a result of their poor state of health caused by the lung condition. Weight loss could be an advantage in patients with psoriasis who are overweight or living with obesity and have poor cardiometabolic parameters.

The psoriasis treatment with oral roflumilast study

The PSORRO study was a phase 2, multicenter, placebo-controlled, randomized trial performed between 2021 and 2022. A total of 46 adults with plaque psoriasis participated; half were initially treated with oral roflumilast and half with placebo.

Treatment was double-blind for the first 12 weeks, with all patients then receiving open-label treatment with roflumilast for 12 weeks.

The primary endpoint was the proportion of patients achieving at least 75% reduction from baseline PASI (PASI75). A host of secondary endpoints were studied, including weight and cardiometabolic parameters, which Dr. Egeberg reported at the EADV meeting.

Looking at the baseline characteristics of the oral roflumilast and placebo groups, the mean age was a respective 38 and 39 years, 65% and 83% were men, and the mean starting body weight was 102 kg and 105.1 kg.

After 12 weeks of treatment, body weight fell by a mean of 5.4 kg in the oral roflumilast group, with a further decrease of 1.4 kg by 24 weeks, bringing the total average weight loss to 6.8 kg. By comparison, weight loss among those in the placebo group was 0 kg at 12 weeks and around 2 kg at 24 weeks.

The majority of participants in both groups had high baseline BMIs; 70% of those who received oral roflumilast and 61% of those who received placebo had a BMI of 30 or higher.

“We wanted to investigate the impact of body weight, [so] we didn’t allow patients to be underweight when they were included,” Dr. Egeberg explained. Thus, for inclusion, patients had to have a BMI of 20 or higher.

An “extraordinary” finding was how some patients’ weight status based on their BMI changed throughout the study.

“We could see people that went from obese class 3, all the way to obese class 1. And we could see people going from being overweight to normal weight, which is really extraordinary for patients with psoriasis,” Dr. Egeberg said.

“But most importantly,” he added, “we didn’t have any patients who became underweight, suggesting that it actually is safe to use also in normal-weight patients.”
 

Reduced appetite behind benefit?

Trying to see why the weight loss occurred, Dr. Egeberg noted that it looked like it could be a result of a reduced appetite.

In common with other PDE-4 inhibitors, oral roflumilast treatment was associated with gastrointestinal symptoms – nausea, diarrhea, and abdominal pain – but all of these “decrease to placebo levels again, quite quickly,” he said.

“This really suggests that it’s not because of diarrhea, it’s not because of nausea and abdominal pain; it is because of a reduced appetite that patients actually lose weight when treated with roflumilast,” Dr. Egeberg said. It’s a potential bonus for the drug’s effects on the skin and could afford clinicians an opportunity to help motivate patients to eat well when they do eat, he observed.

Other cardiometabolic parameters assessed included blood pressure, glycated hemoglobin, total cholesterol and other key lipids, creatinine, alanine aminotransferase, and high-sensitivity C-reactive protein, but there were no noteworthy differences between the groups.

Roflumilast is an inexpensive drug because it is generic, Dr. Egeberg observed, but that also means that its use is likely to be off-label.

“It will be up to the treating physician to decide if this is an optimal therapy for their patients,” he suggested.
 

Cardiometabolic comorbidities important to target

Obesity is a cardiometabolic comorbidity that is important to consider when treating your patients with psoriasis, Paolo Gisondi, MD, of the University of Verona (Italy), said at a separate presentation at the EADV meeting.

While not directly commenting on the roflumilast study, he noted that moderate to severe psoriasis was “frequently associated” with metabolic disorders that put people at additional risk for cardiovascular and fatty liver diseases.

The PSORRO study was an investigator-initiated and investigator-led study and received no commercial funding. Research funding came from the Danish Psoriasis Foundation, Herlev and Gentofte Hospital, and several charitable and humanitarian organizations. Dr. Egeberg acknowledged acting as the principal investigator, speaker, and/or consultant to multiple pharma companies, all of which were unrelated to the study he presented. Dr. Gisondi’s comments were from a separate presentation, and he was not involved in the study.

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

According to the CDC, the prevalence of autism spectrum disorders (ASD) has gone from roughly 1 in 68 children in 2010 to 1 in 36 children in 2020.¹ This is nearly a 50% increase over that 10-year period. Over the last several years, there has been evidence suggesting that increasing numbers of young people with ASD or other neurodivergent conditions identify as transgender or gender diverse.² Experts agree more careful attention must be paid to these patients.

UT Southwestern Medical Center

Clinical work with neurodivergent youth, especially those with ASD, can be complicated. This includes things such as difficulty with communication, possible concrete thinking, and obsessive interests. While earlier research has shown a higher incidence of ASD in those referred to specialized gender medical clinics, it is important to realize that not all of these youth are seeking medical care. They may be brought to the attention of a primary care pediatrician (PCP) if the child has discussed their gender identity at home. It is important that PCPs approach these young people with an open mind and address any coexisting mental health conditions. PCPs must be careful not to dismiss any gender identity concerns as another of the patient’s “obsessions”; rather, they should ensure the patient receives the appropriate mental health care that they need to explore these concerns. One challenge for PCPs is that there is a dearth of mental health professionals who have experience in working with young people who have both gender dysphoria and a neurodivergent condition.

For those clinicians who provide gender-affirming medical care to these young people, it is imperative that they have a thorough understanding of the patient’s gender identity and medical goals before starting any treatment. This may require extensive collaboration with the patient’s mental health provider. The clinician providing medical care may also choose to proceed slower with the introduction of hormones and their subsequent dosing to allow the young person time to continue discussing their effects with their mental health provider. To help clinicians, Dr. John Strang and a multidisciplinary group of collaborators developed a set of guidelines for co-occurring ASD and gender dysphoria in adolescents.³ More recently, Dr. Strang and other collaborators have also developed a questionnaire that can be used by clinicians in the care of these patients.⁴ The goal of this questionnaire is to allow the young people to “communicate their experiences and needs in a report format attuned to common autistic thinking and communication styles.”

In summary, pediatricians and those who care for children and adolescents need to be aware of the increased association between those with ASD or other neurodivergent conditions and gender dysphoria. To ensure that these young people receive optimal care, it is important to connect them to experts (if possible) in coexisting ASD and gender dysphoria. If such experts are not readily available, the National LGBTQIA+ Health Education Center has developed a resource for providing an affirmative approach to care for these young people.⁵ While more research is needed to better understand young people with coexisting ASD (or other neurodivergent conditions), taking an individualized approach to their care can help ensure optimal outcomes.
 

Dr. Cooper is assistant professor of pediatrics at University of Texas Southwestern, Dallas, and an adolescent medicine specialist at Children’s Medical Center Dallas.

References

1. Data & Statistics on Autism Spectrum Disorder. https://www.cdc.gov/ncbddd/autism/data.html.

2. Glidden D et al. Gender dysphoria and autism spectrum disorder: A systematic review of the literature. Sex Med Rev. 2016;4(1):3-14. doi:10.1016/j.sxmr.2015.10.003.

3. Strang JF et al. Initial clinical guidelines for co-occurring autism spectrum disorder and gender dysphoria or incongruence in adolescents. J Clin Child Adolesc Psychol. 2018;47(1):105-15. doi:10.1080/15374416.2016.1228462.

4. Strang JF et. al. The Gender-Diversity and Autism Questionnaire: A Community-Developed Clinical, Research, and Self-Advocacy Tool for Autistic Transgender and Gender-Diverse Young Adults. Autism Adulthood. 2023 Jun 1;5(2):175-90. doi: 10.1089/aut.2023.0002.

5. National LGBT Health Education Center. Neurodiversity & gender-diverse youth: An affirming approach to care 2020. https://www.lgbtqiahealtheducation.org/publication/neurodiversity-gender-diverse-youth-an-affirming-approach-to-care-2020/download

According to the CDC, the prevalence of autism spectrum disorders (ASD) has gone from roughly 1 in 68 children in 2010 to 1 in 36 children in 2020.¹ This is nearly a 50% increase over that 10-year period. Over the last several years, there has been evidence suggesting that increasing numbers of young people with ASD or other neurodivergent conditions identify as transgender or gender diverse.² Experts agree more careful attention must be paid to these patients.

UT Southwestern Medical Center

Clinical work with neurodivergent youth, especially those with ASD, can be complicated. This includes things such as difficulty with communication, possible concrete thinking, and obsessive interests. While earlier research has shown a higher incidence of ASD in those referred to specialized gender medical clinics, it is important to realize that not all of these youth are seeking medical care. They may be brought to the attention of a primary care pediatrician (PCP) if the child has discussed their gender identity at home. It is important that PCPs approach these young people with an open mind and address any coexisting mental health conditions. PCPs must be careful not to dismiss any gender identity concerns as another of the patient’s “obsessions”; rather, they should ensure the patient receives the appropriate mental health care that they need to explore these concerns. One challenge for PCPs is that there is a dearth of mental health professionals who have experience in working with young people who have both gender dysphoria and a neurodivergent condition.

For those clinicians who provide gender-affirming medical care to these young people, it is imperative that they have a thorough understanding of the patient’s gender identity and medical goals before starting any treatment. This may require extensive collaboration with the patient’s mental health provider. The clinician providing medical care may also choose to proceed slower with the introduction of hormones and their subsequent dosing to allow the young person time to continue discussing their effects with their mental health provider. To help clinicians, Dr. John Strang and a multidisciplinary group of collaborators developed a set of guidelines for co-occurring ASD and gender dysphoria in adolescents.³ More recently, Dr. Strang and other collaborators have also developed a questionnaire that can be used by clinicians in the care of these patients.⁴ The goal of this questionnaire is to allow the young people to “communicate their experiences and needs in a report format attuned to common autistic thinking and communication styles.”

In summary, pediatricians and those who care for children and adolescents need to be aware of the increased association between those with ASD or other neurodivergent conditions and gender dysphoria. To ensure that these young people receive optimal care, it is important to connect them to experts (if possible) in coexisting ASD and gender dysphoria. If such experts are not readily available, the National LGBTQIA+ Health Education Center has developed a resource for providing an affirmative approach to care for these young people.⁵ While more research is needed to better understand young people with coexisting ASD (or other neurodivergent conditions), taking an individualized approach to their care can help ensure optimal outcomes.
 

Dr. Cooper is assistant professor of pediatrics at University of Texas Southwestern, Dallas, and an adolescent medicine specialist at Children’s Medical Center Dallas.

References

1. Data & Statistics on Autism Spectrum Disorder. https://www.cdc.gov/ncbddd/autism/data.html.

2. Glidden D et al. Gender dysphoria and autism spectrum disorder: A systematic review of the literature. Sex Med Rev. 2016;4(1):3-14. doi:10.1016/j.sxmr.2015.10.003.

3. Strang JF et al. Initial clinical guidelines for co-occurring autism spectrum disorder and gender dysphoria or incongruence in adolescents. J Clin Child Adolesc Psychol. 2018;47(1):105-15. doi:10.1080/15374416.2016.1228462.

4. Strang JF et. al. The Gender-Diversity and Autism Questionnaire: A Community-Developed Clinical, Research, and Self-Advocacy Tool for Autistic Transgender and Gender-Diverse Young Adults. Autism Adulthood. 2023 Jun 1;5(2):175-90. doi: 10.1089/aut.2023.0002.

5. National LGBT Health Education Center. Neurodiversity & gender-diverse youth: An affirming approach to care 2020. https://www.lgbtqiahealtheducation.org/publication/neurodiversity-gender-diverse-youth-an-affirming-approach-to-care-2020/download

According to the CDC, the prevalence of autism spectrum disorders (ASD) has gone from roughly 1 in 68 children in 2010 to 1 in 36 children in 2020.¹ This is nearly a 50% increase over that 10-year period. Over the last several years, there has been evidence suggesting that increasing numbers of young people with ASD or other neurodivergent conditions identify as transgender or gender diverse.² Experts agree more careful attention must be paid to these patients.

UT Southwestern Medical Center

Clinical work with neurodivergent youth, especially those with ASD, can be complicated. This includes things such as difficulty with communication, possible concrete thinking, and obsessive interests. While earlier research has shown a higher incidence of ASD in those referred to specialized gender medical clinics, it is important to realize that not all of these youth are seeking medical care. They may be brought to the attention of a primary care pediatrician (PCP) if the child has discussed their gender identity at home. It is important that PCPs approach these young people with an open mind and address any coexisting mental health conditions. PCPs must be careful not to dismiss any gender identity concerns as another of the patient’s “obsessions”; rather, they should ensure the patient receives the appropriate mental health care that they need to explore these concerns. One challenge for PCPs is that there is a dearth of mental health professionals who have experience in working with young people who have both gender dysphoria and a neurodivergent condition.

For those clinicians who provide gender-affirming medical care to these young people, it is imperative that they have a thorough understanding of the patient’s gender identity and medical goals before starting any treatment. This may require extensive collaboration with the patient’s mental health provider. The clinician providing medical care may also choose to proceed slower with the introduction of hormones and their subsequent dosing to allow the young person time to continue discussing their effects with their mental health provider. To help clinicians, Dr. John Strang and a multidisciplinary group of collaborators developed a set of guidelines for co-occurring ASD and gender dysphoria in adolescents.³ More recently, Dr. Strang and other collaborators have also developed a questionnaire that can be used by clinicians in the care of these patients.⁴ The goal of this questionnaire is to allow the young people to “communicate their experiences and needs in a report format attuned to common autistic thinking and communication styles.”

In summary, pediatricians and those who care for children and adolescents need to be aware of the increased association between those with ASD or other neurodivergent conditions and gender dysphoria. To ensure that these young people receive optimal care, it is important to connect them to experts (if possible) in coexisting ASD and gender dysphoria. If such experts are not readily available, the National LGBTQIA+ Health Education Center has developed a resource for providing an affirmative approach to care for these young people.⁵ While more research is needed to better understand young people with coexisting ASD (or other neurodivergent conditions), taking an individualized approach to their care can help ensure optimal outcomes.
 

Dr. Cooper is assistant professor of pediatrics at University of Texas Southwestern, Dallas, and an adolescent medicine specialist at Children’s Medical Center Dallas.

References

1. Data & Statistics on Autism Spectrum Disorder. https://www.cdc.gov/ncbddd/autism/data.html.

2. Glidden D et al. Gender dysphoria and autism spectrum disorder: A systematic review of the literature. Sex Med Rev. 2016;4(1):3-14. doi:10.1016/j.sxmr.2015.10.003.

3. Strang JF et al. Initial clinical guidelines for co-occurring autism spectrum disorder and gender dysphoria or incongruence in adolescents. J Clin Child Adolesc Psychol. 2018;47(1):105-15. doi:10.1080/15374416.2016.1228462.

4. Strang JF et. al. The Gender-Diversity and Autism Questionnaire: A Community-Developed Clinical, Research, and Self-Advocacy Tool for Autistic Transgender and Gender-Diverse Young Adults. Autism Adulthood. 2023 Jun 1;5(2):175-90. doi: 10.1089/aut.2023.0002.

5. National LGBT Health Education Center. Neurodiversity & gender-diverse youth: An affirming approach to care 2020. https://www.lgbtqiahealtheducation.org/publication/neurodiversity-gender-diverse-youth-an-affirming-approach-to-care-2020/download

TOPLINE:

User-friendly transjugular intracardiac echocardiography (TJ-ICE)–guided transcatheter aortic valve replacement (TAVR) lowers the rate of atrioventricular block requiring permanent pacemaker implantation (PPMI) and has minimal complications, results of a new study suggest.

Researchers developed TJ-ICE–guided TAVR to facilitate implanting a heart valve at an optimal depth, guided by direct visualization of the membranous septum (MS) during the procedure.

METHODOLOGY:

• The single-center study included 163 patients with severe aortic stenosis (AS) from an ongoing registry, mean age 85 years, 71% women, and median Society of Thoracic Surgeons score of 6.3%, who underwent TAVR.
• The primary endpoint was the incidence at 30 days of PPMI; secondary endpoints included the feasibility of TJ-ICE–guided TAVR and safety, including complications related to TJ-ICE.

TAKEAWAY:

• Although all patients underwent valve placement in the proper anatomical location, moderate paravalvular leakage (PVL) occurred in four patients, and a second valve was required in two patients, resulting in a device success of 96.3%.
• New PPMI within 30 days was required in 11 patients (6.7%), all because of complete atrioventricular block; patients with baseline right bundle branch block (RBBB) had a higher incidence of new PPMI than did those without RBBB (23.8% vs. 4.2%; P < .001).
• Patients whose device was implanted inside the MS had a significantly lower incidence of new PPMI (overall 2.1% vs. 13.4%; P = .005); this finding was consistent in patients with baseline RBBB (6.7% vs. 66.7%; P = .004) or without RBBB (1.2% vs. 8.2%; P = .041).
• By 30 days, there was one death, which occurred as a result of bleeding in a patient with liver cirrhosis after a successful TAVR procedure; four patients experienced disabling strokes, and vascular complications developed in 16 patients.

IN PRACTICE:

The study demonstrated the “notable feasibility and safety” of TJ-ICE–guided TAVR, the authors write. They point to the “strong association of TAV position with new PPMI rate, which was clearly visualized by ICE during the procedure.”

In an accompanying editorial, Thomas Bartel, MD, PHD, Flexdoc Inc., Düsseldorf, Germany, noted that the study is the first to report a clinical benefit using a TJ-ICE approach, although barriers such as cost and lack of expertise could prevent interventional cardiologists from taking full advantage of ICE monitoring during TAVR, and further research is warranted.

Randomized and prospective trials comparing the accuracy, reproducibility, and outcomes of ICE guidance vs. guidance by transesophageal echocardiography, and pure fluoroscopy and angiography, “need to be performed before ICE imaging is adopted as the primary nonradiographic imaging modality for TAVR.”

SOURCE:

The study was carried out by Tsutomu Murakami, MD, department of cardiology, Tokai University, Isehara, Japan, and colleagues. It was published online in JACC: Asia.

LIMITATIONS:

The retrospective nonrandomized design has inherent limitations. The choice of intraprocedural imaging modality was decided based on heart team discussion, which may have introduced selection bias. Operators’ implantation skills could have influenced the results although most cases involved highly experienced board-certified operators. The limited number of subjects and the relatively low event rates preclude definitive conclusions.

DISCLOSURES:

Dr. Murakami has no relevant conflicts of interest; see paper for disclosures of other study authors. Dr. Bartel has no relevant conflicts of interest.

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

TOPLINE:

User-friendly transjugular intracardiac echocardiography (TJ-ICE)–guided transcatheter aortic valve replacement (TAVR) lowers the rate of atrioventricular block requiring permanent pacemaker implantation (PPMI) and has minimal complications, results of a new study suggest.

Researchers developed TJ-ICE–guided TAVR to facilitate implanting a heart valve at an optimal depth, guided by direct visualization of the membranous septum (MS) during the procedure.

METHODOLOGY:

• The single-center study included 163 patients with severe aortic stenosis (AS) from an ongoing registry, mean age 85 years, 71% women, and median Society of Thoracic Surgeons score of 6.3%, who underwent TAVR.
• The primary endpoint was the incidence at 30 days of PPMI; secondary endpoints included the feasibility of TJ-ICE–guided TAVR and safety, including complications related to TJ-ICE.

TAKEAWAY:

• Although all patients underwent valve placement in the proper anatomical location, moderate paravalvular leakage (PVL) occurred in four patients, and a second valve was required in two patients, resulting in a device success of 96.3%.
• New PPMI within 30 days was required in 11 patients (6.7%), all because of complete atrioventricular block; patients with baseline right bundle branch block (RBBB) had a higher incidence of new PPMI than did those without RBBB (23.8% vs. 4.2%; P < .001).
• Patients whose device was implanted inside the MS had a significantly lower incidence of new PPMI (overall 2.1% vs. 13.4%; P = .005); this finding was consistent in patients with baseline RBBB (6.7% vs. 66.7%; P = .004) or without RBBB (1.2% vs. 8.2%; P = .041).
• By 30 days, there was one death, which occurred as a result of bleeding in a patient with liver cirrhosis after a successful TAVR procedure; four patients experienced disabling strokes, and vascular complications developed in 16 patients.

IN PRACTICE:

The study demonstrated the “notable feasibility and safety” of TJ-ICE–guided TAVR, the authors write. They point to the “strong association of TAV position with new PPMI rate, which was clearly visualized by ICE during the procedure.”

In an accompanying editorial, Thomas Bartel, MD, PHD, Flexdoc Inc., Düsseldorf, Germany, noted that the study is the first to report a clinical benefit using a TJ-ICE approach, although barriers such as cost and lack of expertise could prevent interventional cardiologists from taking full advantage of ICE monitoring during TAVR, and further research is warranted.

Randomized and prospective trials comparing the accuracy, reproducibility, and outcomes of ICE guidance vs. guidance by transesophageal echocardiography, and pure fluoroscopy and angiography, “need to be performed before ICE imaging is adopted as the primary nonradiographic imaging modality for TAVR.”

SOURCE:

The study was carried out by Tsutomu Murakami, MD, department of cardiology, Tokai University, Isehara, Japan, and colleagues. It was published online in JACC: Asia.

LIMITATIONS:

The retrospective nonrandomized design has inherent limitations. The choice of intraprocedural imaging modality was decided based on heart team discussion, which may have introduced selection bias. Operators’ implantation skills could have influenced the results although most cases involved highly experienced board-certified operators. The limited number of subjects and the relatively low event rates preclude definitive conclusions.

DISCLOSURES:

Dr. Murakami has no relevant conflicts of interest; see paper for disclosures of other study authors. Dr. Bartel has no relevant conflicts of interest.

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

TOPLINE:

User-friendly transjugular intracardiac echocardiography (TJ-ICE)–guided transcatheter aortic valve replacement (TAVR) lowers the rate of atrioventricular block requiring permanent pacemaker implantation (PPMI) and has minimal complications, results of a new study suggest.

Researchers developed TJ-ICE–guided TAVR to facilitate implanting a heart valve at an optimal depth, guided by direct visualization of the membranous septum (MS) during the procedure.

METHODOLOGY:

• The single-center study included 163 patients with severe aortic stenosis (AS) from an ongoing registry, mean age 85 years, 71% women, and median Society of Thoracic Surgeons score of 6.3%, who underwent TAVR.
• The primary endpoint was the incidence at 30 days of PPMI; secondary endpoints included the feasibility of TJ-ICE–guided TAVR and safety, including complications related to TJ-ICE.

TAKEAWAY:

• Although all patients underwent valve placement in the proper anatomical location, moderate paravalvular leakage (PVL) occurred in four patients, and a second valve was required in two patients, resulting in a device success of 96.3%.
• New PPMI within 30 days was required in 11 patients (6.7%), all because of complete atrioventricular block; patients with baseline right bundle branch block (RBBB) had a higher incidence of new PPMI than did those without RBBB (23.8% vs. 4.2%; P < .001).
• Patients whose device was implanted inside the MS had a significantly lower incidence of new PPMI (overall 2.1% vs. 13.4%; P = .005); this finding was consistent in patients with baseline RBBB (6.7% vs. 66.7%; P = .004) or without RBBB (1.2% vs. 8.2%; P = .041).
• By 30 days, there was one death, which occurred as a result of bleeding in a patient with liver cirrhosis after a successful TAVR procedure; four patients experienced disabling strokes, and vascular complications developed in 16 patients.

IN PRACTICE:

The study demonstrated the “notable feasibility and safety” of TJ-ICE–guided TAVR, the authors write. They point to the “strong association of TAV position with new PPMI rate, which was clearly visualized by ICE during the procedure.”

In an accompanying editorial, Thomas Bartel, MD, PHD, Flexdoc Inc., Düsseldorf, Germany, noted that the study is the first to report a clinical benefit using a TJ-ICE approach, although barriers such as cost and lack of expertise could prevent interventional cardiologists from taking full advantage of ICE monitoring during TAVR, and further research is warranted.

Randomized and prospective trials comparing the accuracy, reproducibility, and outcomes of ICE guidance vs. guidance by transesophageal echocardiography, and pure fluoroscopy and angiography, “need to be performed before ICE imaging is adopted as the primary nonradiographic imaging modality for TAVR.”

SOURCE:

The study was carried out by Tsutomu Murakami, MD, department of cardiology, Tokai University, Isehara, Japan, and colleagues. It was published online in JACC: Asia.

LIMITATIONS:

The retrospective nonrandomized design has inherent limitations. The choice of intraprocedural imaging modality was decided based on heart team discussion, which may have introduced selection bias. Operators’ implantation skills could have influenced the results although most cases involved highly experienced board-certified operators. The limited number of subjects and the relatively low event rates preclude definitive conclusions.

DISCLOSURES:

Dr. Murakami has no relevant conflicts of interest; see paper for disclosures of other study authors. Dr. Bartel has no relevant conflicts of interest.

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

TOPLINE:

A topical fixed-dose combination of three approved acne treatments significantly improves moderate to severe acne with a strong safety profile.

METHODOLOGY:

• The two multicenter studies included 363 individuals aged 9 years and older with moderate to severe acne from 30 centers, including 15 in North America.
• Moderate to severe acne was defined as having 30-100 inflammatory lesions (papules, pustules, or nodules), 35-150 noninflammatory lesions (open or closed comedones), and at least two nodules.
• Participants were randomly assigned to receive treatment with a combination gel containing  phosphate 1.2%,  0.15%, and  3.1% (known as IDP-126) or a vehicle gel for once-daily application for 12 weeks.
• Treatment success was defined as a reduction of at least two grades from baseline on the Evaluator’s Global Severity Score (EGSS) and lesion counts of clear (0) or almost clear (1) at weeks 2, 4, 8, and 12.

TAKEAWAY:

• Treatment success occurred in 49.6% of the IDP-126 group, vs 24.9% of the vehicle group in study 1, and in 50.5% of the IDP-126 group, vs 20.5% of the vehicle group in study 2. Overall treatment compliance was 93.7% and 91.3% for studies 1 and 2, respectively (P < .01 for both).
• Patients in the IDP-126 groups for both studies 1 and 2 had significantly greater absolute mean reductions in both inflammatory and noninflammatory lesions from baseline to week 12 compared to the vehicle patients (P ≤ .001 for all).
• Significantly more patients in the IDP-126 group achieved a grade reduction of 2 or more in EGSS compared with those who received the vehicle, with treatment differences of approximately 32% in both studies. Changes in lesion reductions between the treatment and the vehicle groups were significantly greater as early as week 4.
• The most common treatment-related adverse events among patients treated with IDP-126 were erythema, application-site pain, dryness, irritation, and exfoliation. Discontinuation of the study drug as a result of adverse events occurred in 2.5% and 3.3% of these patients in studies 1 and 2, respectively.

IN PRACTICE:

“With its simple treatment regimen containing 3 recommended acne treatments (benzoyl peroxide, a topical retinoid, and a topical antibiotic), IDP-126 is a potential new treatment option for acne,” the researchers concluded.

SOURCE:

The study was led by Linda Stein Gold, MD, of Henry Ford Hospital, Detroit. The study was published online in the Journal of the American Academy of Dermatology.

LIMITATIONS:

In both studies, treatment duration was short, and the studies may not reflect patients’ real-world experiences. The results may be affected by interobserver bias or variation in assessment of acne severity.

DISCLOSURES:

Gold has served as investigator/consultant or speaker for Ortho Dermatologics, LEO Pharma, Dermavant, Incyte, Novartis, AbbVie, Pfizer, Sun Pharma, UCB, Arcutis, and Lilly. Other study coauthors have relationships with multiple companies, including Ortho Dermatologics, which provided medical writing support for the study.

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

TOPLINE:

A topical fixed-dose combination of three approved acne treatments significantly improves moderate to severe acne with a strong safety profile.

METHODOLOGY:

• The two multicenter studies included 363 individuals aged 9 years and older with moderate to severe acne from 30 centers, including 15 in North America.
• Moderate to severe acne was defined as having 30-100 inflammatory lesions (papules, pustules, or nodules), 35-150 noninflammatory lesions (open or closed comedones), and at least two nodules.
• Participants were randomly assigned to receive treatment with a combination gel containing  phosphate 1.2%,  0.15%, and  3.1% (known as IDP-126) or a vehicle gel for once-daily application for 12 weeks.
• Treatment success was defined as a reduction of at least two grades from baseline on the Evaluator’s Global Severity Score (EGSS) and lesion counts of clear (0) or almost clear (1) at weeks 2, 4, 8, and 12.

TAKEAWAY:

• Treatment success occurred in 49.6% of the IDP-126 group, vs 24.9% of the vehicle group in study 1, and in 50.5% of the IDP-126 group, vs 20.5% of the vehicle group in study 2. Overall treatment compliance was 93.7% and 91.3% for studies 1 and 2, respectively (P < .01 for both).
• Patients in the IDP-126 groups for both studies 1 and 2 had significantly greater absolute mean reductions in both inflammatory and noninflammatory lesions from baseline to week 12 compared to the vehicle patients (P ≤ .001 for all).
• Significantly more patients in the IDP-126 group achieved a grade reduction of 2 or more in EGSS compared with those who received the vehicle, with treatment differences of approximately 32% in both studies. Changes in lesion reductions between the treatment and the vehicle groups were significantly greater as early as week 4.
• The most common treatment-related adverse events among patients treated with IDP-126 were erythema, application-site pain, dryness, irritation, and exfoliation. Discontinuation of the study drug as a result of adverse events occurred in 2.5% and 3.3% of these patients in studies 1 and 2, respectively.

IN PRACTICE:

“With its simple treatment regimen containing 3 recommended acne treatments (benzoyl peroxide, a topical retinoid, and a topical antibiotic), IDP-126 is a potential new treatment option for acne,” the researchers concluded.

SOURCE:

The study was led by Linda Stein Gold, MD, of Henry Ford Hospital, Detroit. The study was published online in the Journal of the American Academy of Dermatology.

LIMITATIONS:

In both studies, treatment duration was short, and the studies may not reflect patients’ real-world experiences. The results may be affected by interobserver bias or variation in assessment of acne severity.

DISCLOSURES:

Gold has served as investigator/consultant or speaker for Ortho Dermatologics, LEO Pharma, Dermavant, Incyte, Novartis, AbbVie, Pfizer, Sun Pharma, UCB, Arcutis, and Lilly. Other study coauthors have relationships with multiple companies, including Ortho Dermatologics, which provided medical writing support for the study.

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

TOPLINE:

A topical fixed-dose combination of three approved acne treatments significantly improves moderate to severe acne with a strong safety profile.

METHODOLOGY:

• The two multicenter studies included 363 individuals aged 9 years and older with moderate to severe acne from 30 centers, including 15 in North America.
• Moderate to severe acne was defined as having 30-100 inflammatory lesions (papules, pustules, or nodules), 35-150 noninflammatory lesions (open or closed comedones), and at least two nodules.
• Participants were randomly assigned to receive treatment with a combination gel containing  phosphate 1.2%,  0.15%, and  3.1% (known as IDP-126) or a vehicle gel for once-daily application for 12 weeks.
• Treatment success was defined as a reduction of at least two grades from baseline on the Evaluator’s Global Severity Score (EGSS) and lesion counts of clear (0) or almost clear (1) at weeks 2, 4, 8, and 12.

TAKEAWAY:

• Treatment success occurred in 49.6% of the IDP-126 group, vs 24.9% of the vehicle group in study 1, and in 50.5% of the IDP-126 group, vs 20.5% of the vehicle group in study 2. Overall treatment compliance was 93.7% and 91.3% for studies 1 and 2, respectively (P < .01 for both).
• Patients in the IDP-126 groups for both studies 1 and 2 had significantly greater absolute mean reductions in both inflammatory and noninflammatory lesions from baseline to week 12 compared to the vehicle patients (P ≤ .001 for all).
• Significantly more patients in the IDP-126 group achieved a grade reduction of 2 or more in EGSS compared with those who received the vehicle, with treatment differences of approximately 32% in both studies. Changes in lesion reductions between the treatment and the vehicle groups were significantly greater as early as week 4.
• The most common treatment-related adverse events among patients treated with IDP-126 were erythema, application-site pain, dryness, irritation, and exfoliation. Discontinuation of the study drug as a result of adverse events occurred in 2.5% and 3.3% of these patients in studies 1 and 2, respectively.

IN PRACTICE:

“With its simple treatment regimen containing 3 recommended acne treatments (benzoyl peroxide, a topical retinoid, and a topical antibiotic), IDP-126 is a potential new treatment option for acne,” the researchers concluded.

SOURCE:

The study was led by Linda Stein Gold, MD, of Henry Ford Hospital, Detroit. The study was published online in the Journal of the American Academy of Dermatology.

LIMITATIONS:

In both studies, treatment duration was short, and the studies may not reflect patients’ real-world experiences. The results may be affected by interobserver bias or variation in assessment of acne severity.

DISCLOSURES:

Gold has served as investigator/consultant or speaker for Ortho Dermatologics, LEO Pharma, Dermavant, Incyte, Novartis, AbbVie, Pfizer, Sun Pharma, UCB, Arcutis, and Lilly. Other study coauthors have relationships with multiple companies, including Ortho Dermatologics, which provided medical writing support for the study.

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

Personal beliefs and health care system barriers contribute to inappropriate antibiotic use by patients, report researchers presenting results at an annual scientific meeting on infectious diseases.

Nonprescription antibiotic use includes accessing medication left over from a prior prescribed course, obtained from social networks, and purchased over-the-counter in other countries or illegally in stores and markets in the United States.

Overuse and misuse of antibiotics contributes to a growing threat of antimicrobial resistance, and it is tough to say how common it is, Lindsey A. Laytner, PhD, MPH, with Baylor College of Medicine, Houston, pointed out in her presentation.

“This is an understudied area. We don’t routinely collect these data, so we don’t actually know what the true prevalence is. The factors that contribute to this unsafe practice in the U.S. are also underexplored,” Dr. Laytner said.

To investigate, the researchers conducted in-depth interviews with 86 adults (median age, 49 years; 62% women) to identify patients’ motivations to use antibiotics without a prescription. All of them answered “yes” when asked in a previous survey whether they would use antibiotics without contacting a doctor, nurse, dentist, or clinic.

Dr. Laytner said several prominent themes emerged.

Nearly all interviewees reported nonprescription antibiotic use for symptoms that mostly do not warrant antibiotics. These included symptoms of COVID-19, influenza, and the common cold, as well as for pain management, allergies, and even wounds.
 

Ineffectively treating symptoms

Many felt they “knew their body, knew what they had, and knew how to treat themselves” without a health care provider, Dr. Laytner said.

They also felt the over-the-counter medicines “don’t always work and that antibiotics are like gold or this cure-all and because they are difficult to get a prescription for, they should be kept on hand,” she explained.

A variety of health care system barriers also contribute to inappropriate antibiotic use, including long wait times to schedule appointments and to see the doctor while at their appointments; high costs for clinic visits and prescriptions; and transportation issues.

Many patients opted to use nonprescription antibiotics out of “convenience,” Laytner added.

She explains that the findings could help inform community-level education efforts on inappropriate use of antibiotics and help shape policies to promote antibiotic stewardship.
 

Access to care, education

Commenting on the study, Emily Sydnor Spivak, MD, associate professor of medicine at University of Utah, Salt Lake City, said she “wasn’t totally surprised by the results, but found it very interesting how there was a theme of autonomy, or ‘I know my body,’ that seemed to drive patients to get antibiotics for relief of symptoms.”

“There is patient education that needs to happen about the role of antibiotics, how they act, and how they don’t actually provide symptom relief and have downsides and side effects,” said Dr. Spivak, who is also medical director of antimicrobial stewardship programs at University of Utah Health and VA Salt Lake City Health Care System.

“Given the lack of access to health care as a reason some patients use nonprescription antibiotics, we need to think about access to the health care system and process changes and policy changes to allow better access. Without better access or interaction with the health care system, we can’t educate patients,” Dr. Spivak said.

The study had no commercial funding. Dr. Laytner and Dr. Spivak report no relevant financial disclosures.

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

Personal beliefs and health care system barriers contribute to inappropriate antibiotic use by patients, report researchers presenting results at an annual scientific meeting on infectious diseases.

Nonprescription antibiotic use includes accessing medication left over from a prior prescribed course, obtained from social networks, and purchased over-the-counter in other countries or illegally in stores and markets in the United States.

Overuse and misuse of antibiotics contributes to a growing threat of antimicrobial resistance, and it is tough to say how common it is, Lindsey A. Laytner, PhD, MPH, with Baylor College of Medicine, Houston, pointed out in her presentation.

“This is an understudied area. We don’t routinely collect these data, so we don’t actually know what the true prevalence is. The factors that contribute to this unsafe practice in the U.S. are also underexplored,” Dr. Laytner said.

To investigate, the researchers conducted in-depth interviews with 86 adults (median age, 49 years; 62% women) to identify patients’ motivations to use antibiotics without a prescription. All of them answered “yes” when asked in a previous survey whether they would use antibiotics without contacting a doctor, nurse, dentist, or clinic.

Dr. Laytner said several prominent themes emerged.

Nearly all interviewees reported nonprescription antibiotic use for symptoms that mostly do not warrant antibiotics. These included symptoms of COVID-19, influenza, and the common cold, as well as for pain management, allergies, and even wounds.
 

Ineffectively treating symptoms

Many felt they “knew their body, knew what they had, and knew how to treat themselves” without a health care provider, Dr. Laytner said.

They also felt the over-the-counter medicines “don’t always work and that antibiotics are like gold or this cure-all and because they are difficult to get a prescription for, they should be kept on hand,” she explained.

A variety of health care system barriers also contribute to inappropriate antibiotic use, including long wait times to schedule appointments and to see the doctor while at their appointments; high costs for clinic visits and prescriptions; and transportation issues.

Many patients opted to use nonprescription antibiotics out of “convenience,” Laytner added.

She explains that the findings could help inform community-level education efforts on inappropriate use of antibiotics and help shape policies to promote antibiotic stewardship.
 

Access to care, education

Commenting on the study, Emily Sydnor Spivak, MD, associate professor of medicine at University of Utah, Salt Lake City, said she “wasn’t totally surprised by the results, but found it very interesting how there was a theme of autonomy, or ‘I know my body,’ that seemed to drive patients to get antibiotics for relief of symptoms.”

“There is patient education that needs to happen about the role of antibiotics, how they act, and how they don’t actually provide symptom relief and have downsides and side effects,” said Dr. Spivak, who is also medical director of antimicrobial stewardship programs at University of Utah Health and VA Salt Lake City Health Care System.

“Given the lack of access to health care as a reason some patients use nonprescription antibiotics, we need to think about access to the health care system and process changes and policy changes to allow better access. Without better access or interaction with the health care system, we can’t educate patients,” Dr. Spivak said.

The study had no commercial funding. Dr. Laytner and Dr. Spivak report no relevant financial disclosures.

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

Personal beliefs and health care system barriers contribute to inappropriate antibiotic use by patients, report researchers presenting results at an annual scientific meeting on infectious diseases.

Nonprescription antibiotic use includes accessing medication left over from a prior prescribed course, obtained from social networks, and purchased over-the-counter in other countries or illegally in stores and markets in the United States.

Overuse and misuse of antibiotics contributes to a growing threat of antimicrobial resistance, and it is tough to say how common it is, Lindsey A. Laytner, PhD, MPH, with Baylor College of Medicine, Houston, pointed out in her presentation.

“This is an understudied area. We don’t routinely collect these data, so we don’t actually know what the true prevalence is. The factors that contribute to this unsafe practice in the U.S. are also underexplored,” Dr. Laytner said.

To investigate, the researchers conducted in-depth interviews with 86 adults (median age, 49 years; 62% women) to identify patients’ motivations to use antibiotics without a prescription. All of them answered “yes” when asked in a previous survey whether they would use antibiotics without contacting a doctor, nurse, dentist, or clinic.

Dr. Laytner said several prominent themes emerged.

Nearly all interviewees reported nonprescription antibiotic use for symptoms that mostly do not warrant antibiotics. These included symptoms of COVID-19, influenza, and the common cold, as well as for pain management, allergies, and even wounds.
 

Ineffectively treating symptoms

Many felt they “knew their body, knew what they had, and knew how to treat themselves” without a health care provider, Dr. Laytner said.

They also felt the over-the-counter medicines “don’t always work and that antibiotics are like gold or this cure-all and because they are difficult to get a prescription for, they should be kept on hand,” she explained.

A variety of health care system barriers also contribute to inappropriate antibiotic use, including long wait times to schedule appointments and to see the doctor while at their appointments; high costs for clinic visits and prescriptions; and transportation issues.

Many patients opted to use nonprescription antibiotics out of “convenience,” Laytner added.

She explains that the findings could help inform community-level education efforts on inappropriate use of antibiotics and help shape policies to promote antibiotic stewardship.
 

Access to care, education

Commenting on the study, Emily Sydnor Spivak, MD, associate professor of medicine at University of Utah, Salt Lake City, said she “wasn’t totally surprised by the results, but found it very interesting how there was a theme of autonomy, or ‘I know my body,’ that seemed to drive patients to get antibiotics for relief of symptoms.”

“There is patient education that needs to happen about the role of antibiotics, how they act, and how they don’t actually provide symptom relief and have downsides and side effects,” said Dr. Spivak, who is also medical director of antimicrobial stewardship programs at University of Utah Health and VA Salt Lake City Health Care System.

“Given the lack of access to health care as a reason some patients use nonprescription antibiotics, we need to think about access to the health care system and process changes and policy changes to allow better access. Without better access or interaction with the health care system, we can’t educate patients,” Dr. Spivak said.

The study had no commercial funding. Dr. Laytner and Dr. Spivak report no relevant financial disclosures.

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

This transcript has been edited for clarity.

I had a case come to me of a 32-year-old resident who works in a hospital near where I am and was very interested in freezing her eggs. She wasn’t married and was getting worried that maybe she wouldn’t have a partner soon. She was also getting worried that the potential ability of her eggs to be fertilized would begin to decline, which is a phenomenon that does occur with age. She thought, I’m 32; maybe I should freeze my eggs now, as it’s better than to try freezing them when I’m 35 or 37. The potency may be far less.

There are many programs out there now. There have been academic programs for a long time that have been doing egg freezing, and there are many children who have been born successfully. However, it’s also true that people freeze their eggs when they’re 40 years old, and the likelihood of their “working,” if you will, is far less. I wouldn’t say it’s impossible, but age matters. This medical resident knew that and she decided to look into egg freezing.

Well, it turned out that egg freezing is not something that her student insurance plan – or most insurance plans in general – covers. The opportunity to do this is probably going to cost her about $10,000. There are many new egg-freezing infertility programs that have stared up that aren’t part of hospitals. There are clinics that are run for profit. They sometimes encourage women to freeze their eggs.

The student resident quickly found out that there were companies near her who would do egg freezing but would cut a deal if she agreed to take drugs to super-ovulate, make a large number of eggs, and they would be procured if she agreed to give half of them to other women who needed eggs for their infertility treatment. She could keep half and she could get very discounted treatment of egg freezing. In other words, she could barter her own eggs, said the clinic, if she was willing to accept the idea that she’d be donating them to others.

That may be a deal that she’s going to accept. She doesn’t have a path forward. She’s worried about freezing her eggs right now. But there are many ethical considerations that really have to be thought through here.

First and foremost, she’s giving eggs to others. They’re going to use them to try to make children. They can’t make their own eggs, for some reason. She’s going to have some biologically related kids out there. It used to be that you could say to someone who donated sperm or eggs that this will be anonymous.

But in today’s day and age with 23andMe, Ancestry, and better genetic testing, there’s a pretty good likelihood that somebody is going to find out that the person they thought was their biological mom isn’t, and they have someone out there who was the person who, in this case, donated an egg.

Is she willing to risk having that connection, that contact, to have someone enter her life in the future? It’s a situation where she’s donating the eggs, but I’ll tell you that the clinic is going to make far more money using the donated eggs, probably getting $10,000 or $15,000 a cycle with people who are trying to have a child. They’ll make much more money than she’s going to get by donating.

She may get a $5,000 discount, if you will, but the clinic has a business interest. The more they get women involved in bartering their eggs, the more they’re going to profit. In a sense, she’s being coerced, perhaps – I’m going to put it glibly – to sell cheaply. She probably is getting undervalue, even though she needs a path to do this egg freezing.

The other big issue is that we don’t know that egg freezing is going to work for her until someone tries to use those eggs. She may have her own infertility problem not due to age but to other things. Approximately 8%-9% of couples do have infertility problems, sometimes related to gametes. She may never get a partner. Maybe she doesn’t want to use these eggs on her own as a single mom. All of these issues have to be talked through.

What really troubles me here is not so much that someone would choose to barter their eggs, but that they don’t get counseling. They don’t get independent advice about thinking this all through. It’s turning into a business. A business has a commodity – her eggs – that they want. She’s getting more and more desperate, willing to cut a deal to get where she needs to be, but perhaps is not really thinking through all of the ethical dimensions that bartering or trading one’s eggs in order to gain access to freezing entails.

We have to set up a system where there’s independent advice and independent counseling; otherwise, I think we’re closer to exploitation.

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

Dr. Caplan is director, division of medical ethics, New York University Langone Medical Center, New York. He has served as a director, officer, partner, employee, advisor, consultant, or trustee for Johnson & Johnson’s Panel for Compassionate Drug Use.

This transcript has been edited for clarity.

I had a case come to me of a 32-year-old resident who works in a hospital near where I am and was very interested in freezing her eggs. She wasn’t married and was getting worried that maybe she wouldn’t have a partner soon. She was also getting worried that the potential ability of her eggs to be fertilized would begin to decline, which is a phenomenon that does occur with age. She thought, I’m 32; maybe I should freeze my eggs now, as it’s better than to try freezing them when I’m 35 or 37. The potency may be far less.

There are many programs out there now. There have been academic programs for a long time that have been doing egg freezing, and there are many children who have been born successfully. However, it’s also true that people freeze their eggs when they’re 40 years old, and the likelihood of their “working,” if you will, is far less. I wouldn’t say it’s impossible, but age matters. This medical resident knew that and she decided to look into egg freezing.

Well, it turned out that egg freezing is not something that her student insurance plan – or most insurance plans in general – covers. The opportunity to do this is probably going to cost her about $10,000. There are many new egg-freezing infertility programs that have stared up that aren’t part of hospitals. There are clinics that are run for profit. They sometimes encourage women to freeze their eggs.

The student resident quickly found out that there were companies near her who would do egg freezing but would cut a deal if she agreed to take drugs to super-ovulate, make a large number of eggs, and they would be procured if she agreed to give half of them to other women who needed eggs for their infertility treatment. She could keep half and she could get very discounted treatment of egg freezing. In other words, she could barter her own eggs, said the clinic, if she was willing to accept the idea that she’d be donating them to others.

That may be a deal that she’s going to accept. She doesn’t have a path forward. She’s worried about freezing her eggs right now. But there are many ethical considerations that really have to be thought through here.

First and foremost, she’s giving eggs to others. They’re going to use them to try to make children. They can’t make their own eggs, for some reason. She’s going to have some biologically related kids out there. It used to be that you could say to someone who donated sperm or eggs that this will be anonymous.

But in today’s day and age with 23andMe, Ancestry, and better genetic testing, there’s a pretty good likelihood that somebody is going to find out that the person they thought was their biological mom isn’t, and they have someone out there who was the person who, in this case, donated an egg.

Is she willing to risk having that connection, that contact, to have someone enter her life in the future? It’s a situation where she’s donating the eggs, but I’ll tell you that the clinic is going to make far more money using the donated eggs, probably getting $10,000 or $15,000 a cycle with people who are trying to have a child. They’ll make much more money than she’s going to get by donating.

She may get a $5,000 discount, if you will, but the clinic has a business interest. The more they get women involved in bartering their eggs, the more they’re going to profit. In a sense, she’s being coerced, perhaps – I’m going to put it glibly – to sell cheaply. She probably is getting undervalue, even though she needs a path to do this egg freezing.

The other big issue is that we don’t know that egg freezing is going to work for her until someone tries to use those eggs. She may have her own infertility problem not due to age but to other things. Approximately 8%-9% of couples do have infertility problems, sometimes related to gametes. She may never get a partner. Maybe she doesn’t want to use these eggs on her own as a single mom. All of these issues have to be talked through.

What really troubles me here is not so much that someone would choose to barter their eggs, but that they don’t get counseling. They don’t get independent advice about thinking this all through. It’s turning into a business. A business has a commodity – her eggs – that they want. She’s getting more and more desperate, willing to cut a deal to get where she needs to be, but perhaps is not really thinking through all of the ethical dimensions that bartering or trading one’s eggs in order to gain access to freezing entails.

We have to set up a system where there’s independent advice and independent counseling; otherwise, I think we’re closer to exploitation.

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

Dr. Caplan is director, division of medical ethics, New York University Langone Medical Center, New York. He has served as a director, officer, partner, employee, advisor, consultant, or trustee for Johnson & Johnson’s Panel for Compassionate Drug Use.

This transcript has been edited for clarity.

I had a case come to me of a 32-year-old resident who works in a hospital near where I am and was very interested in freezing her eggs. She wasn’t married and was getting worried that maybe she wouldn’t have a partner soon. She was also getting worried that the potential ability of her eggs to be fertilized would begin to decline, which is a phenomenon that does occur with age. She thought, I’m 32; maybe I should freeze my eggs now, as it’s better than to try freezing them when I’m 35 or 37. The potency may be far less.

There are many programs out there now. There have been academic programs for a long time that have been doing egg freezing, and there are many children who have been born successfully. However, it’s also true that people freeze their eggs when they’re 40 years old, and the likelihood of their “working,” if you will, is far less. I wouldn’t say it’s impossible, but age matters. This medical resident knew that and she decided to look into egg freezing.

Well, it turned out that egg freezing is not something that her student insurance plan – or most insurance plans in general – covers. The opportunity to do this is probably going to cost her about $10,000. There are many new egg-freezing infertility programs that have stared up that aren’t part of hospitals. There are clinics that are run for profit. They sometimes encourage women to freeze their eggs.

The student resident quickly found out that there were companies near her who would do egg freezing but would cut a deal if she agreed to take drugs to super-ovulate, make a large number of eggs, and they would be procured if she agreed to give half of them to other women who needed eggs for their infertility treatment. She could keep half and she could get very discounted treatment of egg freezing. In other words, she could barter her own eggs, said the clinic, if she was willing to accept the idea that she’d be donating them to others.

That may be a deal that she’s going to accept. She doesn’t have a path forward. She’s worried about freezing her eggs right now. But there are many ethical considerations that really have to be thought through here.

First and foremost, she’s giving eggs to others. They’re going to use them to try to make children. They can’t make their own eggs, for some reason. She’s going to have some biologically related kids out there. It used to be that you could say to someone who donated sperm or eggs that this will be anonymous.

But in today’s day and age with 23andMe, Ancestry, and better genetic testing, there’s a pretty good likelihood that somebody is going to find out that the person they thought was their biological mom isn’t, and they have someone out there who was the person who, in this case, donated an egg.

Is she willing to risk having that connection, that contact, to have someone enter her life in the future? It’s a situation where she’s donating the eggs, but I’ll tell you that the clinic is going to make far more money using the donated eggs, probably getting $10,000 or $15,000 a cycle with people who are trying to have a child. They’ll make much more money than she’s going to get by donating.

She may get a $5,000 discount, if you will, but the clinic has a business interest. The more they get women involved in bartering their eggs, the more they’re going to profit. In a sense, she’s being coerced, perhaps – I’m going to put it glibly – to sell cheaply. She probably is getting undervalue, even though she needs a path to do this egg freezing.

The other big issue is that we don’t know that egg freezing is going to work for her until someone tries to use those eggs. She may have her own infertility problem not due to age but to other things. Approximately 8%-9% of couples do have infertility problems, sometimes related to gametes. She may never get a partner. Maybe she doesn’t want to use these eggs on her own as a single mom. All of these issues have to be talked through.

What really troubles me here is not so much that someone would choose to barter their eggs, but that they don’t get counseling. They don’t get independent advice about thinking this all through. It’s turning into a business. A business has a commodity – her eggs – that they want. She’s getting more and more desperate, willing to cut a deal to get where she needs to be, but perhaps is not really thinking through all of the ethical dimensions that bartering or trading one’s eggs in order to gain access to freezing entails.

We have to set up a system where there’s independent advice and independent counseling; otherwise, I think we’re closer to exploitation.

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

Dr. Caplan is director, division of medical ethics, New York University Langone Medical Center, New York. He has served as a director, officer, partner, employee, advisor, consultant, or trustee for Johnson & Johnson’s Panel for Compassionate Drug Use.

According to research results published in the American Journal of Obstetrics and Gynecology, consuming a primarily plant-based diet is associated with a lower risk of developing hypertensive disorders of pregnancy.
 

The prospective cohort study followed 11,459 women older than 18 years and evaluated their diet from the beginning using a validated questionnaire about the frequency and quality of plant-based foods. The participants had taken part in the Nurses’ Health Study II (1991-2009). From responses on the questionnaire, the investigators calculated the plant-based diet index (PDI) even among participants with an omnivorous diet. A higher score indicated greater adherence to the PDI.

“We wanted to know how one’s diet leading up to pregnancy influences the pregnancy, so we monitored women for virtually their entire reproductive life – almost 20 years – and gained an awareness of their typical diet before pregnancy,” study author Jorge E. Chavarro, MD, ScD, told this news organization. Dr. Chavarro is a professor of nutrition, epidemiology, and medicine at Harvard Medical School, Boston, and Harvard University’s School of Public Health in Cambridge, Mass. He researches how nutrition and lifestyle influence reproductive health and overall lifelong health in women.

Analysis of the data from the Nurses’ Health Study II revealed that as the proportion of animal products in diets decreased and the proportion of plant-based products increased, the risk of women experiencing hypertensive disorders of pregnancy decreased as well. Women in the highest PDI quintile had a significantly lower risk of hypertensive disorders of pregnancy, in comparison with those in the lowest quintile (relative risk, 0.76). This association was slightly stronger for pregnancy-related hypertension (RR, 0.77) than for preeclampsia (RR, 0.80).

Women in the highest PDI quintile had a 24% lower risk of hypertensive disorders of pregnancy than those in the lowest quintile; the risk of pregnancy-related hypertension decreased in a linear fashion as PDI increased, while the relationship of PDI to preeclampsia was restricted to women in the quintile with the highest adherence.

“It was clearer for pregnancy-related hypertension than for preeclampsia, but a diet made up primarily of plant-based foods seemed to be protective for both,” said Dr. Chavarro. He added that in addition to the problems these conditions cause during pregnancy, both increase the risk of subsequently developing other chronic diseases. “Could it be that modifiable lifestyle factors before and during pregnancy may not only help reduce problems during gestation but also prevent women’s health problems years later? That was the general motivation for this study.”

Mercedes Sotos-Prieto, PhD, a researcher at the Autonomous University of Madrid and an associate professor at Harvard University’s School of Public Health, told this news organization that the study’s methodology was very robust and that the investigators utilized appropriate statistical techniques for the analysis. She highlighted the fact that they used a validated food frequency questionnaire. She believes the study is also important because of the population group it focused on. “There has always been greater resistance when it comes to the diet of pregnant women, and the same is true for older adults. But we have seen that this type of diet, if it’s a quality diet, may be associated with health benefits.” She did not participate in the study.

Dr. Sotos-Prieto has a doctorate in nutritional epidemiology and public health. She works with large epidemiologic cohorts, such as the cohort of American nurses on which this study was based, and ENRICA, a cohort that is representative of the Spanish population and the population of older adults. She is the author of other studies that, like this one, found an association between a plant-based diet and a lower risk of frailty, both in the study involving American nurses and in a study involving a cohort of individuals aged 60 years or older in Spain (ENRICA-1).

Dr. Sotos-Prieto is also principal investigator on a project assessing the risk of cardiovascular disease based on modifiable lifestyles. For this project, the researchers created a tool, the healthy heart test, that can be used to evaluate diet quality “in 5 minutes, because we all know that doctors don’t have any time.” She thinks this test could be implemented in clinical practice to identify lifestyle behaviors that can be improved, such as by replacing refined cereals with whole grains or increasing legume consumption.
 

Tomatoes and French fries

The greatest benefit of a plant-based diet comes from the diet overall, not from any single food item. That said, these studies use a scoring system to reflect which items are healthy and which are not.

Diet was assessed every 4 years, starting in 1991, using a semiquantitative food frequency questionnaire that recorded the consumption of 131 foods and drinks during the previous year. The researchers determined the average frequency with which participants consumed each food. Eighteen food groups were sorted into three categories: healthy plant-based foods (whole grains, fruits, vegetables, nuts, legumes, vegetable oils, tea, and coffee), unhealthy plant-based foods (fruit juices, refined grains, potatoes, sugary drinks, sweets, and desserts), and animal-based foods (dairy, eggs, fish or shellfish, meat, and various foods of animal origin).

Healthy plant-based foods were given positive scores, while less healthy plant-based foods and the animal-based food groups were given negative scores. The consumption of each food group was classified into PDI using quintiles.

Women in the highest PDI quintile had a significantly lower risk for hypertensive disorders of pregnancy, compared with women in the lowest quintile. There was a negative dose-response relationship between PDI and risk of the disease. “A vegetarian diet isn’t necessarily healthier than a nonvegetarian diet if it’s made up of superfluous foods like French fries and soft drinks,” said Dr. Sotos-Prieto. “The difference lies in the quality of the plant-based foods. That’s what makes the difference between a healthy and an unhealthy diet.”
 

Give up meat?

Dr. Chavarro said that removing meat from his dinner menu 22 years ago was one of the hardest things he ever did. “Now, it’s no problem,” he said. But he understands that there are people for whom changing the diet by replacing animal products with nonanimal products is difficult. But meat need not be entirely abandoned.

“The women in the highest quintile aren’t necessarily vegetarian or vegan, but they consume much fewer animal-based foods than the others,” he noted. He added that vegetarian or vegan diets are not incompatible with a healthy pregnancy. “All vegans know how to get vitamin B12 from supplements.”
 

Diet or weight loss?

Much of the benefit observed in the study appears to be related to better weight control. The body mass index between dietary assessment and pregnancy accounted for 39% of the relationship between PDI and hypertensive disorders of pregnancy and 48% of the relationship between PDI and pregnancy-related hypertension.

“Part of the association seems to be explained by better weight control over long periods,” explained Dr. Chavarro. Women who adopted diets with more plant-based foods gained weight more slowly than those who consumed more animal-based foods. “They are different in terms of their weight trajectory over many years. So, part of the association that we observe is related to better long-term weight control. But the other half of the association is attributable to the diet itself and not necessarily to weight.” The authors suggest mechanisms of action such as endothelial dysfunction, inflammation, or blood pressure before pregnancy to explain the association.

Dr. Sotos-Prieto believes that this point is “extremely relevant.” In her opinion, it reveals that controlling weight at the start of pregnancy is important for pregnant women. Weight control may also improve other factors, like gestational diabetes. “I think preventive measures should focus on that. These results show that interventions are needed to increase the likelihood of going into pregnancy with an appropriate weight. And this includes modifying diet.”
 

Generalizable results?

More than 90% of the participants in the Nurses’ Health Study were White, not Hispanic. Can the results be extrapolated to other populations? “The answer: The study needs to be repeated in other populations,” said Dr. Chavarro, “and that’s going to take time. But even without that information, I think we can use this study to inform other populations, regardless of ethnicity.”

Dr. Sotos-Prieto admitted that this hypothesis has not yet been tested in the Spanish population, but she is the author of a similar study that followed nearly 12,000 Spanish adults for a decade using the same PDI. In this study, every 10-point increase in PDI was associated with a 14% lower risk of mortality from any cause (hazard ratio, 0.86) and a 37% lower risk of death from cardiovascular disease (HR, 0.63). She also believes that the recommendations derived from the study could be generalized to other populations “as long as each country’s culture is taken into account, to see how it can be culturally adapted. If it’s a population that consumes a lot of refined cereals, for example, make small changes to whole grains.”
 

Weighing the evidence

The study has strengths and limitations, owing to its methodology, and Dr. Chavarro himself recognizes that “in terms of hypertensive disorders of pregnancy specifically, this won’t be the last word.” But there is a pressing need to find answers.

The American College of Obstetricians and Gynecologists and the World Health Organization encourage women to follow healthy diets before and during pregnancy. But they provide little guidance on what constitutes a healthy diet when it comes to minimizing the risks of adverse pregnancy outcomes. “They are quite ambiguous and vague,” said Dr. Chavarro.

These new findings suggest that plant-based diets may be one such strategy, particularly because some evidence was found that these diets may be beneficial for women older than 35 years, who are considered a high-risk group.

“There are certainly many ways to eat healthily, but if we think about these pregnancy complications that can have serious consequences for the mother and the fetus, we might consider this as a healthy diet option,” Dr. Chavarro noted.

But is the evidence robust enough to recommend that patients make changes? “Ideally, there will be more studies,” stated Dr. Chavarro. “There are two ways to understand the problem. One is not making recommendations until you have three controlled clinical trials, which, even with the willingness and funding to do so, will take 15-20 years. But if we have to provide the best available information to those who need it today, I think these are solid results for guiding behavior.

“It’s always better if we can make decisions based on solid, incontrovertible information. But it’s not always available, and you must learn to live in both worlds and make decisions with uncertainties,” he concluded.

Dr. Sotos-Prieto and Dr. Chavarro have disclosed no relevant financial relationships.

This article was translated from the Medscape Spanish Edition. A version of this article first appeared on Medscape.com.

According to research results published in the American Journal of Obstetrics and Gynecology, consuming a primarily plant-based diet is associated with a lower risk of developing hypertensive disorders of pregnancy.
 

The prospective cohort study followed 11,459 women older than 18 years and evaluated their diet from the beginning using a validated questionnaire about the frequency and quality of plant-based foods. The participants had taken part in the Nurses’ Health Study II (1991-2009). From responses on the questionnaire, the investigators calculated the plant-based diet index (PDI) even among participants with an omnivorous diet. A higher score indicated greater adherence to the PDI.

“We wanted to know how one’s diet leading up to pregnancy influences the pregnancy, so we monitored women for virtually their entire reproductive life – almost 20 years – and gained an awareness of their typical diet before pregnancy,” study author Jorge E. Chavarro, MD, ScD, told this news organization. Dr. Chavarro is a professor of nutrition, epidemiology, and medicine at Harvard Medical School, Boston, and Harvard University’s School of Public Health in Cambridge, Mass. He researches how nutrition and lifestyle influence reproductive health and overall lifelong health in women.

Analysis of the data from the Nurses’ Health Study II revealed that as the proportion of animal products in diets decreased and the proportion of plant-based products increased, the risk of women experiencing hypertensive disorders of pregnancy decreased as well. Women in the highest PDI quintile had a significantly lower risk of hypertensive disorders of pregnancy, in comparison with those in the lowest quintile (relative risk, 0.76). This association was slightly stronger for pregnancy-related hypertension (RR, 0.77) than for preeclampsia (RR, 0.80).

Women in the highest PDI quintile had a 24% lower risk of hypertensive disorders of pregnancy than those in the lowest quintile; the risk of pregnancy-related hypertension decreased in a linear fashion as PDI increased, while the relationship of PDI to preeclampsia was restricted to women in the quintile with the highest adherence.

“It was clearer for pregnancy-related hypertension than for preeclampsia, but a diet made up primarily of plant-based foods seemed to be protective for both,” said Dr. Chavarro. He added that in addition to the problems these conditions cause during pregnancy, both increase the risk of subsequently developing other chronic diseases. “Could it be that modifiable lifestyle factors before and during pregnancy may not only help reduce problems during gestation but also prevent women’s health problems years later? That was the general motivation for this study.”

Mercedes Sotos-Prieto, PhD, a researcher at the Autonomous University of Madrid and an associate professor at Harvard University’s School of Public Health, told this news organization that the study’s methodology was very robust and that the investigators utilized appropriate statistical techniques for the analysis. She highlighted the fact that they used a validated food frequency questionnaire. She believes the study is also important because of the population group it focused on. “There has always been greater resistance when it comes to the diet of pregnant women, and the same is true for older adults. But we have seen that this type of diet, if it’s a quality diet, may be associated with health benefits.” She did not participate in the study.

Dr. Sotos-Prieto has a doctorate in nutritional epidemiology and public health. She works with large epidemiologic cohorts, such as the cohort of American nurses on which this study was based, and ENRICA, a cohort that is representative of the Spanish population and the population of older adults. She is the author of other studies that, like this one, found an association between a plant-based diet and a lower risk of frailty, both in the study involving American nurses and in a study involving a cohort of individuals aged 60 years or older in Spain (ENRICA-1).

Dr. Sotos-Prieto is also principal investigator on a project assessing the risk of cardiovascular disease based on modifiable lifestyles. For this project, the researchers created a tool, the healthy heart test, that can be used to evaluate diet quality “in 5 minutes, because we all know that doctors don’t have any time.” She thinks this test could be implemented in clinical practice to identify lifestyle behaviors that can be improved, such as by replacing refined cereals with whole grains or increasing legume consumption.
 

Tomatoes and French fries

The greatest benefit of a plant-based diet comes from the diet overall, not from any single food item. That said, these studies use a scoring system to reflect which items are healthy and which are not.

Diet was assessed every 4 years, starting in 1991, using a semiquantitative food frequency questionnaire that recorded the consumption of 131 foods and drinks during the previous year. The researchers determined the average frequency with which participants consumed each food. Eighteen food groups were sorted into three categories: healthy plant-based foods (whole grains, fruits, vegetables, nuts, legumes, vegetable oils, tea, and coffee), unhealthy plant-based foods (fruit juices, refined grains, potatoes, sugary drinks, sweets, and desserts), and animal-based foods (dairy, eggs, fish or shellfish, meat, and various foods of animal origin).

Healthy plant-based foods were given positive scores, while less healthy plant-based foods and the animal-based food groups were given negative scores. The consumption of each food group was classified into PDI using quintiles.

Women in the highest PDI quintile had a significantly lower risk for hypertensive disorders of pregnancy, compared with women in the lowest quintile. There was a negative dose-response relationship between PDI and risk of the disease. “A vegetarian diet isn’t necessarily healthier than a nonvegetarian diet if it’s made up of superfluous foods like French fries and soft drinks,” said Dr. Sotos-Prieto. “The difference lies in the quality of the plant-based foods. That’s what makes the difference between a healthy and an unhealthy diet.”
 

Give up meat?

Dr. Chavarro said that removing meat from his dinner menu 22 years ago was one of the hardest things he ever did. “Now, it’s no problem,” he said. But he understands that there are people for whom changing the diet by replacing animal products with nonanimal products is difficult. But meat need not be entirely abandoned.

“The women in the highest quintile aren’t necessarily vegetarian or vegan, but they consume much fewer animal-based foods than the others,” he noted. He added that vegetarian or vegan diets are not incompatible with a healthy pregnancy. “All vegans know how to get vitamin B12 from supplements.”
 

Diet or weight loss?

Much of the benefit observed in the study appears to be related to better weight control. The body mass index between dietary assessment and pregnancy accounted for 39% of the relationship between PDI and hypertensive disorders of pregnancy and 48% of the relationship between PDI and pregnancy-related hypertension.

“Part of the association seems to be explained by better weight control over long periods,” explained Dr. Chavarro. Women who adopted diets with more plant-based foods gained weight more slowly than those who consumed more animal-based foods. “They are different in terms of their weight trajectory over many years. So, part of the association that we observe is related to better long-term weight control. But the other half of the association is attributable to the diet itself and not necessarily to weight.” The authors suggest mechanisms of action such as endothelial dysfunction, inflammation, or blood pressure before pregnancy to explain the association.

Dr. Sotos-Prieto believes that this point is “extremely relevant.” In her opinion, it reveals that controlling weight at the start of pregnancy is important for pregnant women. Weight control may also improve other factors, like gestational diabetes. “I think preventive measures should focus on that. These results show that interventions are needed to increase the likelihood of going into pregnancy with an appropriate weight. And this includes modifying diet.”
 

Generalizable results?

More than 90% of the participants in the Nurses’ Health Study were White, not Hispanic. Can the results be extrapolated to other populations? “The answer: The study needs to be repeated in other populations,” said Dr. Chavarro, “and that’s going to take time. But even without that information, I think we can use this study to inform other populations, regardless of ethnicity.”

Dr. Sotos-Prieto admitted that this hypothesis has not yet been tested in the Spanish population, but she is the author of a similar study that followed nearly 12,000 Spanish adults for a decade using the same PDI. In this study, every 10-point increase in PDI was associated with a 14% lower risk of mortality from any cause (hazard ratio, 0.86) and a 37% lower risk of death from cardiovascular disease (HR, 0.63). She also believes that the recommendations derived from the study could be generalized to other populations “as long as each country’s culture is taken into account, to see how it can be culturally adapted. If it’s a population that consumes a lot of refined cereals, for example, make small changes to whole grains.”
 

Weighing the evidence

The study has strengths and limitations, owing to its methodology, and Dr. Chavarro himself recognizes that “in terms of hypertensive disorders of pregnancy specifically, this won’t be the last word.” But there is a pressing need to find answers.

The American College of Obstetricians and Gynecologists and the World Health Organization encourage women to follow healthy diets before and during pregnancy. But they provide little guidance on what constitutes a healthy diet when it comes to minimizing the risks of adverse pregnancy outcomes. “They are quite ambiguous and vague,” said Dr. Chavarro.

These new findings suggest that plant-based diets may be one such strategy, particularly because some evidence was found that these diets may be beneficial for women older than 35 years, who are considered a high-risk group.

“There are certainly many ways to eat healthily, but if we think about these pregnancy complications that can have serious consequences for the mother and the fetus, we might consider this as a healthy diet option,” Dr. Chavarro noted.

But is the evidence robust enough to recommend that patients make changes? “Ideally, there will be more studies,” stated Dr. Chavarro. “There are two ways to understand the problem. One is not making recommendations until you have three controlled clinical trials, which, even with the willingness and funding to do so, will take 15-20 years. But if we have to provide the best available information to those who need it today, I think these are solid results for guiding behavior.

“It’s always better if we can make decisions based on solid, incontrovertible information. But it’s not always available, and you must learn to live in both worlds and make decisions with uncertainties,” he concluded.

Dr. Sotos-Prieto and Dr. Chavarro have disclosed no relevant financial relationships.

This article was translated from the Medscape Spanish Edition. A version of this article first appeared on Medscape.com.

According to research results published in the American Journal of Obstetrics and Gynecology, consuming a primarily plant-based diet is associated with a lower risk of developing hypertensive disorders of pregnancy.
 

The prospective cohort study followed 11,459 women older than 18 years and evaluated their diet from the beginning using a validated questionnaire about the frequency and quality of plant-based foods. The participants had taken part in the Nurses’ Health Study II (1991-2009). From responses on the questionnaire, the investigators calculated the plant-based diet index (PDI) even among participants with an omnivorous diet. A higher score indicated greater adherence to the PDI.

“We wanted to know how one’s diet leading up to pregnancy influences the pregnancy, so we monitored women for virtually their entire reproductive life – almost 20 years – and gained an awareness of their typical diet before pregnancy,” study author Jorge E. Chavarro, MD, ScD, told this news organization. Dr. Chavarro is a professor of nutrition, epidemiology, and medicine at Harvard Medical School, Boston, and Harvard University’s School of Public Health in Cambridge, Mass. He researches how nutrition and lifestyle influence reproductive health and overall lifelong health in women.

Analysis of the data from the Nurses’ Health Study II revealed that as the proportion of animal products in diets decreased and the proportion of plant-based products increased, the risk of women experiencing hypertensive disorders of pregnancy decreased as well. Women in the highest PDI quintile had a significantly lower risk of hypertensive disorders of pregnancy, in comparison with those in the lowest quintile (relative risk, 0.76). This association was slightly stronger for pregnancy-related hypertension (RR, 0.77) than for preeclampsia (RR, 0.80).

Women in the highest PDI quintile had a 24% lower risk of hypertensive disorders of pregnancy than those in the lowest quintile; the risk of pregnancy-related hypertension decreased in a linear fashion as PDI increased, while the relationship of PDI to preeclampsia was restricted to women in the quintile with the highest adherence.

“It was clearer for pregnancy-related hypertension than for preeclampsia, but a diet made up primarily of plant-based foods seemed to be protective for both,” said Dr. Chavarro. He added that in addition to the problems these conditions cause during pregnancy, both increase the risk of subsequently developing other chronic diseases. “Could it be that modifiable lifestyle factors before and during pregnancy may not only help reduce problems during gestation but also prevent women’s health problems years later? That was the general motivation for this study.”

Mercedes Sotos-Prieto, PhD, a researcher at the Autonomous University of Madrid and an associate professor at Harvard University’s School of Public Health, told this news organization that the study’s methodology was very robust and that the investigators utilized appropriate statistical techniques for the analysis. She highlighted the fact that they used a validated food frequency questionnaire. She believes the study is also important because of the population group it focused on. “There has always been greater resistance when it comes to the diet of pregnant women, and the same is true for older adults. But we have seen that this type of diet, if it’s a quality diet, may be associated with health benefits.” She did not participate in the study.

Dr. Sotos-Prieto has a doctorate in nutritional epidemiology and public health. She works with large epidemiologic cohorts, such as the cohort of American nurses on which this study was based, and ENRICA, a cohort that is representative of the Spanish population and the population of older adults. She is the author of other studies that, like this one, found an association between a plant-based diet and a lower risk of frailty, both in the study involving American nurses and in a study involving a cohort of individuals aged 60 years or older in Spain (ENRICA-1).

Dr. Sotos-Prieto is also principal investigator on a project assessing the risk of cardiovascular disease based on modifiable lifestyles. For this project, the researchers created a tool, the healthy heart test, that can be used to evaluate diet quality “in 5 minutes, because we all know that doctors don’t have any time.” She thinks this test could be implemented in clinical practice to identify lifestyle behaviors that can be improved, such as by replacing refined cereals with whole grains or increasing legume consumption.
 

Tomatoes and French fries

The greatest benefit of a plant-based diet comes from the diet overall, not from any single food item. That said, these studies use a scoring system to reflect which items are healthy and which are not.

Diet was assessed every 4 years, starting in 1991, using a semiquantitative food frequency questionnaire that recorded the consumption of 131 foods and drinks during the previous year. The researchers determined the average frequency with which participants consumed each food. Eighteen food groups were sorted into three categories: healthy plant-based foods (whole grains, fruits, vegetables, nuts, legumes, vegetable oils, tea, and coffee), unhealthy plant-based foods (fruit juices, refined grains, potatoes, sugary drinks, sweets, and desserts), and animal-based foods (dairy, eggs, fish or shellfish, meat, and various foods of animal origin).

Healthy plant-based foods were given positive scores, while less healthy plant-based foods and the animal-based food groups were given negative scores. The consumption of each food group was classified into PDI using quintiles.

Women in the highest PDI quintile had a significantly lower risk for hypertensive disorders of pregnancy, compared with women in the lowest quintile. There was a negative dose-response relationship between PDI and risk of the disease. “A vegetarian diet isn’t necessarily healthier than a nonvegetarian diet if it’s made up of superfluous foods like French fries and soft drinks,” said Dr. Sotos-Prieto. “The difference lies in the quality of the plant-based foods. That’s what makes the difference between a healthy and an unhealthy diet.”
 

Give up meat?

Dr. Chavarro said that removing meat from his dinner menu 22 years ago was one of the hardest things he ever did. “Now, it’s no problem,” he said. But he understands that there are people for whom changing the diet by replacing animal products with nonanimal products is difficult. But meat need not be entirely abandoned.

“The women in the highest quintile aren’t necessarily vegetarian or vegan, but they consume much fewer animal-based foods than the others,” he noted. He added that vegetarian or vegan diets are not incompatible with a healthy pregnancy. “All vegans know how to get vitamin B12 from supplements.”
 

Diet or weight loss?

Much of the benefit observed in the study appears to be related to better weight control. The body mass index between dietary assessment and pregnancy accounted for 39% of the relationship between PDI and hypertensive disorders of pregnancy and 48% of the relationship between PDI and pregnancy-related hypertension.

“Part of the association seems to be explained by better weight control over long periods,” explained Dr. Chavarro. Women who adopted diets with more plant-based foods gained weight more slowly than those who consumed more animal-based foods. “They are different in terms of their weight trajectory over many years. So, part of the association that we observe is related to better long-term weight control. But the other half of the association is attributable to the diet itself and not necessarily to weight.” The authors suggest mechanisms of action such as endothelial dysfunction, inflammation, or blood pressure before pregnancy to explain the association.

Dr. Sotos-Prieto believes that this point is “extremely relevant.” In her opinion, it reveals that controlling weight at the start of pregnancy is important for pregnant women. Weight control may also improve other factors, like gestational diabetes. “I think preventive measures should focus on that. These results show that interventions are needed to increase the likelihood of going into pregnancy with an appropriate weight. And this includes modifying diet.”
 

Generalizable results?

More than 90% of the participants in the Nurses’ Health Study were White, not Hispanic. Can the results be extrapolated to other populations? “The answer: The study needs to be repeated in other populations,” said Dr. Chavarro, “and that’s going to take time. But even without that information, I think we can use this study to inform other populations, regardless of ethnicity.”

Dr. Sotos-Prieto admitted that this hypothesis has not yet been tested in the Spanish population, but she is the author of a similar study that followed nearly 12,000 Spanish adults for a decade using the same PDI. In this study, every 10-point increase in PDI was associated with a 14% lower risk of mortality from any cause (hazard ratio, 0.86) and a 37% lower risk of death from cardiovascular disease (HR, 0.63). She also believes that the recommendations derived from the study could be generalized to other populations “as long as each country’s culture is taken into account, to see how it can be culturally adapted. If it’s a population that consumes a lot of refined cereals, for example, make small changes to whole grains.”
 

Weighing the evidence

The study has strengths and limitations, owing to its methodology, and Dr. Chavarro himself recognizes that “in terms of hypertensive disorders of pregnancy specifically, this won’t be the last word.” But there is a pressing need to find answers.

The American College of Obstetricians and Gynecologists and the World Health Organization encourage women to follow healthy diets before and during pregnancy. But they provide little guidance on what constitutes a healthy diet when it comes to minimizing the risks of adverse pregnancy outcomes. “They are quite ambiguous and vague,” said Dr. Chavarro.

These new findings suggest that plant-based diets may be one such strategy, particularly because some evidence was found that these diets may be beneficial for women older than 35 years, who are considered a high-risk group.

“There are certainly many ways to eat healthily, but if we think about these pregnancy complications that can have serious consequences for the mother and the fetus, we might consider this as a healthy diet option,” Dr. Chavarro noted.

But is the evidence robust enough to recommend that patients make changes? “Ideally, there will be more studies,” stated Dr. Chavarro. “There are two ways to understand the problem. One is not making recommendations until you have three controlled clinical trials, which, even with the willingness and funding to do so, will take 15-20 years. But if we have to provide the best available information to those who need it today, I think these are solid results for guiding behavior.

“It’s always better if we can make decisions based on solid, incontrovertible information. But it’s not always available, and you must learn to live in both worlds and make decisions with uncertainties,” he concluded.

Dr. Sotos-Prieto and Dr. Chavarro have disclosed no relevant financial relationships.

This article was translated from the Medscape Spanish Edition. A version of this article first appeared on Medscape.com.

The Centers for Medicare & Medicaid Services 2022 National Quality Strategy is described as an “ambitious long-term initiative that aims to promote the highest quality outcomes and safest care for all individuals.” The strategy calls for a multidisciplinary, person-centric approach for individuals throughout the continuum of care, with an emphasis on historically underresourced communities. It is a commendable goal for an overburdened U.S. health care system that spends more than other high-income counties yet experiences poorer outcomes. But whole-person, person-centered care cannot be achieved under current misaligned quality measures that fail to measure what we purport to value: the quintuple aim of improved health outcomes, cost savings, patient satisfaction, clinician well-being, and health equity.
 

Lifestyle first

Clinical practice guidelines for many chronic diseases recommend lifestyle intervention as the first and optimal treatment. A growing body of evidence supports lifestyle behavior interventions to treat and, when used intensively, even reverse common chronic conditions such as cardiovascular disease, obesity, and type 2 diabetes, while also providing effective prevention for those conditions. However, no current quality measures consider lifestyle interventions. In fact, some quality measures unintentionally penalize physicians for successfully treating or reversing disease through lifestyle behavior interventions while rewarding clinicians for meeting process measures – usually adherence to medication – regardless of whether health outcomes improved.

Rewarding medication adherence for the treatment of diseases in which lifestyle is a primary therapy (such as hypertension), combined with other health care constraints (lack of lifestyle education, time to spend with patients, and infrastructure support) incentivizes physicians to skip the conversation about lifestyle changes and go straight to medication prescription. Meanwhile, the clinician who takes the extra time to guide a patient toward lifestyle interventions that could treat their current disease and prevent future diseases – without side effects – is penalized.

Misaligned quality measures like these can stifle clinical judgment and risk reducing the practice of medicine to mindless box-checking. In many cases, patients are not even informed that lifestyle behavior change may be a treatment option (much less the first recommended option) for their conditions. This delivery of care is not person-centered and, in fact, may raise questions about the adequacy of informed treatment consent.
 

Reimbursement barriers

Lifestyle medicine is a growing medical specialty that uses therapeutic lifestyle interventions as a primary modality to treat chronic conditions. Since certification began in 2017, almost 2500 US physicians and 1000 nonphysician health professionals have earned certification. Health systems, including the U.S. military, are increasingly integrating lifestyle medicine. There have been advancements since one survey found that more than half of lifestyle medicine clinicians reported receiving no reimbursement for lifestyle behavior interventions. However, barriers, especially in fee-for-service systems, still inhibit many patients from receiving insurance coverage for comprehensive, interdisciplinary, and whole-person treatments called intensive therapeutic lifestyle change (ITLC) programs.

Existing comprehensive lifestyle programs that patients are eligible for (ie, the Diabetes Prevention Program and intensive behavioral therapy) are often so poorly reimbursed that clinicians and health systems decline to offer them. An example of a well-reimbursed ITLC program is intensive cardiac rehabilitation (ICR), which remains underutilized and limited to a narrow segment of patients, despite ICR›s proven benefits for managing comorbid risk factors such as hemoglobin A1c and weight. Even when lifestyle intervention programs are available and patients are eligible to participate (often through shared medical appointments), patient copays for the frequent visits required to achieve and sustain behavior change – or the lack of reimbursement for interdisciplinary team members – discourage engagement.
 

Penalizing successful outcomes

Despite the fact that lifestyle behaviors are top contributors to health and, conversely, contribute to up to 80% of chronic diseases, few quality measures focus on screening for lifestyle factors or treating diseases with lifestyle interventions. An example of an existing quality measure is screening or treatment for harmful substance use.

Specific quality measures that penalize lifestyle medicine approaches include pharmacotherapy for type 2 diabetes, dyslipidemia, osteoporosis, and gout as well as approaches to rheumatoid arthritis.

Statins offer a useful example of the conundrum faced by clinicians who want to offer lifestyle interventions. A lifestyle medicine primary care physician had a patient covered by Medicare Advantage who was diagnosed with hyperlipidemia. The patient had total cholesterol of 226 and a triglycerides level of 132. Instead of prescribing the routine statin, the physician prescribed lifestyle behavior modifications. Within 3 weeks, the patient›s total cholesterol improved to 171 and triglycerides to 75. This was a great success for the delighted patient. However, the CMS 5-Star Rating System assigned the primary care physician a grade of C rather than A, which put the physician›s 5-star rating at risk. Why? Because the system bases its score largely on medication compliance. The physician was penalized despite achieving the optimal health outcome, and at a lower cost than with medication. This misalignment does not incentivize patient-centered care because it disregards patient preference, shared decision-making, and evidence-based practice.
 

Risk adjustment

Rather than automatically managing disease with ever-increasing quantities of costly medications and procedures, lifestyle medicine clinicians first pursue a goal of health restoration when appropriate. But Medicare risk adjustment incentivizes physicians to manage rather than reverse disease. How much Medicare pays health plans is determined in part by how sick the patients are; the sicker the patient, the more Medicare pays, because those patients› costs are expected to be higher. This ensures that health plans are not penalized for enrolling sicker patients. But a physician utilizing diet alone to achieve remission in a patient with type 2 diabetes is penalized financially because, when the risk is adjusted, diabetes is no longer listed among the patient›s conditions. So, Medicare pays the physician less money. That misalignment incentivizes clinicians to manage the symptoms of type 2 diabetes rather than achieve remission, despite remission being the ideal clinical outcome.

Realigning quality measures

Quality measures were developed to quantify health care processes and outcomes, and to ensure the delivery of safe care to all patients. However, over time the number of quality measures has swelled to 2500, evolving into a confusing, time-consuming, and even soul-crushing responsibility for the physician.

Instead of relying heavily on process measures, we must incentivize outcome measures that honor patient autonomy and allow clinicians to offer lifestyle intervention as the first line of treatment. Risk-score calculations should be adjusted so that we stop incentivizing disease management and penalizing disease reversal.

CMS’s proposed development of “a universal foundation” of quality measures is an opportunity to begin the realignment of quality measures and values. This foundation is intended to establish more consistent and meaningful measures, reduce clinician burnout by streamlining the reporting process, and advance health equity. For this change to be successful, it is vital that lifestyle behavior interventions – optimal nutrition, physical activity, restorative sleep, social connections, stress management, and avoidance of harmful substances – become the foundation of universal quality measures. This will ensure that every clinician is incentivized to discuss lifestyle behaviors with patients and pursue the first clinical step recommended by clinical practice guidelines for most chronic diseases. Only then can we truly deliver high-value, whole-person, person-centered care and achieve the quintuple aim.

Dr. Patel is president-elect, American College of Lifestyle Medicine; Lifestyle Medicine Medical Director, Wellvana Health, Midland, Tex. She has disclosed no relevant financial relationships.

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

The Centers for Medicare & Medicaid Services 2022 National Quality Strategy is described as an “ambitious long-term initiative that aims to promote the highest quality outcomes and safest care for all individuals.” The strategy calls for a multidisciplinary, person-centric approach for individuals throughout the continuum of care, with an emphasis on historically underresourced communities. It is a commendable goal for an overburdened U.S. health care system that spends more than other high-income counties yet experiences poorer outcomes. But whole-person, person-centered care cannot be achieved under current misaligned quality measures that fail to measure what we purport to value: the quintuple aim of improved health outcomes, cost savings, patient satisfaction, clinician well-being, and health equity.
 

Lifestyle first

Clinical practice guidelines for many chronic diseases recommend lifestyle intervention as the first and optimal treatment. A growing body of evidence supports lifestyle behavior interventions to treat and, when used intensively, even reverse common chronic conditions such as cardiovascular disease, obesity, and type 2 diabetes, while also providing effective prevention for those conditions. However, no current quality measures consider lifestyle interventions. In fact, some quality measures unintentionally penalize physicians for successfully treating or reversing disease through lifestyle behavior interventions while rewarding clinicians for meeting process measures – usually adherence to medication – regardless of whether health outcomes improved.

Rewarding medication adherence for the treatment of diseases in which lifestyle is a primary therapy (such as hypertension), combined with other health care constraints (lack of lifestyle education, time to spend with patients, and infrastructure support) incentivizes physicians to skip the conversation about lifestyle changes and go straight to medication prescription. Meanwhile, the clinician who takes the extra time to guide a patient toward lifestyle interventions that could treat their current disease and prevent future diseases – without side effects – is penalized.

Misaligned quality measures like these can stifle clinical judgment and risk reducing the practice of medicine to mindless box-checking. In many cases, patients are not even informed that lifestyle behavior change may be a treatment option (much less the first recommended option) for their conditions. This delivery of care is not person-centered and, in fact, may raise questions about the adequacy of informed treatment consent.
 

Reimbursement barriers

Lifestyle medicine is a growing medical specialty that uses therapeutic lifestyle interventions as a primary modality to treat chronic conditions. Since certification began in 2017, almost 2500 US physicians and 1000 nonphysician health professionals have earned certification. Health systems, including the U.S. military, are increasingly integrating lifestyle medicine. There have been advancements since one survey found that more than half of lifestyle medicine clinicians reported receiving no reimbursement for lifestyle behavior interventions. However, barriers, especially in fee-for-service systems, still inhibit many patients from receiving insurance coverage for comprehensive, interdisciplinary, and whole-person treatments called intensive therapeutic lifestyle change (ITLC) programs.

Existing comprehensive lifestyle programs that patients are eligible for (ie, the Diabetes Prevention Program and intensive behavioral therapy) are often so poorly reimbursed that clinicians and health systems decline to offer them. An example of a well-reimbursed ITLC program is intensive cardiac rehabilitation (ICR), which remains underutilized and limited to a narrow segment of patients, despite ICR›s proven benefits for managing comorbid risk factors such as hemoglobin A1c and weight. Even when lifestyle intervention programs are available and patients are eligible to participate (often through shared medical appointments), patient copays for the frequent visits required to achieve and sustain behavior change – or the lack of reimbursement for interdisciplinary team members – discourage engagement.
 

Penalizing successful outcomes

Despite the fact that lifestyle behaviors are top contributors to health and, conversely, contribute to up to 80% of chronic diseases, few quality measures focus on screening for lifestyle factors or treating diseases with lifestyle interventions. An example of an existing quality measure is screening or treatment for harmful substance use.

Specific quality measures that penalize lifestyle medicine approaches include pharmacotherapy for type 2 diabetes, dyslipidemia, osteoporosis, and gout as well as approaches to rheumatoid arthritis.

Statins offer a useful example of the conundrum faced by clinicians who want to offer lifestyle interventions. A lifestyle medicine primary care physician had a patient covered by Medicare Advantage who was diagnosed with hyperlipidemia. The patient had total cholesterol of 226 and a triglycerides level of 132. Instead of prescribing the routine statin, the physician prescribed lifestyle behavior modifications. Within 3 weeks, the patient›s total cholesterol improved to 171 and triglycerides to 75. This was a great success for the delighted patient. However, the CMS 5-Star Rating System assigned the primary care physician a grade of C rather than A, which put the physician›s 5-star rating at risk. Why? Because the system bases its score largely on medication compliance. The physician was penalized despite achieving the optimal health outcome, and at a lower cost than with medication. This misalignment does not incentivize patient-centered care because it disregards patient preference, shared decision-making, and evidence-based practice.
 

Risk adjustment

Rather than automatically managing disease with ever-increasing quantities of costly medications and procedures, lifestyle medicine clinicians first pursue a goal of health restoration when appropriate. But Medicare risk adjustment incentivizes physicians to manage rather than reverse disease. How much Medicare pays health plans is determined in part by how sick the patients are; the sicker the patient, the more Medicare pays, because those patients› costs are expected to be higher. This ensures that health plans are not penalized for enrolling sicker patients. But a physician utilizing diet alone to achieve remission in a patient with type 2 diabetes is penalized financially because, when the risk is adjusted, diabetes is no longer listed among the patient›s conditions. So, Medicare pays the physician less money. That misalignment incentivizes clinicians to manage the symptoms of type 2 diabetes rather than achieve remission, despite remission being the ideal clinical outcome.

Realigning quality measures

Quality measures were developed to quantify health care processes and outcomes, and to ensure the delivery of safe care to all patients. However, over time the number of quality measures has swelled to 2500, evolving into a confusing, time-consuming, and even soul-crushing responsibility for the physician.

Instead of relying heavily on process measures, we must incentivize outcome measures that honor patient autonomy and allow clinicians to offer lifestyle intervention as the first line of treatment. Risk-score calculations should be adjusted so that we stop incentivizing disease management and penalizing disease reversal.

CMS’s proposed development of “a universal foundation” of quality measures is an opportunity to begin the realignment of quality measures and values. This foundation is intended to establish more consistent and meaningful measures, reduce clinician burnout by streamlining the reporting process, and advance health equity. For this change to be successful, it is vital that lifestyle behavior interventions – optimal nutrition, physical activity, restorative sleep, social connections, stress management, and avoidance of harmful substances – become the foundation of universal quality measures. This will ensure that every clinician is incentivized to discuss lifestyle behaviors with patients and pursue the first clinical step recommended by clinical practice guidelines for most chronic diseases. Only then can we truly deliver high-value, whole-person, person-centered care and achieve the quintuple aim.

Dr. Patel is president-elect, American College of Lifestyle Medicine; Lifestyle Medicine Medical Director, Wellvana Health, Midland, Tex. She has disclosed no relevant financial relationships.

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

The Centers for Medicare & Medicaid Services 2022 National Quality Strategy is described as an “ambitious long-term initiative that aims to promote the highest quality outcomes and safest care for all individuals.” The strategy calls for a multidisciplinary, person-centric approach for individuals throughout the continuum of care, with an emphasis on historically underresourced communities. It is a commendable goal for an overburdened U.S. health care system that spends more than other high-income counties yet experiences poorer outcomes. But whole-person, person-centered care cannot be achieved under current misaligned quality measures that fail to measure what we purport to value: the quintuple aim of improved health outcomes, cost savings, patient satisfaction, clinician well-being, and health equity.
 

Lifestyle first

Clinical practice guidelines for many chronic diseases recommend lifestyle intervention as the first and optimal treatment. A growing body of evidence supports lifestyle behavior interventions to treat and, when used intensively, even reverse common chronic conditions such as cardiovascular disease, obesity, and type 2 diabetes, while also providing effective prevention for those conditions. However, no current quality measures consider lifestyle interventions. In fact, some quality measures unintentionally penalize physicians for successfully treating or reversing disease through lifestyle behavior interventions while rewarding clinicians for meeting process measures – usually adherence to medication – regardless of whether health outcomes improved.

Rewarding medication adherence for the treatment of diseases in which lifestyle is a primary therapy (such as hypertension), combined with other health care constraints (lack of lifestyle education, time to spend with patients, and infrastructure support) incentivizes physicians to skip the conversation about lifestyle changes and go straight to medication prescription. Meanwhile, the clinician who takes the extra time to guide a patient toward lifestyle interventions that could treat their current disease and prevent future diseases – without side effects – is penalized.

Misaligned quality measures like these can stifle clinical judgment and risk reducing the practice of medicine to mindless box-checking. In many cases, patients are not even informed that lifestyle behavior change may be a treatment option (much less the first recommended option) for their conditions. This delivery of care is not person-centered and, in fact, may raise questions about the adequacy of informed treatment consent.
 

Reimbursement barriers

Lifestyle medicine is a growing medical specialty that uses therapeutic lifestyle interventions as a primary modality to treat chronic conditions. Since certification began in 2017, almost 2500 US physicians and 1000 nonphysician health professionals have earned certification. Health systems, including the U.S. military, are increasingly integrating lifestyle medicine. There have been advancements since one survey found that more than half of lifestyle medicine clinicians reported receiving no reimbursement for lifestyle behavior interventions. However, barriers, especially in fee-for-service systems, still inhibit many patients from receiving insurance coverage for comprehensive, interdisciplinary, and whole-person treatments called intensive therapeutic lifestyle change (ITLC) programs.

Existing comprehensive lifestyle programs that patients are eligible for (ie, the Diabetes Prevention Program and intensive behavioral therapy) are often so poorly reimbursed that clinicians and health systems decline to offer them. An example of a well-reimbursed ITLC program is intensive cardiac rehabilitation (ICR), which remains underutilized and limited to a narrow segment of patients, despite ICR›s proven benefits for managing comorbid risk factors such as hemoglobin A1c and weight. Even when lifestyle intervention programs are available and patients are eligible to participate (often through shared medical appointments), patient copays for the frequent visits required to achieve and sustain behavior change – or the lack of reimbursement for interdisciplinary team members – discourage engagement.
 

Penalizing successful outcomes

Despite the fact that lifestyle behaviors are top contributors to health and, conversely, contribute to up to 80% of chronic diseases, few quality measures focus on screening for lifestyle factors or treating diseases with lifestyle interventions. An example of an existing quality measure is screening or treatment for harmful substance use.

Specific quality measures that penalize lifestyle medicine approaches include pharmacotherapy for type 2 diabetes, dyslipidemia, osteoporosis, and gout as well as approaches to rheumatoid arthritis.

Statins offer a useful example of the conundrum faced by clinicians who want to offer lifestyle interventions. A lifestyle medicine primary care physician had a patient covered by Medicare Advantage who was diagnosed with hyperlipidemia. The patient had total cholesterol of 226 and a triglycerides level of 132. Instead of prescribing the routine statin, the physician prescribed lifestyle behavior modifications. Within 3 weeks, the patient›s total cholesterol improved to 171 and triglycerides to 75. This was a great success for the delighted patient. However, the CMS 5-Star Rating System assigned the primary care physician a grade of C rather than A, which put the physician›s 5-star rating at risk. Why? Because the system bases its score largely on medication compliance. The physician was penalized despite achieving the optimal health outcome, and at a lower cost than with medication. This misalignment does not incentivize patient-centered care because it disregards patient preference, shared decision-making, and evidence-based practice.
 

Risk adjustment

Rather than automatically managing disease with ever-increasing quantities of costly medications and procedures, lifestyle medicine clinicians first pursue a goal of health restoration when appropriate. But Medicare risk adjustment incentivizes physicians to manage rather than reverse disease. How much Medicare pays health plans is determined in part by how sick the patients are; the sicker the patient, the more Medicare pays, because those patients› costs are expected to be higher. This ensures that health plans are not penalized for enrolling sicker patients. But a physician utilizing diet alone to achieve remission in a patient with type 2 diabetes is penalized financially because, when the risk is adjusted, diabetes is no longer listed among the patient›s conditions. So, Medicare pays the physician less money. That misalignment incentivizes clinicians to manage the symptoms of type 2 diabetes rather than achieve remission, despite remission being the ideal clinical outcome.

Realigning quality measures

Quality measures were developed to quantify health care processes and outcomes, and to ensure the delivery of safe care to all patients. However, over time the number of quality measures has swelled to 2500, evolving into a confusing, time-consuming, and even soul-crushing responsibility for the physician.

Instead of relying heavily on process measures, we must incentivize outcome measures that honor patient autonomy and allow clinicians to offer lifestyle intervention as the first line of treatment. Risk-score calculations should be adjusted so that we stop incentivizing disease management and penalizing disease reversal.

CMS’s proposed development of “a universal foundation” of quality measures is an opportunity to begin the realignment of quality measures and values. This foundation is intended to establish more consistent and meaningful measures, reduce clinician burnout by streamlining the reporting process, and advance health equity. For this change to be successful, it is vital that lifestyle behavior interventions – optimal nutrition, physical activity, restorative sleep, social connections, stress management, and avoidance of harmful substances – become the foundation of universal quality measures. This will ensure that every clinician is incentivized to discuss lifestyle behaviors with patients and pursue the first clinical step recommended by clinical practice guidelines for most chronic diseases. Only then can we truly deliver high-value, whole-person, person-centered care and achieve the quintuple aim.

Dr. Patel is president-elect, American College of Lifestyle Medicine; Lifestyle Medicine Medical Director, Wellvana Health, Midland, Tex. She has disclosed no relevant financial relationships.

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