The utility of artificial intelligence in pulmonology has focused mainly on using image datasets to detect and diagnose lung malignancies, but now a growing number of AI models are emerging that apply machine learning to improve predictability for other pulmonary conditions, including pulmonary infections, pulmonary fibrosis, and chronic obstructive pulmonary disease (COPD).

These applications are moving beyond the traditional AI model of collecting data from a multitude of images to cast a wider data net that includes electronic health records.

Also on the horizon, ChatGPT technology is poised to have an impact. But pulmonologists and their practices have a number of barriers to clear before they feel a meaningful impact from AI.

The imperative, said AI researcher Ishanu Chattopadhyay, PhD, is to create transformative models that can detect lung disease early on. Dr. Chattopadhyay, an assistant professor of medicine at the University of Chicago and its Institute for Genomics and Systems Biology, and fellow researchers developed an AI algorithm that uses comorbidity signatures in electronic health records to screen for idiopathic pulmonary fibrosis (IPF) (Nature Med. 2022 Sep 29. doi: 10.1038/s41591-022-02010-y).

“If you could do this when somebody walks into a primary care setting and they are barely suspecting something is going on with them or when they don’t have the typical risk factors, there is a certain fraction of these people who do have IPF and they will almost invariably be diagnosed late and/or misdiagnosed,” Dr. Chattopadhyay said, citing a study that found 55% of patients with IPF have had at least one misdiagnosis and 38% have two or more misdiagnoses (BMC Pulm Med. 2018 Jan 17. doi: 10.1186/s12890-017-0560-x).

Harnessing massive data sets

AI models cull data sets, whether banks of radiographic images or files in an EHR, to extract telltale signatures of a disease state. Dr. Chattopadhyay and his team’s model used three databases with almost 3 million participants and 54,247 positive cases of IPF. Hospitals in Scotland have deployed what they’ve claimed are the first AI models to predict COPD built with 55,000 patient records from a regional National Health Service database. Another AI model for staging COPD, developed by researchers in the United States and Romania, used more than 18,000 medical records from 588 patients to identify physiological signals predictive of COPD (Advanced Sci. 2023 Feb 19. doi: 10.1002/advs.202203485).

Said Dr. Chattopadhyay: “If I can bring in AI which doesn’t just look at radiological images but actually gets it back where someone walks into primary care using only the information that is available at that point in the patient files and asking for nothing more, it raises a flag reliably that gets you a pulmonary referral that will hopefully reduce the misdiagnosis and late diagnosis.”

Victor Tseng, MD, medical director for pulmonology at Ansible Health in Mountain View, Calif., who’s researching the potential of AI in pulmonology, speculated on what functions AI can perform in the clinic. “I think you will start to see much more interventional sort of clinically patient care–facing applications,” he said. That would include acting as a triage layer to direct patient queries to a nurse, physician, or another practitioner, providing patient instructions, serving as therapeutic software, coordinating care, integrating supply chain issues,” he said.

 

AI vs. spirometry for COPD

Researchers in the United States and Romania, led by Paul Bogdan, PhD, at the University of Southern California Viterbi School of Engineering, developed a model that predicted COPD with an accuracy of almost 99% (98.66%) and avoids many of the shortcomings of spirometry, Dr. Bogdan said.

USC Viterbi School of Engineering

The models developed by Dr. Bogdan and collaborators use a different principle than existing AI platforms, Dr. Bogdan said. They analyze the properties of the data. As he explained it, they exploit what he called the “geometry of these data” to make inferences and decisions on a patient’s risk for COPD.

“Deep learning is very good for images, for videos, but it doesn’t work that well for signals,” said Mihai Udrescu, PhD, one of the Romanian collaborators. “But if we process the data with the technique brought up by Paul [Bogdan] and his team at USC, deep learning also works well on physiological signals.”

Dr. Paul Bogdan

Said Dr. Bogdan, “Nobody thought about using physiological signals to predict COPD before this work. They used spirometry, but spirometry is cumbersome and several steps have to be performed in order to have an accurate spirometry.” His team’s AI models extract and analyze risk data based on 10 minutes of monitoring.

This technology also has the potential to improve accessibility of COPD screening, Dr. Udrescu said. “It can democratize the access to the health care because you don’t need to travel for 100 or 200 miles to see a specialist,” he said. “You just send an app to the mobile phone of a patient, the person puts on a smart watch and wears it for a couple of minutes and the data is either recorded locally or is transmitted and it is analyzed.” The computations can be done locally and in a matter of minutes, he said.

In Scotland, a 12-month feasibility study is underway to evaluate an AI model to identify COPD patients at greatest risk for adverse events. A press release from Lenus, the company developing the technology, said the study will use a COPD multidisciplinary team to consider real-time AI model outputs to enable proactive patient encounters and reduce emergency care visits.

Researchers in Paris built an AI model that showed a 68% accuracy in distinguishing people with asthma from people with COPD in administrative medical databases (BMC Pulmon Med. 2022 Sep 20. doi: 10.1186/s12890-022-02144-2). They found that asthma patients were younger than those with COPD (a mean of 49.9 vs. 72.1 years) and that COPD occurred mostly in men (68% vs. 33%). And an international team of researchers reported that an AI model that used chest CT scans determined that ever-smokers with COPD who met the imaging criteria for bronchiectasis were more prone to disease exacerbations (Radiology. 2022 Dec 13. doi: 10.1148/radiol.221109). 

 

AI in idiopathic pulmonary fibrosis

The AI model that Dr. Chattopadhyay and collaborators developed had an 88% accuracy in predicting IPF. The model, known as the zero-burden comorbidity risk score for IPF (ZCoR-IPF), identified IPF cases in adults age 45 and older 1-4 years sooner than in a variety of pulmonology practice settings.

The model accounted for about 700 different features of IPF, Dr. Chattopadhyay said, but it deviated from standard AI risk models in that it used a machine learning algorithm to extract disease features that aren’t well understood or even known. “We do not know what all the risk factors of IPF are,” he said. “People who don’t have all the risk factors still get IPF. So we have to step back from the raw EHR data from where the features are being generated automatically, and then you can apply standard ML tools.”

Researchers at Nagoya University in Japan also reported on an AI algorithm for predicting IPF that used 646,800 high-resolution CT images and medical records data from 1,068 patients. Their algorithm had an average diagnostic accuracy of 83.6% and, they reported, demonstrated good accuracy even in patients with signs of interstitial pneumonia or who had surgical lung biopsies (Respirology. 2022 Dec 13. doi: 10.1111/resp.14310).

 

Chat GPT: The next frontier in AI

Dr. Tseng last year led a group of researchers that fed questions from the United States Medical Licensing Exam to a ChatGPT model, which found it answered 60%-65% of questions correctly (PLOS Digit Health. 2023 Feb 9. doi: 10.1371/journal.pdig.0000198). As Dr. Tseng pointed out, that’s good enough to get a medical license.

It may be a matter of time before ChatGPT technology finds its way into the clinic, Dr. Tseng said. A quick ChatGPT query of how it could be used in medicine yielded 12 different answers, from patient triage to providing basic first aid instructions in an emergency.

Dr. Tseng, who’s pulmonology practice places an emphasis on virtual care delivery, went deeper than the ChatGPT answer. “If you’re a respiratory therapist and you’re trying to execute a complicated medical care plan written by a physician, there’s a natural disconnect between our language and their language,” he said. “What we have found is that GPT has significantly harmonized the care plan. And that’s amazing because you end up with this single-stream understanding of the care plan, where the language is halfway between a bedside clinician, like the respiratory therapist or nurse, and is also something that a physician can understand and take the bigger sort of direction of care from.”

 

Barriers to AI in clinic

Numerous barriers face widespread adoption of AI tools in the clinic, Dr. Tseng said, including physician and staff anxiety about learning new technology. “AI tools, for all purposes, are supposed to allay the cognitive burden and the tedium burden on clinicians, but end up actually costing more time,” he said.

Health care organizations will also need to retool for AI, a group of medical informatics and digital health experts, led by Laurie Lovett Novak, PhD, reported (JAMIA Open. 2023 May 3. doi: 10.1093/jamiaopen/ooad028). But it’s coming nonetheless, Dr. Novak, an associate professor of biomedical informatics at Vanderbilt University Medical Center in Nashville, Tenn., said in an interview.

“In the near future, managers in clinics and inpatient units will be overseeing care that involves numerous AI-based technologies, including predictive analytics, imaging tools, language models, and others,” she said. “Organizations need to support managers by implementing capabilities for algorithmo-vigilance.”

That would include dealing with what she called “algorithmic drift” – when the accuracy of an AI model wanes because of changes in the underlying data – and ensuring that models are unbiased and aren’t used in a way that contributes to inequities in health care. “These new organizational capabilities will demand new tools and new competencies,” she said. That would include policies and processes drawing guidance from medical societies for legal and regulatory direction for managers, staff training, and software documentation.

Dr. Tseng envisioned how AI would work in the clinic. “I personally think that, at some time in the near future, AI-driven care coordination, where the AI basically handles appointment scheduling, patient motivation, patient engagement and acts as their health navigator, will be superior to any human health navigator on the whole, only for the reason that AI is indefatigable,” Dr. Tseng said. “It doesn’t get tired, it doesn’t get burned out, and these health navigation care coordination roles are notoriously difficult.”

The physicians and researchers interviewed for this report had no relevant relationships to disclose.

The utility of artificial intelligence in pulmonology has focused mainly on using image datasets to detect and diagnose lung malignancies, but now a growing number of AI models are emerging that apply machine learning to improve predictability for other pulmonary conditions, including pulmonary infections, pulmonary fibrosis, and chronic obstructive pulmonary disease (COPD).

These applications are moving beyond the traditional AI model of collecting data from a multitude of images to cast a wider data net that includes electronic health records.

Also on the horizon, ChatGPT technology is poised to have an impact. But pulmonologists and their practices have a number of barriers to clear before they feel a meaningful impact from AI.

The imperative, said AI researcher Ishanu Chattopadhyay, PhD, is to create transformative models that can detect lung disease early on. Dr. Chattopadhyay, an assistant professor of medicine at the University of Chicago and its Institute for Genomics and Systems Biology, and fellow researchers developed an AI algorithm that uses comorbidity signatures in electronic health records to screen for idiopathic pulmonary fibrosis (IPF) (Nature Med. 2022 Sep 29. doi: 10.1038/s41591-022-02010-y).

“If you could do this when somebody walks into a primary care setting and they are barely suspecting something is going on with them or when they don’t have the typical risk factors, there is a certain fraction of these people who do have IPF and they will almost invariably be diagnosed late and/or misdiagnosed,” Dr. Chattopadhyay said, citing a study that found 55% of patients with IPF have had at least one misdiagnosis and 38% have two or more misdiagnoses (BMC Pulm Med. 2018 Jan 17. doi: 10.1186/s12890-017-0560-x).

Harnessing massive data sets

AI models cull data sets, whether banks of radiographic images or files in an EHR, to extract telltale signatures of a disease state. Dr. Chattopadhyay and his team’s model used three databases with almost 3 million participants and 54,247 positive cases of IPF. Hospitals in Scotland have deployed what they’ve claimed are the first AI models to predict COPD built with 55,000 patient records from a regional National Health Service database. Another AI model for staging COPD, developed by researchers in the United States and Romania, used more than 18,000 medical records from 588 patients to identify physiological signals predictive of COPD (Advanced Sci. 2023 Feb 19. doi: 10.1002/advs.202203485).

Said Dr. Chattopadhyay: “If I can bring in AI which doesn’t just look at radiological images but actually gets it back where someone walks into primary care using only the information that is available at that point in the patient files and asking for nothing more, it raises a flag reliably that gets you a pulmonary referral that will hopefully reduce the misdiagnosis and late diagnosis.”

Victor Tseng, MD, medical director for pulmonology at Ansible Health in Mountain View, Calif., who’s researching the potential of AI in pulmonology, speculated on what functions AI can perform in the clinic. “I think you will start to see much more interventional sort of clinically patient care–facing applications,” he said. That would include acting as a triage layer to direct patient queries to a nurse, physician, or another practitioner, providing patient instructions, serving as therapeutic software, coordinating care, integrating supply chain issues,” he said.

 

AI vs. spirometry for COPD

Researchers in the United States and Romania, led by Paul Bogdan, PhD, at the University of Southern California Viterbi School of Engineering, developed a model that predicted COPD with an accuracy of almost 99% (98.66%) and avoids many of the shortcomings of spirometry, Dr. Bogdan said.

USC Viterbi School of Engineering

The models developed by Dr. Bogdan and collaborators use a different principle than existing AI platforms, Dr. Bogdan said. They analyze the properties of the data. As he explained it, they exploit what he called the “geometry of these data” to make inferences and decisions on a patient’s risk for COPD.

“Deep learning is very good for images, for videos, but it doesn’t work that well for signals,” said Mihai Udrescu, PhD, one of the Romanian collaborators. “But if we process the data with the technique brought up by Paul [Bogdan] and his team at USC, deep learning also works well on physiological signals.”

Dr. Paul Bogdan

Said Dr. Bogdan, “Nobody thought about using physiological signals to predict COPD before this work. They used spirometry, but spirometry is cumbersome and several steps have to be performed in order to have an accurate spirometry.” His team’s AI models extract and analyze risk data based on 10 minutes of monitoring.

This technology also has the potential to improve accessibility of COPD screening, Dr. Udrescu said. “It can democratize the access to the health care because you don’t need to travel for 100 or 200 miles to see a specialist,” he said. “You just send an app to the mobile phone of a patient, the person puts on a smart watch and wears it for a couple of minutes and the data is either recorded locally or is transmitted and it is analyzed.” The computations can be done locally and in a matter of minutes, he said.

In Scotland, a 12-month feasibility study is underway to evaluate an AI model to identify COPD patients at greatest risk for adverse events. A press release from Lenus, the company developing the technology, said the study will use a COPD multidisciplinary team to consider real-time AI model outputs to enable proactive patient encounters and reduce emergency care visits.

Researchers in Paris built an AI model that showed a 68% accuracy in distinguishing people with asthma from people with COPD in administrative medical databases (BMC Pulmon Med. 2022 Sep 20. doi: 10.1186/s12890-022-02144-2). They found that asthma patients were younger than those with COPD (a mean of 49.9 vs. 72.1 years) and that COPD occurred mostly in men (68% vs. 33%). And an international team of researchers reported that an AI model that used chest CT scans determined that ever-smokers with COPD who met the imaging criteria for bronchiectasis were more prone to disease exacerbations (Radiology. 2022 Dec 13. doi: 10.1148/radiol.221109). 

 

AI in idiopathic pulmonary fibrosis

The AI model that Dr. Chattopadhyay and collaborators developed had an 88% accuracy in predicting IPF. The model, known as the zero-burden comorbidity risk score for IPF (ZCoR-IPF), identified IPF cases in adults age 45 and older 1-4 years sooner than in a variety of pulmonology practice settings.

The model accounted for about 700 different features of IPF, Dr. Chattopadhyay said, but it deviated from standard AI risk models in that it used a machine learning algorithm to extract disease features that aren’t well understood or even known. “We do not know what all the risk factors of IPF are,” he said. “People who don’t have all the risk factors still get IPF. So we have to step back from the raw EHR data from where the features are being generated automatically, and then you can apply standard ML tools.”

Researchers at Nagoya University in Japan also reported on an AI algorithm for predicting IPF that used 646,800 high-resolution CT images and medical records data from 1,068 patients. Their algorithm had an average diagnostic accuracy of 83.6% and, they reported, demonstrated good accuracy even in patients with signs of interstitial pneumonia or who had surgical lung biopsies (Respirology. 2022 Dec 13. doi: 10.1111/resp.14310).

 

Chat GPT: The next frontier in AI

Dr. Tseng last year led a group of researchers that fed questions from the United States Medical Licensing Exam to a ChatGPT model, which found it answered 60%-65% of questions correctly (PLOS Digit Health. 2023 Feb 9. doi: 10.1371/journal.pdig.0000198). As Dr. Tseng pointed out, that’s good enough to get a medical license.

It may be a matter of time before ChatGPT technology finds its way into the clinic, Dr. Tseng said. A quick ChatGPT query of how it could be used in medicine yielded 12 different answers, from patient triage to providing basic first aid instructions in an emergency.

Dr. Tseng, who’s pulmonology practice places an emphasis on virtual care delivery, went deeper than the ChatGPT answer. “If you’re a respiratory therapist and you’re trying to execute a complicated medical care plan written by a physician, there’s a natural disconnect between our language and their language,” he said. “What we have found is that GPT has significantly harmonized the care plan. And that’s amazing because you end up with this single-stream understanding of the care plan, where the language is halfway between a bedside clinician, like the respiratory therapist or nurse, and is also something that a physician can understand and take the bigger sort of direction of care from.”

 

Barriers to AI in clinic

Numerous barriers face widespread adoption of AI tools in the clinic, Dr. Tseng said, including physician and staff anxiety about learning new technology. “AI tools, for all purposes, are supposed to allay the cognitive burden and the tedium burden on clinicians, but end up actually costing more time,” he said.

Health care organizations will also need to retool for AI, a group of medical informatics and digital health experts, led by Laurie Lovett Novak, PhD, reported (JAMIA Open. 2023 May 3. doi: 10.1093/jamiaopen/ooad028). But it’s coming nonetheless, Dr. Novak, an associate professor of biomedical informatics at Vanderbilt University Medical Center in Nashville, Tenn., said in an interview.

“In the near future, managers in clinics and inpatient units will be overseeing care that involves numerous AI-based technologies, including predictive analytics, imaging tools, language models, and others,” she said. “Organizations need to support managers by implementing capabilities for algorithmo-vigilance.”

That would include dealing with what she called “algorithmic drift” – when the accuracy of an AI model wanes because of changes in the underlying data – and ensuring that models are unbiased and aren’t used in a way that contributes to inequities in health care. “These new organizational capabilities will demand new tools and new competencies,” she said. That would include policies and processes drawing guidance from medical societies for legal and regulatory direction for managers, staff training, and software documentation.

Dr. Tseng envisioned how AI would work in the clinic. “I personally think that, at some time in the near future, AI-driven care coordination, where the AI basically handles appointment scheduling, patient motivation, patient engagement and acts as their health navigator, will be superior to any human health navigator on the whole, only for the reason that AI is indefatigable,” Dr. Tseng said. “It doesn’t get tired, it doesn’t get burned out, and these health navigation care coordination roles are notoriously difficult.”

The physicians and researchers interviewed for this report had no relevant relationships to disclose.

The utility of artificial intelligence in pulmonology has focused mainly on using image datasets to detect and diagnose lung malignancies, but now a growing number of AI models are emerging that apply machine learning to improve predictability for other pulmonary conditions, including pulmonary infections, pulmonary fibrosis, and chronic obstructive pulmonary disease (COPD).

These applications are moving beyond the traditional AI model of collecting data from a multitude of images to cast a wider data net that includes electronic health records.

Also on the horizon, ChatGPT technology is poised to have an impact. But pulmonologists and their practices have a number of barriers to clear before they feel a meaningful impact from AI.

The imperative, said AI researcher Ishanu Chattopadhyay, PhD, is to create transformative models that can detect lung disease early on. Dr. Chattopadhyay, an assistant professor of medicine at the University of Chicago and its Institute for Genomics and Systems Biology, and fellow researchers developed an AI algorithm that uses comorbidity signatures in electronic health records to screen for idiopathic pulmonary fibrosis (IPF) (Nature Med. 2022 Sep 29. doi: 10.1038/s41591-022-02010-y).

“If you could do this when somebody walks into a primary care setting and they are barely suspecting something is going on with them or when they don’t have the typical risk factors, there is a certain fraction of these people who do have IPF and they will almost invariably be diagnosed late and/or misdiagnosed,” Dr. Chattopadhyay said, citing a study that found 55% of patients with IPF have had at least one misdiagnosis and 38% have two or more misdiagnoses (BMC Pulm Med. 2018 Jan 17. doi: 10.1186/s12890-017-0560-x).

Harnessing massive data sets

AI models cull data sets, whether banks of radiographic images or files in an EHR, to extract telltale signatures of a disease state. Dr. Chattopadhyay and his team’s model used three databases with almost 3 million participants and 54,247 positive cases of IPF. Hospitals in Scotland have deployed what they’ve claimed are the first AI models to predict COPD built with 55,000 patient records from a regional National Health Service database. Another AI model for staging COPD, developed by researchers in the United States and Romania, used more than 18,000 medical records from 588 patients to identify physiological signals predictive of COPD (Advanced Sci. 2023 Feb 19. doi: 10.1002/advs.202203485).

Said Dr. Chattopadhyay: “If I can bring in AI which doesn’t just look at radiological images but actually gets it back where someone walks into primary care using only the information that is available at that point in the patient files and asking for nothing more, it raises a flag reliably that gets you a pulmonary referral that will hopefully reduce the misdiagnosis and late diagnosis.”

Victor Tseng, MD, medical director for pulmonology at Ansible Health in Mountain View, Calif., who’s researching the potential of AI in pulmonology, speculated on what functions AI can perform in the clinic. “I think you will start to see much more interventional sort of clinically patient care–facing applications,” he said. That would include acting as a triage layer to direct patient queries to a nurse, physician, or another practitioner, providing patient instructions, serving as therapeutic software, coordinating care, integrating supply chain issues,” he said.

 

AI vs. spirometry for COPD

Researchers in the United States and Romania, led by Paul Bogdan, PhD, at the University of Southern California Viterbi School of Engineering, developed a model that predicted COPD with an accuracy of almost 99% (98.66%) and avoids many of the shortcomings of spirometry, Dr. Bogdan said.

USC Viterbi School of Engineering

The models developed by Dr. Bogdan and collaborators use a different principle than existing AI platforms, Dr. Bogdan said. They analyze the properties of the data. As he explained it, they exploit what he called the “geometry of these data” to make inferences and decisions on a patient’s risk for COPD.

“Deep learning is very good for images, for videos, but it doesn’t work that well for signals,” said Mihai Udrescu, PhD, one of the Romanian collaborators. “But if we process the data with the technique brought up by Paul [Bogdan] and his team at USC, deep learning also works well on physiological signals.”

Dr. Paul Bogdan

Said Dr. Bogdan, “Nobody thought about using physiological signals to predict COPD before this work. They used spirometry, but spirometry is cumbersome and several steps have to be performed in order to have an accurate spirometry.” His team’s AI models extract and analyze risk data based on 10 minutes of monitoring.

This technology also has the potential to improve accessibility of COPD screening, Dr. Udrescu said. “It can democratize the access to the health care because you don’t need to travel for 100 or 200 miles to see a specialist,” he said. “You just send an app to the mobile phone of a patient, the person puts on a smart watch and wears it for a couple of minutes and the data is either recorded locally or is transmitted and it is analyzed.” The computations can be done locally and in a matter of minutes, he said.

In Scotland, a 12-month feasibility study is underway to evaluate an AI model to identify COPD patients at greatest risk for adverse events. A press release from Lenus, the company developing the technology, said the study will use a COPD multidisciplinary team to consider real-time AI model outputs to enable proactive patient encounters and reduce emergency care visits.

Researchers in Paris built an AI model that showed a 68% accuracy in distinguishing people with asthma from people with COPD in administrative medical databases (BMC Pulmon Med. 2022 Sep 20. doi: 10.1186/s12890-022-02144-2). They found that asthma patients were younger than those with COPD (a mean of 49.9 vs. 72.1 years) and that COPD occurred mostly in men (68% vs. 33%). And an international team of researchers reported that an AI model that used chest CT scans determined that ever-smokers with COPD who met the imaging criteria for bronchiectasis were more prone to disease exacerbations (Radiology. 2022 Dec 13. doi: 10.1148/radiol.221109). 

 

AI in idiopathic pulmonary fibrosis

The AI model that Dr. Chattopadhyay and collaborators developed had an 88% accuracy in predicting IPF. The model, known as the zero-burden comorbidity risk score for IPF (ZCoR-IPF), identified IPF cases in adults age 45 and older 1-4 years sooner than in a variety of pulmonology practice settings.

The model accounted for about 700 different features of IPF, Dr. Chattopadhyay said, but it deviated from standard AI risk models in that it used a machine learning algorithm to extract disease features that aren’t well understood or even known. “We do not know what all the risk factors of IPF are,” he said. “People who don’t have all the risk factors still get IPF. So we have to step back from the raw EHR data from where the features are being generated automatically, and then you can apply standard ML tools.”

Researchers at Nagoya University in Japan also reported on an AI algorithm for predicting IPF that used 646,800 high-resolution CT images and medical records data from 1,068 patients. Their algorithm had an average diagnostic accuracy of 83.6% and, they reported, demonstrated good accuracy even in patients with signs of interstitial pneumonia or who had surgical lung biopsies (Respirology. 2022 Dec 13. doi: 10.1111/resp.14310).

 

Chat GPT: The next frontier in AI

Dr. Tseng last year led a group of researchers that fed questions from the United States Medical Licensing Exam to a ChatGPT model, which found it answered 60%-65% of questions correctly (PLOS Digit Health. 2023 Feb 9. doi: 10.1371/journal.pdig.0000198). As Dr. Tseng pointed out, that’s good enough to get a medical license.

It may be a matter of time before ChatGPT technology finds its way into the clinic, Dr. Tseng said. A quick ChatGPT query of how it could be used in medicine yielded 12 different answers, from patient triage to providing basic first aid instructions in an emergency.

Dr. Tseng, who’s pulmonology practice places an emphasis on virtual care delivery, went deeper than the ChatGPT answer. “If you’re a respiratory therapist and you’re trying to execute a complicated medical care plan written by a physician, there’s a natural disconnect between our language and their language,” he said. “What we have found is that GPT has significantly harmonized the care plan. And that’s amazing because you end up with this single-stream understanding of the care plan, where the language is halfway between a bedside clinician, like the respiratory therapist or nurse, and is also something that a physician can understand and take the bigger sort of direction of care from.”

 

Barriers to AI in clinic

Numerous barriers face widespread adoption of AI tools in the clinic, Dr. Tseng said, including physician and staff anxiety about learning new technology. “AI tools, for all purposes, are supposed to allay the cognitive burden and the tedium burden on clinicians, but end up actually costing more time,” he said.

Health care organizations will also need to retool for AI, a group of medical informatics and digital health experts, led by Laurie Lovett Novak, PhD, reported (JAMIA Open. 2023 May 3. doi: 10.1093/jamiaopen/ooad028). But it’s coming nonetheless, Dr. Novak, an associate professor of biomedical informatics at Vanderbilt University Medical Center in Nashville, Tenn., said in an interview.

“In the near future, managers in clinics and inpatient units will be overseeing care that involves numerous AI-based technologies, including predictive analytics, imaging tools, language models, and others,” she said. “Organizations need to support managers by implementing capabilities for algorithmo-vigilance.”

That would include dealing with what she called “algorithmic drift” – when the accuracy of an AI model wanes because of changes in the underlying data – and ensuring that models are unbiased and aren’t used in a way that contributes to inequities in health care. “These new organizational capabilities will demand new tools and new competencies,” she said. That would include policies and processes drawing guidance from medical societies for legal and regulatory direction for managers, staff training, and software documentation.

Dr. Tseng envisioned how AI would work in the clinic. “I personally think that, at some time in the near future, AI-driven care coordination, where the AI basically handles appointment scheduling, patient motivation, patient engagement and acts as their health navigator, will be superior to any human health navigator on the whole, only for the reason that AI is indefatigable,” Dr. Tseng said. “It doesn’t get tired, it doesn’t get burned out, and these health navigation care coordination roles are notoriously difficult.”

The physicians and researchers interviewed for this report had no relevant relationships to disclose.

The U.S. Food and Drug Administration (FDA) has granted accelerated approval to talquetamab-tgvs (Talvey, Janssen Biotech, Inc), a first-in-class bispecific antibody targeting the GPRC5D receptor, for heavily pretreated adults with relapsed or refractory multiple myeloma.

Patients must have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

The agent, which also received breakthrough and orphan drug designation, is available only through the Tecvayli-Talvey Risk Evaluation and Mitigation Strategy (REMS) because of a boxed warning for life-threatening or fatal cytokine release syndrome (CRS) and neurological toxicity, including immune effector cell–associated neurotoxicity (ICANS), the FDA announced.

Talquetamab-tgvs was evaluated in the single-arm, open-label MonumenTAL-1 study of 187 patients who had previously been treated with at least four prior systemic therapies.

The overall response rate in 100 patients who received a subcutaneous dose of 0.4 mg/kg weekly was 73% and median duration of response was 9.5 months. The overall response rate in 87 patients who received a subcutaneous dose of 0.8 mg/kg biweekly was 73.6%, with about 85% of responders maintaining their response for at least 9 months. In this group, the median duration of response was not estimable.

Patients in the 0.4 mg/kg weekly dose group were treated following two step-up doses in the first week of therapy, and those in the 0.8 mg/kg biweekly group were treated following three step-up doses, until disease progression or unacceptable toxicity.

Adverse reactions occurring in at least 20% of the 339 patients in the safety population included CRS, dysgeusia (foul, metallic taste sensation), nail disorder, musculoskeletal pain, skin disorder, rash, fatigue, decreased weight, dry mouth, pyrexia, xerosis, dysphagia, upper respiratory tract infection, and diarrhea.

Both the weekly 0.4 mg/kg and biweekly 0.8 mg/kg doses are recommended. The full dosing schedule is included in the prescribing information.

The approval follows a series of market withdrawals for other multiple myeloma drugs that initially received accelerated FDA approval. For instance, the FDA recently requested withdrawal of melphalan flufenamide (Pepaxto) after 2021 confirmatory trial results showed an increased risk of death. This agent had received accelerated approval in 2021. GlaxoSmithKline’s blood cancer drugs panobinostat (Farydak) and belantamab mafodotin-blmf (Blenrep) were also withdrawn based on confirmatory trial results.

Continued approval of talquetemab-tgvs for this indication is also contingent on verifying efficacy in confirmatory trials.

The new treatment approach represents a “welcome addition to the myeloma community,” Michael Andreini, president and chief executive officer of the Multiple Myeloma Research Foundation stated in a Janssen press release. “Although options for the treatment of multiple myeloma have expanded significantly in recent years, the disease remains incurable, and therefore, patients are in need of new treatment options.”

Health care professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088.

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

The U.S. Food and Drug Administration (FDA) has granted accelerated approval to talquetamab-tgvs (Talvey, Janssen Biotech, Inc), a first-in-class bispecific antibody targeting the GPRC5D receptor, for heavily pretreated adults with relapsed or refractory multiple myeloma.

Patients must have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

The agent, which also received breakthrough and orphan drug designation, is available only through the Tecvayli-Talvey Risk Evaluation and Mitigation Strategy (REMS) because of a boxed warning for life-threatening or fatal cytokine release syndrome (CRS) and neurological toxicity, including immune effector cell–associated neurotoxicity (ICANS), the FDA announced.

Talquetamab-tgvs was evaluated in the single-arm, open-label MonumenTAL-1 study of 187 patients who had previously been treated with at least four prior systemic therapies.

The overall response rate in 100 patients who received a subcutaneous dose of 0.4 mg/kg weekly was 73% and median duration of response was 9.5 months. The overall response rate in 87 patients who received a subcutaneous dose of 0.8 mg/kg biweekly was 73.6%, with about 85% of responders maintaining their response for at least 9 months. In this group, the median duration of response was not estimable.

Patients in the 0.4 mg/kg weekly dose group were treated following two step-up doses in the first week of therapy, and those in the 0.8 mg/kg biweekly group were treated following three step-up doses, until disease progression or unacceptable toxicity.

Adverse reactions occurring in at least 20% of the 339 patients in the safety population included CRS, dysgeusia (foul, metallic taste sensation), nail disorder, musculoskeletal pain, skin disorder, rash, fatigue, decreased weight, dry mouth, pyrexia, xerosis, dysphagia, upper respiratory tract infection, and diarrhea.

Both the weekly 0.4 mg/kg and biweekly 0.8 mg/kg doses are recommended. The full dosing schedule is included in the prescribing information.

The approval follows a series of market withdrawals for other multiple myeloma drugs that initially received accelerated FDA approval. For instance, the FDA recently requested withdrawal of melphalan flufenamide (Pepaxto) after 2021 confirmatory trial results showed an increased risk of death. This agent had received accelerated approval in 2021. GlaxoSmithKline’s blood cancer drugs panobinostat (Farydak) and belantamab mafodotin-blmf (Blenrep) were also withdrawn based on confirmatory trial results.

Continued approval of talquetemab-tgvs for this indication is also contingent on verifying efficacy in confirmatory trials.

The new treatment approach represents a “welcome addition to the myeloma community,” Michael Andreini, president and chief executive officer of the Multiple Myeloma Research Foundation stated in a Janssen press release. “Although options for the treatment of multiple myeloma have expanded significantly in recent years, the disease remains incurable, and therefore, patients are in need of new treatment options.”

Health care professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088.

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

The U.S. Food and Drug Administration (FDA) has granted accelerated approval to talquetamab-tgvs (Talvey, Janssen Biotech, Inc), a first-in-class bispecific antibody targeting the GPRC5D receptor, for heavily pretreated adults with relapsed or refractory multiple myeloma.

Patients must have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

The agent, which also received breakthrough and orphan drug designation, is available only through the Tecvayli-Talvey Risk Evaluation and Mitigation Strategy (REMS) because of a boxed warning for life-threatening or fatal cytokine release syndrome (CRS) and neurological toxicity, including immune effector cell–associated neurotoxicity (ICANS), the FDA announced.

Talquetamab-tgvs was evaluated in the single-arm, open-label MonumenTAL-1 study of 187 patients who had previously been treated with at least four prior systemic therapies.

The overall response rate in 100 patients who received a subcutaneous dose of 0.4 mg/kg weekly was 73% and median duration of response was 9.5 months. The overall response rate in 87 patients who received a subcutaneous dose of 0.8 mg/kg biweekly was 73.6%, with about 85% of responders maintaining their response for at least 9 months. In this group, the median duration of response was not estimable.

Patients in the 0.4 mg/kg weekly dose group were treated following two step-up doses in the first week of therapy, and those in the 0.8 mg/kg biweekly group were treated following three step-up doses, until disease progression or unacceptable toxicity.

Adverse reactions occurring in at least 20% of the 339 patients in the safety population included CRS, dysgeusia (foul, metallic taste sensation), nail disorder, musculoskeletal pain, skin disorder, rash, fatigue, decreased weight, dry mouth, pyrexia, xerosis, dysphagia, upper respiratory tract infection, and diarrhea.

Both the weekly 0.4 mg/kg and biweekly 0.8 mg/kg doses are recommended. The full dosing schedule is included in the prescribing information.

The approval follows a series of market withdrawals for other multiple myeloma drugs that initially received accelerated FDA approval. For instance, the FDA recently requested withdrawal of melphalan flufenamide (Pepaxto) after 2021 confirmatory trial results showed an increased risk of death. This agent had received accelerated approval in 2021. GlaxoSmithKline’s blood cancer drugs panobinostat (Farydak) and belantamab mafodotin-blmf (Blenrep) were also withdrawn based on confirmatory trial results.

Continued approval of talquetemab-tgvs for this indication is also contingent on verifying efficacy in confirmatory trials.

The new treatment approach represents a “welcome addition to the myeloma community,” Michael Andreini, president and chief executive officer of the Multiple Myeloma Research Foundation stated in a Janssen press release. “Although options for the treatment of multiple myeloma have expanded significantly in recent years, the disease remains incurable, and therefore, patients are in need of new treatment options.”

Health care professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088.

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

After catching COVID-19 for the second time in July 2022, Daniel Lewis suffered persistent headaches, chest pain, and a dangerously high heart rate. He recalls that he was also so exhausted packing for a family wedding that he had to take a break to rest each time he put something into his suitcase.

Instead of attending the wedding, the 30-year-old Washington data analyst visited his doctor, who diagnosed “some postviral thing” and prescribed rest. Mr. Lewis found a new doctor, went to a long COVID clinic, and saw multiple specialists, but a year later, he’s still sick – and disabled. He meets the federal criteria for long COVID (symptoms that last more than 4 weeks).

He now uses an electric wheelchair whenever he leaves his apartment, a far cry from his pre-COVID life, when he was training for a half marathon.

“Some doctors have genuinely tried to help,” he said. “Most don’t really know what long COVID is, and ... since there’s no official guidance on what to do with long COVID patients, they just throw up their hands and say there’s nothing to do.”

That could be changing – at least the part about official guidance. New findings published in JAMA indicate we’re getting closer to unraveling what long COVID is all about and may help refine how it is defined and diagnosed. The study identified the 37 most common symptoms of long COVID, an important step toward better understanding and treatment of the condition, which affects an estimated 65 million people worldwide.

Although the study provides a way to systematically identify the condition, the authors were clear that this is significant but that it is only a first step. Naming symptoms is very different from understanding what causes them, and understanding them is critical for developing effective treatments, said pulmonologist Bruce Levy, MD, a study coauthor who is interim chair of medicine at Brigham and Women’s Hospital and a professor of medicine at Harvard Medical School, both in Boston.

Researchers relied on self-reported symptoms from the 9,764 participants, all adults who are part of the ongoing Researching COVID to Enhance Recovery (RECOVER) Initiative, a longitudinal study run by the National Institutes of Health. Some patients had long COVID when they signed up for the study, some developed it afterward, and some had never had it, or if they had, they were unaware.

Other studies, most of them involving smaller groups of patients, have examined long COVID biomarkers, risk factors, and specific symptoms. Dr. Levy said it’s important to have a symptom-based definition of long COVID that draws from a large cohort of patients who reported on their experiences with symptoms during the aftermath of infection. However, he pointed out that because participants volunteered for the study and were not chosen on the basis of specific criteria, they may not be representative of the more general population of patients with long COVID.

“We need this kind of evidence – it’s important to have self-reported symptoms, because clearly, the patients know what they’re feeling,” Dr. Levy said. “But it’s only part of the picture.”

Dr. Levy said the definition of long COVID needs to be further refined by ongoing research, including objective assessments of clinical findings, laboratory testing, imaging, and biomarkers.

One of the notable findings in the JAMA study is that certain symptoms tend to occur in clusters. The biostatisticians and analysts who processed the data identified four subgroups of very common symptoms that appeared together in more than 80% of the long COVID patients: loss of or change in smell and taste; postexertional malaise and fatigue; brain fog, postexertional malaise, and fatigue; and fatigue, postexertional malaise, dizziness, brain fog, gastrointestinal issues, and palpitations.

Many of those symptoms are also associated with underlying conditions not related to long COVID, which makes an accurate diagnosis a challenge.

“Just the fact that they would cluster into four groups suggests that underlying all this is not just one unifying pathobiology,” Dr. Levy said. He stressed that clinicians need to understand what’s causing the symptoms before they can properly treat patients.

He pointed out that two of the possible disease-driving mechanisms are persistence of the virus and prolonged inflammation that is slow to resolve. For patients experiencing inflammation after the virus is gone, an anti-inflammatory therapy would be most appropriate.

But if they have persistent virus, “you would want to treat with an antiviral antibiotic and not quiet down the body’s antiviral inflammatory response,” he said. “How you treat the two potential underlying causes of long COVID could thus be almost diametrically opposed, so that’s part of the importance of figuring out what is the underlying cause of those symptoms, not just identifying the symptoms themselves.”

More studies are needed to determine whether long COVID is a syndrome or is related to a singular pathobiology, experts said.

That’s consistent with the impression of long COVID researcher Harlan Krumholz, MD, the Harold H. Hines Jr. professor of medicine (cardiology) at Yale University, New Haven, Conn.

Dr. Krumholz worries that some clinicians might use the JAMA findings to dismiss patients whose symptoms meet the criteria in the scoring system developed for the study.

“It’s important for people who read this paper to know that this is preliminary,” said Dr. Krumholz, a principal investigator of another patient-focused study designed to understand long COVID – the Yale Listen to Immune, Symptom, and Treatment Experiences Now (LISTEN) Study. “It’s a condition we don’t understand yet.”

Dr. Krumholz said he has lost track of the number of patients he knows who, like Daniel Lewis, are ill and are unable to get answers. “There is an intense sense of inadequacy on the clinical side and the research side,” he said. “Every day people ask me, ‘Are there any evidence-based strategies?’ And so far I have to say, every day, ‘No.’ I hate to say it, but it’s kind of like every patient is on their own. They’re trying different things because they can’t wait. There is an imperative to help them.”

At the end of July, the National Institutes of Health launched phase 2 clinical trials to evaluate at least four new treatments for long COVID, all part of the RECOVER initiative. By then, Mr. Lewis, who believes his myalgic encephalomyelitis/chronic fatigue syndrome was triggered by the virus, had made plans to try an alternative, experimental therapy.

“My hope is that it will fix me,” he said. “I’m excited about those kinds of hard-hitting infusion, immunological treatment.”

As for the JAMA study, he didn’t allow himself to get excited when it was released, a function of his experience as a data analyst and long COVID patient.

“I don’t think it moves the needle much yet,” he said. “It’s the first study, and we shouldn’t expect much from the first pieces of data to come out of that. If they keep following that cohort and go deeper and deeper, they’re going to find some interesting stuff that will lead to treatments.”

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

After catching COVID-19 for the second time in July 2022, Daniel Lewis suffered persistent headaches, chest pain, and a dangerously high heart rate. He recalls that he was also so exhausted packing for a family wedding that he had to take a break to rest each time he put something into his suitcase.

Instead of attending the wedding, the 30-year-old Washington data analyst visited his doctor, who diagnosed “some postviral thing” and prescribed rest. Mr. Lewis found a new doctor, went to a long COVID clinic, and saw multiple specialists, but a year later, he’s still sick – and disabled. He meets the federal criteria for long COVID (symptoms that last more than 4 weeks).

He now uses an electric wheelchair whenever he leaves his apartment, a far cry from his pre-COVID life, when he was training for a half marathon.

“Some doctors have genuinely tried to help,” he said. “Most don’t really know what long COVID is, and ... since there’s no official guidance on what to do with long COVID patients, they just throw up their hands and say there’s nothing to do.”

That could be changing – at least the part about official guidance. New findings published in JAMA indicate we’re getting closer to unraveling what long COVID is all about and may help refine how it is defined and diagnosed. The study identified the 37 most common symptoms of long COVID, an important step toward better understanding and treatment of the condition, which affects an estimated 65 million people worldwide.

Although the study provides a way to systematically identify the condition, the authors were clear that this is significant but that it is only a first step. Naming symptoms is very different from understanding what causes them, and understanding them is critical for developing effective treatments, said pulmonologist Bruce Levy, MD, a study coauthor who is interim chair of medicine at Brigham and Women’s Hospital and a professor of medicine at Harvard Medical School, both in Boston.

Researchers relied on self-reported symptoms from the 9,764 participants, all adults who are part of the ongoing Researching COVID to Enhance Recovery (RECOVER) Initiative, a longitudinal study run by the National Institutes of Health. Some patients had long COVID when they signed up for the study, some developed it afterward, and some had never had it, or if they had, they were unaware.

Other studies, most of them involving smaller groups of patients, have examined long COVID biomarkers, risk factors, and specific symptoms. Dr. Levy said it’s important to have a symptom-based definition of long COVID that draws from a large cohort of patients who reported on their experiences with symptoms during the aftermath of infection. However, he pointed out that because participants volunteered for the study and were not chosen on the basis of specific criteria, they may not be representative of the more general population of patients with long COVID.

“We need this kind of evidence – it’s important to have self-reported symptoms, because clearly, the patients know what they’re feeling,” Dr. Levy said. “But it’s only part of the picture.”

Dr. Levy said the definition of long COVID needs to be further refined by ongoing research, including objective assessments of clinical findings, laboratory testing, imaging, and biomarkers.

One of the notable findings in the JAMA study is that certain symptoms tend to occur in clusters. The biostatisticians and analysts who processed the data identified four subgroups of very common symptoms that appeared together in more than 80% of the long COVID patients: loss of or change in smell and taste; postexertional malaise and fatigue; brain fog, postexertional malaise, and fatigue; and fatigue, postexertional malaise, dizziness, brain fog, gastrointestinal issues, and palpitations.

Many of those symptoms are also associated with underlying conditions not related to long COVID, which makes an accurate diagnosis a challenge.

“Just the fact that they would cluster into four groups suggests that underlying all this is not just one unifying pathobiology,” Dr. Levy said. He stressed that clinicians need to understand what’s causing the symptoms before they can properly treat patients.

He pointed out that two of the possible disease-driving mechanisms are persistence of the virus and prolonged inflammation that is slow to resolve. For patients experiencing inflammation after the virus is gone, an anti-inflammatory therapy would be most appropriate.

But if they have persistent virus, “you would want to treat with an antiviral antibiotic and not quiet down the body’s antiviral inflammatory response,” he said. “How you treat the two potential underlying causes of long COVID could thus be almost diametrically opposed, so that’s part of the importance of figuring out what is the underlying cause of those symptoms, not just identifying the symptoms themselves.”

More studies are needed to determine whether long COVID is a syndrome or is related to a singular pathobiology, experts said.

That’s consistent with the impression of long COVID researcher Harlan Krumholz, MD, the Harold H. Hines Jr. professor of medicine (cardiology) at Yale University, New Haven, Conn.

Dr. Krumholz worries that some clinicians might use the JAMA findings to dismiss patients whose symptoms meet the criteria in the scoring system developed for the study.

“It’s important for people who read this paper to know that this is preliminary,” said Dr. Krumholz, a principal investigator of another patient-focused study designed to understand long COVID – the Yale Listen to Immune, Symptom, and Treatment Experiences Now (LISTEN) Study. “It’s a condition we don’t understand yet.”

Dr. Krumholz said he has lost track of the number of patients he knows who, like Daniel Lewis, are ill and are unable to get answers. “There is an intense sense of inadequacy on the clinical side and the research side,” he said. “Every day people ask me, ‘Are there any evidence-based strategies?’ And so far I have to say, every day, ‘No.’ I hate to say it, but it’s kind of like every patient is on their own. They’re trying different things because they can’t wait. There is an imperative to help them.”

At the end of July, the National Institutes of Health launched phase 2 clinical trials to evaluate at least four new treatments for long COVID, all part of the RECOVER initiative. By then, Mr. Lewis, who believes his myalgic encephalomyelitis/chronic fatigue syndrome was triggered by the virus, had made plans to try an alternative, experimental therapy.

“My hope is that it will fix me,” he said. “I’m excited about those kinds of hard-hitting infusion, immunological treatment.”

As for the JAMA study, he didn’t allow himself to get excited when it was released, a function of his experience as a data analyst and long COVID patient.

“I don’t think it moves the needle much yet,” he said. “It’s the first study, and we shouldn’t expect much from the first pieces of data to come out of that. If they keep following that cohort and go deeper and deeper, they’re going to find some interesting stuff that will lead to treatments.”

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

After catching COVID-19 for the second time in July 2022, Daniel Lewis suffered persistent headaches, chest pain, and a dangerously high heart rate. He recalls that he was also so exhausted packing for a family wedding that he had to take a break to rest each time he put something into his suitcase.

Instead of attending the wedding, the 30-year-old Washington data analyst visited his doctor, who diagnosed “some postviral thing” and prescribed rest. Mr. Lewis found a new doctor, went to a long COVID clinic, and saw multiple specialists, but a year later, he’s still sick – and disabled. He meets the federal criteria for long COVID (symptoms that last more than 4 weeks).

He now uses an electric wheelchair whenever he leaves his apartment, a far cry from his pre-COVID life, when he was training for a half marathon.

“Some doctors have genuinely tried to help,” he said. “Most don’t really know what long COVID is, and ... since there’s no official guidance on what to do with long COVID patients, they just throw up their hands and say there’s nothing to do.”

That could be changing – at least the part about official guidance. New findings published in JAMA indicate we’re getting closer to unraveling what long COVID is all about and may help refine how it is defined and diagnosed. The study identified the 37 most common symptoms of long COVID, an important step toward better understanding and treatment of the condition, which affects an estimated 65 million people worldwide.

Although the study provides a way to systematically identify the condition, the authors were clear that this is significant but that it is only a first step. Naming symptoms is very different from understanding what causes them, and understanding them is critical for developing effective treatments, said pulmonologist Bruce Levy, MD, a study coauthor who is interim chair of medicine at Brigham and Women’s Hospital and a professor of medicine at Harvard Medical School, both in Boston.

Researchers relied on self-reported symptoms from the 9,764 participants, all adults who are part of the ongoing Researching COVID to Enhance Recovery (RECOVER) Initiative, a longitudinal study run by the National Institutes of Health. Some patients had long COVID when they signed up for the study, some developed it afterward, and some had never had it, or if they had, they were unaware.

Other studies, most of them involving smaller groups of patients, have examined long COVID biomarkers, risk factors, and specific symptoms. Dr. Levy said it’s important to have a symptom-based definition of long COVID that draws from a large cohort of patients who reported on their experiences with symptoms during the aftermath of infection. However, he pointed out that because participants volunteered for the study and were not chosen on the basis of specific criteria, they may not be representative of the more general population of patients with long COVID.

“We need this kind of evidence – it’s important to have self-reported symptoms, because clearly, the patients know what they’re feeling,” Dr. Levy said. “But it’s only part of the picture.”

Dr. Levy said the definition of long COVID needs to be further refined by ongoing research, including objective assessments of clinical findings, laboratory testing, imaging, and biomarkers.

One of the notable findings in the JAMA study is that certain symptoms tend to occur in clusters. The biostatisticians and analysts who processed the data identified four subgroups of very common symptoms that appeared together in more than 80% of the long COVID patients: loss of or change in smell and taste; postexertional malaise and fatigue; brain fog, postexertional malaise, and fatigue; and fatigue, postexertional malaise, dizziness, brain fog, gastrointestinal issues, and palpitations.

Many of those symptoms are also associated with underlying conditions not related to long COVID, which makes an accurate diagnosis a challenge.

“Just the fact that they would cluster into four groups suggests that underlying all this is not just one unifying pathobiology,” Dr. Levy said. He stressed that clinicians need to understand what’s causing the symptoms before they can properly treat patients.

He pointed out that two of the possible disease-driving mechanisms are persistence of the virus and prolonged inflammation that is slow to resolve. For patients experiencing inflammation after the virus is gone, an anti-inflammatory therapy would be most appropriate.

But if they have persistent virus, “you would want to treat with an antiviral antibiotic and not quiet down the body’s antiviral inflammatory response,” he said. “How you treat the two potential underlying causes of long COVID could thus be almost diametrically opposed, so that’s part of the importance of figuring out what is the underlying cause of those symptoms, not just identifying the symptoms themselves.”

More studies are needed to determine whether long COVID is a syndrome or is related to a singular pathobiology, experts said.

That’s consistent with the impression of long COVID researcher Harlan Krumholz, MD, the Harold H. Hines Jr. professor of medicine (cardiology) at Yale University, New Haven, Conn.

Dr. Krumholz worries that some clinicians might use the JAMA findings to dismiss patients whose symptoms meet the criteria in the scoring system developed for the study.

“It’s important for people who read this paper to know that this is preliminary,” said Dr. Krumholz, a principal investigator of another patient-focused study designed to understand long COVID – the Yale Listen to Immune, Symptom, and Treatment Experiences Now (LISTEN) Study. “It’s a condition we don’t understand yet.”

Dr. Krumholz said he has lost track of the number of patients he knows who, like Daniel Lewis, are ill and are unable to get answers. “There is an intense sense of inadequacy on the clinical side and the research side,” he said. “Every day people ask me, ‘Are there any evidence-based strategies?’ And so far I have to say, every day, ‘No.’ I hate to say it, but it’s kind of like every patient is on their own. They’re trying different things because they can’t wait. There is an imperative to help them.”

At the end of July, the National Institutes of Health launched phase 2 clinical trials to evaluate at least four new treatments for long COVID, all part of the RECOVER initiative. By then, Mr. Lewis, who believes his myalgic encephalomyelitis/chronic fatigue syndrome was triggered by the virus, had made plans to try an alternative, experimental therapy.

“My hope is that it will fix me,” he said. “I’m excited about those kinds of hard-hitting infusion, immunological treatment.”

As for the JAMA study, he didn’t allow himself to get excited when it was released, a function of his experience as a data analyst and long COVID patient.

“I don’t think it moves the needle much yet,” he said. “It’s the first study, and we shouldn’t expect much from the first pieces of data to come out of that. If they keep following that cohort and go deeper and deeper, they’re going to find some interesting stuff that will lead to treatments.”

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

TOPLINE:

• No associations were found between preoperative A1c levels and postoperative infection, wound, or ketosis complications in children with type 1 or type 2 diabetes undergoing elective noncardiac surgery or diagnostic procedures.
• Delaying elective surgeries until A1c is consistently normalized may not be warranted, particularly because this is challenging to accomplish rapidly.

METHODOLOGY:

• A retrospective analysis was done of data from surgery and endocrinology medical records of 438 children aged 1-18 years with type 1 (72%) or type 2 diabetes (28%) undergoing elective noncardiac surgery at Texas Children’s Hospital, January 2011 to June 2021.
• Overall, 28% had an A1c less than 7.0%, 42% had A1c 7%-9%, and 30% had A1c greater than 9%.
• The primary outcome was defined as a new-onset postoperative systemic infection, wound complication, or ketosis.

TAKEAWAY:

• The incidence of any postoperative systemic infections was 0.91% (n = 4); postoperative wound disruption, 3.33% (n = 19); and postoperative ketosis, 3.89% (n = 17).
• A1c levels were not associated with any postoperative systemic infections, wound complications, or ketosis.
• No other preoperative factors, including diabetes type, body mass index, or procedure type, were association with these complications.

IN PRACTICE:

“Current recommendations suggest consulting with the diabetes team before surgery and if glycemic status is suboptimal to consider delaying surgery and, if surgery cannot be delayed, considering admission to the hospital before surgery for acute optimization of glycemia, However, there is no guidance on the level of elevated A1c that should prompt consideration of delaying surgery. This issue is of crucial importance because necessary elective surgery or diagnostic procedures may be delayed unnecessarily or for longer than needed in children with elevated A1c because of the difficulty of improving A1c levels rapidly.”

STUDY DETAILS:

The study was led by Grace Kim, MD, of the division of diabetes and endocrinology, Texas Children’s Hospital, Houston. It was published online August 1, 2023, in Diabetes Care.

LIMITATIONS:

• The postoperative complication rate was low.
• Only elective procedures were included.

DISCLOSURES:

The authors have no disclosures.

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

TOPLINE:

• No associations were found between preoperative A1c levels and postoperative infection, wound, or ketosis complications in children with type 1 or type 2 diabetes undergoing elective noncardiac surgery or diagnostic procedures.
• Delaying elective surgeries until A1c is consistently normalized may not be warranted, particularly because this is challenging to accomplish rapidly.

METHODOLOGY:

• A retrospective analysis was done of data from surgery and endocrinology medical records of 438 children aged 1-18 years with type 1 (72%) or type 2 diabetes (28%) undergoing elective noncardiac surgery at Texas Children’s Hospital, January 2011 to June 2021.
• Overall, 28% had an A1c less than 7.0%, 42% had A1c 7%-9%, and 30% had A1c greater than 9%.
• The primary outcome was defined as a new-onset postoperative systemic infection, wound complication, or ketosis.

TAKEAWAY:

• The incidence of any postoperative systemic infections was 0.91% (n = 4); postoperative wound disruption, 3.33% (n = 19); and postoperative ketosis, 3.89% (n = 17).
• A1c levels were not associated with any postoperative systemic infections, wound complications, or ketosis.
• No other preoperative factors, including diabetes type, body mass index, or procedure type, were association with these complications.

IN PRACTICE:

“Current recommendations suggest consulting with the diabetes team before surgery and if glycemic status is suboptimal to consider delaying surgery and, if surgery cannot be delayed, considering admission to the hospital before surgery for acute optimization of glycemia, However, there is no guidance on the level of elevated A1c that should prompt consideration of delaying surgery. This issue is of crucial importance because necessary elective surgery or diagnostic procedures may be delayed unnecessarily or for longer than needed in children with elevated A1c because of the difficulty of improving A1c levels rapidly.”

STUDY DETAILS:

The study was led by Grace Kim, MD, of the division of diabetes and endocrinology, Texas Children’s Hospital, Houston. It was published online August 1, 2023, in Diabetes Care.

LIMITATIONS:

• The postoperative complication rate was low.
• Only elective procedures were included.

DISCLOSURES:

The authors have no disclosures.

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

TOPLINE:

• No associations were found between preoperative A1c levels and postoperative infection, wound, or ketosis complications in children with type 1 or type 2 diabetes undergoing elective noncardiac surgery or diagnostic procedures.
• Delaying elective surgeries until A1c is consistently normalized may not be warranted, particularly because this is challenging to accomplish rapidly.

METHODOLOGY:

• A retrospective analysis was done of data from surgery and endocrinology medical records of 438 children aged 1-18 years with type 1 (72%) or type 2 diabetes (28%) undergoing elective noncardiac surgery at Texas Children’s Hospital, January 2011 to June 2021.
• Overall, 28% had an A1c less than 7.0%, 42% had A1c 7%-9%, and 30% had A1c greater than 9%.
• The primary outcome was defined as a new-onset postoperative systemic infection, wound complication, or ketosis.

TAKEAWAY:

• The incidence of any postoperative systemic infections was 0.91% (n = 4); postoperative wound disruption, 3.33% (n = 19); and postoperative ketosis, 3.89% (n = 17).
• A1c levels were not associated with any postoperative systemic infections, wound complications, or ketosis.
• No other preoperative factors, including diabetes type, body mass index, or procedure type, were association with these complications.

IN PRACTICE:

“Current recommendations suggest consulting with the diabetes team before surgery and if glycemic status is suboptimal to consider delaying surgery and, if surgery cannot be delayed, considering admission to the hospital before surgery for acute optimization of glycemia, However, there is no guidance on the level of elevated A1c that should prompt consideration of delaying surgery. This issue is of crucial importance because necessary elective surgery or diagnostic procedures may be delayed unnecessarily or for longer than needed in children with elevated A1c because of the difficulty of improving A1c levels rapidly.”

STUDY DETAILS:

The study was led by Grace Kim, MD, of the division of diabetes and endocrinology, Texas Children’s Hospital, Houston. It was published online August 1, 2023, in Diabetes Care.

LIMITATIONS:

• The postoperative complication rate was low.
• Only elective procedures were included.

DISCLOSURES:

The authors have no disclosures.

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

The latest clinical practice guideline for managing patients with chronic coronary disease (CCD) takes an evidence-based and patient-centered approach to care and includes key updates on revascularization, beta-blocker use, and routine functional and anatomic testing.

Developed by the American Heart Association, the American College of Cardiology, and other specialty societies, the 2023 guideline both updates and consolidates ACC/AHA guidelines previously published in 2012 and 2014 for the management of patients with stable ischemic heart disease.

It was published online in Circulation and the Journal of the American College of Cardiology .

Among the key recommendations were the following.

• Long-term beta-blocker therapy is no longer recommended for improving outcomes for patients with CCD in the absence of myocardial infarction within the past year, left ventricular ejection fraction (LVEF) less than or equal to 50%, or another primary indication for beta-blocker therapy. Either a calcium channel blocker or a beta-blocker is recommended as first-line antianginal therapy.
• Sodium glucose cotransporter 2 (SGLT2) inhibitors and glucagon-like peptide-1 (GLP-1) receptor agonists are recommended for select groups of patients with CCD, including individuals without diabetes, to improve outcomes.
• Statins remain first-line therapy for lipid lowering for patients with CCD. Several adjunctive therapies, such as ezetimibe, proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors, inclisiran, or bempedoic acid, may be used in select populations, although clinical outcomes data are not yet available for novel agents such as inclisiran and bempedoic acid.
• Shorter durations of dual antiplatelet therapy are safe and effective in many circumstances, particularly when the risk of bleeding is high and the ischemic risk is not high.
• The use of nonprescription or dietary supplements, including fish oil and omega-3 fatty acids or vitamins, is not recommended for patients with CCD, given the lack of benefit in reducing cardiovascular events.
• Revascularization is recommended in two scenarios: (1) for patients with lifestyle-limiting angina despite guideline-directed medical therapy and with coronary stenoses amenable to revascularization, with the goal of improving symptoms; and (2) for patients with significant left main disease or multivessel disease with severe LV dysfunction (LVEF ≤ 35%), for whom coronary artery bypass grafting plus medical therapy is recommended over medical therapy alone, with the goal of improving survival.
• Routine periodic anatomic or ischemic testing in the absence of a change in clinical or functional status is not recommended for risk stratification or to guide therapeutic decision-making for patients with CCD.
• Nondrug therapies, including healthy dietary habits and exercise, are recommended for all patients with CCD. When possible, patients should participate in regular physical activity, including activities to reduce sitting time and to increase aerobic and resistance exercise.
• Cardiac rehabilitation for eligible patients provides significant cardiovascular benefits, including decreased morbidity and mortality.
• Electronic cigarettes increase the odds of successful smoking cessation, but they are not recommended as first-line therapy, owing to the lack of long-term safety data and risks associated with sustained use.

Living document

The co-authors of a related editorial note that “CCD as defined in the 2023 guideline includes patients who may or may not have classic signs and symptoms of CAD.

“The 2023 guideline reflects this heterogeneity by including patients stabilized after acute coronary syndrome hospitalization, those with ischemic cardiomyopathy, stable angina or equivalent with or without a positive imaging test, vasospasm or microvascular disease, and positive noninvasive screening test leading to a clinician diagnosis of CAD,” write Sunil V. Rao, MD, with NYU Langone Health System, and co-authors.

“The focus of the guideline is on extending life and improving quality of life for CCD patients, taking into account patient priorities and the importance of equitable care. There is emphasis on shared decision-making that involves the patient’s preferences and values when considering treatment options,” they point out.

“Importantly, the guidelines exist to provide guidance and are meant to complement, not supplant, clinical judgment. As the evidence for the management of CCD continues to evolve, the guidelines will need to be a ‘living document’ to ensure that clinicians and patients can achieve their shared therapeutic goals of reducing mortality and improving quality of life,” they add.

The 2023 guideline on management of patients with CCD was developed in collaboration with and was endorsed by the American College of Clinical Pharmacy, the American Society for Preventive Cardiology, the National Lipid Association, and the Preventive Cardiovascular Nurses Association. It has been endorsed by the Society for Cardiovascular Angiography and Interventions.

The research had no commercial funding.

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

The latest clinical practice guideline for managing patients with chronic coronary disease (CCD) takes an evidence-based and patient-centered approach to care and includes key updates on revascularization, beta-blocker use, and routine functional and anatomic testing.

Developed by the American Heart Association, the American College of Cardiology, and other specialty societies, the 2023 guideline both updates and consolidates ACC/AHA guidelines previously published in 2012 and 2014 for the management of patients with stable ischemic heart disease.

It was published online in Circulation and the Journal of the American College of Cardiology .

Among the key recommendations were the following.

• Long-term beta-blocker therapy is no longer recommended for improving outcomes for patients with CCD in the absence of myocardial infarction within the past year, left ventricular ejection fraction (LVEF) less than or equal to 50%, or another primary indication for beta-blocker therapy. Either a calcium channel blocker or a beta-blocker is recommended as first-line antianginal therapy.
• Sodium glucose cotransporter 2 (SGLT2) inhibitors and glucagon-like peptide-1 (GLP-1) receptor agonists are recommended for select groups of patients with CCD, including individuals without diabetes, to improve outcomes.
• Statins remain first-line therapy for lipid lowering for patients with CCD. Several adjunctive therapies, such as ezetimibe, proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors, inclisiran, or bempedoic acid, may be used in select populations, although clinical outcomes data are not yet available for novel agents such as inclisiran and bempedoic acid.
• Shorter durations of dual antiplatelet therapy are safe and effective in many circumstances, particularly when the risk of bleeding is high and the ischemic risk is not high.
• The use of nonprescription or dietary supplements, including fish oil and omega-3 fatty acids or vitamins, is not recommended for patients with CCD, given the lack of benefit in reducing cardiovascular events.
• Revascularization is recommended in two scenarios: (1) for patients with lifestyle-limiting angina despite guideline-directed medical therapy and with coronary stenoses amenable to revascularization, with the goal of improving symptoms; and (2) for patients with significant left main disease or multivessel disease with severe LV dysfunction (LVEF ≤ 35%), for whom coronary artery bypass grafting plus medical therapy is recommended over medical therapy alone, with the goal of improving survival.
• Routine periodic anatomic or ischemic testing in the absence of a change in clinical or functional status is not recommended for risk stratification or to guide therapeutic decision-making for patients with CCD.
• Nondrug therapies, including healthy dietary habits and exercise, are recommended for all patients with CCD. When possible, patients should participate in regular physical activity, including activities to reduce sitting time and to increase aerobic and resistance exercise.
• Cardiac rehabilitation for eligible patients provides significant cardiovascular benefits, including decreased morbidity and mortality.
• Electronic cigarettes increase the odds of successful smoking cessation, but they are not recommended as first-line therapy, owing to the lack of long-term safety data and risks associated with sustained use.

Living document

The co-authors of a related editorial note that “CCD as defined in the 2023 guideline includes patients who may or may not have classic signs and symptoms of CAD.

“The 2023 guideline reflects this heterogeneity by including patients stabilized after acute coronary syndrome hospitalization, those with ischemic cardiomyopathy, stable angina or equivalent with or without a positive imaging test, vasospasm or microvascular disease, and positive noninvasive screening test leading to a clinician diagnosis of CAD,” write Sunil V. Rao, MD, with NYU Langone Health System, and co-authors.

“The focus of the guideline is on extending life and improving quality of life for CCD patients, taking into account patient priorities and the importance of equitable care. There is emphasis on shared decision-making that involves the patient’s preferences and values when considering treatment options,” they point out.

“Importantly, the guidelines exist to provide guidance and are meant to complement, not supplant, clinical judgment. As the evidence for the management of CCD continues to evolve, the guidelines will need to be a ‘living document’ to ensure that clinicians and patients can achieve their shared therapeutic goals of reducing mortality and improving quality of life,” they add.

The 2023 guideline on management of patients with CCD was developed in collaboration with and was endorsed by the American College of Clinical Pharmacy, the American Society for Preventive Cardiology, the National Lipid Association, and the Preventive Cardiovascular Nurses Association. It has been endorsed by the Society for Cardiovascular Angiography and Interventions.

The research had no commercial funding.

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

The latest clinical practice guideline for managing patients with chronic coronary disease (CCD) takes an evidence-based and patient-centered approach to care and includes key updates on revascularization, beta-blocker use, and routine functional and anatomic testing.

Developed by the American Heart Association, the American College of Cardiology, and other specialty societies, the 2023 guideline both updates and consolidates ACC/AHA guidelines previously published in 2012 and 2014 for the management of patients with stable ischemic heart disease.

It was published online in Circulation and the Journal of the American College of Cardiology .

Among the key recommendations were the following.

• Long-term beta-blocker therapy is no longer recommended for improving outcomes for patients with CCD in the absence of myocardial infarction within the past year, left ventricular ejection fraction (LVEF) less than or equal to 50%, or another primary indication for beta-blocker therapy. Either a calcium channel blocker or a beta-blocker is recommended as first-line antianginal therapy.
• Sodium glucose cotransporter 2 (SGLT2) inhibitors and glucagon-like peptide-1 (GLP-1) receptor agonists are recommended for select groups of patients with CCD, including individuals without diabetes, to improve outcomes.
• Statins remain first-line therapy for lipid lowering for patients with CCD. Several adjunctive therapies, such as ezetimibe, proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors, inclisiran, or bempedoic acid, may be used in select populations, although clinical outcomes data are not yet available for novel agents such as inclisiran and bempedoic acid.
• Shorter durations of dual antiplatelet therapy are safe and effective in many circumstances, particularly when the risk of bleeding is high and the ischemic risk is not high.
• The use of nonprescription or dietary supplements, including fish oil and omega-3 fatty acids or vitamins, is not recommended for patients with CCD, given the lack of benefit in reducing cardiovascular events.
• Revascularization is recommended in two scenarios: (1) for patients with lifestyle-limiting angina despite guideline-directed medical therapy and with coronary stenoses amenable to revascularization, with the goal of improving symptoms; and (2) for patients with significant left main disease or multivessel disease with severe LV dysfunction (LVEF ≤ 35%), for whom coronary artery bypass grafting plus medical therapy is recommended over medical therapy alone, with the goal of improving survival.
• Routine periodic anatomic or ischemic testing in the absence of a change in clinical or functional status is not recommended for risk stratification or to guide therapeutic decision-making for patients with CCD.
• Nondrug therapies, including healthy dietary habits and exercise, are recommended for all patients with CCD. When possible, patients should participate in regular physical activity, including activities to reduce sitting time and to increase aerobic and resistance exercise.
• Cardiac rehabilitation for eligible patients provides significant cardiovascular benefits, including decreased morbidity and mortality.
• Electronic cigarettes increase the odds of successful smoking cessation, but they are not recommended as first-line therapy, owing to the lack of long-term safety data and risks associated with sustained use.

Living document

The co-authors of a related editorial note that “CCD as defined in the 2023 guideline includes patients who may or may not have classic signs and symptoms of CAD.

“The 2023 guideline reflects this heterogeneity by including patients stabilized after acute coronary syndrome hospitalization, those with ischemic cardiomyopathy, stable angina or equivalent with or without a positive imaging test, vasospasm or microvascular disease, and positive noninvasive screening test leading to a clinician diagnosis of CAD,” write Sunil V. Rao, MD, with NYU Langone Health System, and co-authors.

“The focus of the guideline is on extending life and improving quality of life for CCD patients, taking into account patient priorities and the importance of equitable care. There is emphasis on shared decision-making that involves the patient’s preferences and values when considering treatment options,” they point out.

“Importantly, the guidelines exist to provide guidance and are meant to complement, not supplant, clinical judgment. As the evidence for the management of CCD continues to evolve, the guidelines will need to be a ‘living document’ to ensure that clinicians and patients can achieve their shared therapeutic goals of reducing mortality and improving quality of life,” they add.

The 2023 guideline on management of patients with CCD was developed in collaboration with and was endorsed by the American College of Clinical Pharmacy, the American Society for Preventive Cardiology, the National Lipid Association, and the Preventive Cardiovascular Nurses Association. It has been endorsed by the Society for Cardiovascular Angiography and Interventions.

The research had no commercial funding.

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

TOPLINE:
 

Patients with spondyloarthritis (SpA) experience similar gut microbiota dysbiosis with related inflammatory conditions, such as acute anterior uveitis (AAU) and Crohn’s disease (CD), new data show.

METHODOLOGY:

• Researchers performed 16S rRNA sequencing on stool samples from 277 adult patients from the German Spondyloarthritis Inception Cohort (102 with SpA, 72 with CD, and 103 with AAU) and 62 control patients with chronic back pain for whom SpA had been ruled out.
• Patients were treatment naive to biologic disease-modifying antirheumatic drugs or had not received them for more than 3 months prior to study enrollment.
• The study is the first to identify the same microbiota in patients with SpA, AAU, and CD.

TAKEAWAY:

• “Our results showed a shared depletion of predominately Lachnospiraceae taxa, most notably Fusicatenibacter, which partially mediated increased CRP [C-reactive protein], and was most abundant in controls receiving NSAID monotherapy,” the researchers wrote.
• Among patients who tested positive for HLA-B27, an allele associated with SpA and other spondyloarthropathies, levels of Faecalibacterium were increased; among patients with SpA, levels of Collinsella were enriched; and among patients with CD, there was an abundance of beneficial Ruminococcus bacteria.
• The results suggest the diagnostic and therapeutic potential of the gut microbiome for mediating disease activity for patients with autoimmune diseases.
• Additional research is needed to clarify the roles of different bacteria in gut-joint inflammation and to understand the relationship between genetics and gut microbes.

IN PRACTICE:

The study is too preliminary to have applications for practice.

SOURCE:

Co–first authors Morgan Essex, MSc, and Valeria Rios Rodriguez, MD, of Charité–Universitätsmedizin Berlin and colleagues conducted the study, which was published online July 20, 2023, in Arthritis and Rheumatology.

LIMITATIONS:

• The results were limited by several factors, including the restriction to amplicon sequencing, which prevented in-depth characterization of the gut microbiome.
• More studies are needed to validate the findings, especially regarding gut bacteria as potential mediators of inflammation or disease activity. The researchers recommended studies with whole-genome sequencing and fecal metabolite quantification.

DISCLOSURES:

The study was supported in part by the Deutsche Forschungsgemeinschaft. Additional funding came from the German Federal Ministry for Health and Research and the Berlin Institute of Health. Two patient cohorts were partially and separately supported by grants from Novartis and AbbVie.

A version of this article appeared on Medscape.com.

TOPLINE:
 

Patients with spondyloarthritis (SpA) experience similar gut microbiota dysbiosis with related inflammatory conditions, such as acute anterior uveitis (AAU) and Crohn’s disease (CD), new data show.

METHODOLOGY:

• Researchers performed 16S rRNA sequencing on stool samples from 277 adult patients from the German Spondyloarthritis Inception Cohort (102 with SpA, 72 with CD, and 103 with AAU) and 62 control patients with chronic back pain for whom SpA had been ruled out.
• Patients were treatment naive to biologic disease-modifying antirheumatic drugs or had not received them for more than 3 months prior to study enrollment.
• The study is the first to identify the same microbiota in patients with SpA, AAU, and CD.

TAKEAWAY:

• “Our results showed a shared depletion of predominately Lachnospiraceae taxa, most notably Fusicatenibacter, which partially mediated increased CRP [C-reactive protein], and was most abundant in controls receiving NSAID monotherapy,” the researchers wrote.
• Among patients who tested positive for HLA-B27, an allele associated with SpA and other spondyloarthropathies, levels of Faecalibacterium were increased; among patients with SpA, levels of Collinsella were enriched; and among patients with CD, there was an abundance of beneficial Ruminococcus bacteria.
• The results suggest the diagnostic and therapeutic potential of the gut microbiome for mediating disease activity for patients with autoimmune diseases.
• Additional research is needed to clarify the roles of different bacteria in gut-joint inflammation and to understand the relationship between genetics and gut microbes.

IN PRACTICE:

The study is too preliminary to have applications for practice.

SOURCE:

Co–first authors Morgan Essex, MSc, and Valeria Rios Rodriguez, MD, of Charité–Universitätsmedizin Berlin and colleagues conducted the study, which was published online July 20, 2023, in Arthritis and Rheumatology.

LIMITATIONS:

• The results were limited by several factors, including the restriction to amplicon sequencing, which prevented in-depth characterization of the gut microbiome.
• More studies are needed to validate the findings, especially regarding gut bacteria as potential mediators of inflammation or disease activity. The researchers recommended studies with whole-genome sequencing and fecal metabolite quantification.

DISCLOSURES:

The study was supported in part by the Deutsche Forschungsgemeinschaft. Additional funding came from the German Federal Ministry for Health and Research and the Berlin Institute of Health. Two patient cohorts were partially and separately supported by grants from Novartis and AbbVie.

A version of this article appeared on Medscape.com.

TOPLINE:
 

Patients with spondyloarthritis (SpA) experience similar gut microbiota dysbiosis with related inflammatory conditions, such as acute anterior uveitis (AAU) and Crohn’s disease (CD), new data show.

METHODOLOGY:

• Researchers performed 16S rRNA sequencing on stool samples from 277 adult patients from the German Spondyloarthritis Inception Cohort (102 with SpA, 72 with CD, and 103 with AAU) and 62 control patients with chronic back pain for whom SpA had been ruled out.
• Patients were treatment naive to biologic disease-modifying antirheumatic drugs or had not received them for more than 3 months prior to study enrollment.
• The study is the first to identify the same microbiota in patients with SpA, AAU, and CD.

TAKEAWAY:

• “Our results showed a shared depletion of predominately Lachnospiraceae taxa, most notably Fusicatenibacter, which partially mediated increased CRP [C-reactive protein], and was most abundant in controls receiving NSAID monotherapy,” the researchers wrote.
• Among patients who tested positive for HLA-B27, an allele associated with SpA and other spondyloarthropathies, levels of Faecalibacterium were increased; among patients with SpA, levels of Collinsella were enriched; and among patients with CD, there was an abundance of beneficial Ruminococcus bacteria.
• The results suggest the diagnostic and therapeutic potential of the gut microbiome for mediating disease activity for patients with autoimmune diseases.
• Additional research is needed to clarify the roles of different bacteria in gut-joint inflammation and to understand the relationship between genetics and gut microbes.

IN PRACTICE:

The study is too preliminary to have applications for practice.

SOURCE:

Co–first authors Morgan Essex, MSc, and Valeria Rios Rodriguez, MD, of Charité–Universitätsmedizin Berlin and colleagues conducted the study, which was published online July 20, 2023, in Arthritis and Rheumatology.

LIMITATIONS:

• The results were limited by several factors, including the restriction to amplicon sequencing, which prevented in-depth characterization of the gut microbiome.
• More studies are needed to validate the findings, especially regarding gut bacteria as potential mediators of inflammation or disease activity. The researchers recommended studies with whole-genome sequencing and fecal metabolite quantification.

DISCLOSURES:

The study was supported in part by the Deutsche Forschungsgemeinschaft. Additional funding came from the German Federal Ministry for Health and Research and the Berlin Institute of Health. Two patient cohorts were partially and separately supported by grants from Novartis and AbbVie.

A version of this article appeared on Medscape.com.

Questions about omega-3 fatty acid supplements come up often in the atrial fibrillation (AFib) clinic.

The story begins with the simple observation that populations who eat lots of oily fish have fewer coronary events. This correlation provoked great interest in concentrating fish oils in pill form and studying their use to promote health.

A small post hoc study from a group in Norway stimulated me to review what we do and don’t know about fish pills, as I call them in clinic.
 

OMENI secondary analysis

Peder Myhre, MD, and colleagues recently published a secondary analysis of the OMENI trial looking at both the risk and possible causes of AFib in the omega-3 group.

The OMENI trial randomly assigned slightly more than 1,000 older patients (mean age, 75 years) post–myocardial infarction to either 1.8 g/d of fish oil supplements versus placebo for 2 years. The supplements comprised 930 mg of eicosapentaenoic acid (EPA) and 660 mg of docosahexaenoic acid (DHA). The main trial reported no difference in a composite primary endpoint of MI, revascularization, stroke, death, or hospitalization for heart failure.

The secondary analysis explored the 75% of patients in the main trial who had no history of AFib. It looked at how many in each group developed either true clinical AFib or what the authors called micro-AFib, defined as short bursts of irregular atrial activity lasting seconds.

The sub-analysis had three main findings: Patients in the supplement arm had a 90% higher rate of AFib or micro-AFib, compared with patients on placebo, EPA had the strongest effect on the association, and there was a graded risk for AFib with increasing serum EPA levels.  

The authors raised the possibility that more micro-AFib might be a possible mediator of AFib risk.
 

Trials of low-dose EPA and DHA

First, the low-dose trials. In the ASCEND trial from 2018, more than 15,000 patients with diabetes were randomly assigned to either 1 g of omega-3 fatty acids (460-mg EPA and 380-mg DHA) or mineral oil.

The trial was neutral. After 7.4 years, the primary endpoint of MI, stroke, transient ischemic attack, or cardiovascular death occurred in 8.9% of the supplement group versus 9.2% of the placebo arm.The incidence of AFib was higher in the omega-3 group but did not reach statistical significance (2.1% vs. 1.7% for placebo; hazard ratio, 1.23; 95% confidence interval, 0.98-1.54).

Another neutral CV trial, VITAL, specifically studied the effects of marine omega-3 pills (460-mg EPA and 380-mg DHA) in older adults without heart disease, cancer, or AFib. After slightly more than 5 years, AFib occurred at a similar rate in the active arm and placebo arms (3.7% vs. 3.4% for placebo; HR, 1.09; 95% CI, 0.96-1.24; P = .19)
 

Trials of very high-dose marine omega-3s

Next came trials of higher doses in higher-risk populations.

In 2020, JAMA published the STRENGTH trial, which compared 4 g/d of a carboxylic acid formulation of EPA and DHA with a corn oil placebo in more than 13,000 patients who either had established atherosclerotic CV disease (ASCVD) or were at high risk for ASCVD.

The trial was terminated early because of futility and a signal of increased AFib risk in the supplement arm.

Nearly the same number of patients in the supplement versus placebo arm experienced a primary composite endpoint of major adverse cardiac events: 12.0% versus 12.2%, respectively.

AFib was a tertiary endpoint in this trial. An increase in investigator-reported new-onset AFib was observed in the omega-3 group: 2.2% vs. 1.3% for corn oil (HR, 1.69; 95% CI, 1.29-2.21; nominal P < .001).

The REDUCE-IT trial randomly assigned more than 8,000 patients who had ASCVD or diabetes and high ASCVD risk and elevated triglyceride levels to either 4 g of icosapent ethyl daily, a concentrated form of EPA, or a mineral oil placebo.

After nearly 5 years, there was a 4.8% absolute risk reduction in the primary endpoint of CV death, MI, stroke, revascularization, or unstable angina with icosapent ethyl. An increase in atherogenic biomarkers in the mineral oil placebo complicated interpretation of this trial.

Hospitalization for AFib or flutter occurred in 3.1% of the active arm versus 2.1% of the mineral oil group (P = .004).
 

Meta-analysis of marine omega-3 supplement trials

In 2021, Baris Gencer and colleagues performed a meta-analysis of these five trials plus 2 more (GISSI-HF and RP) looking specifically at risk for AFib. Their final analysis included more than 81,000 patients followed for nearly 5 years.

Omega 3 fatty acid supplements associated with a 25% increase in the risk for AFib (HR, 1.25; 95% CI, 1.07-1.46P =.013). Exploring further, they noted a dose-dependent relationship. Most of the increased risk occurred in trials that tested greater than 1 g/d.
 

Summary

When faced with surprise findings, I like to think things through.

First about plausibility. Omega-3 fatty acids clearly exert electrophysiologic effects on cardiac cells, an increase in AFib risk is plausible. The exact underlying mechanism may be unknown, but exact mechanisms are less important than actual clinical effects (see sodium-glucose cotransporter 2 inhibitors).

What about causality? Factors supporting causality include plausibility, consistency of increased AFib risk in multiple studies, and a dose-response relationship.

I see multiple clinical implications of this observation.

The first is the power of the randomized trial to inform practice. If we relied only on observational evidence, we might have assumed that since high fish consumption in populations associated with lower rates of cardiac events, fish oil supplementation would also reduce cardiac events. Other than the outlier trial, REDUCE-IT, with its mineral oil placebo, the preponderance of the randomized controlled trial evidence does not support fish oils for the reduction of CV events.

Randomized controlled trials also exposed the AFib risk. This would have been difficult to sort out in nonrandom observational studies.

Another underappreciated lesson is the notion that drugs, including supplements, can have off-target effects.

Consider the case of statin drugs. It is widely assumed that statins reduce cardiac events by lowering low-density lipoprotein cholesterol (LDL-C). Yet, statins became a mainstay not because of LDL-C lowering but because multiple trials found that this class of drugs reduced cardiac events without increasing adverse effects.

Omega-3 fatty acids reduce triglyceride levels, but this is not enough to adopt the use of these pills. The lack of consistent reduction in CV events and the off-target signal of AFib risk argue against routine use of fish-oil pills.

I will close with uncertainty. Though there is plausibility and multiple reasons to infer causality of marine omega-3s in increasing AFib risk, the effect size remains unknown.

In an editorial accompanying the recent meta-analysis, epidemiologist Michelle Samuel, MPH, PhD, and electrophysiologist Stanley Nattel, MD, cautioned readers on a technical but important point. It concerns the matter of competing risks, such as death, in the analysis of AFib risk, meaning that patients who died may have developed AFib had they lived. They provide a detailed explanation in the open access article, but the take-home is that the exact effect size is difficult to quantify without patient-level original data.

No matter. I find the signal of increased AFib risk an important one to use at the bedside.

Intermittent AFib has an unpredictable natural history. It often resolves as mysteriously as it arises. When patients take fish-oil supplements, I cite these studies, note the lack of CV protection, then I recommend stopping the pills.

This allows for one of the most important interventions in AFib care: time.

Dr. Mandrola is a clinical electrophysiologist with Baptist Medical Associates, Louisville, Ky. He has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

Questions about omega-3 fatty acid supplements come up often in the atrial fibrillation (AFib) clinic.

The story begins with the simple observation that populations who eat lots of oily fish have fewer coronary events. This correlation provoked great interest in concentrating fish oils in pill form and studying their use to promote health.

A small post hoc study from a group in Norway stimulated me to review what we do and don’t know about fish pills, as I call them in clinic.
 

OMENI secondary analysis

Peder Myhre, MD, and colleagues recently published a secondary analysis of the OMENI trial looking at both the risk and possible causes of AFib in the omega-3 group.

The OMENI trial randomly assigned slightly more than 1,000 older patients (mean age, 75 years) post–myocardial infarction to either 1.8 g/d of fish oil supplements versus placebo for 2 years. The supplements comprised 930 mg of eicosapentaenoic acid (EPA) and 660 mg of docosahexaenoic acid (DHA). The main trial reported no difference in a composite primary endpoint of MI, revascularization, stroke, death, or hospitalization for heart failure.

The secondary analysis explored the 75% of patients in the main trial who had no history of AFib. It looked at how many in each group developed either true clinical AFib or what the authors called micro-AFib, defined as short bursts of irregular atrial activity lasting seconds.

The sub-analysis had three main findings: Patients in the supplement arm had a 90% higher rate of AFib or micro-AFib, compared with patients on placebo, EPA had the strongest effect on the association, and there was a graded risk for AFib with increasing serum EPA levels.  

The authors raised the possibility that more micro-AFib might be a possible mediator of AFib risk.
 

Trials of low-dose EPA and DHA

First, the low-dose trials. In the ASCEND trial from 2018, more than 15,000 patients with diabetes were randomly assigned to either 1 g of omega-3 fatty acids (460-mg EPA and 380-mg DHA) or mineral oil.

The trial was neutral. After 7.4 years, the primary endpoint of MI, stroke, transient ischemic attack, or cardiovascular death occurred in 8.9% of the supplement group versus 9.2% of the placebo arm.The incidence of AFib was higher in the omega-3 group but did not reach statistical significance (2.1% vs. 1.7% for placebo; hazard ratio, 1.23; 95% confidence interval, 0.98-1.54).

Another neutral CV trial, VITAL, specifically studied the effects of marine omega-3 pills (460-mg EPA and 380-mg DHA) in older adults without heart disease, cancer, or AFib. After slightly more than 5 years, AFib occurred at a similar rate in the active arm and placebo arms (3.7% vs. 3.4% for placebo; HR, 1.09; 95% CI, 0.96-1.24; P = .19)
 

Trials of very high-dose marine omega-3s

Next came trials of higher doses in higher-risk populations.

In 2020, JAMA published the STRENGTH trial, which compared 4 g/d of a carboxylic acid formulation of EPA and DHA with a corn oil placebo in more than 13,000 patients who either had established atherosclerotic CV disease (ASCVD) or were at high risk for ASCVD.

The trial was terminated early because of futility and a signal of increased AFib risk in the supplement arm.

Nearly the same number of patients in the supplement versus placebo arm experienced a primary composite endpoint of major adverse cardiac events: 12.0% versus 12.2%, respectively.

AFib was a tertiary endpoint in this trial. An increase in investigator-reported new-onset AFib was observed in the omega-3 group: 2.2% vs. 1.3% for corn oil (HR, 1.69; 95% CI, 1.29-2.21; nominal P < .001).

The REDUCE-IT trial randomly assigned more than 8,000 patients who had ASCVD or diabetes and high ASCVD risk and elevated triglyceride levels to either 4 g of icosapent ethyl daily, a concentrated form of EPA, or a mineral oil placebo.

After nearly 5 years, there was a 4.8% absolute risk reduction in the primary endpoint of CV death, MI, stroke, revascularization, or unstable angina with icosapent ethyl. An increase in atherogenic biomarkers in the mineral oil placebo complicated interpretation of this trial.

Hospitalization for AFib or flutter occurred in 3.1% of the active arm versus 2.1% of the mineral oil group (P = .004).
 

Meta-analysis of marine omega-3 supplement trials

In 2021, Baris Gencer and colleagues performed a meta-analysis of these five trials plus 2 more (GISSI-HF and RP) looking specifically at risk for AFib. Their final analysis included more than 81,000 patients followed for nearly 5 years.

Omega 3 fatty acid supplements associated with a 25% increase in the risk for AFib (HR, 1.25; 95% CI, 1.07-1.46P =.013). Exploring further, they noted a dose-dependent relationship. Most of the increased risk occurred in trials that tested greater than 1 g/d.
 

Summary

When faced with surprise findings, I like to think things through.

First about plausibility. Omega-3 fatty acids clearly exert electrophysiologic effects on cardiac cells, an increase in AFib risk is plausible. The exact underlying mechanism may be unknown, but exact mechanisms are less important than actual clinical effects (see sodium-glucose cotransporter 2 inhibitors).

What about causality? Factors supporting causality include plausibility, consistency of increased AFib risk in multiple studies, and a dose-response relationship.

I see multiple clinical implications of this observation.

The first is the power of the randomized trial to inform practice. If we relied only on observational evidence, we might have assumed that since high fish consumption in populations associated with lower rates of cardiac events, fish oil supplementation would also reduce cardiac events. Other than the outlier trial, REDUCE-IT, with its mineral oil placebo, the preponderance of the randomized controlled trial evidence does not support fish oils for the reduction of CV events.

Randomized controlled trials also exposed the AFib risk. This would have been difficult to sort out in nonrandom observational studies.

Another underappreciated lesson is the notion that drugs, including supplements, can have off-target effects.

Consider the case of statin drugs. It is widely assumed that statins reduce cardiac events by lowering low-density lipoprotein cholesterol (LDL-C). Yet, statins became a mainstay not because of LDL-C lowering but because multiple trials found that this class of drugs reduced cardiac events without increasing adverse effects.

Omega-3 fatty acids reduce triglyceride levels, but this is not enough to adopt the use of these pills. The lack of consistent reduction in CV events and the off-target signal of AFib risk argue against routine use of fish-oil pills.

I will close with uncertainty. Though there is plausibility and multiple reasons to infer causality of marine omega-3s in increasing AFib risk, the effect size remains unknown.

In an editorial accompanying the recent meta-analysis, epidemiologist Michelle Samuel, MPH, PhD, and electrophysiologist Stanley Nattel, MD, cautioned readers on a technical but important point. It concerns the matter of competing risks, such as death, in the analysis of AFib risk, meaning that patients who died may have developed AFib had they lived. They provide a detailed explanation in the open access article, but the take-home is that the exact effect size is difficult to quantify without patient-level original data.

No matter. I find the signal of increased AFib risk an important one to use at the bedside.

Intermittent AFib has an unpredictable natural history. It often resolves as mysteriously as it arises. When patients take fish-oil supplements, I cite these studies, note the lack of CV protection, then I recommend stopping the pills.

This allows for one of the most important interventions in AFib care: time.

Dr. Mandrola is a clinical electrophysiologist with Baptist Medical Associates, Louisville, Ky. He has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

Questions about omega-3 fatty acid supplements come up often in the atrial fibrillation (AFib) clinic.

The story begins with the simple observation that populations who eat lots of oily fish have fewer coronary events. This correlation provoked great interest in concentrating fish oils in pill form and studying their use to promote health.

A small post hoc study from a group in Norway stimulated me to review what we do and don’t know about fish pills, as I call them in clinic.
 

OMENI secondary analysis

Peder Myhre, MD, and colleagues recently published a secondary analysis of the OMENI trial looking at both the risk and possible causes of AFib in the omega-3 group.

The OMENI trial randomly assigned slightly more than 1,000 older patients (mean age, 75 years) post–myocardial infarction to either 1.8 g/d of fish oil supplements versus placebo for 2 years. The supplements comprised 930 mg of eicosapentaenoic acid (EPA) and 660 mg of docosahexaenoic acid (DHA). The main trial reported no difference in a composite primary endpoint of MI, revascularization, stroke, death, or hospitalization for heart failure.

The secondary analysis explored the 75% of patients in the main trial who had no history of AFib. It looked at how many in each group developed either true clinical AFib or what the authors called micro-AFib, defined as short bursts of irregular atrial activity lasting seconds.

The sub-analysis had three main findings: Patients in the supplement arm had a 90% higher rate of AFib or micro-AFib, compared with patients on placebo, EPA had the strongest effect on the association, and there was a graded risk for AFib with increasing serum EPA levels.  

The authors raised the possibility that more micro-AFib might be a possible mediator of AFib risk.
 

Trials of low-dose EPA and DHA

First, the low-dose trials. In the ASCEND trial from 2018, more than 15,000 patients with diabetes were randomly assigned to either 1 g of omega-3 fatty acids (460-mg EPA and 380-mg DHA) or mineral oil.

The trial was neutral. After 7.4 years, the primary endpoint of MI, stroke, transient ischemic attack, or cardiovascular death occurred in 8.9% of the supplement group versus 9.2% of the placebo arm.The incidence of AFib was higher in the omega-3 group but did not reach statistical significance (2.1% vs. 1.7% for placebo; hazard ratio, 1.23; 95% confidence interval, 0.98-1.54).

Another neutral CV trial, VITAL, specifically studied the effects of marine omega-3 pills (460-mg EPA and 380-mg DHA) in older adults without heart disease, cancer, or AFib. After slightly more than 5 years, AFib occurred at a similar rate in the active arm and placebo arms (3.7% vs. 3.4% for placebo; HR, 1.09; 95% CI, 0.96-1.24; P = .19)
 

Trials of very high-dose marine omega-3s

Next came trials of higher doses in higher-risk populations.

In 2020, JAMA published the STRENGTH trial, which compared 4 g/d of a carboxylic acid formulation of EPA and DHA with a corn oil placebo in more than 13,000 patients who either had established atherosclerotic CV disease (ASCVD) or were at high risk for ASCVD.

The trial was terminated early because of futility and a signal of increased AFib risk in the supplement arm.

Nearly the same number of patients in the supplement versus placebo arm experienced a primary composite endpoint of major adverse cardiac events: 12.0% versus 12.2%, respectively.

AFib was a tertiary endpoint in this trial. An increase in investigator-reported new-onset AFib was observed in the omega-3 group: 2.2% vs. 1.3% for corn oil (HR, 1.69; 95% CI, 1.29-2.21; nominal P < .001).

The REDUCE-IT trial randomly assigned more than 8,000 patients who had ASCVD or diabetes and high ASCVD risk and elevated triglyceride levels to either 4 g of icosapent ethyl daily, a concentrated form of EPA, or a mineral oil placebo.

After nearly 5 years, there was a 4.8% absolute risk reduction in the primary endpoint of CV death, MI, stroke, revascularization, or unstable angina with icosapent ethyl. An increase in atherogenic biomarkers in the mineral oil placebo complicated interpretation of this trial.

Hospitalization for AFib or flutter occurred in 3.1% of the active arm versus 2.1% of the mineral oil group (P = .004).
 

Meta-analysis of marine omega-3 supplement trials

In 2021, Baris Gencer and colleagues performed a meta-analysis of these five trials plus 2 more (GISSI-HF and RP) looking specifically at risk for AFib. Their final analysis included more than 81,000 patients followed for nearly 5 years.

Omega 3 fatty acid supplements associated with a 25% increase in the risk for AFib (HR, 1.25; 95% CI, 1.07-1.46P =.013). Exploring further, they noted a dose-dependent relationship. Most of the increased risk occurred in trials that tested greater than 1 g/d.
 

Summary

When faced with surprise findings, I like to think things through.

First about plausibility. Omega-3 fatty acids clearly exert electrophysiologic effects on cardiac cells, an increase in AFib risk is plausible. The exact underlying mechanism may be unknown, but exact mechanisms are less important than actual clinical effects (see sodium-glucose cotransporter 2 inhibitors).

What about causality? Factors supporting causality include plausibility, consistency of increased AFib risk in multiple studies, and a dose-response relationship.

I see multiple clinical implications of this observation.

The first is the power of the randomized trial to inform practice. If we relied only on observational evidence, we might have assumed that since high fish consumption in populations associated with lower rates of cardiac events, fish oil supplementation would also reduce cardiac events. Other than the outlier trial, REDUCE-IT, with its mineral oil placebo, the preponderance of the randomized controlled trial evidence does not support fish oils for the reduction of CV events.

Randomized controlled trials also exposed the AFib risk. This would have been difficult to sort out in nonrandom observational studies.

Another underappreciated lesson is the notion that drugs, including supplements, can have off-target effects.

Consider the case of statin drugs. It is widely assumed that statins reduce cardiac events by lowering low-density lipoprotein cholesterol (LDL-C). Yet, statins became a mainstay not because of LDL-C lowering but because multiple trials found that this class of drugs reduced cardiac events without increasing adverse effects.

Omega-3 fatty acids reduce triglyceride levels, but this is not enough to adopt the use of these pills. The lack of consistent reduction in CV events and the off-target signal of AFib risk argue against routine use of fish-oil pills.

I will close with uncertainty. Though there is plausibility and multiple reasons to infer causality of marine omega-3s in increasing AFib risk, the effect size remains unknown.

In an editorial accompanying the recent meta-analysis, epidemiologist Michelle Samuel, MPH, PhD, and electrophysiologist Stanley Nattel, MD, cautioned readers on a technical but important point. It concerns the matter of competing risks, such as death, in the analysis of AFib risk, meaning that patients who died may have developed AFib had they lived. They provide a detailed explanation in the open access article, but the take-home is that the exact effect size is difficult to quantify without patient-level original data.

No matter. I find the signal of increased AFib risk an important one to use at the bedside.

Intermittent AFib has an unpredictable natural history. It often resolves as mysteriously as it arises. When patients take fish-oil supplements, I cite these studies, note the lack of CV protection, then I recommend stopping the pills.

This allows for one of the most important interventions in AFib care: time.

Dr. Mandrola is a clinical electrophysiologist with Baptist Medical Associates, Louisville, Ky. He has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

Use current health and desire for pregnancy to guide contraception discussions in primary care, according to authors of an updated report.

In an installment of the American College of Physicians’ In the Clinic series, Rachel Cannon, MD, Kelly Treder, MD, and Elisabeth J. Woodhams, MD, all of Boston Medical Center, presented an article on the complex topic of contraception for patients with chronic illness.

“Many patients with chronic illness or complex medical issues interact with a primary care provider on a frequent basis, which provides a great access point for contraceptive counseling with a provider they trust and know,” said Dr. Cannon and Dr. Treder in a joint interview. “We wanted to create a ‘go to’ resource for primary care physicians to review contraceptive options and counseling best practices for all of their patients. Contraceptive care is part of overall health care and should be included in the primary care encounter.”

The authors discussed the types of contraception, as well as risks and benefits, and offered guidance for choosing a contraceptive method for medically complex patients.

“In recent years, there has been a shift in contraceptive counseling toward shared decision-making, a counseling strategy that honors the patient as the expert in their body and their life experiences and emphasizes their autonomy and values,” the authors said. “For providers, this translates to understanding that contraceptive efficacy is not the only important characteristic to patients, and that many other important factors contribute to an individual’s decision to use a particular method or not use birth control at all,” they said.
 

Start the conversation

Start by assessing a patient’s interest in and readiness for pregnancy, if applicable, the authors said. One example of a screen, the PATH questionnaire (Parent/Pregnancy Attitudes, Timing, and How important), is designed for patients in any demographic, and includes questions about the timing and desire for pregnancy and feelings about birth control, as well as options for patients to express uncertainty or ambivalence about pregnancy and contraception.

Some patients may derive benefits from hormonal contraceptives beyond pregnancy prevention, the authors wrote. Combined hormonal contraceptives (CHCs) may improve menorrhagia, and data suggest that CHC use also may reduce risk for some cancer types, including endometrial and ovarian cancers, they said.

Overall, contraceptive counseling should include discussions of safety, efficacy, and the patient’s lived experience.
 

Clinical considerations and contraindications

Medically complex patients who desire contraception may consider hormonal or nonhormonal methods based on their preferences and medical conditions, but clinicians need to consider comorbidities and contraindications, the authors wrote.

When a woman of childbearing age with any complex medical issue starts a new medication or receives a new diagnosis, contraception and pregnancy planning should be part of the discussion, the authors said. Safe and successful pregnancies are possible for women with complex medical issues when underlying health concerns are identified and addressed in advance, they added. Alternatively, for patients seeking to avoid pregnancy permanently, options for sterilization can be part of an informed discussion.

The Centers for Disease Control and Prevention’s Medical Eligibility Criteria for Contraceptive Use offers clinicians detailed information about the risks of both contraceptives and pregnancy for patients with various medical conditions, according to the authors.

The CDC document lists medical conditions associated with an increased risk for adverse health events if the individual becomes pregnant. These conditions include breast cancer, complicated valvular heart disease, cystic fibrosis, diabetes, endometrial or ovarian cancer, epilepsy, hypertension, bariatric surgery within 2 years of the pregnancy, HIV, ischemic heart disease, severe cirrhosis, stroke, lupus, solid organ transplant within 2 years of the pregnancy, and tuberculosis. Women with these and other conditions associated with increased risk of adverse events if pregnancy occurs should be advised of the high failure rate of barrier and behavior-based contraceptive methods, and informed about options for long-acting contraceptives, according to the CDC.
 

Risks, benefits, and balance

“It is important to remember that the alternative to contraception for many patients is pregnancy – for many patients with complex medical conditions, pregnancy is far more dangerous than any contraceptive method,” Dr. Cannon and Dr. Treder said in an interview. “This is important to consider when thinking about relative contraindications to a certain method or when thinking about ‘less effective’ contraception methods. The most effective method is a method the patient will actually continue to use,” they said.

The recent approval of the over-the-counter minipill is “a huge win for reproductive health care,” said Dr. Cannon and Dr. Treder. The minipill has very few contraindications, and it is the most effective over-the-counter contraceptive now available, they said.

“An over-the-counter contraceptive pill can increase access to contraception without having to see a physician in the clinic, freeing patients from many of the challenges of navigating the health care system,” the authors added.

As for additional research, the establishment of a long-term safety record may help support other OTC contraceptive methods in the future, the authors said.
 

Contraceptive counseling is everyone’s specialty

In an accompanying editorial, Amy A. Sarma, MD, a cardiologist at Massachusetts General Hospital, Boston, shared an example of the importance of contraceptive discussions with medically complex patients outside of an ob.gyn. setting. A young woman with a family history of myocardial infarction had neglected her own primary care until an MI of her own sent her to the hospital. While hospitalized, the patient was diagnosed with diabetes, hypertension, and hyperlipidemia.

“Her cardiology care team made every effort to optimize her cardiac care, but no one considered that she was also a woman of childbearing potential despite the teratogenic potential of several of her prescribed medications,” Dr. Sarma wrote. When the patient visited Dr. Sarma to discuss prevention of future MIs, Dr. Sarma took the opportunity to discuss the cardiovascular risks of pregnancy and the risks for this patient not only because of her recent MI, but also because of her chronic health conditions.

As it happened, the woman did not want a high-risk pregnancy and was interested in contraceptive methods. Dr. Sarma pointed out that, had the woman been engaged in routine primary care, these issues would have arisen in that setting, but like many younger women with cardiovascular disease, she did not make her own primary care a priority, and had missed out on other opportunities to discuss contraception. “Her MI opened a window of opportunity to help prevent an unintended and high-risk pregnancy,” Dr. Sarma noted.

Dr. Sarma’s patient anecdote illustrated the point of the In the Clinic review: that any clinician can discuss pregnancy and contraception with patients of childbearing age who have medical comorbidities that could affect a pregnancy. “All clinicians who care for patients of reproductive potential should become comfortable discussing pregnancy intent, preconception risk assessment, and contraceptive counseling,” Dr. Sarma said.

The research for this article was funded by the American College of Physicians. The review authors had no financial conflicts to disclose. Dr. Sarma had no financial conflicts to disclose.

Use current health and desire for pregnancy to guide contraception discussions in primary care, according to authors of an updated report.

In an installment of the American College of Physicians’ In the Clinic series, Rachel Cannon, MD, Kelly Treder, MD, and Elisabeth J. Woodhams, MD, all of Boston Medical Center, presented an article on the complex topic of contraception for patients with chronic illness.

“Many patients with chronic illness or complex medical issues interact with a primary care provider on a frequent basis, which provides a great access point for contraceptive counseling with a provider they trust and know,” said Dr. Cannon and Dr. Treder in a joint interview. “We wanted to create a ‘go to’ resource for primary care physicians to review contraceptive options and counseling best practices for all of their patients. Contraceptive care is part of overall health care and should be included in the primary care encounter.”

The authors discussed the types of contraception, as well as risks and benefits, and offered guidance for choosing a contraceptive method for medically complex patients.

“In recent years, there has been a shift in contraceptive counseling toward shared decision-making, a counseling strategy that honors the patient as the expert in their body and their life experiences and emphasizes their autonomy and values,” the authors said. “For providers, this translates to understanding that contraceptive efficacy is not the only important characteristic to patients, and that many other important factors contribute to an individual’s decision to use a particular method or not use birth control at all,” they said.
 

Start the conversation

Start by assessing a patient’s interest in and readiness for pregnancy, if applicable, the authors said. One example of a screen, the PATH questionnaire (Parent/Pregnancy Attitudes, Timing, and How important), is designed for patients in any demographic, and includes questions about the timing and desire for pregnancy and feelings about birth control, as well as options for patients to express uncertainty or ambivalence about pregnancy and contraception.

Some patients may derive benefits from hormonal contraceptives beyond pregnancy prevention, the authors wrote. Combined hormonal contraceptives (CHCs) may improve menorrhagia, and data suggest that CHC use also may reduce risk for some cancer types, including endometrial and ovarian cancers, they said.

Overall, contraceptive counseling should include discussions of safety, efficacy, and the patient’s lived experience.
 

Clinical considerations and contraindications

Medically complex patients who desire contraception may consider hormonal or nonhormonal methods based on their preferences and medical conditions, but clinicians need to consider comorbidities and contraindications, the authors wrote.

When a woman of childbearing age with any complex medical issue starts a new medication or receives a new diagnosis, contraception and pregnancy planning should be part of the discussion, the authors said. Safe and successful pregnancies are possible for women with complex medical issues when underlying health concerns are identified and addressed in advance, they added. Alternatively, for patients seeking to avoid pregnancy permanently, options for sterilization can be part of an informed discussion.

The Centers for Disease Control and Prevention’s Medical Eligibility Criteria for Contraceptive Use offers clinicians detailed information about the risks of both contraceptives and pregnancy for patients with various medical conditions, according to the authors.

The CDC document lists medical conditions associated with an increased risk for adverse health events if the individual becomes pregnant. These conditions include breast cancer, complicated valvular heart disease, cystic fibrosis, diabetes, endometrial or ovarian cancer, epilepsy, hypertension, bariatric surgery within 2 years of the pregnancy, HIV, ischemic heart disease, severe cirrhosis, stroke, lupus, solid organ transplant within 2 years of the pregnancy, and tuberculosis. Women with these and other conditions associated with increased risk of adverse events if pregnancy occurs should be advised of the high failure rate of barrier and behavior-based contraceptive methods, and informed about options for long-acting contraceptives, according to the CDC.
 

Risks, benefits, and balance

“It is important to remember that the alternative to contraception for many patients is pregnancy – for many patients with complex medical conditions, pregnancy is far more dangerous than any contraceptive method,” Dr. Cannon and Dr. Treder said in an interview. “This is important to consider when thinking about relative contraindications to a certain method or when thinking about ‘less effective’ contraception methods. The most effective method is a method the patient will actually continue to use,” they said.

The recent approval of the over-the-counter minipill is “a huge win for reproductive health care,” said Dr. Cannon and Dr. Treder. The minipill has very few contraindications, and it is the most effective over-the-counter contraceptive now available, they said.

“An over-the-counter contraceptive pill can increase access to contraception without having to see a physician in the clinic, freeing patients from many of the challenges of navigating the health care system,” the authors added.

As for additional research, the establishment of a long-term safety record may help support other OTC contraceptive methods in the future, the authors said.
 

Contraceptive counseling is everyone’s specialty

In an accompanying editorial, Amy A. Sarma, MD, a cardiologist at Massachusetts General Hospital, Boston, shared an example of the importance of contraceptive discussions with medically complex patients outside of an ob.gyn. setting. A young woman with a family history of myocardial infarction had neglected her own primary care until an MI of her own sent her to the hospital. While hospitalized, the patient was diagnosed with diabetes, hypertension, and hyperlipidemia.

“Her cardiology care team made every effort to optimize her cardiac care, but no one considered that she was also a woman of childbearing potential despite the teratogenic potential of several of her prescribed medications,” Dr. Sarma wrote. When the patient visited Dr. Sarma to discuss prevention of future MIs, Dr. Sarma took the opportunity to discuss the cardiovascular risks of pregnancy and the risks for this patient not only because of her recent MI, but also because of her chronic health conditions.

As it happened, the woman did not want a high-risk pregnancy and was interested in contraceptive methods. Dr. Sarma pointed out that, had the woman been engaged in routine primary care, these issues would have arisen in that setting, but like many younger women with cardiovascular disease, she did not make her own primary care a priority, and had missed out on other opportunities to discuss contraception. “Her MI opened a window of opportunity to help prevent an unintended and high-risk pregnancy,” Dr. Sarma noted.

Dr. Sarma’s patient anecdote illustrated the point of the In the Clinic review: that any clinician can discuss pregnancy and contraception with patients of childbearing age who have medical comorbidities that could affect a pregnancy. “All clinicians who care for patients of reproductive potential should become comfortable discussing pregnancy intent, preconception risk assessment, and contraceptive counseling,” Dr. Sarma said.

The research for this article was funded by the American College of Physicians. The review authors had no financial conflicts to disclose. Dr. Sarma had no financial conflicts to disclose.

Use current health and desire for pregnancy to guide contraception discussions in primary care, according to authors of an updated report.

In an installment of the American College of Physicians’ In the Clinic series, Rachel Cannon, MD, Kelly Treder, MD, and Elisabeth J. Woodhams, MD, all of Boston Medical Center, presented an article on the complex topic of contraception for patients with chronic illness.

“Many patients with chronic illness or complex medical issues interact with a primary care provider on a frequent basis, which provides a great access point for contraceptive counseling with a provider they trust and know,” said Dr. Cannon and Dr. Treder in a joint interview. “We wanted to create a ‘go to’ resource for primary care physicians to review contraceptive options and counseling best practices for all of their patients. Contraceptive care is part of overall health care and should be included in the primary care encounter.”

The authors discussed the types of contraception, as well as risks and benefits, and offered guidance for choosing a contraceptive method for medically complex patients.

“In recent years, there has been a shift in contraceptive counseling toward shared decision-making, a counseling strategy that honors the patient as the expert in their body and their life experiences and emphasizes their autonomy and values,” the authors said. “For providers, this translates to understanding that contraceptive efficacy is not the only important characteristic to patients, and that many other important factors contribute to an individual’s decision to use a particular method or not use birth control at all,” they said.
 

Start the conversation

Start by assessing a patient’s interest in and readiness for pregnancy, if applicable, the authors said. One example of a screen, the PATH questionnaire (Parent/Pregnancy Attitudes, Timing, and How important), is designed for patients in any demographic, and includes questions about the timing and desire for pregnancy and feelings about birth control, as well as options for patients to express uncertainty or ambivalence about pregnancy and contraception.

Some patients may derive benefits from hormonal contraceptives beyond pregnancy prevention, the authors wrote. Combined hormonal contraceptives (CHCs) may improve menorrhagia, and data suggest that CHC use also may reduce risk for some cancer types, including endometrial and ovarian cancers, they said.

Overall, contraceptive counseling should include discussions of safety, efficacy, and the patient’s lived experience.
 

Clinical considerations and contraindications

Medically complex patients who desire contraception may consider hormonal or nonhormonal methods based on their preferences and medical conditions, but clinicians need to consider comorbidities and contraindications, the authors wrote.

When a woman of childbearing age with any complex medical issue starts a new medication or receives a new diagnosis, contraception and pregnancy planning should be part of the discussion, the authors said. Safe and successful pregnancies are possible for women with complex medical issues when underlying health concerns are identified and addressed in advance, they added. Alternatively, for patients seeking to avoid pregnancy permanently, options for sterilization can be part of an informed discussion.

The Centers for Disease Control and Prevention’s Medical Eligibility Criteria for Contraceptive Use offers clinicians detailed information about the risks of both contraceptives and pregnancy for patients with various medical conditions, according to the authors.

The CDC document lists medical conditions associated with an increased risk for adverse health events if the individual becomes pregnant. These conditions include breast cancer, complicated valvular heart disease, cystic fibrosis, diabetes, endometrial or ovarian cancer, epilepsy, hypertension, bariatric surgery within 2 years of the pregnancy, HIV, ischemic heart disease, severe cirrhosis, stroke, lupus, solid organ transplant within 2 years of the pregnancy, and tuberculosis. Women with these and other conditions associated with increased risk of adverse events if pregnancy occurs should be advised of the high failure rate of barrier and behavior-based contraceptive methods, and informed about options for long-acting contraceptives, according to the CDC.
 

Risks, benefits, and balance

“It is important to remember that the alternative to contraception for many patients is pregnancy – for many patients with complex medical conditions, pregnancy is far more dangerous than any contraceptive method,” Dr. Cannon and Dr. Treder said in an interview. “This is important to consider when thinking about relative contraindications to a certain method or when thinking about ‘less effective’ contraception methods. The most effective method is a method the patient will actually continue to use,” they said.

The recent approval of the over-the-counter minipill is “a huge win for reproductive health care,” said Dr. Cannon and Dr. Treder. The minipill has very few contraindications, and it is the most effective over-the-counter contraceptive now available, they said.

“An over-the-counter contraceptive pill can increase access to contraception without having to see a physician in the clinic, freeing patients from many of the challenges of navigating the health care system,” the authors added.

As for additional research, the establishment of a long-term safety record may help support other OTC contraceptive methods in the future, the authors said.
 

Contraceptive counseling is everyone’s specialty

In an accompanying editorial, Amy A. Sarma, MD, a cardiologist at Massachusetts General Hospital, Boston, shared an example of the importance of contraceptive discussions with medically complex patients outside of an ob.gyn. setting. A young woman with a family history of myocardial infarction had neglected her own primary care until an MI of her own sent her to the hospital. While hospitalized, the patient was diagnosed with diabetes, hypertension, and hyperlipidemia.

“Her cardiology care team made every effort to optimize her cardiac care, but no one considered that she was also a woman of childbearing potential despite the teratogenic potential of several of her prescribed medications,” Dr. Sarma wrote. When the patient visited Dr. Sarma to discuss prevention of future MIs, Dr. Sarma took the opportunity to discuss the cardiovascular risks of pregnancy and the risks for this patient not only because of her recent MI, but also because of her chronic health conditions.

As it happened, the woman did not want a high-risk pregnancy and was interested in contraceptive methods. Dr. Sarma pointed out that, had the woman been engaged in routine primary care, these issues would have arisen in that setting, but like many younger women with cardiovascular disease, she did not make her own primary care a priority, and had missed out on other opportunities to discuss contraception. “Her MI opened a window of opportunity to help prevent an unintended and high-risk pregnancy,” Dr. Sarma noted.

Dr. Sarma’s patient anecdote illustrated the point of the In the Clinic review: that any clinician can discuss pregnancy and contraception with patients of childbearing age who have medical comorbidities that could affect a pregnancy. “All clinicians who care for patients of reproductive potential should become comfortable discussing pregnancy intent, preconception risk assessment, and contraceptive counseling,” Dr. Sarma said.

The research for this article was funded by the American College of Physicians. The review authors had no financial conflicts to disclose. Dr. Sarma had no financial conflicts to disclose.

This transcript has been edited for clarity.

I’d like to discuss an article that’s appeared recently in The Lancet. It looks at the impact of minimum unit pricing for alcohol on alcohol-related deaths and hospital admissions in Scotland, my home country. Why is that important to me as a cancer doctor? We know that alcohol underpins epidemiologically a whole range of different tumor types.

Anyway, it’s a really interesting experiment. It also looks at the impact of governments and health policy. In 2018, the Scottish government introduced a minimum unit pricing for alcohol of around $0.60 per unit of alcohol. The idea was that if you drive up the price of getting access to alcohol, that should reduce harm, deaths, and hospital admissions.

Wyper and colleagues did a rather nice controlled, time-interrupted series. The legislation was introduced in 2018, so they looked at our public-health databases, hospital admissions, deaths, and so on for the time span from 2012 to 2018, then for about 3 years after the introduction of legislation in 2018. They used England as a control.

They showed that there was a reduction in fully alcohol-attributed deaths by 13.4% in Scotland, and a reduction in chronic hospital admissions related to alcohol by almost 10%. It works.

What was also interesting was that the benefits were confined to the lower socioeconomic classes. One could argue, whether intended or otherwise, that this was a health-policy intervention targeted at the lower socioeconomic classes. Perhaps, one would hope as a consequence that this would reduce the health equity gap.

We know that the differences in Scotland are remarkable. When we compare the highest with the lowest socioeconomic classes, there’s a 4- to 4.5-fold difference in likelihood of death benefiting, of course, the wealthy. The health-equity gap between rich and poor is getting wider, not becoming narrower. Interventions of this sort make a difference.

Of course, there’s good evidence from other areas in which price control can make a difference. Tobacco is perhaps the best example of it. People have also talked about sugar or fat taxes to see whether their actions reduce levels of obesity, overeating, and other problems.

It’s a really nice study, with very compelling data, very well worked out in terms of the methodology and statistics. There are lives saved and lives prolonged.

What it doesn’t do is tell us about the amount of alcohol that people were taking. It shows that if you are less well off and the price of alcohol goes up, you’ve got less money to spend on alcohol. Therefore, that reduction results in the reduction in harm associated with it.

What’s really interesting is something I hadn’t realized about what’s called the alcohol-harm paradox. When you look at drinkers across the socioeconomic spectrum, including wealthy and poor drinkers, even for those who have exactly the same consumption of alcohol, there seems to be significantly more harm done to the poor than to the wealthy.

There may be some behavioral explanations for this, but they don’t explain all the difference. More work needs to be done there. It’s a really interesting story and I think a brave policy put forward by the Scottish government, which has returned rewards and is something that one would consider replicating around the world to see what other benefits might accrue from it.

I’m very interested to watch further forward over the next 2 decades to see what impact, if any, this alcohol-pricing legislation has on the incidence of cancer, looking at breast cancer, some gastrointestinal tumors, and so on, in which we know alcohol plays a part in their carcinogenesis.

Dr. Kerris a professor of cancer medicine at the University of Oxford (England). He reported conflicts of interest with Celleron Therapeutics, Oxford Cancer Biomarkers, Afrox, GlaxoSmithKline, Bayer, Genomic Health, Merck Serono, and Roche.

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

This transcript has been edited for clarity.

I’d like to discuss an article that’s appeared recently in The Lancet. It looks at the impact of minimum unit pricing for alcohol on alcohol-related deaths and hospital admissions in Scotland, my home country. Why is that important to me as a cancer doctor? We know that alcohol underpins epidemiologically a whole range of different tumor types.

Anyway, it’s a really interesting experiment. It also looks at the impact of governments and health policy. In 2018, the Scottish government introduced a minimum unit pricing for alcohol of around $0.60 per unit of alcohol. The idea was that if you drive up the price of getting access to alcohol, that should reduce harm, deaths, and hospital admissions.

Wyper and colleagues did a rather nice controlled, time-interrupted series. The legislation was introduced in 2018, so they looked at our public-health databases, hospital admissions, deaths, and so on for the time span from 2012 to 2018, then for about 3 years after the introduction of legislation in 2018. They used England as a control.

They showed that there was a reduction in fully alcohol-attributed deaths by 13.4% in Scotland, and a reduction in chronic hospital admissions related to alcohol by almost 10%. It works.

What was also interesting was that the benefits were confined to the lower socioeconomic classes. One could argue, whether intended or otherwise, that this was a health-policy intervention targeted at the lower socioeconomic classes. Perhaps, one would hope as a consequence that this would reduce the health equity gap.

We know that the differences in Scotland are remarkable. When we compare the highest with the lowest socioeconomic classes, there’s a 4- to 4.5-fold difference in likelihood of death benefiting, of course, the wealthy. The health-equity gap between rich and poor is getting wider, not becoming narrower. Interventions of this sort make a difference.

Of course, there’s good evidence from other areas in which price control can make a difference. Tobacco is perhaps the best example of it. People have also talked about sugar or fat taxes to see whether their actions reduce levels of obesity, overeating, and other problems.

It’s a really nice study, with very compelling data, very well worked out in terms of the methodology and statistics. There are lives saved and lives prolonged.

What it doesn’t do is tell us about the amount of alcohol that people were taking. It shows that if you are less well off and the price of alcohol goes up, you’ve got less money to spend on alcohol. Therefore, that reduction results in the reduction in harm associated with it.

What’s really interesting is something I hadn’t realized about what’s called the alcohol-harm paradox. When you look at drinkers across the socioeconomic spectrum, including wealthy and poor drinkers, even for those who have exactly the same consumption of alcohol, there seems to be significantly more harm done to the poor than to the wealthy.

There may be some behavioral explanations for this, but they don’t explain all the difference. More work needs to be done there. It’s a really interesting story and I think a brave policy put forward by the Scottish government, which has returned rewards and is something that one would consider replicating around the world to see what other benefits might accrue from it.

I’m very interested to watch further forward over the next 2 decades to see what impact, if any, this alcohol-pricing legislation has on the incidence of cancer, looking at breast cancer, some gastrointestinal tumors, and so on, in which we know alcohol plays a part in their carcinogenesis.

Dr. Kerris a professor of cancer medicine at the University of Oxford (England). He reported conflicts of interest with Celleron Therapeutics, Oxford Cancer Biomarkers, Afrox, GlaxoSmithKline, Bayer, Genomic Health, Merck Serono, and Roche.

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

This transcript has been edited for clarity.

I’d like to discuss an article that’s appeared recently in The Lancet. It looks at the impact of minimum unit pricing for alcohol on alcohol-related deaths and hospital admissions in Scotland, my home country. Why is that important to me as a cancer doctor? We know that alcohol underpins epidemiologically a whole range of different tumor types.

Anyway, it’s a really interesting experiment. It also looks at the impact of governments and health policy. In 2018, the Scottish government introduced a minimum unit pricing for alcohol of around $0.60 per unit of alcohol. The idea was that if you drive up the price of getting access to alcohol, that should reduce harm, deaths, and hospital admissions.

Wyper and colleagues did a rather nice controlled, time-interrupted series. The legislation was introduced in 2018, so they looked at our public-health databases, hospital admissions, deaths, and so on for the time span from 2012 to 2018, then for about 3 years after the introduction of legislation in 2018. They used England as a control.

They showed that there was a reduction in fully alcohol-attributed deaths by 13.4% in Scotland, and a reduction in chronic hospital admissions related to alcohol by almost 10%. It works.

What was also interesting was that the benefits were confined to the lower socioeconomic classes. One could argue, whether intended or otherwise, that this was a health-policy intervention targeted at the lower socioeconomic classes. Perhaps, one would hope as a consequence that this would reduce the health equity gap.

We know that the differences in Scotland are remarkable. When we compare the highest with the lowest socioeconomic classes, there’s a 4- to 4.5-fold difference in likelihood of death benefiting, of course, the wealthy. The health-equity gap between rich and poor is getting wider, not becoming narrower. Interventions of this sort make a difference.

Of course, there’s good evidence from other areas in which price control can make a difference. Tobacco is perhaps the best example of it. People have also talked about sugar or fat taxes to see whether their actions reduce levels of obesity, overeating, and other problems.

It’s a really nice study, with very compelling data, very well worked out in terms of the methodology and statistics. There are lives saved and lives prolonged.

What it doesn’t do is tell us about the amount of alcohol that people were taking. It shows that if you are less well off and the price of alcohol goes up, you’ve got less money to spend on alcohol. Therefore, that reduction results in the reduction in harm associated with it.

What’s really interesting is something I hadn’t realized about what’s called the alcohol-harm paradox. When you look at drinkers across the socioeconomic spectrum, including wealthy and poor drinkers, even for those who have exactly the same consumption of alcohol, there seems to be significantly more harm done to the poor than to the wealthy.

There may be some behavioral explanations for this, but they don’t explain all the difference. More work needs to be done there. It’s a really interesting story and I think a brave policy put forward by the Scottish government, which has returned rewards and is something that one would consider replicating around the world to see what other benefits might accrue from it.

I’m very interested to watch further forward over the next 2 decades to see what impact, if any, this alcohol-pricing legislation has on the incidence of cancer, looking at breast cancer, some gastrointestinal tumors, and so on, in which we know alcohol plays a part in their carcinogenesis.

Dr. Kerris a professor of cancer medicine at the University of Oxford (England). He reported conflicts of interest with Celleron Therapeutics, Oxford Cancer Biomarkers, Afrox, GlaxoSmithKline, Bayer, Genomic Health, Merck Serono, and Roche.

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

FRANCE – Did you know that, long before anyone else, Leonardo da Vinci called into question Galen’s description of how the heart works?

This is just one of the many interesting tidbits featured in “Leonardo da Vinci and Anatomy, the Mechanics of Life,” an exhibition that runs until Sept. 17 at the Château du Clos Lucé – a home once owned by da Vinci – in Amboise, France.

In his book about this exhibition, Jean-Jacques Monsuez, MD, a cardiologist at Paris’ René-Muret Hospital, noted, “For a long time, very few people knew about Leonardo’s observations on the cardiovascular system’s anatomy or his rather physiological analysis of its hemodynamics. Had this not been the case, his work would, very likely, have had a significant influence on the subsequent development of knowledge about the cardiovascular system.”
 

A visionary view

In the second century AD, Galen put forth the following novel theory: The liver transforms food into blood. The blood is carried through veins to the various organs and is sent to the right ventricle through ebb and flow and to the left ventricle through intraventricular pores [which, we now know, do not exist].

In the left ventricle, the blood mixes with air – “pneuma” – from the lungs and is transformed into vital spirits. Clear blood, enriched with vital heat, is then carried by the arteries to peripheral tissues.

This erroneous explanation of how blood circulates went unchallenged for hundreds and hundreds of years.

And then along came Leonardo, anatomy pioneer and experimenter extraordinaire. Around 1513, after looking more closely at the heart chambers and the aortic valve, he arrived at the belief that, contrary to Galen’s theory, blood flow starts in the heart, not the liver.

“The heart in itself is not the origin of life, but [simply] a vessel made of dense muscle vivified and nourished by an artery and a vein, as are other muscles.”

He arrived at this insight through his in-depth dissections and studies of pig, ox, and human hearts.

A vast number of folios came about, all dedicated to the functioning of the heart. Taking his lead from Galen and Avicenna, Leonardo started off by drawing two atria and two ventricles along with Galen’s intraventricular pores.

But he quickly moved in a different direction when it came to the question of what enables the heart to produce vital spirits from blood flow.

On a double sheet showing several views of an ox heart, he drew all the components – this time with the aortic valve both open and closed.

“The accuracy of the description of the aortic valve is impressive, considering that, in a normal subject, its surface is on the order of 3 cm²,” Monsuez noted.

But Leonardo went even further, explaining the sequence of the opening and closing of the valve. To complete his demonstration, he even used a model from one of his experiments. He took some water with a suspension of grass seeds and pumped it through a glass tube that had a bulge representing the aortic sinuses. He tracked the resultant flow and eddies that mimic the hemodynamics enabling the valve to open and close.

“Recently, Professor Choudhury’s team at Oxford took Leonardo’s sketch illustrating this ingenious description and superimposed it on the 4D-MRI image of systolic flow vortices. They confirmed that Leonardo was accurate,” Monsuez reported.

But Leonardo’s ideas about the heart didn’t stop there. The polymath also provided a description of cardiac contraction. This was based on observations he had made by watching the movement of spiles that had been driven into the hearts of pigs at a slaughterhouse. He made an ancillary diagram confirming his interpretation. “N, the firm muscle is pulled back, and it’s the first cause of the heart’s movement, for, thus pulled, it lengthens, and lengthening, it shortens.”

Leonardo was the first to explain the role of the atria. “The atria are the antechambers that receive the blood from the heart when it escapes from its ventricle from the beginning until the end of the pressure.”

In addition, he showed, for the first time, the round crown-like appearance of the heart’s vasculature. “The heart has its surface divided into three parts by three veins which descend from its base, of which veins two terminate the extremities of the right ventricle and have two arteries in contact below them […] the surface space of the heart enclosed within its arteries occupies half the surface circle of the thickness of the heart […].”

Finally, Leonardo was the first to give a description and sketch of a bicuspid aortic valve, as can be seen on a 500-year-old plate in the Royal Collection Trust.
 

Wealth of knowledge

Because Leonardo’s discoveries about the cardiovascular system remained in the shadows, they did not factor into the thinking of physicians and surgeons during his lifetime or in the years that followed.

That is, until 1773, when Scottish anatomist Dr. William Hunter found out that the collection of King Charles II of England contained folios on the human body – folios that were made by Leonardo da Vinci.

The world would have to wait until the 19th century for a complete facsimile edition of the collection kept at Windsor Castle.
 

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

FRANCE – Did you know that, long before anyone else, Leonardo da Vinci called into question Galen’s description of how the heart works?

This is just one of the many interesting tidbits featured in “Leonardo da Vinci and Anatomy, the Mechanics of Life,” an exhibition that runs until Sept. 17 at the Château du Clos Lucé – a home once owned by da Vinci – in Amboise, France.

In his book about this exhibition, Jean-Jacques Monsuez, MD, a cardiologist at Paris’ René-Muret Hospital, noted, “For a long time, very few people knew about Leonardo’s observations on the cardiovascular system’s anatomy or his rather physiological analysis of its hemodynamics. Had this not been the case, his work would, very likely, have had a significant influence on the subsequent development of knowledge about the cardiovascular system.”
 

A visionary view

In the second century AD, Galen put forth the following novel theory: The liver transforms food into blood. The blood is carried through veins to the various organs and is sent to the right ventricle through ebb and flow and to the left ventricle through intraventricular pores [which, we now know, do not exist].

In the left ventricle, the blood mixes with air – “pneuma” – from the lungs and is transformed into vital spirits. Clear blood, enriched with vital heat, is then carried by the arteries to peripheral tissues.

This erroneous explanation of how blood circulates went unchallenged for hundreds and hundreds of years.

And then along came Leonardo, anatomy pioneer and experimenter extraordinaire. Around 1513, after looking more closely at the heart chambers and the aortic valve, he arrived at the belief that, contrary to Galen’s theory, blood flow starts in the heart, not the liver.

“The heart in itself is not the origin of life, but [simply] a vessel made of dense muscle vivified and nourished by an artery and a vein, as are other muscles.”

He arrived at this insight through his in-depth dissections and studies of pig, ox, and human hearts.

A vast number of folios came about, all dedicated to the functioning of the heart. Taking his lead from Galen and Avicenna, Leonardo started off by drawing two atria and two ventricles along with Galen’s intraventricular pores.

But he quickly moved in a different direction when it came to the question of what enables the heart to produce vital spirits from blood flow.

On a double sheet showing several views of an ox heart, he drew all the components – this time with the aortic valve both open and closed.

“The accuracy of the description of the aortic valve is impressive, considering that, in a normal subject, its surface is on the order of 3 cm²,” Monsuez noted.

But Leonardo went even further, explaining the sequence of the opening and closing of the valve. To complete his demonstration, he even used a model from one of his experiments. He took some water with a suspension of grass seeds and pumped it through a glass tube that had a bulge representing the aortic sinuses. He tracked the resultant flow and eddies that mimic the hemodynamics enabling the valve to open and close.

“Recently, Professor Choudhury’s team at Oxford took Leonardo’s sketch illustrating this ingenious description and superimposed it on the 4D-MRI image of systolic flow vortices. They confirmed that Leonardo was accurate,” Monsuez reported.

But Leonardo’s ideas about the heart didn’t stop there. The polymath also provided a description of cardiac contraction. This was based on observations he had made by watching the movement of spiles that had been driven into the hearts of pigs at a slaughterhouse. He made an ancillary diagram confirming his interpretation. “N, the firm muscle is pulled back, and it’s the first cause of the heart’s movement, for, thus pulled, it lengthens, and lengthening, it shortens.”

Leonardo was the first to explain the role of the atria. “The atria are the antechambers that receive the blood from the heart when it escapes from its ventricle from the beginning until the end of the pressure.”

In addition, he showed, for the first time, the round crown-like appearance of the heart’s vasculature. “The heart has its surface divided into three parts by three veins which descend from its base, of which veins two terminate the extremities of the right ventricle and have two arteries in contact below them […] the surface space of the heart enclosed within its arteries occupies half the surface circle of the thickness of the heart […].”

Finally, Leonardo was the first to give a description and sketch of a bicuspid aortic valve, as can be seen on a 500-year-old plate in the Royal Collection Trust.
 

Wealth of knowledge

Because Leonardo’s discoveries about the cardiovascular system remained in the shadows, they did not factor into the thinking of physicians and surgeons during his lifetime or in the years that followed.

That is, until 1773, when Scottish anatomist Dr. William Hunter found out that the collection of King Charles II of England contained folios on the human body – folios that were made by Leonardo da Vinci.

The world would have to wait until the 19th century for a complete facsimile edition of the collection kept at Windsor Castle.
 

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

FRANCE – Did you know that, long before anyone else, Leonardo da Vinci called into question Galen’s description of how the heart works?

This is just one of the many interesting tidbits featured in “Leonardo da Vinci and Anatomy, the Mechanics of Life,” an exhibition that runs until Sept. 17 at the Château du Clos Lucé – a home once owned by da Vinci – in Amboise, France.

In his book about this exhibition, Jean-Jacques Monsuez, MD, a cardiologist at Paris’ René-Muret Hospital, noted, “For a long time, very few people knew about Leonardo’s observations on the cardiovascular system’s anatomy or his rather physiological analysis of its hemodynamics. Had this not been the case, his work would, very likely, have had a significant influence on the subsequent development of knowledge about the cardiovascular system.”
 

A visionary view

In the second century AD, Galen put forth the following novel theory: The liver transforms food into blood. The blood is carried through veins to the various organs and is sent to the right ventricle through ebb and flow and to the left ventricle through intraventricular pores [which, we now know, do not exist].

In the left ventricle, the blood mixes with air – “pneuma” – from the lungs and is transformed into vital spirits. Clear blood, enriched with vital heat, is then carried by the arteries to peripheral tissues.

This erroneous explanation of how blood circulates went unchallenged for hundreds and hundreds of years.

And then along came Leonardo, anatomy pioneer and experimenter extraordinaire. Around 1513, after looking more closely at the heart chambers and the aortic valve, he arrived at the belief that, contrary to Galen’s theory, blood flow starts in the heart, not the liver.

“The heart in itself is not the origin of life, but [simply] a vessel made of dense muscle vivified and nourished by an artery and a vein, as are other muscles.”

He arrived at this insight through his in-depth dissections and studies of pig, ox, and human hearts.

A vast number of folios came about, all dedicated to the functioning of the heart. Taking his lead from Galen and Avicenna, Leonardo started off by drawing two atria and two ventricles along with Galen’s intraventricular pores.

But he quickly moved in a different direction when it came to the question of what enables the heart to produce vital spirits from blood flow.

On a double sheet showing several views of an ox heart, he drew all the components – this time with the aortic valve both open and closed.

“The accuracy of the description of the aortic valve is impressive, considering that, in a normal subject, its surface is on the order of 3 cm²,” Monsuez noted.

But Leonardo went even further, explaining the sequence of the opening and closing of the valve. To complete his demonstration, he even used a model from one of his experiments. He took some water with a suspension of grass seeds and pumped it through a glass tube that had a bulge representing the aortic sinuses. He tracked the resultant flow and eddies that mimic the hemodynamics enabling the valve to open and close.

“Recently, Professor Choudhury’s team at Oxford took Leonardo’s sketch illustrating this ingenious description and superimposed it on the 4D-MRI image of systolic flow vortices. They confirmed that Leonardo was accurate,” Monsuez reported.

But Leonardo’s ideas about the heart didn’t stop there. The polymath also provided a description of cardiac contraction. This was based on observations he had made by watching the movement of spiles that had been driven into the hearts of pigs at a slaughterhouse. He made an ancillary diagram confirming his interpretation. “N, the firm muscle is pulled back, and it’s the first cause of the heart’s movement, for, thus pulled, it lengthens, and lengthening, it shortens.”

Leonardo was the first to explain the role of the atria. “The atria are the antechambers that receive the blood from the heart when it escapes from its ventricle from the beginning until the end of the pressure.”

In addition, he showed, for the first time, the round crown-like appearance of the heart’s vasculature. “The heart has its surface divided into three parts by three veins which descend from its base, of which veins two terminate the extremities of the right ventricle and have two arteries in contact below them […] the surface space of the heart enclosed within its arteries occupies half the surface circle of the thickness of the heart […].”

Finally, Leonardo was the first to give a description and sketch of a bicuspid aortic valve, as can be seen on a 500-year-old plate in the Royal Collection Trust.
 

Wealth of knowledge

Because Leonardo’s discoveries about the cardiovascular system remained in the shadows, they did not factor into the thinking of physicians and surgeons during his lifetime or in the years that followed.

That is, until 1773, when Scottish anatomist Dr. William Hunter found out that the collection of King Charles II of England contained folios on the human body – folios that were made by Leonardo da Vinci.

The world would have to wait until the 19th century for a complete facsimile edition of the collection kept at Windsor Castle.
 

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