Caffeine consumption may improve thyroid function for people with metabolic disorders, new research shows.

“Although the causal relationship between caffeine intake and thyroid function requires further verification, as an easily obtainable and widely consumed dietary ingredient, caffeine is a potential candidate for improving thyroid health in people with metabolic disorders,” reported the authors in the study, published in Nutritional Journal.

Caffeine intake, within established healthy ranges, showed a nonlinear association with thyroid levels.

Moderate caffeine intake has been associated with reducing the risk of metabolic disorders in addition to showing some mental health benefits. However, research on its effects on thyroid hormone, which importantly plays a key role in systemic metabolism and neurologic development, is lacking.

To investigate the effects, Yu Zhou, of the Department of Rehabilitation Medicine, School of Health, Fujian Medical University, Fuzhou, China, and colleagues evaluated data from the National Health and Nutrition Examination Survey (NHANES) III 2007-2012 study involving 2,582 participants for whom data were available regarding medical conditions, dietary intake, thyroid function, and demographic background.

The participants were divided into three subgroups based on sex, age, body mass index, hyperglycemia, hypertension, and cardio-cerebral vascular disease (CVD).

Group 1 (n = 208) was the most metabolically unhealthy. Patients in that group had the highest BMI and were of oldest age. In addition, that group had higher rates of hypertension, hyperglycemia, and CVD, but, notably, it had the lowest level of caffeine consumption.

In group 2 (n = 543), all participants were current smokers, and 90.4% had a habit of drinking alcohol. That group also had the highest percentage of men.

Group 3 (n = 1,183) was the most metabolically healthy, with more women, younger age, and lowest BMI. No participants in that group had hyperglycemia, hypertension, or CVD.

Group 1, the most metabolically unhealthy, had the highest serum thyroid-stimulating hormone (TSH) levels. Of note, while participants with thyroid diseases were initially excluded from the analysis, higher TSH levels are predictive of subclinical hypothyroidism or progression to overt hypothyroidism.

Overall, there was no association between caffeine and TSH levels.

However, a subgroup analysis of the groups showed that in group 1, caffeine intake correlated with TSH nonlinearly (P = .0019), with minimal average consumption of caffeine (< 9.97 mg/d). There was an association with slightly higher TSH levels (P = .035) after adjustment for age, sex, race, drink, disease state, micronutrients, and macronutrients.

However, in higher, moderate amounts of caffeine consumption (9.97 – 264.97 mg/d), there was an inverse association, with lower TSH (P = .001).

There was no association between daily caffeine consumption of more than 264.97 mg and TSH levels.

For context, a typical 8-ounce cup of coffee generally contains 80-100 mg of caffeine, and the Food and Drug Administration indicates that 400 mg/d of caffeine is safe for healthy adults.

Group 2 consumed the highest amount of caffeine. Notably, that group had the lowest serum TSH levels of the three groups. There were no significant associations between caffeine consumption and TSH levels in group 2 or group 3.

There were no significant associations between caffeine consumption and levels of serum FT4 or FT3, also linked to thyroid dysfunction, in any of the groups.

The findings show that “caffeine consumption was correlated with serum TSH nonlinearly, and when taken in moderate amounts (9.97-264.97 mg/d), caffeine demonstrated a positive correlation with serum TSH levels in patients with metabolic disorders,” the authors concluded.
 

Mechanisms?

Caffeine is believed to modulate pituitary hormone secretion, which has been shown to influence the hypothalamic-pituitary-adrenal axis. The authors speculated that caffeine could potentially affect thyroid activity by affecting pituitary function.

“However, the effects of transient and chronic caffeine administration on human thyroid function need to be verified further, and the related mechanisms remain unclear,” they noted.

Commenting on the study, Maik Pietzner, PhD, of the Berlin Institute of Health, noted that an important limitation of the study is that various patient groups were excluded, including those with abnormal TSH levels.

“What makes me wonder is the high number of exclusions and the focus on very specific groups of people. This almost certainly introduces bias, e.g., what is specific to people not reporting coffee consumption,” Dr. Pietzner said.

Furthermore, “we already know that patients with poor metabolic health do also have slight variations in thyroid hormone levels and also have different dietary patterns,” he explained.

“So reverse confounding might occur in which the poor metabolic health is associated with both poor thyroid hormone levels and coffee consumption,” Dr. Pietzner said.

He also noted the “somewhat odd” finding that the group with the highest metabolic disorders had the lowest coffee consumption, yet the highest TSH levels.

“My guess would be that this might also be a chance finding, given that the distribution of TSH values is very skewed, which can have a strong effect in linear regression models,” Dr. Pietzner said.

In general, “the evidence generated by the study is rather weak, but there is good evidence that higher coffee consumption is linked to better metabolic health, although the exact mechanisms is not known, if indeed causal,” Dr. Pietzner added. “Prospective studies are needed to evaluate whether higher coffee consumption indeed lowers the risk for thyroid disease.”

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

Caffeine consumption may improve thyroid function for people with metabolic disorders, new research shows.

“Although the causal relationship between caffeine intake and thyroid function requires further verification, as an easily obtainable and widely consumed dietary ingredient, caffeine is a potential candidate for improving thyroid health in people with metabolic disorders,” reported the authors in the study, published in Nutritional Journal.

Caffeine intake, within established healthy ranges, showed a nonlinear association with thyroid levels.

Moderate caffeine intake has been associated with reducing the risk of metabolic disorders in addition to showing some mental health benefits. However, research on its effects on thyroid hormone, which importantly plays a key role in systemic metabolism and neurologic development, is lacking.

To investigate the effects, Yu Zhou, of the Department of Rehabilitation Medicine, School of Health, Fujian Medical University, Fuzhou, China, and colleagues evaluated data from the National Health and Nutrition Examination Survey (NHANES) III 2007-2012 study involving 2,582 participants for whom data were available regarding medical conditions, dietary intake, thyroid function, and demographic background.

The participants were divided into three subgroups based on sex, age, body mass index, hyperglycemia, hypertension, and cardio-cerebral vascular disease (CVD).

Group 1 (n = 208) was the most metabolically unhealthy. Patients in that group had the highest BMI and were of oldest age. In addition, that group had higher rates of hypertension, hyperglycemia, and CVD, but, notably, it had the lowest level of caffeine consumption.

In group 2 (n = 543), all participants were current smokers, and 90.4% had a habit of drinking alcohol. That group also had the highest percentage of men.

Group 3 (n = 1,183) was the most metabolically healthy, with more women, younger age, and lowest BMI. No participants in that group had hyperglycemia, hypertension, or CVD.

Group 1, the most metabolically unhealthy, had the highest serum thyroid-stimulating hormone (TSH) levels. Of note, while participants with thyroid diseases were initially excluded from the analysis, higher TSH levels are predictive of subclinical hypothyroidism or progression to overt hypothyroidism.

Overall, there was no association between caffeine and TSH levels.

However, a subgroup analysis of the groups showed that in group 1, caffeine intake correlated with TSH nonlinearly (P = .0019), with minimal average consumption of caffeine (< 9.97 mg/d). There was an association with slightly higher TSH levels (P = .035) after adjustment for age, sex, race, drink, disease state, micronutrients, and macronutrients.

However, in higher, moderate amounts of caffeine consumption (9.97 – 264.97 mg/d), there was an inverse association, with lower TSH (P = .001).

There was no association between daily caffeine consumption of more than 264.97 mg and TSH levels.

For context, a typical 8-ounce cup of coffee generally contains 80-100 mg of caffeine, and the Food and Drug Administration indicates that 400 mg/d of caffeine is safe for healthy adults.

Group 2 consumed the highest amount of caffeine. Notably, that group had the lowest serum TSH levels of the three groups. There were no significant associations between caffeine consumption and TSH levels in group 2 or group 3.

There were no significant associations between caffeine consumption and levels of serum FT4 or FT3, also linked to thyroid dysfunction, in any of the groups.

The findings show that “caffeine consumption was correlated with serum TSH nonlinearly, and when taken in moderate amounts (9.97-264.97 mg/d), caffeine demonstrated a positive correlation with serum TSH levels in patients with metabolic disorders,” the authors concluded.
 

Mechanisms?

Caffeine is believed to modulate pituitary hormone secretion, which has been shown to influence the hypothalamic-pituitary-adrenal axis. The authors speculated that caffeine could potentially affect thyroid activity by affecting pituitary function.

“However, the effects of transient and chronic caffeine administration on human thyroid function need to be verified further, and the related mechanisms remain unclear,” they noted.

Commenting on the study, Maik Pietzner, PhD, of the Berlin Institute of Health, noted that an important limitation of the study is that various patient groups were excluded, including those with abnormal TSH levels.

“What makes me wonder is the high number of exclusions and the focus on very specific groups of people. This almost certainly introduces bias, e.g., what is specific to people not reporting coffee consumption,” Dr. Pietzner said.

Furthermore, “we already know that patients with poor metabolic health do also have slight variations in thyroid hormone levels and also have different dietary patterns,” he explained.

“So reverse confounding might occur in which the poor metabolic health is associated with both poor thyroid hormone levels and coffee consumption,” Dr. Pietzner said.

He also noted the “somewhat odd” finding that the group with the highest metabolic disorders had the lowest coffee consumption, yet the highest TSH levels.

“My guess would be that this might also be a chance finding, given that the distribution of TSH values is very skewed, which can have a strong effect in linear regression models,” Dr. Pietzner said.

In general, “the evidence generated by the study is rather weak, but there is good evidence that higher coffee consumption is linked to better metabolic health, although the exact mechanisms is not known, if indeed causal,” Dr. Pietzner added. “Prospective studies are needed to evaluate whether higher coffee consumption indeed lowers the risk for thyroid disease.”

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

Caffeine consumption may improve thyroid function for people with metabolic disorders, new research shows.

“Although the causal relationship between caffeine intake and thyroid function requires further verification, as an easily obtainable and widely consumed dietary ingredient, caffeine is a potential candidate for improving thyroid health in people with metabolic disorders,” reported the authors in the study, published in Nutritional Journal.

Caffeine intake, within established healthy ranges, showed a nonlinear association with thyroid levels.

Moderate caffeine intake has been associated with reducing the risk of metabolic disorders in addition to showing some mental health benefits. However, research on its effects on thyroid hormone, which importantly plays a key role in systemic metabolism and neurologic development, is lacking.

To investigate the effects, Yu Zhou, of the Department of Rehabilitation Medicine, School of Health, Fujian Medical University, Fuzhou, China, and colleagues evaluated data from the National Health and Nutrition Examination Survey (NHANES) III 2007-2012 study involving 2,582 participants for whom data were available regarding medical conditions, dietary intake, thyroid function, and demographic background.

The participants were divided into three subgroups based on sex, age, body mass index, hyperglycemia, hypertension, and cardio-cerebral vascular disease (CVD).

Group 1 (n = 208) was the most metabolically unhealthy. Patients in that group had the highest BMI and were of oldest age. In addition, that group had higher rates of hypertension, hyperglycemia, and CVD, but, notably, it had the lowest level of caffeine consumption.

In group 2 (n = 543), all participants were current smokers, and 90.4% had a habit of drinking alcohol. That group also had the highest percentage of men.

Group 3 (n = 1,183) was the most metabolically healthy, with more women, younger age, and lowest BMI. No participants in that group had hyperglycemia, hypertension, or CVD.

Group 1, the most metabolically unhealthy, had the highest serum thyroid-stimulating hormone (TSH) levels. Of note, while participants with thyroid diseases were initially excluded from the analysis, higher TSH levels are predictive of subclinical hypothyroidism or progression to overt hypothyroidism.

Overall, there was no association between caffeine and TSH levels.

However, a subgroup analysis of the groups showed that in group 1, caffeine intake correlated with TSH nonlinearly (P = .0019), with minimal average consumption of caffeine (< 9.97 mg/d). There was an association with slightly higher TSH levels (P = .035) after adjustment for age, sex, race, drink, disease state, micronutrients, and macronutrients.

However, in higher, moderate amounts of caffeine consumption (9.97 – 264.97 mg/d), there was an inverse association, with lower TSH (P = .001).

There was no association between daily caffeine consumption of more than 264.97 mg and TSH levels.

For context, a typical 8-ounce cup of coffee generally contains 80-100 mg of caffeine, and the Food and Drug Administration indicates that 400 mg/d of caffeine is safe for healthy adults.

Group 2 consumed the highest amount of caffeine. Notably, that group had the lowest serum TSH levels of the three groups. There were no significant associations between caffeine consumption and TSH levels in group 2 or group 3.

There were no significant associations between caffeine consumption and levels of serum FT4 or FT3, also linked to thyroid dysfunction, in any of the groups.

The findings show that “caffeine consumption was correlated with serum TSH nonlinearly, and when taken in moderate amounts (9.97-264.97 mg/d), caffeine demonstrated a positive correlation with serum TSH levels in patients with metabolic disorders,” the authors concluded.
 

Mechanisms?

Caffeine is believed to modulate pituitary hormone secretion, which has been shown to influence the hypothalamic-pituitary-adrenal axis. The authors speculated that caffeine could potentially affect thyroid activity by affecting pituitary function.

“However, the effects of transient and chronic caffeine administration on human thyroid function need to be verified further, and the related mechanisms remain unclear,” they noted.

Commenting on the study, Maik Pietzner, PhD, of the Berlin Institute of Health, noted that an important limitation of the study is that various patient groups were excluded, including those with abnormal TSH levels.

“What makes me wonder is the high number of exclusions and the focus on very specific groups of people. This almost certainly introduces bias, e.g., what is specific to people not reporting coffee consumption,” Dr. Pietzner said.

Furthermore, “we already know that patients with poor metabolic health do also have slight variations in thyroid hormone levels and also have different dietary patterns,” he explained.

“So reverse confounding might occur in which the poor metabolic health is associated with both poor thyroid hormone levels and coffee consumption,” Dr. Pietzner said.

He also noted the “somewhat odd” finding that the group with the highest metabolic disorders had the lowest coffee consumption, yet the highest TSH levels.

“My guess would be that this might also be a chance finding, given that the distribution of TSH values is very skewed, which can have a strong effect in linear regression models,” Dr. Pietzner said.

In general, “the evidence generated by the study is rather weak, but there is good evidence that higher coffee consumption is linked to better metabolic health, although the exact mechanisms is not known, if indeed causal,” Dr. Pietzner added. “Prospective studies are needed to evaluate whether higher coffee consumption indeed lowers the risk for thyroid disease.”

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

Artificial intelligence (AI) technology has increasingly been incorporated in medicine. In dermatology, AI has been used to detect and diagnose skin lesions, including skin cancer.¹ ChatGPT (OpenAI) is a novel, highly popular development in generative AI technology. A large language model released in 2022, ChatGPT is a chatbot designed to mimic human conversation and generate specific detailed information when prompted. Free and publicly available, it has been used by millions of people. ChatGPT’s application in the medical field currently is being evaluated across several specialties, including plastic surgery, radiology, and urology.^2-4 ChatGPT has the potential to assist health care professionals, including dermatologists, though its use raises important ethical considerations. Herein, we focus on the potential benefits as well as the pitfalls of using ChatGPT in dermatology clinical practice.

Potential Uses of ChatGPT in Practice

A major benefit of ChatGPT is its ability to improve clinical efficiency. First, ChatGPT can provide quick access to general medical information, similar to a search engine but with more natural language processing and contextual understanding to synthesize information.⁵ This function is useful for rapid concise answers to specific and directed questions. ChatGPT also can interact with its user by asking follow-up questions to produce more precise and relevant responses; this feature may help dermatologists form more accurate differential diagnoses. Additionally, ChatGPT can increase efficiency in clinical practice by drafting generic medical documents,² including templates for after-visit summaries, postprocedure instructions, referrals, prior authorization appeal letters, and educational handouts. Importantly, increased efficiency can reduce provider burnout and lead to improved patient care. Another useful feature of ChatGPT is its ability to output information modeling human conversation. Because of this feature, ChatGPT also could be employed in clinical practice to serve as an interpreter for patients during clinic visits. Currently, the use of virtual translators can be cumbersome and subject to technical constraints. ChatGPT can provide accurate and conversational translations for patients and dermatologists, improving the patient-provider relationship.

ChatGPT also can contribute to major advancements in the field of dermatology beyond the clinical setting. Because of its ability to draw from extensive data that have already been uploaded, there are some uses of ChatGPT in a research context: to assist in finding resources for research and reviews, formulating hypotheses, drafting study protocols, and collecting large amounts of data within seconds.⁶

ChatGPT also has potential in advancing medical education. It could be used by medical schools to model interactive patient encounters to help students practice taking a patient’s history and creating differential diagnoses.⁶ This application of ChatGPT may help medical students hone their clinical skills in a low-stress environment without the restrictions that can come with hiring and training standardized patients, especially when mimicking dermatologic clinical encounters.

Other possibilities for ChatGPT in dermatologic practice include survey administration, clinical trial recruitment, and even automatic high-risk medication monitoring. Despite the many potential applications of ChatGPT in clinical practice, the question raised in each scenario is the quality, accuracy, and safety of what it produces.

Potential Pitfalls of ChatGPT in Practice and Possible Mitigation Strategies

A main concern in using ChatGPT in clinical practice is its potential to produce inaccurate or biased information. When prompted to create a research abstract based on previously published research, ChatGPT drafted abstracts that were clear and digestible but supplemented with incorrect data.⁷ A group of medical researchers who reviewed these ChatGPT-generated abstracts mistook 32% of the abstracts as having been written by human researchers. The implications of this finding are worrisome. If inaccurate or false information is used by ChatGPT in documents sent to insurance companies or patients, the patient’s safety as well as the dermatologist’s license and credibility are at stake. Thus, dermatologists looking to use ChatGPT to draft generic medical documents should actively review the output to ensure that the information is accurate. Importantly, ChatGPT also is only currently programmed with information up to 2021, limiting its access to recently published research articles and updated International Classification of Diseases, Tenth Revision codes.⁵ The continued development of ChatGPT will lead to regular updates by OpenAI that resolve this shortcoming in the future. Further, AI models may encode and perpetuate harmful stereotypes and social biases that are present in training data.⁸

When considering its potential in clinical practice, ChatGPT itself states that it can aid in clinical decision-making by processing patient information, including history, current symptoms, and biopsy and test results. This is uncharted territory, and providers who use ChatGPT at this stage to aid in decision-making should regard it similarly to information retrieved from a search engine. The information produced by ChatGPT should be used to substantiate but not definitively confirm a diagnosis or dictate management. Clinical suspicion by the dermatologist should always trump ChatGPT output. If physicians recommend ChatGPT output over their own advice, it can become a liability, as the technology is not regulated to any degree. Patients also should be cautious when seeking and following medical advice from ChatGPT, as it could be misleading or incorrect and could undermine the patient-physician relationship.⁶

Additionally, the specific use of ChatGPT to evaluate patient health records raises concerns related to patient privacy and confidentiality. Providers should never enter patient information protected by the Health Insurance Portability and Accountability Act into ChatGPT or anywhere else on the internet. Mitigation of this risk is not currently possible; ChatGPT requires more development and further understanding to even consider its integration into current electronic health records without compromising patient confidentiality.

The Bottom Line

Overall, ChatGPT has the potential to improve efficiency in clinical practice by assisting with informational searches and document drafting. Importantly, increased efficiency can reduce provider burnout and lead to improved patient care. However, dermatologists should carefully weigh the ethical issues of nonmaleficence and justice in evaluating ChatGPT for accuracy, biases, and the protection of patient confidentiality.

Finally, we asked ChatGPT on February 28, 2023, what it thinks:

User: Should dermatologists use ChatGPT in clinical practice?

ChatGPT: As an AI language model, ChatGPT can be a useful tool in dermatology clinical practice, but it should be used with caution in conjunction with other sources of information and clinical judgement.

Dermatologists should be aware of the potential benefits and risks of using ChatGPT and make informed decisions about how to integrate it into their clinical practice. It’s important to remember that ChatGPT is not a substitute for clinical expertise or human interaction with patients, and it should only be used as a supplement to enhance the quality of patient care.

Dermatologists who choose to use ChatGPT should also be aware of its limitations and potential risks, such as limited accuracy, lack of context, and liability issues if it provides incorrect information or recommendations that lead to patient harm. Dermatologists should use their professional judgement and consult with other health care professionals when making important decisions regarding patient care.

Artificial intelligence (AI) technology has increasingly been incorporated in medicine. In dermatology, AI has been used to detect and diagnose skin lesions, including skin cancer.¹ ChatGPT (OpenAI) is a novel, highly popular development in generative AI technology. A large language model released in 2022, ChatGPT is a chatbot designed to mimic human conversation and generate specific detailed information when prompted. Free and publicly available, it has been used by millions of people. ChatGPT’s application in the medical field currently is being evaluated across several specialties, including plastic surgery, radiology, and urology.^2-4 ChatGPT has the potential to assist health care professionals, including dermatologists, though its use raises important ethical considerations. Herein, we focus on the potential benefits as well as the pitfalls of using ChatGPT in dermatology clinical practice.

Potential Uses of ChatGPT in Practice

A major benefit of ChatGPT is its ability to improve clinical efficiency. First, ChatGPT can provide quick access to general medical information, similar to a search engine but with more natural language processing and contextual understanding to synthesize information.⁵ This function is useful for rapid concise answers to specific and directed questions. ChatGPT also can interact with its user by asking follow-up questions to produce more precise and relevant responses; this feature may help dermatologists form more accurate differential diagnoses. Additionally, ChatGPT can increase efficiency in clinical practice by drafting generic medical documents,² including templates for after-visit summaries, postprocedure instructions, referrals, prior authorization appeal letters, and educational handouts. Importantly, increased efficiency can reduce provider burnout and lead to improved patient care. Another useful feature of ChatGPT is its ability to output information modeling human conversation. Because of this feature, ChatGPT also could be employed in clinical practice to serve as an interpreter for patients during clinic visits. Currently, the use of virtual translators can be cumbersome and subject to technical constraints. ChatGPT can provide accurate and conversational translations for patients and dermatologists, improving the patient-provider relationship.

ChatGPT also can contribute to major advancements in the field of dermatology beyond the clinical setting. Because of its ability to draw from extensive data that have already been uploaded, there are some uses of ChatGPT in a research context: to assist in finding resources for research and reviews, formulating hypotheses, drafting study protocols, and collecting large amounts of data within seconds.⁶

ChatGPT also has potential in advancing medical education. It could be used by medical schools to model interactive patient encounters to help students practice taking a patient’s history and creating differential diagnoses.⁶ This application of ChatGPT may help medical students hone their clinical skills in a low-stress environment without the restrictions that can come with hiring and training standardized patients, especially when mimicking dermatologic clinical encounters.

Other possibilities for ChatGPT in dermatologic practice include survey administration, clinical trial recruitment, and even automatic high-risk medication monitoring. Despite the many potential applications of ChatGPT in clinical practice, the question raised in each scenario is the quality, accuracy, and safety of what it produces.

Potential Pitfalls of ChatGPT in Practice and Possible Mitigation Strategies

A main concern in using ChatGPT in clinical practice is its potential to produce inaccurate or biased information. When prompted to create a research abstract based on previously published research, ChatGPT drafted abstracts that were clear and digestible but supplemented with incorrect data.⁷ A group of medical researchers who reviewed these ChatGPT-generated abstracts mistook 32% of the abstracts as having been written by human researchers. The implications of this finding are worrisome. If inaccurate or false information is used by ChatGPT in documents sent to insurance companies or patients, the patient’s safety as well as the dermatologist’s license and credibility are at stake. Thus, dermatologists looking to use ChatGPT to draft generic medical documents should actively review the output to ensure that the information is accurate. Importantly, ChatGPT also is only currently programmed with information up to 2021, limiting its access to recently published research articles and updated International Classification of Diseases, Tenth Revision codes.⁵ The continued development of ChatGPT will lead to regular updates by OpenAI that resolve this shortcoming in the future. Further, AI models may encode and perpetuate harmful stereotypes and social biases that are present in training data.⁸

When considering its potential in clinical practice, ChatGPT itself states that it can aid in clinical decision-making by processing patient information, including history, current symptoms, and biopsy and test results. This is uncharted territory, and providers who use ChatGPT at this stage to aid in decision-making should regard it similarly to information retrieved from a search engine. The information produced by ChatGPT should be used to substantiate but not definitively confirm a diagnosis or dictate management. Clinical suspicion by the dermatologist should always trump ChatGPT output. If physicians recommend ChatGPT output over their own advice, it can become a liability, as the technology is not regulated to any degree. Patients also should be cautious when seeking and following medical advice from ChatGPT, as it could be misleading or incorrect and could undermine the patient-physician relationship.⁶

Additionally, the specific use of ChatGPT to evaluate patient health records raises concerns related to patient privacy and confidentiality. Providers should never enter patient information protected by the Health Insurance Portability and Accountability Act into ChatGPT or anywhere else on the internet. Mitigation of this risk is not currently possible; ChatGPT requires more development and further understanding to even consider its integration into current electronic health records without compromising patient confidentiality.

The Bottom Line

Overall, ChatGPT has the potential to improve efficiency in clinical practice by assisting with informational searches and document drafting. Importantly, increased efficiency can reduce provider burnout and lead to improved patient care. However, dermatologists should carefully weigh the ethical issues of nonmaleficence and justice in evaluating ChatGPT for accuracy, biases, and the protection of patient confidentiality.

Finally, we asked ChatGPT on February 28, 2023, what it thinks:

User: Should dermatologists use ChatGPT in clinical practice?

ChatGPT: As an AI language model, ChatGPT can be a useful tool in dermatology clinical practice, but it should be used with caution in conjunction with other sources of information and clinical judgement.

Dermatologists should be aware of the potential benefits and risks of using ChatGPT and make informed decisions about how to integrate it into their clinical practice. It’s important to remember that ChatGPT is not a substitute for clinical expertise or human interaction with patients, and it should only be used as a supplement to enhance the quality of patient care.

Dermatologists who choose to use ChatGPT should also be aware of its limitations and potential risks, such as limited accuracy, lack of context, and liability issues if it provides incorrect information or recommendations that lead to patient harm. Dermatologists should use their professional judgement and consult with other health care professionals when making important decisions regarding patient care.

Artificial intelligence (AI) technology has increasingly been incorporated in medicine. In dermatology, AI has been used to detect and diagnose skin lesions, including skin cancer.¹ ChatGPT (OpenAI) is a novel, highly popular development in generative AI technology. A large language model released in 2022, ChatGPT is a chatbot designed to mimic human conversation and generate specific detailed information when prompted. Free and publicly available, it has been used by millions of people. ChatGPT’s application in the medical field currently is being evaluated across several specialties, including plastic surgery, radiology, and urology.^2-4 ChatGPT has the potential to assist health care professionals, including dermatologists, though its use raises important ethical considerations. Herein, we focus on the potential benefits as well as the pitfalls of using ChatGPT in dermatology clinical practice.

Potential Uses of ChatGPT in Practice

A major benefit of ChatGPT is its ability to improve clinical efficiency. First, ChatGPT can provide quick access to general medical information, similar to a search engine but with more natural language processing and contextual understanding to synthesize information.⁵ This function is useful for rapid concise answers to specific and directed questions. ChatGPT also can interact with its user by asking follow-up questions to produce more precise and relevant responses; this feature may help dermatologists form more accurate differential diagnoses. Additionally, ChatGPT can increase efficiency in clinical practice by drafting generic medical documents,² including templates for after-visit summaries, postprocedure instructions, referrals, prior authorization appeal letters, and educational handouts. Importantly, increased efficiency can reduce provider burnout and lead to improved patient care. Another useful feature of ChatGPT is its ability to output information modeling human conversation. Because of this feature, ChatGPT also could be employed in clinical practice to serve as an interpreter for patients during clinic visits. Currently, the use of virtual translators can be cumbersome and subject to technical constraints. ChatGPT can provide accurate and conversational translations for patients and dermatologists, improving the patient-provider relationship.

ChatGPT also can contribute to major advancements in the field of dermatology beyond the clinical setting. Because of its ability to draw from extensive data that have already been uploaded, there are some uses of ChatGPT in a research context: to assist in finding resources for research and reviews, formulating hypotheses, drafting study protocols, and collecting large amounts of data within seconds.⁶

ChatGPT also has potential in advancing medical education. It could be used by medical schools to model interactive patient encounters to help students practice taking a patient’s history and creating differential diagnoses.⁶ This application of ChatGPT may help medical students hone their clinical skills in a low-stress environment without the restrictions that can come with hiring and training standardized patients, especially when mimicking dermatologic clinical encounters.

Other possibilities for ChatGPT in dermatologic practice include survey administration, clinical trial recruitment, and even automatic high-risk medication monitoring. Despite the many potential applications of ChatGPT in clinical practice, the question raised in each scenario is the quality, accuracy, and safety of what it produces.

Potential Pitfalls of ChatGPT in Practice and Possible Mitigation Strategies

A main concern in using ChatGPT in clinical practice is its potential to produce inaccurate or biased information. When prompted to create a research abstract based on previously published research, ChatGPT drafted abstracts that were clear and digestible but supplemented with incorrect data.⁷ A group of medical researchers who reviewed these ChatGPT-generated abstracts mistook 32% of the abstracts as having been written by human researchers. The implications of this finding are worrisome. If inaccurate or false information is used by ChatGPT in documents sent to insurance companies or patients, the patient’s safety as well as the dermatologist’s license and credibility are at stake. Thus, dermatologists looking to use ChatGPT to draft generic medical documents should actively review the output to ensure that the information is accurate. Importantly, ChatGPT also is only currently programmed with information up to 2021, limiting its access to recently published research articles and updated International Classification of Diseases, Tenth Revision codes.⁵ The continued development of ChatGPT will lead to regular updates by OpenAI that resolve this shortcoming in the future. Further, AI models may encode and perpetuate harmful stereotypes and social biases that are present in training data.⁸

When considering its potential in clinical practice, ChatGPT itself states that it can aid in clinical decision-making by processing patient information, including history, current symptoms, and biopsy and test results. This is uncharted territory, and providers who use ChatGPT at this stage to aid in decision-making should regard it similarly to information retrieved from a search engine. The information produced by ChatGPT should be used to substantiate but not definitively confirm a diagnosis or dictate management. Clinical suspicion by the dermatologist should always trump ChatGPT output. If physicians recommend ChatGPT output over their own advice, it can become a liability, as the technology is not regulated to any degree. Patients also should be cautious when seeking and following medical advice from ChatGPT, as it could be misleading or incorrect and could undermine the patient-physician relationship.⁶

Additionally, the specific use of ChatGPT to evaluate patient health records raises concerns related to patient privacy and confidentiality. Providers should never enter patient information protected by the Health Insurance Portability and Accountability Act into ChatGPT or anywhere else on the internet. Mitigation of this risk is not currently possible; ChatGPT requires more development and further understanding to even consider its integration into current electronic health records without compromising patient confidentiality.

The Bottom Line

Overall, ChatGPT has the potential to improve efficiency in clinical practice by assisting with informational searches and document drafting. Importantly, increased efficiency can reduce provider burnout and lead to improved patient care. However, dermatologists should carefully weigh the ethical issues of nonmaleficence and justice in evaluating ChatGPT for accuracy, biases, and the protection of patient confidentiality.

Finally, we asked ChatGPT on February 28, 2023, what it thinks:

User: Should dermatologists use ChatGPT in clinical practice?

ChatGPT: As an AI language model, ChatGPT can be a useful tool in dermatology clinical practice, but it should be used with caution in conjunction with other sources of information and clinical judgement.

Dermatologists should be aware of the potential benefits and risks of using ChatGPT and make informed decisions about how to integrate it into their clinical practice. It’s important to remember that ChatGPT is not a substitute for clinical expertise or human interaction with patients, and it should only be used as a supplement to enhance the quality of patient care.

Dermatologists who choose to use ChatGPT should also be aware of its limitations and potential risks, such as limited accuracy, lack of context, and liability issues if it provides incorrect information or recommendations that lead to patient harm. Dermatologists should use their professional judgement and consult with other health care professionals when making important decisions regarding patient care.

Nearly 90% of women who self-managed medication abortion in pregnancies of 9-16 weeks’ gestation had complete abortions with no need for procedural intervention, based on data from more than 200 individuals.

Although most abortions happen within the first 9 weeks of pregnancy, it is important to understand the effectiveness of different models of care in a wider gestational range, corresponding author Heidi Moseson, PhD, of Ibis Reproductive Health in Oakland, Calif., said in an interview.

“There will always be people who need abortions after 9 weeks of pregnancy,” she said, whether because of delayed recognition of the pregnancy, changes in the pregnant person’s health, a fetal diagnosis, changes in life circumstances, time required to gather money, transportation to care, or other reasons.

“This study builds on prior research from the same SAFE study cohort that established self-managed medication abortion in the first 9 weeks of pregnancy as safe and effective, and noninferior to clinician-managed abortion,” Dr. Moseson said. “With this analysis, we wanted to explore whether self-managed medication abortion remained effective after 9 weeks of pregnancy, too.”

In the study, published in Obstetrics & Gynecology, Dr. Moseson and colleagues recruited 1,352 women who were initiating self-managed medication abortion through one of three abortion-accompaniment groups in Argentina, Nigeria, and Southeast Asia between 2019 and 2020. Of these, 264 were self-managing a medication abortion at 9 or more weeks’ gestation.

Participants completed a baseline phone survey before beginning the pill regimen, and follow-up surveys at 1 week and 3 weeks after taking the pills. The average age of the participants was 26 years; 75% were at 9-11 weeks’ gestation, 19.3% were at 12-14 weeks’ gestation, and 5.7% were at 15-22 weeks’ gestation. Slightly more than half of the participants (56.4%) used a combination of mifepristone plus misoprostol, and 43.6% used misoprostol only.

The primary outcome was abortion completion. Secondary outcomes included health care seeking and treatment as well as physical experiences.

A total of 89.4% of participants had an abortion completion without the need for procedural intervention. Another 5.3% had a complete abortion with manual vacuum aspiration or dilation and curettage, 4.9% had an incomplete abortion, and one patient reported no abortion outcome.

Of the participants who sought health care during or after the self-managed abortion, 15.9% sought to confirm abortion completion, and 9.1% needed additional medical intervention, including procedural evacuation, antibiotics, additional misoprostol, intravenous fluids, blood transfusion, or an overnight stay in the health care facility.

Overall, women who were at least 12 weeks pregnant were more likely to seek care at a clinic or hospital than those who were 9-11 weeks pregnant (adjusted relative risk, 1.62).

“Particularly in the United States, the [Food and Drug Administration] label only endorsed medication abortion use through 10 weeks of pregnancy; as a result, many people in the U.S. have the incorrect assumption that the pills are not effective after 10 weeks of pregnancy,” Dr. Moseson said. “This isn’t true. There is no magic line at 10 or 12 weeks after which the pills stop working – in fact, the uterus becomes more sensitive, not less, to misoprostol as a pregnancy progresses. This is why the misoprostol dose is reduced by half for abortions after 12-14 weeks or so.”

The findings were limited by several factors including the use of self-reports for gestational age and abortion outcome, without confirmation by ultrasonogram, the researchers noted. Other limitations included the inability to randomize participants to medication regimens because of legal restrictions on abortion access within the study sites, and the small number of participants (three) who underwent self-managed medication abortion at 17-22 weeks’ gestation.
 

Data support self-management medication abortion later in pregnancy

“Many people are not aware that there is a robust randomized clinical trial literature that demonstrates that both medication abortion regimens remain highly effective up to 24-28 weeks of pregnancy,” as well as a Cochrane review, Dr. Moseson said. “We know that when these pills are administered in a clinical setting well beyond 9 weeks of pregnancy, that they are highly effective and safe.

“We did not expect that the pills would work differently just because someone takes all doses at home, rather than just the second or third dose at home, as happens in most clinician-managed medication abortions,” she noted. However, “we were interested to see differences in likelihood of health care seeking during or after the abortion by country, but in some ways, also not surprised by these differences given that the risks of seeking care and the expectations around care varied significantly across the study sites.”

Looking ahead, “as we think about the United States and we see more and more bans and restrictions on abortion care going into effect, we will see people seeking abortion later into their pregnancies due to these additional barriers people have to overcome to get care,” said Dr. Moseson. “This need for abortion care later in pregnancy extends to self-managed medication abortion, and in that light, I find the results from this study to be reassuring.

“For people who for some reason or another can’t obtain pills until they are 12 or 13 or more weeks’ pregnant, these findings suggest that people can still safely use the pills on their own to end their pregnancy,” she said. Notably, “the participants in this study had high-quality information on how to take the pills, and phone-based counseling and support available to them throughout their abortion via the accompaniment groups, so ensuring that people who self-manage with pills have accurate, accessible information on how to use the pills and monitor for warning signs is also key. 

“Additional research is needed to understand the unique informational and support needs of people who are self-managing their abortions beyond 10 weeks of pregnancy,” Dr. Moseson said. “What information do they need and want to feel secure and safe, what resources do they need to protect themselves from legal risk, where and how can they safely access clinical care if needed? These sorts of practical questions feel urgent, and there is much that can be learned from the activist abortion accompaniment groups around the world that have been providing this sort of informational, emotional, and physical support to aborting people for decades.”
 

Rising rate of self-managed abortions highlights need for more data

“As abortion restrictions increase in the United States, more people may choose to self-manage their abortions,” Lauren Owens, MD, of the University of Washington, Seattle, said in an interview. “Worldwide, self-managed abortion with accompaniment has been shown to be noninferior to medication abortion involving clinical settings at gestational ages less than 9 weeks, as shown in the SAFE study. However, legal and other logistical barriers to care may mean that people can’t access abortion care until after 9 weeks, and we need more data about the effectiveness of these medications when used outside clinical settings.”

courtesy University of Washington

Dr. Owens was not surprised by the effectiveness of the medications to end pregnancies between 9 and 16 weeks’ gestation, with few needing follow-up care. However, “it makes sense that as gestational age increases, the percent of people seeking follow-up care also increases, even as it remains a minority of people,” she said.

The World Health Organization’s guidance on self-managed abortion, issued in 2022, was similar to the regimen in the current study, she added.“Self-managed abortion at home can be very safe and effective from 9-16 weeks’ gestation,” said Dr. Owens. “Having access to accompaniment or support, such as the Medication and Abortion Hotline in the United States, can help people through the process.”

According to a recent report, “more than half the abortions in the U.S. were done using medication in 2020, and protocols developed during the pandemic helped us see how safe medication abortion can be without in-person clinic visits,” Dr. Owens said. “I would encourage clinicians who view the 9.1% rate of need for further interventions (such as intravenous fluids, suction, transfusion) in this study as high to compare this to the rate of interventions and morbidity in ongoing pregnancy.”

According to data from the Centers for Disease Control and Prevention, the cesarean rate in the United States varies by state, but ranges from 21% to 35% of pregnancies; “some of the states with the highest cesarean rates are also those with the most abortion restrictions,” Dr. Owens said. “Abortion is generally safer than continuing pregnancy, and patients deserve access to safe options for abortion care and pregnancy care. Clinicians should know that patients can access these medications through Aid Access, accompaniment through the Miscarriage and Abortion Hotline, and legal advice through If/When/How.”

“We still need more data on self-managed abortion at higher gestational ages,” said Dr. Owens. “Few participants in the study were 14 or more weeks’ pregnant; also, despite the WHO recommendation against criminalization of self-managed abortion, we have seen criminalization for adverse pregnancy outcomes in the United States. As self-managed abortion may carry more legal than medical risks for people, creating and evaluating patient and clinician education to minimize that risk is important.”

The study was supported by the David and Lucile Packard Foundation; the researchers also received support for their time from a National Institutes of Health grant. The researchers had no financial conflicts to disclose. Dr. Owens had no financial conflicts to disclose.

Nearly 90% of women who self-managed medication abortion in pregnancies of 9-16 weeks’ gestation had complete abortions with no need for procedural intervention, based on data from more than 200 individuals.

Although most abortions happen within the first 9 weeks of pregnancy, it is important to understand the effectiveness of different models of care in a wider gestational range, corresponding author Heidi Moseson, PhD, of Ibis Reproductive Health in Oakland, Calif., said in an interview.

“There will always be people who need abortions after 9 weeks of pregnancy,” she said, whether because of delayed recognition of the pregnancy, changes in the pregnant person’s health, a fetal diagnosis, changes in life circumstances, time required to gather money, transportation to care, or other reasons.

“This study builds on prior research from the same SAFE study cohort that established self-managed medication abortion in the first 9 weeks of pregnancy as safe and effective, and noninferior to clinician-managed abortion,” Dr. Moseson said. “With this analysis, we wanted to explore whether self-managed medication abortion remained effective after 9 weeks of pregnancy, too.”

In the study, published in Obstetrics & Gynecology, Dr. Moseson and colleagues recruited 1,352 women who were initiating self-managed medication abortion through one of three abortion-accompaniment groups in Argentina, Nigeria, and Southeast Asia between 2019 and 2020. Of these, 264 were self-managing a medication abortion at 9 or more weeks’ gestation.

Participants completed a baseline phone survey before beginning the pill regimen, and follow-up surveys at 1 week and 3 weeks after taking the pills. The average age of the participants was 26 years; 75% were at 9-11 weeks’ gestation, 19.3% were at 12-14 weeks’ gestation, and 5.7% were at 15-22 weeks’ gestation. Slightly more than half of the participants (56.4%) used a combination of mifepristone plus misoprostol, and 43.6% used misoprostol only.

The primary outcome was abortion completion. Secondary outcomes included health care seeking and treatment as well as physical experiences.

A total of 89.4% of participants had an abortion completion without the need for procedural intervention. Another 5.3% had a complete abortion with manual vacuum aspiration or dilation and curettage, 4.9% had an incomplete abortion, and one patient reported no abortion outcome.

Of the participants who sought health care during or after the self-managed abortion, 15.9% sought to confirm abortion completion, and 9.1% needed additional medical intervention, including procedural evacuation, antibiotics, additional misoprostol, intravenous fluids, blood transfusion, or an overnight stay in the health care facility.

Overall, women who were at least 12 weeks pregnant were more likely to seek care at a clinic or hospital than those who were 9-11 weeks pregnant (adjusted relative risk, 1.62).

“Particularly in the United States, the [Food and Drug Administration] label only endorsed medication abortion use through 10 weeks of pregnancy; as a result, many people in the U.S. have the incorrect assumption that the pills are not effective after 10 weeks of pregnancy,” Dr. Moseson said. “This isn’t true. There is no magic line at 10 or 12 weeks after which the pills stop working – in fact, the uterus becomes more sensitive, not less, to misoprostol as a pregnancy progresses. This is why the misoprostol dose is reduced by half for abortions after 12-14 weeks or so.”

The findings were limited by several factors including the use of self-reports for gestational age and abortion outcome, without confirmation by ultrasonogram, the researchers noted. Other limitations included the inability to randomize participants to medication regimens because of legal restrictions on abortion access within the study sites, and the small number of participants (three) who underwent self-managed medication abortion at 17-22 weeks’ gestation.
 

Data support self-management medication abortion later in pregnancy

“Many people are not aware that there is a robust randomized clinical trial literature that demonstrates that both medication abortion regimens remain highly effective up to 24-28 weeks of pregnancy,” as well as a Cochrane review, Dr. Moseson said. “We know that when these pills are administered in a clinical setting well beyond 9 weeks of pregnancy, that they are highly effective and safe.

“We did not expect that the pills would work differently just because someone takes all doses at home, rather than just the second or third dose at home, as happens in most clinician-managed medication abortions,” she noted. However, “we were interested to see differences in likelihood of health care seeking during or after the abortion by country, but in some ways, also not surprised by these differences given that the risks of seeking care and the expectations around care varied significantly across the study sites.”

Looking ahead, “as we think about the United States and we see more and more bans and restrictions on abortion care going into effect, we will see people seeking abortion later into their pregnancies due to these additional barriers people have to overcome to get care,” said Dr. Moseson. “This need for abortion care later in pregnancy extends to self-managed medication abortion, and in that light, I find the results from this study to be reassuring.

“For people who for some reason or another can’t obtain pills until they are 12 or 13 or more weeks’ pregnant, these findings suggest that people can still safely use the pills on their own to end their pregnancy,” she said. Notably, “the participants in this study had high-quality information on how to take the pills, and phone-based counseling and support available to them throughout their abortion via the accompaniment groups, so ensuring that people who self-manage with pills have accurate, accessible information on how to use the pills and monitor for warning signs is also key. 

“Additional research is needed to understand the unique informational and support needs of people who are self-managing their abortions beyond 10 weeks of pregnancy,” Dr. Moseson said. “What information do they need and want to feel secure and safe, what resources do they need to protect themselves from legal risk, where and how can they safely access clinical care if needed? These sorts of practical questions feel urgent, and there is much that can be learned from the activist abortion accompaniment groups around the world that have been providing this sort of informational, emotional, and physical support to aborting people for decades.”
 

Rising rate of self-managed abortions highlights need for more data

“As abortion restrictions increase in the United States, more people may choose to self-manage their abortions,” Lauren Owens, MD, of the University of Washington, Seattle, said in an interview. “Worldwide, self-managed abortion with accompaniment has been shown to be noninferior to medication abortion involving clinical settings at gestational ages less than 9 weeks, as shown in the SAFE study. However, legal and other logistical barriers to care may mean that people can’t access abortion care until after 9 weeks, and we need more data about the effectiveness of these medications when used outside clinical settings.”

courtesy University of Washington

Dr. Owens was not surprised by the effectiveness of the medications to end pregnancies between 9 and 16 weeks’ gestation, with few needing follow-up care. However, “it makes sense that as gestational age increases, the percent of people seeking follow-up care also increases, even as it remains a minority of people,” she said.

The World Health Organization’s guidance on self-managed abortion, issued in 2022, was similar to the regimen in the current study, she added.“Self-managed abortion at home can be very safe and effective from 9-16 weeks’ gestation,” said Dr. Owens. “Having access to accompaniment or support, such as the Medication and Abortion Hotline in the United States, can help people through the process.”

According to a recent report, “more than half the abortions in the U.S. were done using medication in 2020, and protocols developed during the pandemic helped us see how safe medication abortion can be without in-person clinic visits,” Dr. Owens said. “I would encourage clinicians who view the 9.1% rate of need for further interventions (such as intravenous fluids, suction, transfusion) in this study as high to compare this to the rate of interventions and morbidity in ongoing pregnancy.”

According to data from the Centers for Disease Control and Prevention, the cesarean rate in the United States varies by state, but ranges from 21% to 35% of pregnancies; “some of the states with the highest cesarean rates are also those with the most abortion restrictions,” Dr. Owens said. “Abortion is generally safer than continuing pregnancy, and patients deserve access to safe options for abortion care and pregnancy care. Clinicians should know that patients can access these medications through Aid Access, accompaniment through the Miscarriage and Abortion Hotline, and legal advice through If/When/How.”

“We still need more data on self-managed abortion at higher gestational ages,” said Dr. Owens. “Few participants in the study were 14 or more weeks’ pregnant; also, despite the WHO recommendation against criminalization of self-managed abortion, we have seen criminalization for adverse pregnancy outcomes in the United States. As self-managed abortion may carry more legal than medical risks for people, creating and evaluating patient and clinician education to minimize that risk is important.”

The study was supported by the David and Lucile Packard Foundation; the researchers also received support for their time from a National Institutes of Health grant. The researchers had no financial conflicts to disclose. Dr. Owens had no financial conflicts to disclose.

Nearly 90% of women who self-managed medication abortion in pregnancies of 9-16 weeks’ gestation had complete abortions with no need for procedural intervention, based on data from more than 200 individuals.

Although most abortions happen within the first 9 weeks of pregnancy, it is important to understand the effectiveness of different models of care in a wider gestational range, corresponding author Heidi Moseson, PhD, of Ibis Reproductive Health in Oakland, Calif., said in an interview.

“There will always be people who need abortions after 9 weeks of pregnancy,” she said, whether because of delayed recognition of the pregnancy, changes in the pregnant person’s health, a fetal diagnosis, changes in life circumstances, time required to gather money, transportation to care, or other reasons.

“This study builds on prior research from the same SAFE study cohort that established self-managed medication abortion in the first 9 weeks of pregnancy as safe and effective, and noninferior to clinician-managed abortion,” Dr. Moseson said. “With this analysis, we wanted to explore whether self-managed medication abortion remained effective after 9 weeks of pregnancy, too.”

In the study, published in Obstetrics & Gynecology, Dr. Moseson and colleagues recruited 1,352 women who were initiating self-managed medication abortion through one of three abortion-accompaniment groups in Argentina, Nigeria, and Southeast Asia between 2019 and 2020. Of these, 264 were self-managing a medication abortion at 9 or more weeks’ gestation.

Participants completed a baseline phone survey before beginning the pill regimen, and follow-up surveys at 1 week and 3 weeks after taking the pills. The average age of the participants was 26 years; 75% were at 9-11 weeks’ gestation, 19.3% were at 12-14 weeks’ gestation, and 5.7% were at 15-22 weeks’ gestation. Slightly more than half of the participants (56.4%) used a combination of mifepristone plus misoprostol, and 43.6% used misoprostol only.

The primary outcome was abortion completion. Secondary outcomes included health care seeking and treatment as well as physical experiences.

A total of 89.4% of participants had an abortion completion without the need for procedural intervention. Another 5.3% had a complete abortion with manual vacuum aspiration or dilation and curettage, 4.9% had an incomplete abortion, and one patient reported no abortion outcome.

Of the participants who sought health care during or after the self-managed abortion, 15.9% sought to confirm abortion completion, and 9.1% needed additional medical intervention, including procedural evacuation, antibiotics, additional misoprostol, intravenous fluids, blood transfusion, or an overnight stay in the health care facility.

Overall, women who were at least 12 weeks pregnant were more likely to seek care at a clinic or hospital than those who were 9-11 weeks pregnant (adjusted relative risk, 1.62).

“Particularly in the United States, the [Food and Drug Administration] label only endorsed medication abortion use through 10 weeks of pregnancy; as a result, many people in the U.S. have the incorrect assumption that the pills are not effective after 10 weeks of pregnancy,” Dr. Moseson said. “This isn’t true. There is no magic line at 10 or 12 weeks after which the pills stop working – in fact, the uterus becomes more sensitive, not less, to misoprostol as a pregnancy progresses. This is why the misoprostol dose is reduced by half for abortions after 12-14 weeks or so.”

The findings were limited by several factors including the use of self-reports for gestational age and abortion outcome, without confirmation by ultrasonogram, the researchers noted. Other limitations included the inability to randomize participants to medication regimens because of legal restrictions on abortion access within the study sites, and the small number of participants (three) who underwent self-managed medication abortion at 17-22 weeks’ gestation.
 

Data support self-management medication abortion later in pregnancy

“Many people are not aware that there is a robust randomized clinical trial literature that demonstrates that both medication abortion regimens remain highly effective up to 24-28 weeks of pregnancy,” as well as a Cochrane review, Dr. Moseson said. “We know that when these pills are administered in a clinical setting well beyond 9 weeks of pregnancy, that they are highly effective and safe.

“We did not expect that the pills would work differently just because someone takes all doses at home, rather than just the second or third dose at home, as happens in most clinician-managed medication abortions,” she noted. However, “we were interested to see differences in likelihood of health care seeking during or after the abortion by country, but in some ways, also not surprised by these differences given that the risks of seeking care and the expectations around care varied significantly across the study sites.”

Looking ahead, “as we think about the United States and we see more and more bans and restrictions on abortion care going into effect, we will see people seeking abortion later into their pregnancies due to these additional barriers people have to overcome to get care,” said Dr. Moseson. “This need for abortion care later in pregnancy extends to self-managed medication abortion, and in that light, I find the results from this study to be reassuring.

“For people who for some reason or another can’t obtain pills until they are 12 or 13 or more weeks’ pregnant, these findings suggest that people can still safely use the pills on their own to end their pregnancy,” she said. Notably, “the participants in this study had high-quality information on how to take the pills, and phone-based counseling and support available to them throughout their abortion via the accompaniment groups, so ensuring that people who self-manage with pills have accurate, accessible information on how to use the pills and monitor for warning signs is also key. 

“Additional research is needed to understand the unique informational and support needs of people who are self-managing their abortions beyond 10 weeks of pregnancy,” Dr. Moseson said. “What information do they need and want to feel secure and safe, what resources do they need to protect themselves from legal risk, where and how can they safely access clinical care if needed? These sorts of practical questions feel urgent, and there is much that can be learned from the activist abortion accompaniment groups around the world that have been providing this sort of informational, emotional, and physical support to aborting people for decades.”
 

Rising rate of self-managed abortions highlights need for more data

“As abortion restrictions increase in the United States, more people may choose to self-manage their abortions,” Lauren Owens, MD, of the University of Washington, Seattle, said in an interview. “Worldwide, self-managed abortion with accompaniment has been shown to be noninferior to medication abortion involving clinical settings at gestational ages less than 9 weeks, as shown in the SAFE study. However, legal and other logistical barriers to care may mean that people can’t access abortion care until after 9 weeks, and we need more data about the effectiveness of these medications when used outside clinical settings.”

courtesy University of Washington

Dr. Owens was not surprised by the effectiveness of the medications to end pregnancies between 9 and 16 weeks’ gestation, with few needing follow-up care. However, “it makes sense that as gestational age increases, the percent of people seeking follow-up care also increases, even as it remains a minority of people,” she said.

The World Health Organization’s guidance on self-managed abortion, issued in 2022, was similar to the regimen in the current study, she added.“Self-managed abortion at home can be very safe and effective from 9-16 weeks’ gestation,” said Dr. Owens. “Having access to accompaniment or support, such as the Medication and Abortion Hotline in the United States, can help people through the process.”

According to a recent report, “more than half the abortions in the U.S. were done using medication in 2020, and protocols developed during the pandemic helped us see how safe medication abortion can be without in-person clinic visits,” Dr. Owens said. “I would encourage clinicians who view the 9.1% rate of need for further interventions (such as intravenous fluids, suction, transfusion) in this study as high to compare this to the rate of interventions and morbidity in ongoing pregnancy.”

According to data from the Centers for Disease Control and Prevention, the cesarean rate in the United States varies by state, but ranges from 21% to 35% of pregnancies; “some of the states with the highest cesarean rates are also those with the most abortion restrictions,” Dr. Owens said. “Abortion is generally safer than continuing pregnancy, and patients deserve access to safe options for abortion care and pregnancy care. Clinicians should know that patients can access these medications through Aid Access, accompaniment through the Miscarriage and Abortion Hotline, and legal advice through If/When/How.”

“We still need more data on self-managed abortion at higher gestational ages,” said Dr. Owens. “Few participants in the study were 14 or more weeks’ pregnant; also, despite the WHO recommendation against criminalization of self-managed abortion, we have seen criminalization for adverse pregnancy outcomes in the United States. As self-managed abortion may carry more legal than medical risks for people, creating and evaluating patient and clinician education to minimize that risk is important.”

The study was supported by the David and Lucile Packard Foundation; the researchers also received support for their time from a National Institutes of Health grant. The researchers had no financial conflicts to disclose. Dr. Owens had no financial conflicts to disclose.

Significant reductions in hemoglobin A1c have occurred over time among adults with type 1 diabetes as their use of diabetes technology has increased, yet there is still room for improvement, new data suggest.

The new findings are from a study involving patients at the Barbara Davis Center for Diabetes Adult Clinic between Jan. 1, 2014, and Dec. 31, 2021. They show that as technology use has increased, A1c levels have dropped in parallel. Moreover, progression from use of stand-alone continuous glucose monitors (CGMs) to automated insulin delivery systems (AIDs), which comprise insulin pumps and connected CGMs, furthered that progress.

The findings “are in agreement with American Diabetes Association standards of care, and recent international consensus recommending CGM and AID for most people with type 1 diabetes, and early initiation of diabetes technology from the onset of type 1 diabetes,” write Kagan E. Karakus, MD, of the University of Colorado’s Barbara Davis Center, Aurora, and colleagues in the article, which was published online in Diabetes Care.

“It’s very rewarding to us. We can see clearly that the uptake is going up and the A1c is dropping,” lead author Viral N. Shah, MD, of the Barbara Davis Center, told this news organization.

On the flip side, A1c levels rose significantly over the study period among nonusers of technology. “We cannot rule out provider bias for not prescribing diabetes technology among those with higher A1c or from disadvantaged socioeconomic backgrounds,” Dr. Karakus and colleagues write.

Also of note, even with use of the most advanced AID systems available during the study period, just under half of patients were still not achieving A1c levels below 7%. “The technology helps, but it’s not perfect,” Dr. Shah observed.

This study is the first to examine the relationship of A1c with technology use over time, in contrast to prior cross-sectional studies. “The intention here was to look at the landscape over a decade,” Dr. Shah said.
 

As overall use of technology use rose, A1c levels fell

The analysis included data for 4,174 unique patients (mean number of patients, 1,988/yr); 15,903 clinic visits were included over the 8-year study period. Technology use was defined as CGM use without an AID system or with an AID system.

Over the study period, diabetes technology use increased from 26.9% to 82.7% of the clinic population (P < .001). At the same time, the overall proportion patients who achieved the A1c goal of less than 7% increased from 32.3% to 41.7%, while the mean A1c level dropped from 7.7% to 7.5% (P < .001).

But among the technology nonusers, A1c rose from 7.85% in 2014 to 8.4% in 2021 (P < .001).

Regardless of diabetes technology use, White patients (about 80% of the total study population) had significantly lower A1c than non-White patients (7.5% vs. 7.7% for technology users [P = .02]; 8.0% vs. 8.3% for nontechnology users [P < .001]).

The non-White group was too small to enable the researchers to break down the data by technology type. Nonetheless, Dr. Shah said, “As a clinician, I can say that the penetration of diabetes technology in non-White populations remains low. These are also the people more vulnerable for socioeconomic and psychosocial reasons.”

The A1c increase among technology nonusers may be a result of a statistical artifact, as the number of those individuals was much lower in 2021 than in 2014. It’s possible that those remaining individuals have exceedingly high A1c levels, bringing the average up. “It’s still not good, though,” Dr. Shah said.
 

The more technology, the lower the A1c

Over the study period, the proportion of stand-alone CGM users rose from 26.9% to 44.1%, while use of AIDs rose from 0% in 2014 and 2015 to 38.6% in 2021. The latter group included patients who used first-generation Medtronic 670G and 770G devices and second-generation Tandem t:slim X2 with Control-IQ devices.

Between 2017 and 2021, AIDs users had significantly lower A1c levels than nontechnology users: 7.4% vs. 8.1% in 2017, and 7.3% vs. 8.4% in 2021 (P < .001 for every year). CGM users also had significantly lower A1c levels than nonusers at all time points (P < .001 per year).

The proportions achieving an A1c less than 7% differed significantly across users of CGMs, AIDs, and no technology (P < .01 for all years). In 2021, the percentage of people who achieved an A1c less than 7% were 50.9% with AIDs and 44.1% for CGMs vs, just 15.2% with no technology.
 

Work to be done: Why aren’t more achieving < 7% with AIDs?

Asked why only slightly more than half of patients who used AIDs achieved A1c levels below 7%, Dr. Shah listed three possibilities:

First, the 7% goal doesn’t apply to everyone with type 1 diabetes, including those with multiple comorbidities or with short life expectancy, for whom the recommended goal is 7.5%-8.0% to prevent hypoglycemia. “We didn’t separate out patients by A1c goals. If we add that, the number might go up,” Dr. Shah said.

Second, AID technology is continually improving, but it’s not perfect. Users still must enter carbohydrate counts and signal the devices for exercise, which can lead to errors. “It’s a wonderful technology for overnight control, but still, during the daytime, there are so many factors with the user interface and how much a person is engaged with the technology,” Dr. Shah explained.

Third, he said, “Unfortunately, obesity is increasing in type 1 diabetes, and insulin doses are increasing. Higher BMI [body mass index] and more insulin resistance can mean higher A1c. I really think for many patients, we probably will need an adjunct therapy, such as an SGLT2 [sodium-glucose cotransporter-2] inhibitor or a GLP-1 [glucagonlike peptide-1] agonist, even though they’re not approved in type 1 diabetes, for both glycemic and metabolic control including weight. I think that’s another missing piece.”

He also pointed out, “If someone has an A1c of 7.5%, I don’t expect a huge change. But if they’re at 10%, a drop to 8% is a huge change.”

Overall, Dr. Shah said, the news from the study is good. “In the past, only 30% were achieving an A1c less than 7%. Now we’re 20% above that. ... It’s a glass half full.”

Dr. Karakus has disclosed no relevant financial relationships. Dr. Shah has received, through the University of Colorado, research support from Novo Nordisk, Insulet, Tandem Diabetes, and Dexcom, and honoraria from Medscape, Lifescan, Novo Nordisk, and DKSH Singapore for advisory board attendance and from Insulet and Dexcom for speaking engagements.

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

Significant reductions in hemoglobin A1c have occurred over time among adults with type 1 diabetes as their use of diabetes technology has increased, yet there is still room for improvement, new data suggest.

The new findings are from a study involving patients at the Barbara Davis Center for Diabetes Adult Clinic between Jan. 1, 2014, and Dec. 31, 2021. They show that as technology use has increased, A1c levels have dropped in parallel. Moreover, progression from use of stand-alone continuous glucose monitors (CGMs) to automated insulin delivery systems (AIDs), which comprise insulin pumps and connected CGMs, furthered that progress.

The findings “are in agreement with American Diabetes Association standards of care, and recent international consensus recommending CGM and AID for most people with type 1 diabetes, and early initiation of diabetes technology from the onset of type 1 diabetes,” write Kagan E. Karakus, MD, of the University of Colorado’s Barbara Davis Center, Aurora, and colleagues in the article, which was published online in Diabetes Care.

“It’s very rewarding to us. We can see clearly that the uptake is going up and the A1c is dropping,” lead author Viral N. Shah, MD, of the Barbara Davis Center, told this news organization.

On the flip side, A1c levels rose significantly over the study period among nonusers of technology. “We cannot rule out provider bias for not prescribing diabetes technology among those with higher A1c or from disadvantaged socioeconomic backgrounds,” Dr. Karakus and colleagues write.

Also of note, even with use of the most advanced AID systems available during the study period, just under half of patients were still not achieving A1c levels below 7%. “The technology helps, but it’s not perfect,” Dr. Shah observed.

This study is the first to examine the relationship of A1c with technology use over time, in contrast to prior cross-sectional studies. “The intention here was to look at the landscape over a decade,” Dr. Shah said.
 

As overall use of technology use rose, A1c levels fell

The analysis included data for 4,174 unique patients (mean number of patients, 1,988/yr); 15,903 clinic visits were included over the 8-year study period. Technology use was defined as CGM use without an AID system or with an AID system.

Over the study period, diabetes technology use increased from 26.9% to 82.7% of the clinic population (P < .001). At the same time, the overall proportion patients who achieved the A1c goal of less than 7% increased from 32.3% to 41.7%, while the mean A1c level dropped from 7.7% to 7.5% (P < .001).

But among the technology nonusers, A1c rose from 7.85% in 2014 to 8.4% in 2021 (P < .001).

Regardless of diabetes technology use, White patients (about 80% of the total study population) had significantly lower A1c than non-White patients (7.5% vs. 7.7% for technology users [P = .02]; 8.0% vs. 8.3% for nontechnology users [P < .001]).

The non-White group was too small to enable the researchers to break down the data by technology type. Nonetheless, Dr. Shah said, “As a clinician, I can say that the penetration of diabetes technology in non-White populations remains low. These are also the people more vulnerable for socioeconomic and psychosocial reasons.”

The A1c increase among technology nonusers may be a result of a statistical artifact, as the number of those individuals was much lower in 2021 than in 2014. It’s possible that those remaining individuals have exceedingly high A1c levels, bringing the average up. “It’s still not good, though,” Dr. Shah said.
 

The more technology, the lower the A1c

Over the study period, the proportion of stand-alone CGM users rose from 26.9% to 44.1%, while use of AIDs rose from 0% in 2014 and 2015 to 38.6% in 2021. The latter group included patients who used first-generation Medtronic 670G and 770G devices and second-generation Tandem t:slim X2 with Control-IQ devices.

Between 2017 and 2021, AIDs users had significantly lower A1c levels than nontechnology users: 7.4% vs. 8.1% in 2017, and 7.3% vs. 8.4% in 2021 (P < .001 for every year). CGM users also had significantly lower A1c levels than nonusers at all time points (P < .001 per year).

The proportions achieving an A1c less than 7% differed significantly across users of CGMs, AIDs, and no technology (P < .01 for all years). In 2021, the percentage of people who achieved an A1c less than 7% were 50.9% with AIDs and 44.1% for CGMs vs, just 15.2% with no technology.
 

Work to be done: Why aren’t more achieving < 7% with AIDs?

Asked why only slightly more than half of patients who used AIDs achieved A1c levels below 7%, Dr. Shah listed three possibilities:

First, the 7% goal doesn’t apply to everyone with type 1 diabetes, including those with multiple comorbidities or with short life expectancy, for whom the recommended goal is 7.5%-8.0% to prevent hypoglycemia. “We didn’t separate out patients by A1c goals. If we add that, the number might go up,” Dr. Shah said.

Second, AID technology is continually improving, but it’s not perfect. Users still must enter carbohydrate counts and signal the devices for exercise, which can lead to errors. “It’s a wonderful technology for overnight control, but still, during the daytime, there are so many factors with the user interface and how much a person is engaged with the technology,” Dr. Shah explained.

Third, he said, “Unfortunately, obesity is increasing in type 1 diabetes, and insulin doses are increasing. Higher BMI [body mass index] and more insulin resistance can mean higher A1c. I really think for many patients, we probably will need an adjunct therapy, such as an SGLT2 [sodium-glucose cotransporter-2] inhibitor or a GLP-1 [glucagonlike peptide-1] agonist, even though they’re not approved in type 1 diabetes, for both glycemic and metabolic control including weight. I think that’s another missing piece.”

He also pointed out, “If someone has an A1c of 7.5%, I don’t expect a huge change. But if they’re at 10%, a drop to 8% is a huge change.”

Overall, Dr. Shah said, the news from the study is good. “In the past, only 30% were achieving an A1c less than 7%. Now we’re 20% above that. ... It’s a glass half full.”

Dr. Karakus has disclosed no relevant financial relationships. Dr. Shah has received, through the University of Colorado, research support from Novo Nordisk, Insulet, Tandem Diabetes, and Dexcom, and honoraria from Medscape, Lifescan, Novo Nordisk, and DKSH Singapore for advisory board attendance and from Insulet and Dexcom for speaking engagements.

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

Significant reductions in hemoglobin A1c have occurred over time among adults with type 1 diabetes as their use of diabetes technology has increased, yet there is still room for improvement, new data suggest.

The new findings are from a study involving patients at the Barbara Davis Center for Diabetes Adult Clinic between Jan. 1, 2014, and Dec. 31, 2021. They show that as technology use has increased, A1c levels have dropped in parallel. Moreover, progression from use of stand-alone continuous glucose monitors (CGMs) to automated insulin delivery systems (AIDs), which comprise insulin pumps and connected CGMs, furthered that progress.

The findings “are in agreement with American Diabetes Association standards of care, and recent international consensus recommending CGM and AID for most people with type 1 diabetes, and early initiation of diabetes technology from the onset of type 1 diabetes,” write Kagan E. Karakus, MD, of the University of Colorado’s Barbara Davis Center, Aurora, and colleagues in the article, which was published online in Diabetes Care.

“It’s very rewarding to us. We can see clearly that the uptake is going up and the A1c is dropping,” lead author Viral N. Shah, MD, of the Barbara Davis Center, told this news organization.

On the flip side, A1c levels rose significantly over the study period among nonusers of technology. “We cannot rule out provider bias for not prescribing diabetes technology among those with higher A1c or from disadvantaged socioeconomic backgrounds,” Dr. Karakus and colleagues write.

Also of note, even with use of the most advanced AID systems available during the study period, just under half of patients were still not achieving A1c levels below 7%. “The technology helps, but it’s not perfect,” Dr. Shah observed.

This study is the first to examine the relationship of A1c with technology use over time, in contrast to prior cross-sectional studies. “The intention here was to look at the landscape over a decade,” Dr. Shah said.
 

As overall use of technology use rose, A1c levels fell

The analysis included data for 4,174 unique patients (mean number of patients, 1,988/yr); 15,903 clinic visits were included over the 8-year study period. Technology use was defined as CGM use without an AID system or with an AID system.

Over the study period, diabetes technology use increased from 26.9% to 82.7% of the clinic population (P < .001). At the same time, the overall proportion patients who achieved the A1c goal of less than 7% increased from 32.3% to 41.7%, while the mean A1c level dropped from 7.7% to 7.5% (P < .001).

But among the technology nonusers, A1c rose from 7.85% in 2014 to 8.4% in 2021 (P < .001).

Regardless of diabetes technology use, White patients (about 80% of the total study population) had significantly lower A1c than non-White patients (7.5% vs. 7.7% for technology users [P = .02]; 8.0% vs. 8.3% for nontechnology users [P < .001]).

The non-White group was too small to enable the researchers to break down the data by technology type. Nonetheless, Dr. Shah said, “As a clinician, I can say that the penetration of diabetes technology in non-White populations remains low. These are also the people more vulnerable for socioeconomic and psychosocial reasons.”

The A1c increase among technology nonusers may be a result of a statistical artifact, as the number of those individuals was much lower in 2021 than in 2014. It’s possible that those remaining individuals have exceedingly high A1c levels, bringing the average up. “It’s still not good, though,” Dr. Shah said.
 

The more technology, the lower the A1c

Over the study period, the proportion of stand-alone CGM users rose from 26.9% to 44.1%, while use of AIDs rose from 0% in 2014 and 2015 to 38.6% in 2021. The latter group included patients who used first-generation Medtronic 670G and 770G devices and second-generation Tandem t:slim X2 with Control-IQ devices.

Between 2017 and 2021, AIDs users had significantly lower A1c levels than nontechnology users: 7.4% vs. 8.1% in 2017, and 7.3% vs. 8.4% in 2021 (P < .001 for every year). CGM users also had significantly lower A1c levels than nonusers at all time points (P < .001 per year).

The proportions achieving an A1c less than 7% differed significantly across users of CGMs, AIDs, and no technology (P < .01 for all years). In 2021, the percentage of people who achieved an A1c less than 7% were 50.9% with AIDs and 44.1% for CGMs vs, just 15.2% with no technology.
 

Work to be done: Why aren’t more achieving < 7% with AIDs?

Asked why only slightly more than half of patients who used AIDs achieved A1c levels below 7%, Dr. Shah listed three possibilities:

First, the 7% goal doesn’t apply to everyone with type 1 diabetes, including those with multiple comorbidities or with short life expectancy, for whom the recommended goal is 7.5%-8.0% to prevent hypoglycemia. “We didn’t separate out patients by A1c goals. If we add that, the number might go up,” Dr. Shah said.

Second, AID technology is continually improving, but it’s not perfect. Users still must enter carbohydrate counts and signal the devices for exercise, which can lead to errors. “It’s a wonderful technology for overnight control, but still, during the daytime, there are so many factors with the user interface and how much a person is engaged with the technology,” Dr. Shah explained.

Third, he said, “Unfortunately, obesity is increasing in type 1 diabetes, and insulin doses are increasing. Higher BMI [body mass index] and more insulin resistance can mean higher A1c. I really think for many patients, we probably will need an adjunct therapy, such as an SGLT2 [sodium-glucose cotransporter-2] inhibitor or a GLP-1 [glucagonlike peptide-1] agonist, even though they’re not approved in type 1 diabetes, for both glycemic and metabolic control including weight. I think that’s another missing piece.”

He also pointed out, “If someone has an A1c of 7.5%, I don’t expect a huge change. But if they’re at 10%, a drop to 8% is a huge change.”

Overall, Dr. Shah said, the news from the study is good. “In the past, only 30% were achieving an A1c less than 7%. Now we’re 20% above that. ... It’s a glass half full.”

Dr. Karakus has disclosed no relevant financial relationships. Dr. Shah has received, through the University of Colorado, research support from Novo Nordisk, Insulet, Tandem Diabetes, and Dexcom, and honoraria from Medscape, Lifescan, Novo Nordisk, and DKSH Singapore for advisory board attendance and from Insulet and Dexcom for speaking engagements.

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

The Food and Drug Administration’s Circulatory System Devices Panel has deemed the ReCor Paradise Ultrasound Renal Denervation (uRDN) System safe and effective in lowering blood pressure for adults with uncontrolled hypertension who may be inadequately responsive to, or who are intolerant of, antihypertensive medications.

The device is intended to be used in renal arteries with diameters of 3.0 to 8.0 mm.

Olivier Le Moal/Getty Images

After hearing data from three trials, RADIANCE-HTN SOLO, RADIANCE II, and RADIANCE-HTN TRIO, the 12-member panel unanimously agreed that there was “reasonable assurance” that the ReCor Paradise Ultrasound Renal Denervation System (ReCor Medical) was safe.

However, while most of the panel felt the device was effective, a few disagreed.

Keith Allen, MD, director of surgical research for the Mid-America Heart and Lung Surgeons, Kansas City, Mo., who was one of the three panel members who voted no regarding efficacy, stated that he had concerns about the duration and the degree of efficacy shown in the trials.

Mark Lockhart, MD, University of Alabama, Birmingham, also voted no. “I do think there was an effect for 2 months, but the duration of that positive effect appears to decline after that period of time.”

Benjamin Saville, PhD, echoed Dr. Lockhart’s concern: “The benefit is more short term, it is unclear what the long term benefit would be.”

Data from all three trials showed a significant drop in blood pressure with the device compared with pharmacologic therapy, but after 2 months of follow-up, that advantage disappeared.

The FDA highlighted data from the trials that showed that at 2 months, uRDN patients experienced significant reductions in systolic blood pressure compared with those treated with a sham device; however, by 6 months, there was a difference of only 1 mm Hg between the two groups.

“It seems when I look at 6 months and 12 months, the benefit is very tiny. We know the safety is fine, but a benefit of less than 1 mm Hg difference would not make me want to have an intervention,” said statistician Janet Wittes, PhD.

“I think the device is efficacious, even though there is not much difference between sham and treatment, but a big issue is the fact that half of our patients are not compliant. That will make the benefits over sham more clear,” noted Jim Blankenship, MD, professor of medicine and director of the division of cardiology at the University of New Mexico in Albuquerque.

John Hirshfeld Jr., MD, professor emeritus of medicine at the University of Pennsylvania, Philadelphia, said he voted yes on safety and efficacy but admitted he had some misgivings. “The sample size was small, but it is a novel tool to add to our tool box, and hopefully it will be used responsibly,” he said.

John Somberg, MD, professor emeritus of medicine, cardiology, and pharmacology, Rush University, Chicago, said the data on this procedure show “that antihypertensive medication works. Denervation is not superior to medications. It lowers blood pressure and is persistent, but when you can take the sham group to almost as good control as you get in the denervation group, that shows it can also be done with medicines.”

The panel wants to see results from additional studies in important subpopulations who are affected by hypertension, including Black people, women, the elderly, and people who already have cardiovascular risk factors, such as diabetes and heart failure.

Deneen Hesser, RN, the panel’s patient representative, called for any postmarketing studies that may be conducted by ReCor to include a good patient education program and also a way of documenting patient-reported outcomes.

“This would help us ascertain how happy people were if they were able to reduce their medication burden by, for example, one drug, or if they were willing to undergo a procedure to be able to stop taking so many antihypertensive medications,” she said.

The panel will meet again to review data on Medtronic’s Simplicity Spyral Renal Denervation System, which is also for patients with uncontrolled hypertension.
 

A version of this article appeared on Medscape.com.

The Food and Drug Administration’s Circulatory System Devices Panel has deemed the ReCor Paradise Ultrasound Renal Denervation (uRDN) System safe and effective in lowering blood pressure for adults with uncontrolled hypertension who may be inadequately responsive to, or who are intolerant of, antihypertensive medications.

The device is intended to be used in renal arteries with diameters of 3.0 to 8.0 mm.

Olivier Le Moal/Getty Images

After hearing data from three trials, RADIANCE-HTN SOLO, RADIANCE II, and RADIANCE-HTN TRIO, the 12-member panel unanimously agreed that there was “reasonable assurance” that the ReCor Paradise Ultrasound Renal Denervation System (ReCor Medical) was safe.

However, while most of the panel felt the device was effective, a few disagreed.

Keith Allen, MD, director of surgical research for the Mid-America Heart and Lung Surgeons, Kansas City, Mo., who was one of the three panel members who voted no regarding efficacy, stated that he had concerns about the duration and the degree of efficacy shown in the trials.

Mark Lockhart, MD, University of Alabama, Birmingham, also voted no. “I do think there was an effect for 2 months, but the duration of that positive effect appears to decline after that period of time.”

Benjamin Saville, PhD, echoed Dr. Lockhart’s concern: “The benefit is more short term, it is unclear what the long term benefit would be.”

Data from all three trials showed a significant drop in blood pressure with the device compared with pharmacologic therapy, but after 2 months of follow-up, that advantage disappeared.

The FDA highlighted data from the trials that showed that at 2 months, uRDN patients experienced significant reductions in systolic blood pressure compared with those treated with a sham device; however, by 6 months, there was a difference of only 1 mm Hg between the two groups.

“It seems when I look at 6 months and 12 months, the benefit is very tiny. We know the safety is fine, but a benefit of less than 1 mm Hg difference would not make me want to have an intervention,” said statistician Janet Wittes, PhD.

“I think the device is efficacious, even though there is not much difference between sham and treatment, but a big issue is the fact that half of our patients are not compliant. That will make the benefits over sham more clear,” noted Jim Blankenship, MD, professor of medicine and director of the division of cardiology at the University of New Mexico in Albuquerque.

John Hirshfeld Jr., MD, professor emeritus of medicine at the University of Pennsylvania, Philadelphia, said he voted yes on safety and efficacy but admitted he had some misgivings. “The sample size was small, but it is a novel tool to add to our tool box, and hopefully it will be used responsibly,” he said.

John Somberg, MD, professor emeritus of medicine, cardiology, and pharmacology, Rush University, Chicago, said the data on this procedure show “that antihypertensive medication works. Denervation is not superior to medications. It lowers blood pressure and is persistent, but when you can take the sham group to almost as good control as you get in the denervation group, that shows it can also be done with medicines.”

The panel wants to see results from additional studies in important subpopulations who are affected by hypertension, including Black people, women, the elderly, and people who already have cardiovascular risk factors, such as diabetes and heart failure.

Deneen Hesser, RN, the panel’s patient representative, called for any postmarketing studies that may be conducted by ReCor to include a good patient education program and also a way of documenting patient-reported outcomes.

“This would help us ascertain how happy people were if they were able to reduce their medication burden by, for example, one drug, or if they were willing to undergo a procedure to be able to stop taking so many antihypertensive medications,” she said.

The panel will meet again to review data on Medtronic’s Simplicity Spyral Renal Denervation System, which is also for patients with uncontrolled hypertension.
 

A version of this article appeared on Medscape.com.

The Food and Drug Administration’s Circulatory System Devices Panel has deemed the ReCor Paradise Ultrasound Renal Denervation (uRDN) System safe and effective in lowering blood pressure for adults with uncontrolled hypertension who may be inadequately responsive to, or who are intolerant of, antihypertensive medications.

The device is intended to be used in renal arteries with diameters of 3.0 to 8.0 mm.

Olivier Le Moal/Getty Images

After hearing data from three trials, RADIANCE-HTN SOLO, RADIANCE II, and RADIANCE-HTN TRIO, the 12-member panel unanimously agreed that there was “reasonable assurance” that the ReCor Paradise Ultrasound Renal Denervation System (ReCor Medical) was safe.

However, while most of the panel felt the device was effective, a few disagreed.

Keith Allen, MD, director of surgical research for the Mid-America Heart and Lung Surgeons, Kansas City, Mo., who was one of the three panel members who voted no regarding efficacy, stated that he had concerns about the duration and the degree of efficacy shown in the trials.

Mark Lockhart, MD, University of Alabama, Birmingham, also voted no. “I do think there was an effect for 2 months, but the duration of that positive effect appears to decline after that period of time.”

Benjamin Saville, PhD, echoed Dr. Lockhart’s concern: “The benefit is more short term, it is unclear what the long term benefit would be.”

Data from all three trials showed a significant drop in blood pressure with the device compared with pharmacologic therapy, but after 2 months of follow-up, that advantage disappeared.

The FDA highlighted data from the trials that showed that at 2 months, uRDN patients experienced significant reductions in systolic blood pressure compared with those treated with a sham device; however, by 6 months, there was a difference of only 1 mm Hg between the two groups.

“It seems when I look at 6 months and 12 months, the benefit is very tiny. We know the safety is fine, but a benefit of less than 1 mm Hg difference would not make me want to have an intervention,” said statistician Janet Wittes, PhD.

“I think the device is efficacious, even though there is not much difference between sham and treatment, but a big issue is the fact that half of our patients are not compliant. That will make the benefits over sham more clear,” noted Jim Blankenship, MD, professor of medicine and director of the division of cardiology at the University of New Mexico in Albuquerque.

John Hirshfeld Jr., MD, professor emeritus of medicine at the University of Pennsylvania, Philadelphia, said he voted yes on safety and efficacy but admitted he had some misgivings. “The sample size was small, but it is a novel tool to add to our tool box, and hopefully it will be used responsibly,” he said.

John Somberg, MD, professor emeritus of medicine, cardiology, and pharmacology, Rush University, Chicago, said the data on this procedure show “that antihypertensive medication works. Denervation is not superior to medications. It lowers blood pressure and is persistent, but when you can take the sham group to almost as good control as you get in the denervation group, that shows it can also be done with medicines.”

The panel wants to see results from additional studies in important subpopulations who are affected by hypertension, including Black people, women, the elderly, and people who already have cardiovascular risk factors, such as diabetes and heart failure.

Deneen Hesser, RN, the panel’s patient representative, called for any postmarketing studies that may be conducted by ReCor to include a good patient education program and also a way of documenting patient-reported outcomes.

“This would help us ascertain how happy people were if they were able to reduce their medication burden by, for example, one drug, or if they were willing to undergo a procedure to be able to stop taking so many antihypertensive medications,” she said.

The panel will meet again to review data on Medtronic’s Simplicity Spyral Renal Denervation System, which is also for patients with uncontrolled hypertension.
 

A version of this article appeared on Medscape.com.

The latest results of the Monitoring the Future (MTF) longitudinal survey show that American adults are consuming marijuana and hallucinogens, vaping, and binge drinking at historic levels.

“In 2022, we are seeing that marijuana and hallucinogen use, and vaping of nicotine and marijuana, are higher than ever among young adults ages 19-30,” said Megan Patrick, research professor and principal investigator of the MTF study. “In addition, midlife adults ages 35-50 have the highest level of binge drinking we have ever seen in that age group,” she said in a statement.

The survey, conducted annually since 1975 by the University of Michigan’s Institute for Social Research, Ann Arbor, queries nationally representative samples of 8th, 10th, and 12th graders and then follows a subset through adulthood to come up with longitudinal data. It is funded by the National Institute on Drug Abuse.

The adult data for 2022 were gathered by online and paper surveys from April to October 2022 and included responses from some 10,000 individuals. Participants were divided into two cohorts: those aged 19-30 years and those aged 35-50 years.

About a third of the older age group reported using marijuana in the past year, an all-time high, up from 25% in 2021 and more than double the users in 2012 (13%). Of this group, 4% reported past-year hallucinogen use, also a record high and double the reported use in 2021.

Alcohol use among adults aged 35-50 has gradually increased over the past decade. Of this group, 85% reported past-year drinking in 2022, up from 83% in 2012.

Binge drinking – defined as having five or more drinks in a row in the past 2 weeks – has also been on the rise in the past decade. One-third of older adults reported binge drinking in 2022. Binge drinking was highest among White (31.4%) and Hispanic (30.6%) midlife adults and was lower among Black (17.1%) midlife adults.

Vaping among the older age cohort has remained at similar levels since first measured in 2019; 9% vaped marijuana in the past year, while 7% vaped nicotine.
 

Marijuana popular among younger Americans

“In 2022, marijuana use among young adults reached the highest levels ever recorded since the indices were first available in 1988,” the study authors write. Both past-year and daily use hit record levels for the cohort of those aged 19-30.

Forty-four percent reported past-year marijuana use, up from 28% in 2012. The highest levels of use were in those aged 27-28. One in five reported daily use, up from 6% a decade ago; almost 14% of 23- to 24-year-olds reported daily use.

Past-year use of hallucinogens – including LSD, MDMA, mescaline, peyote, mushrooms or psilocybin, and PCP – was reported by 8% of this age group. Most of the increase was driven by use of hallucinogens other than LSD, which accounted for 7% of the reported use.

Young adults also reported record levels of vaping marijuana, with 21% reporting past-year use and 14% reporting past-month use. Vaping of nicotine has doubled in prevalence since the survey started asking about it, from 14% for past-year use in 2017 to 24% in 2022.

NIDA Director Nora Volkow, MD, noted in a statement that the survey results show that “substance use is not limited to teens and young adults,” adding that “these data help us understand how people use drugs across the lifespan.”

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

The latest results of the Monitoring the Future (MTF) longitudinal survey show that American adults are consuming marijuana and hallucinogens, vaping, and binge drinking at historic levels.

“In 2022, we are seeing that marijuana and hallucinogen use, and vaping of nicotine and marijuana, are higher than ever among young adults ages 19-30,” said Megan Patrick, research professor and principal investigator of the MTF study. “In addition, midlife adults ages 35-50 have the highest level of binge drinking we have ever seen in that age group,” she said in a statement.

The survey, conducted annually since 1975 by the University of Michigan’s Institute for Social Research, Ann Arbor, queries nationally representative samples of 8th, 10th, and 12th graders and then follows a subset through adulthood to come up with longitudinal data. It is funded by the National Institute on Drug Abuse.

The adult data for 2022 were gathered by online and paper surveys from April to October 2022 and included responses from some 10,000 individuals. Participants were divided into two cohorts: those aged 19-30 years and those aged 35-50 years.

About a third of the older age group reported using marijuana in the past year, an all-time high, up from 25% in 2021 and more than double the users in 2012 (13%). Of this group, 4% reported past-year hallucinogen use, also a record high and double the reported use in 2021.

Alcohol use among adults aged 35-50 has gradually increased over the past decade. Of this group, 85% reported past-year drinking in 2022, up from 83% in 2012.

Binge drinking – defined as having five or more drinks in a row in the past 2 weeks – has also been on the rise in the past decade. One-third of older adults reported binge drinking in 2022. Binge drinking was highest among White (31.4%) and Hispanic (30.6%) midlife adults and was lower among Black (17.1%) midlife adults.

Vaping among the older age cohort has remained at similar levels since first measured in 2019; 9% vaped marijuana in the past year, while 7% vaped nicotine.
 

Marijuana popular among younger Americans

“In 2022, marijuana use among young adults reached the highest levels ever recorded since the indices were first available in 1988,” the study authors write. Both past-year and daily use hit record levels for the cohort of those aged 19-30.

Forty-four percent reported past-year marijuana use, up from 28% in 2012. The highest levels of use were in those aged 27-28. One in five reported daily use, up from 6% a decade ago; almost 14% of 23- to 24-year-olds reported daily use.

Past-year use of hallucinogens – including LSD, MDMA, mescaline, peyote, mushrooms or psilocybin, and PCP – was reported by 8% of this age group. Most of the increase was driven by use of hallucinogens other than LSD, which accounted for 7% of the reported use.

Young adults also reported record levels of vaping marijuana, with 21% reporting past-year use and 14% reporting past-month use. Vaping of nicotine has doubled in prevalence since the survey started asking about it, from 14% for past-year use in 2017 to 24% in 2022.

NIDA Director Nora Volkow, MD, noted in a statement that the survey results show that “substance use is not limited to teens and young adults,” adding that “these data help us understand how people use drugs across the lifespan.”

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

The latest results of the Monitoring the Future (MTF) longitudinal survey show that American adults are consuming marijuana and hallucinogens, vaping, and binge drinking at historic levels.

“In 2022, we are seeing that marijuana and hallucinogen use, and vaping of nicotine and marijuana, are higher than ever among young adults ages 19-30,” said Megan Patrick, research professor and principal investigator of the MTF study. “In addition, midlife adults ages 35-50 have the highest level of binge drinking we have ever seen in that age group,” she said in a statement.

The survey, conducted annually since 1975 by the University of Michigan’s Institute for Social Research, Ann Arbor, queries nationally representative samples of 8th, 10th, and 12th graders and then follows a subset through adulthood to come up with longitudinal data. It is funded by the National Institute on Drug Abuse.

The adult data for 2022 were gathered by online and paper surveys from April to October 2022 and included responses from some 10,000 individuals. Participants were divided into two cohorts: those aged 19-30 years and those aged 35-50 years.

About a third of the older age group reported using marijuana in the past year, an all-time high, up from 25% in 2021 and more than double the users in 2012 (13%). Of this group, 4% reported past-year hallucinogen use, also a record high and double the reported use in 2021.

Alcohol use among adults aged 35-50 has gradually increased over the past decade. Of this group, 85% reported past-year drinking in 2022, up from 83% in 2012.

Binge drinking – defined as having five or more drinks in a row in the past 2 weeks – has also been on the rise in the past decade. One-third of older adults reported binge drinking in 2022. Binge drinking was highest among White (31.4%) and Hispanic (30.6%) midlife adults and was lower among Black (17.1%) midlife adults.

Vaping among the older age cohort has remained at similar levels since first measured in 2019; 9% vaped marijuana in the past year, while 7% vaped nicotine.
 

Marijuana popular among younger Americans

“In 2022, marijuana use among young adults reached the highest levels ever recorded since the indices were first available in 1988,” the study authors write. Both past-year and daily use hit record levels for the cohort of those aged 19-30.

Forty-four percent reported past-year marijuana use, up from 28% in 2012. The highest levels of use were in those aged 27-28. One in five reported daily use, up from 6% a decade ago; almost 14% of 23- to 24-year-olds reported daily use.

Past-year use of hallucinogens – including LSD, MDMA, mescaline, peyote, mushrooms or psilocybin, and PCP – was reported by 8% of this age group. Most of the increase was driven by use of hallucinogens other than LSD, which accounted for 7% of the reported use.

Young adults also reported record levels of vaping marijuana, with 21% reporting past-year use and 14% reporting past-month use. Vaping of nicotine has doubled in prevalence since the survey started asking about it, from 14% for past-year use in 2017 to 24% in 2022.

NIDA Director Nora Volkow, MD, noted in a statement that the survey results show that “substance use is not limited to teens and young adults,” adding that “these data help us understand how people use drugs across the lifespan.”

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

It’s no secret that many physicians question the value of Maintenance of Certification requirements and are concerned about the amount of time, effort, and money the process takes. Now, they and at least two cardiology societies are starting to speak up.

MOC is an initiative from the American Board of Internal Medicine that requires an initial certification that costs thousands of dollars and must be repeated every 10 years. Annual MOC requirements involve tests that cost $220 for the first certificate a physician holds and about $120 for each subsequent one.

Interventional cardiologists (ICs) and other subspecialists have additional fees and requirements.
 

MOC ‘burdensome,’ ‘costly,’ ‘complex’

On July 21, hematologist-oncologist Aaron Goodman, MD, an associate professor at the University of California, San Diego, posted a petition on behalf of ABIM diplomates. It calls on ABIM to eliminate the MOC requirement because it is “burdensome,” “costly,” and “complex and time-consuming.”

As of August 22, the petition had garnered more than 18,000 signatures. 

Dr. Goodman recently debated ABIM President and CEO Richard J. Baron, MD, in a Healthcare Unfiltered podcast. Before the debate, host Chadi Nabhan, MD, MBA, tweeted that he could not find a single physician who would defend the MOC and recertification.

The debate touched on topics such as fees, evidence of value, the certification test format, and the cost and requirements to maintain more than one board certification. Overall, Dr. Goodman made the analogy to giving a patient chemotherapy: Because there are harms, he better know that there are also benefits. He cited that the harms associated with MOC include “financial toxicity, time toxicity, and stress toxicity,” with the latter being particularly toxic to him personally.

Though the podcast gave both participants ample opportunities to express their views, it’s not clear that either participant persuaded the other.

Cardiologists who are unhappy with MOC are speaking up on X, formerly known as Twitter. IC Matthew Sample, MD, listed five things he’s done to improve his practice since IC graduation, for which he received no MOC points.

In response, internist Artem Minalyan, MD, asked: “Hypothetically, if Dr. Baron required an IC procedure, I wonder if he would request you to get all your MOC points prior to consenting.”
 

SCAI and HRS weigh in

Some professional societies have responded to the ABIM’s threat to revoke the certifications of cardiologists who don’t participate in periodic MOC activities. 

The Society for Cardiovascular Angiography & Interventions published its “Position on ABIM Revocation of Certification for Not Participating in MOC.” In it, SCAI states that ABIM diplomates who pass their exams and report procedural volumes as required should be “indisputably” recognized as “certified” for the relevant time frame (for example, 10 years), regardless of whether they participate in any other MOC activities.

SCAI President George D. Dangas, MD, PhD, said in an interview that “many of our members have expressed their frustration surrounding the confusion regarding their MOC requirements, including myself. We felt that this confusion could endanger the certified status of members, which would inevitably impact patient care, which is our greatest concern.”

The society has received an “overwhelmingly positive response” to its statement, he said. “Our hope is that ABIM will consider simpler, transparent regulations that are reflective of the feedback received from their constituents.” 

In response to the COVID-19 pandemic, ABIM extended the deadline for diplomates whose certificate expired in 2020 or 2021 until the end of 2022; Dr. Dangas suggested ABIM further extend the deadline to enroll in or renew the MOC to the end of 2024 and that ABIM should “develop a recertification program that can be explained in a single slide/page.”

Other subspecialty groups are following SCAI’s lead including the EP Advocacy Foundation, and the Heart Rhythm Society.
 

MOC alternatives

The ABIM touts the value of MOC on its website, stating: “There is compelling evidence showing that MOC improves value of care without sacrificing quality and that board certified physicians command higher salaries.”

Alternative options that are arguably less arduous are available.

In collaboration with ABIM, the American College of Cardiology launched the ABIM/ACC Collaborative Maintenance Pathway in 2019 as an alternative MOC assessment option. 

The CMP “focuses on one or a small group of topics within cardiology each year, incorporating learning activities as well as a pre-/postformative knowledge assessment,” Janice Sibley, ACC’s executive vice president of education and publishing said in an interview, adding that the program continues to evolve. 

In 2022, she noted that the ACC increased the flexibility of the CMP by removing the 7-hour learning engagement requirement, allowing users to choose how much time to spend learning in the CMP program. They also extended the performance assessment windows from 7 to 9 days each, covering 2 weekends for each.

She said that, to date, more than “6,400 learners” are enrolled in the CMP program. 

Though the collaboration seems to make MOC less onerous, some cardiologists think it makes the ACC “complicit.”

A certification program that is independent of the ABIM launched in 2015. The National Board of Physicians and Surgeons is a nonprofit organization led by an advisory board of unpaid physicians. NBPAS seems to be gaining momentum and acceptance. 

Cardiologist Melissa Walton-Shirley, MD, recounted her recertification experience with the NBPAS late in 2022. She now maintains a “hybrid” certification with both ABIM and NBPAS. Though she wants to support the latter, she found that the alternative certification option still requires an initial ABIM certification and is not recognized in all states or by many insurers and hospitals.

Will MOC ever disappear? Ms. Sibley said that the ACC is always looking to improve and enhance their offerings. “It is time to lead a change in the conversation from certification to continuous competency, from punitive to supportive options, from random knowledge testing to focused assessing knowledge gaps and lifelong learning. This will require innovation, technology, and new ways of thinking that offer cardiologists flexibility, relevance, and value and ultimately benefit the patients they serve.”

Many physicians, including cardiologists, are hoping that Dr. Goodman’s petition and further pressure from professional societies may finally translate into action.

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

It’s no secret that many physicians question the value of Maintenance of Certification requirements and are concerned about the amount of time, effort, and money the process takes. Now, they and at least two cardiology societies are starting to speak up.

MOC is an initiative from the American Board of Internal Medicine that requires an initial certification that costs thousands of dollars and must be repeated every 10 years. Annual MOC requirements involve tests that cost $220 for the first certificate a physician holds and about $120 for each subsequent one.

Interventional cardiologists (ICs) and other subspecialists have additional fees and requirements.
 

MOC ‘burdensome,’ ‘costly,’ ‘complex’

On July 21, hematologist-oncologist Aaron Goodman, MD, an associate professor at the University of California, San Diego, posted a petition on behalf of ABIM diplomates. It calls on ABIM to eliminate the MOC requirement because it is “burdensome,” “costly,” and “complex and time-consuming.”

As of August 22, the petition had garnered more than 18,000 signatures. 

Dr. Goodman recently debated ABIM President and CEO Richard J. Baron, MD, in a Healthcare Unfiltered podcast. Before the debate, host Chadi Nabhan, MD, MBA, tweeted that he could not find a single physician who would defend the MOC and recertification.

The debate touched on topics such as fees, evidence of value, the certification test format, and the cost and requirements to maintain more than one board certification. Overall, Dr. Goodman made the analogy to giving a patient chemotherapy: Because there are harms, he better know that there are also benefits. He cited that the harms associated with MOC include “financial toxicity, time toxicity, and stress toxicity,” with the latter being particularly toxic to him personally.

Though the podcast gave both participants ample opportunities to express their views, it’s not clear that either participant persuaded the other.

Cardiologists who are unhappy with MOC are speaking up on X, formerly known as Twitter. IC Matthew Sample, MD, listed five things he’s done to improve his practice since IC graduation, for which he received no MOC points.

In response, internist Artem Minalyan, MD, asked: “Hypothetically, if Dr. Baron required an IC procedure, I wonder if he would request you to get all your MOC points prior to consenting.”
 

SCAI and HRS weigh in

Some professional societies have responded to the ABIM’s threat to revoke the certifications of cardiologists who don’t participate in periodic MOC activities. 

The Society for Cardiovascular Angiography & Interventions published its “Position on ABIM Revocation of Certification for Not Participating in MOC.” In it, SCAI states that ABIM diplomates who pass their exams and report procedural volumes as required should be “indisputably” recognized as “certified” for the relevant time frame (for example, 10 years), regardless of whether they participate in any other MOC activities.

SCAI President George D. Dangas, MD, PhD, said in an interview that “many of our members have expressed their frustration surrounding the confusion regarding their MOC requirements, including myself. We felt that this confusion could endanger the certified status of members, which would inevitably impact patient care, which is our greatest concern.”

The society has received an “overwhelmingly positive response” to its statement, he said. “Our hope is that ABIM will consider simpler, transparent regulations that are reflective of the feedback received from their constituents.” 

In response to the COVID-19 pandemic, ABIM extended the deadline for diplomates whose certificate expired in 2020 or 2021 until the end of 2022; Dr. Dangas suggested ABIM further extend the deadline to enroll in or renew the MOC to the end of 2024 and that ABIM should “develop a recertification program that can be explained in a single slide/page.”

Other subspecialty groups are following SCAI’s lead including the EP Advocacy Foundation, and the Heart Rhythm Society.
 

MOC alternatives

The ABIM touts the value of MOC on its website, stating: “There is compelling evidence showing that MOC improves value of care without sacrificing quality and that board certified physicians command higher salaries.”

Alternative options that are arguably less arduous are available.

In collaboration with ABIM, the American College of Cardiology launched the ABIM/ACC Collaborative Maintenance Pathway in 2019 as an alternative MOC assessment option. 

The CMP “focuses on one or a small group of topics within cardiology each year, incorporating learning activities as well as a pre-/postformative knowledge assessment,” Janice Sibley, ACC’s executive vice president of education and publishing said in an interview, adding that the program continues to evolve. 

In 2022, she noted that the ACC increased the flexibility of the CMP by removing the 7-hour learning engagement requirement, allowing users to choose how much time to spend learning in the CMP program. They also extended the performance assessment windows from 7 to 9 days each, covering 2 weekends for each.

She said that, to date, more than “6,400 learners” are enrolled in the CMP program. 

Though the collaboration seems to make MOC less onerous, some cardiologists think it makes the ACC “complicit.”

A certification program that is independent of the ABIM launched in 2015. The National Board of Physicians and Surgeons is a nonprofit organization led by an advisory board of unpaid physicians. NBPAS seems to be gaining momentum and acceptance. 

Cardiologist Melissa Walton-Shirley, MD, recounted her recertification experience with the NBPAS late in 2022. She now maintains a “hybrid” certification with both ABIM and NBPAS. Though she wants to support the latter, she found that the alternative certification option still requires an initial ABIM certification and is not recognized in all states or by many insurers and hospitals.

Will MOC ever disappear? Ms. Sibley said that the ACC is always looking to improve and enhance their offerings. “It is time to lead a change in the conversation from certification to continuous competency, from punitive to supportive options, from random knowledge testing to focused assessing knowledge gaps and lifelong learning. This will require innovation, technology, and new ways of thinking that offer cardiologists flexibility, relevance, and value and ultimately benefit the patients they serve.”

Many physicians, including cardiologists, are hoping that Dr. Goodman’s petition and further pressure from professional societies may finally translate into action.

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

It’s no secret that many physicians question the value of Maintenance of Certification requirements and are concerned about the amount of time, effort, and money the process takes. Now, they and at least two cardiology societies are starting to speak up.

MOC is an initiative from the American Board of Internal Medicine that requires an initial certification that costs thousands of dollars and must be repeated every 10 years. Annual MOC requirements involve tests that cost $220 for the first certificate a physician holds and about $120 for each subsequent one.

Interventional cardiologists (ICs) and other subspecialists have additional fees and requirements.
 

MOC ‘burdensome,’ ‘costly,’ ‘complex’

On July 21, hematologist-oncologist Aaron Goodman, MD, an associate professor at the University of California, San Diego, posted a petition on behalf of ABIM diplomates. It calls on ABIM to eliminate the MOC requirement because it is “burdensome,” “costly,” and “complex and time-consuming.”

As of August 22, the petition had garnered more than 18,000 signatures. 

Dr. Goodman recently debated ABIM President and CEO Richard J. Baron, MD, in a Healthcare Unfiltered podcast. Before the debate, host Chadi Nabhan, MD, MBA, tweeted that he could not find a single physician who would defend the MOC and recertification.

The debate touched on topics such as fees, evidence of value, the certification test format, and the cost and requirements to maintain more than one board certification. Overall, Dr. Goodman made the analogy to giving a patient chemotherapy: Because there are harms, he better know that there are also benefits. He cited that the harms associated with MOC include “financial toxicity, time toxicity, and stress toxicity,” with the latter being particularly toxic to him personally.

Though the podcast gave both participants ample opportunities to express their views, it’s not clear that either participant persuaded the other.

Cardiologists who are unhappy with MOC are speaking up on X, formerly known as Twitter. IC Matthew Sample, MD, listed five things he’s done to improve his practice since IC graduation, for which he received no MOC points.

In response, internist Artem Minalyan, MD, asked: “Hypothetically, if Dr. Baron required an IC procedure, I wonder if he would request you to get all your MOC points prior to consenting.”
 

SCAI and HRS weigh in

Some professional societies have responded to the ABIM’s threat to revoke the certifications of cardiologists who don’t participate in periodic MOC activities. 

The Society for Cardiovascular Angiography & Interventions published its “Position on ABIM Revocation of Certification for Not Participating in MOC.” In it, SCAI states that ABIM diplomates who pass their exams and report procedural volumes as required should be “indisputably” recognized as “certified” for the relevant time frame (for example, 10 years), regardless of whether they participate in any other MOC activities.

SCAI President George D. Dangas, MD, PhD, said in an interview that “many of our members have expressed their frustration surrounding the confusion regarding their MOC requirements, including myself. We felt that this confusion could endanger the certified status of members, which would inevitably impact patient care, which is our greatest concern.”

The society has received an “overwhelmingly positive response” to its statement, he said. “Our hope is that ABIM will consider simpler, transparent regulations that are reflective of the feedback received from their constituents.” 

In response to the COVID-19 pandemic, ABIM extended the deadline for diplomates whose certificate expired in 2020 or 2021 until the end of 2022; Dr. Dangas suggested ABIM further extend the deadline to enroll in or renew the MOC to the end of 2024 and that ABIM should “develop a recertification program that can be explained in a single slide/page.”

Other subspecialty groups are following SCAI’s lead including the EP Advocacy Foundation, and the Heart Rhythm Society.
 

MOC alternatives

The ABIM touts the value of MOC on its website, stating: “There is compelling evidence showing that MOC improves value of care without sacrificing quality and that board certified physicians command higher salaries.”

Alternative options that are arguably less arduous are available.

In collaboration with ABIM, the American College of Cardiology launched the ABIM/ACC Collaborative Maintenance Pathway in 2019 as an alternative MOC assessment option. 

The CMP “focuses on one or a small group of topics within cardiology each year, incorporating learning activities as well as a pre-/postformative knowledge assessment,” Janice Sibley, ACC’s executive vice president of education and publishing said in an interview, adding that the program continues to evolve. 

In 2022, she noted that the ACC increased the flexibility of the CMP by removing the 7-hour learning engagement requirement, allowing users to choose how much time to spend learning in the CMP program. They also extended the performance assessment windows from 7 to 9 days each, covering 2 weekends for each.

She said that, to date, more than “6,400 learners” are enrolled in the CMP program. 

Though the collaboration seems to make MOC less onerous, some cardiologists think it makes the ACC “complicit.”

A certification program that is independent of the ABIM launched in 2015. The National Board of Physicians and Surgeons is a nonprofit organization led by an advisory board of unpaid physicians. NBPAS seems to be gaining momentum and acceptance. 

Cardiologist Melissa Walton-Shirley, MD, recounted her recertification experience with the NBPAS late in 2022. She now maintains a “hybrid” certification with both ABIM and NBPAS. Though she wants to support the latter, she found that the alternative certification option still requires an initial ABIM certification and is not recognized in all states or by many insurers and hospitals.

Will MOC ever disappear? Ms. Sibley said that the ACC is always looking to improve and enhance their offerings. “It is time to lead a change in the conversation from certification to continuous competency, from punitive to supportive options, from random knowledge testing to focused assessing knowledge gaps and lifelong learning. This will require innovation, technology, and new ways of thinking that offer cardiologists flexibility, relevance, and value and ultimately benefit the patients they serve.”

Many physicians, including cardiologists, are hoping that Dr. Goodman’s petition and further pressure from professional societies may finally translate into action.

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

Clinicians are using dupilumab off label to treat a wider range of allergic conditions in adults and children.

The drug, marketed as Dupixent, is currently approved in the United States to treat atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, and prurigo nodularis in adults. Dupilumab is also approved to treat eosinophilic esophagitis in patients aged 12 years and older and atopic dermatitis and asthma in some patients as young as age 6 months.

As the roster of approved and off-label indications grows, skin specialists said, pediatricians and other primary care providers should become familiar with the drug – given the increasing likelihood that their patients may be taking the medication.

The U.S. Food and Drug Administration first approved dupilumab in 2017 for eczema and has continued to add new treatment indications, the most recent being for prurigo nodularis, in 2022. Sanofi, which markets the drug with Regeneron, announced in April 2022 that some 430,000 patients worldwide were taking the drug – a figure it hoped to raise by 1.5 million by 2025.
 

A well-tolerated – if expensive – drug

Dupilumab, an interleukin-4 (IL-4) receptor alpha-antagonist biologic, blocks both IL-4 and IL-13 signaling, Marlys Fassett, MD, PhD, associate professor of dermatology at the University of California, San Francisco, told this news organization.

Dr. Fassett said she prescribes the drug off label for chronic idiopathic urticaria, including in older patients, and finds that the side effects in older patients are similar to those in younger people. The medication costs $36,000 per year, although some patients can get it more cheaply.

“Dupixent is a super-safe drug because it doesn’t immunosuppress any other part of the immune system, so you still have good antibacterial, antiviral, and antifungal immunity,” she added. “That makes perfect sense as a biological mechanism, and it’s been found safe in clinical trials.”

Case reports of potential adverse reactions to dupilumab have included ocular surface disease, lichen planus, and rash on the face and neck.

“We’re still learning about complications and are watching patients carefully,” said Marissa J. Perman, MD, section chief of dermatology at Children’s Hospital of Philadelphia.

Many people with atopic dermatitis also have other allergic conditions, such as contact dermatitis, asthma, prurigo nodularis, allergic rhinitis, and seasonal allergies. Each of these conditions has a pathway that depends on IL-4 receptors, Dr. Fassett said.

“It’s amazing how many conditions Dupixent improves. Sometimes we prescribe on-label Dupixent for atopic dermatitis, and inadvertently, the drug also improves that patient’s other, off-label conditions,” Dr. Fassett said. “I think that’s the best evidence that Dupixent works in these off-label cases.”

Lindsay C. Strowd, MD, associate professor of dermatology at Wake Forest University, Winston-Salem, N.C., said she uses off-label dupilumab to treat bullous pemphigoid and intense pruritus of unknown etiology.

“And several times I have treated drug reaction with eosinophilia and systemic symptoms, a rare adverse drug reaction that causes a rash and eosinophilia,” Dr. Strowd added.

Tissa Hata, MD, professor of medicine and clinical service chief at the University of California, San Diego, mainly treats elderly patients. She uses dupilumab to treat bullous pemphigoid and chronic pruritus. “There have been reports of using Dupixent to treat adult alopecia areata, chronic urticaria, localized scleroderma, and even keloids,” she told this news organization.

As a pediatric dermatologist, Dr. Perman treats children with atopic dermatitis as young as 3 months of age. She also uses dupilumab for alopecia areata, graft vs. host disease, and pruritus not otherwise specified.

Conjunctivitis and facial redness are two side effects Dr. Fassett sometimes sees with dupilumab. They occur similarly with all conditions and in all age groups. “We don’t know why they occur, and we don’t always know how to alleviate them,” she said. “So a small number of patients stop using Dupixent because they can’t tolerate those two side effects.

“We’re not worried about infection risk,” Dr. Fassett said. “Your patients may have heard of dupilumab as an immunosuppressant, but its immunosuppression is very focused. You can reassure them that they’re not at increased risk for viral or bacterial infections when they’re on this drug.”

“I don’t think there are any different safety signals to watch for with on-label vs. off-label Dupixent use,” Dr. Strowd added. “In general, the medicine is very safe.”

Dr. Hata said she is impressed with dupilumab’s safety in her elderly patients. All her patients older than 85 years who have taken the drug for bullous pemphigoid have tolerated it well, she said.

“Dupixent seems to be a safe alternative for elderly patients with pruritus because they often cannot tolerate sedating antihistamines due to the risk of falling,” Dr. Hata said. “And UV therapy may be difficult for elderly patients due to problems with transport.”

Although some of Dr. Hata’s elderly patients with atopic dermatitis have discontinued use of the drug after developing conjunctivitis, none taking the drug off label have discontinued it because of side effects, she noted.

“Dupixent manages the condition, but it is not a cure,” Dr. Fassett noted. “Based on the current data, we think it’s safe and effective to take long term, potentially for life.”

Making injections less bothersome

Dupilumab is injected subcutaneously from a single-dose prefilled syringe or a prefilled pen (syringe hidden in an opaque sheath), typically in the thigh, arm, abdomen, or buttocks. According to Sanofi and Regeneron, patients receive dupilumab injections every 2 to 4 weeks in doses based on their age and weight.

“The medication is somewhat viscous, so taking the syringe or pen out of the refrigerator ahead of time to warm it up can make the experience less painful,” Dr. Strowd advised. “For pediatric patients, I sometimes prescribe topical lidocaine applied 30 minutes before injection.”

Dr. Hata suggested icing the skin prior to injecting or distracting the patient by tapping a different area of the skin.

For her pediatric patients, Dr. Perman said she uses “lots of distraction, EMLA cream, and having one person hold the child while a second person injects.”

Clinic and pharmacy staff may show patients how to inject properly, Dr. Fassett added; and the product website provides injection tutorials.
 

Off-label dupixent can be expensive, difficult to obtain

The list price per injection, regardless of dose, is around $1,800. But according to the company’s website, most patients have health insurance or qualify for other assistance, so “very few patients pay the list price.”

Even so, “due to cost and insurance coverage hurdles, obtaining Dupixent for off-label use can be difficult,” Dr. Strowd said.

“In academic medicine, we can obtain drugs for our patients that community doctors may not get approval for,” Dr. Fassett added. “Community doctors can use information in the medical literature and in news articles to press insurance companies to spend money to provide their patients with Dupixent.”

The experts who commented have disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

Clinicians are using dupilumab off label to treat a wider range of allergic conditions in adults and children.

The drug, marketed as Dupixent, is currently approved in the United States to treat atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, and prurigo nodularis in adults. Dupilumab is also approved to treat eosinophilic esophagitis in patients aged 12 years and older and atopic dermatitis and asthma in some patients as young as age 6 months.

As the roster of approved and off-label indications grows, skin specialists said, pediatricians and other primary care providers should become familiar with the drug – given the increasing likelihood that their patients may be taking the medication.

The U.S. Food and Drug Administration first approved dupilumab in 2017 for eczema and has continued to add new treatment indications, the most recent being for prurigo nodularis, in 2022. Sanofi, which markets the drug with Regeneron, announced in April 2022 that some 430,000 patients worldwide were taking the drug – a figure it hoped to raise by 1.5 million by 2025.
 

A well-tolerated – if expensive – drug

Dupilumab, an interleukin-4 (IL-4) receptor alpha-antagonist biologic, blocks both IL-4 and IL-13 signaling, Marlys Fassett, MD, PhD, associate professor of dermatology at the University of California, San Francisco, told this news organization.

Dr. Fassett said she prescribes the drug off label for chronic idiopathic urticaria, including in older patients, and finds that the side effects in older patients are similar to those in younger people. The medication costs $36,000 per year, although some patients can get it more cheaply.

“Dupixent is a super-safe drug because it doesn’t immunosuppress any other part of the immune system, so you still have good antibacterial, antiviral, and antifungal immunity,” she added. “That makes perfect sense as a biological mechanism, and it’s been found safe in clinical trials.”

Case reports of potential adverse reactions to dupilumab have included ocular surface disease, lichen planus, and rash on the face and neck.

“We’re still learning about complications and are watching patients carefully,” said Marissa J. Perman, MD, section chief of dermatology at Children’s Hospital of Philadelphia.

Many people with atopic dermatitis also have other allergic conditions, such as contact dermatitis, asthma, prurigo nodularis, allergic rhinitis, and seasonal allergies. Each of these conditions has a pathway that depends on IL-4 receptors, Dr. Fassett said.

“It’s amazing how many conditions Dupixent improves. Sometimes we prescribe on-label Dupixent for atopic dermatitis, and inadvertently, the drug also improves that patient’s other, off-label conditions,” Dr. Fassett said. “I think that’s the best evidence that Dupixent works in these off-label cases.”

Lindsay C. Strowd, MD, associate professor of dermatology at Wake Forest University, Winston-Salem, N.C., said she uses off-label dupilumab to treat bullous pemphigoid and intense pruritus of unknown etiology.

“And several times I have treated drug reaction with eosinophilia and systemic symptoms, a rare adverse drug reaction that causes a rash and eosinophilia,” Dr. Strowd added.

Tissa Hata, MD, professor of medicine and clinical service chief at the University of California, San Diego, mainly treats elderly patients. She uses dupilumab to treat bullous pemphigoid and chronic pruritus. “There have been reports of using Dupixent to treat adult alopecia areata, chronic urticaria, localized scleroderma, and even keloids,” she told this news organization.

As a pediatric dermatologist, Dr. Perman treats children with atopic dermatitis as young as 3 months of age. She also uses dupilumab for alopecia areata, graft vs. host disease, and pruritus not otherwise specified.

Conjunctivitis and facial redness are two side effects Dr. Fassett sometimes sees with dupilumab. They occur similarly with all conditions and in all age groups. “We don’t know why they occur, and we don’t always know how to alleviate them,” she said. “So a small number of patients stop using Dupixent because they can’t tolerate those two side effects.

“We’re not worried about infection risk,” Dr. Fassett said. “Your patients may have heard of dupilumab as an immunosuppressant, but its immunosuppression is very focused. You can reassure them that they’re not at increased risk for viral or bacterial infections when they’re on this drug.”

“I don’t think there are any different safety signals to watch for with on-label vs. off-label Dupixent use,” Dr. Strowd added. “In general, the medicine is very safe.”

Dr. Hata said she is impressed with dupilumab’s safety in her elderly patients. All her patients older than 85 years who have taken the drug for bullous pemphigoid have tolerated it well, she said.

“Dupixent seems to be a safe alternative for elderly patients with pruritus because they often cannot tolerate sedating antihistamines due to the risk of falling,” Dr. Hata said. “And UV therapy may be difficult for elderly patients due to problems with transport.”

Although some of Dr. Hata’s elderly patients with atopic dermatitis have discontinued use of the drug after developing conjunctivitis, none taking the drug off label have discontinued it because of side effects, she noted.

“Dupixent manages the condition, but it is not a cure,” Dr. Fassett noted. “Based on the current data, we think it’s safe and effective to take long term, potentially for life.”

Making injections less bothersome

Dupilumab is injected subcutaneously from a single-dose prefilled syringe or a prefilled pen (syringe hidden in an opaque sheath), typically in the thigh, arm, abdomen, or buttocks. According to Sanofi and Regeneron, patients receive dupilumab injections every 2 to 4 weeks in doses based on their age and weight.

“The medication is somewhat viscous, so taking the syringe or pen out of the refrigerator ahead of time to warm it up can make the experience less painful,” Dr. Strowd advised. “For pediatric patients, I sometimes prescribe topical lidocaine applied 30 minutes before injection.”

Dr. Hata suggested icing the skin prior to injecting or distracting the patient by tapping a different area of the skin.

For her pediatric patients, Dr. Perman said she uses “lots of distraction, EMLA cream, and having one person hold the child while a second person injects.”

Clinic and pharmacy staff may show patients how to inject properly, Dr. Fassett added; and the product website provides injection tutorials.
 

Off-label dupixent can be expensive, difficult to obtain

The list price per injection, regardless of dose, is around $1,800. But according to the company’s website, most patients have health insurance or qualify for other assistance, so “very few patients pay the list price.”

Even so, “due to cost and insurance coverage hurdles, obtaining Dupixent for off-label use can be difficult,” Dr. Strowd said.

“In academic medicine, we can obtain drugs for our patients that community doctors may not get approval for,” Dr. Fassett added. “Community doctors can use information in the medical literature and in news articles to press insurance companies to spend money to provide their patients with Dupixent.”

The experts who commented have disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

Clinicians are using dupilumab off label to treat a wider range of allergic conditions in adults and children.

The drug, marketed as Dupixent, is currently approved in the United States to treat atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, and prurigo nodularis in adults. Dupilumab is also approved to treat eosinophilic esophagitis in patients aged 12 years and older and atopic dermatitis and asthma in some patients as young as age 6 months.

As the roster of approved and off-label indications grows, skin specialists said, pediatricians and other primary care providers should become familiar with the drug – given the increasing likelihood that their patients may be taking the medication.

The U.S. Food and Drug Administration first approved dupilumab in 2017 for eczema and has continued to add new treatment indications, the most recent being for prurigo nodularis, in 2022. Sanofi, which markets the drug with Regeneron, announced in April 2022 that some 430,000 patients worldwide were taking the drug – a figure it hoped to raise by 1.5 million by 2025.
 

A well-tolerated – if expensive – drug

Dupilumab, an interleukin-4 (IL-4) receptor alpha-antagonist biologic, blocks both IL-4 and IL-13 signaling, Marlys Fassett, MD, PhD, associate professor of dermatology at the University of California, San Francisco, told this news organization.

Dr. Fassett said she prescribes the drug off label for chronic idiopathic urticaria, including in older patients, and finds that the side effects in older patients are similar to those in younger people. The medication costs $36,000 per year, although some patients can get it more cheaply.

“Dupixent is a super-safe drug because it doesn’t immunosuppress any other part of the immune system, so you still have good antibacterial, antiviral, and antifungal immunity,” she added. “That makes perfect sense as a biological mechanism, and it’s been found safe in clinical trials.”

Case reports of potential adverse reactions to dupilumab have included ocular surface disease, lichen planus, and rash on the face and neck.

“We’re still learning about complications and are watching patients carefully,” said Marissa J. Perman, MD, section chief of dermatology at Children’s Hospital of Philadelphia.

Many people with atopic dermatitis also have other allergic conditions, such as contact dermatitis, asthma, prurigo nodularis, allergic rhinitis, and seasonal allergies. Each of these conditions has a pathway that depends on IL-4 receptors, Dr. Fassett said.

“It’s amazing how many conditions Dupixent improves. Sometimes we prescribe on-label Dupixent for atopic dermatitis, and inadvertently, the drug also improves that patient’s other, off-label conditions,” Dr. Fassett said. “I think that’s the best evidence that Dupixent works in these off-label cases.”

Lindsay C. Strowd, MD, associate professor of dermatology at Wake Forest University, Winston-Salem, N.C., said she uses off-label dupilumab to treat bullous pemphigoid and intense pruritus of unknown etiology.

“And several times I have treated drug reaction with eosinophilia and systemic symptoms, a rare adverse drug reaction that causes a rash and eosinophilia,” Dr. Strowd added.

Tissa Hata, MD, professor of medicine and clinical service chief at the University of California, San Diego, mainly treats elderly patients. She uses dupilumab to treat bullous pemphigoid and chronic pruritus. “There have been reports of using Dupixent to treat adult alopecia areata, chronic urticaria, localized scleroderma, and even keloids,” she told this news organization.

As a pediatric dermatologist, Dr. Perman treats children with atopic dermatitis as young as 3 months of age. She also uses dupilumab for alopecia areata, graft vs. host disease, and pruritus not otherwise specified.

Conjunctivitis and facial redness are two side effects Dr. Fassett sometimes sees with dupilumab. They occur similarly with all conditions and in all age groups. “We don’t know why they occur, and we don’t always know how to alleviate them,” she said. “So a small number of patients stop using Dupixent because they can’t tolerate those two side effects.

“We’re not worried about infection risk,” Dr. Fassett said. “Your patients may have heard of dupilumab as an immunosuppressant, but its immunosuppression is very focused. You can reassure them that they’re not at increased risk for viral or bacterial infections when they’re on this drug.”

“I don’t think there are any different safety signals to watch for with on-label vs. off-label Dupixent use,” Dr. Strowd added. “In general, the medicine is very safe.”

Dr. Hata said she is impressed with dupilumab’s safety in her elderly patients. All her patients older than 85 years who have taken the drug for bullous pemphigoid have tolerated it well, she said.

“Dupixent seems to be a safe alternative for elderly patients with pruritus because they often cannot tolerate sedating antihistamines due to the risk of falling,” Dr. Hata said. “And UV therapy may be difficult for elderly patients due to problems with transport.”

Although some of Dr. Hata’s elderly patients with atopic dermatitis have discontinued use of the drug after developing conjunctivitis, none taking the drug off label have discontinued it because of side effects, she noted.

“Dupixent manages the condition, but it is not a cure,” Dr. Fassett noted. “Based on the current data, we think it’s safe and effective to take long term, potentially for life.”

Making injections less bothersome

Dupilumab is injected subcutaneously from a single-dose prefilled syringe or a prefilled pen (syringe hidden in an opaque sheath), typically in the thigh, arm, abdomen, or buttocks. According to Sanofi and Regeneron, patients receive dupilumab injections every 2 to 4 weeks in doses based on their age and weight.

“The medication is somewhat viscous, so taking the syringe or pen out of the refrigerator ahead of time to warm it up can make the experience less painful,” Dr. Strowd advised. “For pediatric patients, I sometimes prescribe topical lidocaine applied 30 minutes before injection.”

Dr. Hata suggested icing the skin prior to injecting or distracting the patient by tapping a different area of the skin.

For her pediatric patients, Dr. Perman said she uses “lots of distraction, EMLA cream, and having one person hold the child while a second person injects.”

Clinic and pharmacy staff may show patients how to inject properly, Dr. Fassett added; and the product website provides injection tutorials.
 

Off-label dupixent can be expensive, difficult to obtain

The list price per injection, regardless of dose, is around $1,800. But according to the company’s website, most patients have health insurance or qualify for other assistance, so “very few patients pay the list price.”

Even so, “due to cost and insurance coverage hurdles, obtaining Dupixent for off-label use can be difficult,” Dr. Strowd said.

“In academic medicine, we can obtain drugs for our patients that community doctors may not get approval for,” Dr. Fassett added. “Community doctors can use information in the medical literature and in news articles to press insurance companies to spend money to provide their patients with Dupixent.”

The experts who commented have disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

People may get more protection against COVID-19 if they get their vaccinations and boosters in the same arm, a new study says.

Scientists in Germany looked at health data for 303 people who got the mRNA vaccine and then a booster shot. Their antibody levels were measured two weeks after the second shot. None of the people had had COVID before the vaccinations.

Scientists found that the number of protective “killer T cells” was higher in the 147 study participants who got both shots in the same arm, said the study published in EBioMedicine.

The killer cells were found in 67% of cases in which both shots went into the same arm, compared with 43% of cases with different arms.

“That may suggest that that ipsilateral vaccination (in the same arm) is more likely to provide better protection should the vaccinated person become infected with the SARS-CoV-2 virus,” Laura Ziegler, a doctoral student at Saarland University, Germany, said in a news release.

William Schaffner, MD, a professor in the Division of Infectious Diseases at Vanderbilt University Medical Center, Nashville, Tenn., told CBS News that same-arm vaccinations may work better because the cells that provide the immune response are in local lymph nodes.

There’s greater immunological response if the immune cells in the lymph nodes are restimulated in the same place, said Dr. Schaffner, who was not involved in the German study.

The scientists from Saarland University said more research is needed before they can be certain that having vaccinations in the same arm is actually more effective for COVID shots and sequential vaccinations against diseases such as the flu.

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

People may get more protection against COVID-19 if they get their vaccinations and boosters in the same arm, a new study says.

Scientists in Germany looked at health data for 303 people who got the mRNA vaccine and then a booster shot. Their antibody levels were measured two weeks after the second shot. None of the people had had COVID before the vaccinations.

Scientists found that the number of protective “killer T cells” was higher in the 147 study participants who got both shots in the same arm, said the study published in EBioMedicine.

The killer cells were found in 67% of cases in which both shots went into the same arm, compared with 43% of cases with different arms.

“That may suggest that that ipsilateral vaccination (in the same arm) is more likely to provide better protection should the vaccinated person become infected with the SARS-CoV-2 virus,” Laura Ziegler, a doctoral student at Saarland University, Germany, said in a news release.

William Schaffner, MD, a professor in the Division of Infectious Diseases at Vanderbilt University Medical Center, Nashville, Tenn., told CBS News that same-arm vaccinations may work better because the cells that provide the immune response are in local lymph nodes.

There’s greater immunological response if the immune cells in the lymph nodes are restimulated in the same place, said Dr. Schaffner, who was not involved in the German study.

The scientists from Saarland University said more research is needed before they can be certain that having vaccinations in the same arm is actually more effective for COVID shots and sequential vaccinations against diseases such as the flu.

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

People may get more protection against COVID-19 if they get their vaccinations and boosters in the same arm, a new study says.

Scientists in Germany looked at health data for 303 people who got the mRNA vaccine and then a booster shot. Their antibody levels were measured two weeks after the second shot. None of the people had had COVID before the vaccinations.

Scientists found that the number of protective “killer T cells” was higher in the 147 study participants who got both shots in the same arm, said the study published in EBioMedicine.

The killer cells were found in 67% of cases in which both shots went into the same arm, compared with 43% of cases with different arms.

“That may suggest that that ipsilateral vaccination (in the same arm) is more likely to provide better protection should the vaccinated person become infected with the SARS-CoV-2 virus,” Laura Ziegler, a doctoral student at Saarland University, Germany, said in a news release.

William Schaffner, MD, a professor in the Division of Infectious Diseases at Vanderbilt University Medical Center, Nashville, Tenn., told CBS News that same-arm vaccinations may work better because the cells that provide the immune response are in local lymph nodes.

There’s greater immunological response if the immune cells in the lymph nodes are restimulated in the same place, said Dr. Schaffner, who was not involved in the German study.

The scientists from Saarland University said more research is needed before they can be certain that having vaccinations in the same arm is actually more effective for COVID shots and sequential vaccinations against diseases such as the flu.

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

The Cutis Editorial Board is now accepting applications for the 2024 Resident Corner column. The Editorial Board will select 2 to 3 residents to serve as the Resident Corner columnists for 1 year. Articles are posted online only at www.mdedge.com/dermatology but will be referenced in Index Medicus. All applicants must be current residents and will be in residency throughout 2024.

For consideration, send your curriculum vitae along with a brief (not to exceed 500 words) statement of why you enjoy Cutis and what you can offer your fellow residents in contributing a monthly column.

A signed letter of recommendation from the Director of the dermatology residency program also should be supplied.

All materials should be submitted via email to Melissa Sears ([email protected]) by November 1. The residents who are selected to write the column for the upcoming year will be notified by November 15.

We look forward to continuing to educate dermatology residents on topics that are most important to them!

The Cutis Editorial Board is now accepting applications for the 2024 Resident Corner column. The Editorial Board will select 2 to 3 residents to serve as the Resident Corner columnists for 1 year. Articles are posted online only at www.mdedge.com/dermatology but will be referenced in Index Medicus. All applicants must be current residents and will be in residency throughout 2024.

For consideration, send your curriculum vitae along with a brief (not to exceed 500 words) statement of why you enjoy Cutis and what you can offer your fellow residents in contributing a monthly column.

A signed letter of recommendation from the Director of the dermatology residency program also should be supplied.

All materials should be submitted via email to Melissa Sears ([email protected]) by November 1. The residents who are selected to write the column for the upcoming year will be notified by November 15.

We look forward to continuing to educate dermatology residents on topics that are most important to them!

The Cutis Editorial Board is now accepting applications for the 2024 Resident Corner column. The Editorial Board will select 2 to 3 residents to serve as the Resident Corner columnists for 1 year. Articles are posted online only at www.mdedge.com/dermatology but will be referenced in Index Medicus. All applicants must be current residents and will be in residency throughout 2024.

For consideration, send your curriculum vitae along with a brief (not to exceed 500 words) statement of why you enjoy Cutis and what you can offer your fellow residents in contributing a monthly column.

A signed letter of recommendation from the Director of the dermatology residency program also should be supplied.

All materials should be submitted via email to Melissa Sears ([email protected]) by November 1. The residents who are selected to write the column for the upcoming year will be notified by November 15.

We look forward to continuing to educate dermatology residents on topics that are most important to them!