Around 50% of patients develop an infection in the final months, weeks, or days before their deaths. Diagnosing an infection is complex because of the presence of symptoms that are often nonspecific and that are common in patients in decline toward the end of life. Use of antibiotic therapy in this patient population is still controversial, because the clinical benefits are not clear and the risk of pointless overmedicalization is very high.

Etiology

For patients who are receiving palliative care, the following factors predispose to an infection:

• Increasing fragility.
• Bedbound status and anorexia/cachexia syndrome.
• Weakened immune defenses owing to disease or treatments.
• Changes to skin integrity, related to venous access sites and/or bladder catheterization.

Four-week cutoff

For patients who are expected to live for fewer than 4 weeks, evidence from the literature shows that antimicrobial therapy does not resolve a potential infection or improve the prognosis. Antibiotics should therefore be used only for improving symptom management.

In practice, the most common infections in patients receiving end-of-life care are in the urinary and respiratory tracts. Antibiotics are beneficial in the short term in managing symptoms associated with urinary tract infections (effective in 60%-92% of cases), so they should be considered if the patient is not in the agonal or pre-agonal phase of death.

Antibiotics are also beneficial in managing symptoms associated with respiratory tract infections (effective in up to 53% of cases), so they should be considered if the patient is not in the agonal or pre-agonal phase of death. However, the risk of futility is high. As an alternative, opioids and antitussives could provide greater benefit for patients with dyspnea and cough.

No benefit has been observed with the use of antibiotics to treat symptoms associated with sepsis, abscesses, and deep and complicated infections. Antibiotics are therefore deemed futile in these cases.

In unclear cases, the “2-day rule” is useful. This involves waiting for 2 days, and if the patient remains clinically stable, prescribing antibiotics. If the patient’s condition deteriorates rapidly and progressively, antibiotics should not be prescribed.

Alternatively, one can prescribe antibiotics immediately. If no clinical improvement is observed after 2 days, the antibiotics should be stopped, especially if deterioration of the patient’s condition is rapid and progressive.

Increased body temperature is somewhat common in the last days and hours of life and is not generally associated with symptoms. Fever in these cases is not an indication for the use of antimicrobial therapy.

The most common laboratory markers of infection (C-reactive protein level, erythrocyte sedimentation rate, leukocyte level) are not particularly useful in this patient population, because they are affected by the baseline condition as well as by any treatments given and the state of systemic inflammation, which is associated with the decline in overall health in the last few weeks of life.

The choice should be individualized and shared with patients and family members so that the clinical appropriateness of the therapeutic strategy is evident and that decisions regarding antibiotic treatment are not regarded as a failure to treat the patient.
 

The longer term

In deciding to start antibiotic therapy, consideration must be given to the patient’s overall health, the treatment objectives, the possibility that the antibiotic will resolve the infection or improve the patient’s symptoms, and the estimated prognosis, which must be sufficiently long to allow the antibiotic time to take effect.

This article was translated from Univadis Italy, which is part of the Medscape Professional Network. A version of this article appeared on Medscape.com.

Around 50% of patients develop an infection in the final months, weeks, or days before their deaths. Diagnosing an infection is complex because of the presence of symptoms that are often nonspecific and that are common in patients in decline toward the end of life. Use of antibiotic therapy in this patient population is still controversial, because the clinical benefits are not clear and the risk of pointless overmedicalization is very high.

Etiology

For patients who are receiving palliative care, the following factors predispose to an infection:

• Increasing fragility.
• Bedbound status and anorexia/cachexia syndrome.
• Weakened immune defenses owing to disease or treatments.
• Changes to skin integrity, related to venous access sites and/or bladder catheterization.

Four-week cutoff

For patients who are expected to live for fewer than 4 weeks, evidence from the literature shows that antimicrobial therapy does not resolve a potential infection or improve the prognosis. Antibiotics should therefore be used only for improving symptom management.

In practice, the most common infections in patients receiving end-of-life care are in the urinary and respiratory tracts. Antibiotics are beneficial in the short term in managing symptoms associated with urinary tract infections (effective in 60%-92% of cases), so they should be considered if the patient is not in the agonal or pre-agonal phase of death.

Antibiotics are also beneficial in managing symptoms associated with respiratory tract infections (effective in up to 53% of cases), so they should be considered if the patient is not in the agonal or pre-agonal phase of death. However, the risk of futility is high. As an alternative, opioids and antitussives could provide greater benefit for patients with dyspnea and cough.

No benefit has been observed with the use of antibiotics to treat symptoms associated with sepsis, abscesses, and deep and complicated infections. Antibiotics are therefore deemed futile in these cases.

In unclear cases, the “2-day rule” is useful. This involves waiting for 2 days, and if the patient remains clinically stable, prescribing antibiotics. If the patient’s condition deteriorates rapidly and progressively, antibiotics should not be prescribed.

Alternatively, one can prescribe antibiotics immediately. If no clinical improvement is observed after 2 days, the antibiotics should be stopped, especially if deterioration of the patient’s condition is rapid and progressive.

Increased body temperature is somewhat common in the last days and hours of life and is not generally associated with symptoms. Fever in these cases is not an indication for the use of antimicrobial therapy.

The most common laboratory markers of infection (C-reactive protein level, erythrocyte sedimentation rate, leukocyte level) are not particularly useful in this patient population, because they are affected by the baseline condition as well as by any treatments given and the state of systemic inflammation, which is associated with the decline in overall health in the last few weeks of life.

The choice should be individualized and shared with patients and family members so that the clinical appropriateness of the therapeutic strategy is evident and that decisions regarding antibiotic treatment are not regarded as a failure to treat the patient.
 

The longer term

In deciding to start antibiotic therapy, consideration must be given to the patient’s overall health, the treatment objectives, the possibility that the antibiotic will resolve the infection or improve the patient’s symptoms, and the estimated prognosis, which must be sufficiently long to allow the antibiotic time to take effect.

This article was translated from Univadis Italy, which is part of the Medscape Professional Network. A version of this article appeared on Medscape.com.

Around 50% of patients develop an infection in the final months, weeks, or days before their deaths. Diagnosing an infection is complex because of the presence of symptoms that are often nonspecific and that are common in patients in decline toward the end of life. Use of antibiotic therapy in this patient population is still controversial, because the clinical benefits are not clear and the risk of pointless overmedicalization is very high.

Etiology

For patients who are receiving palliative care, the following factors predispose to an infection:

• Increasing fragility.
• Bedbound status and anorexia/cachexia syndrome.
• Weakened immune defenses owing to disease or treatments.
• Changes to skin integrity, related to venous access sites and/or bladder catheterization.

Four-week cutoff

For patients who are expected to live for fewer than 4 weeks, evidence from the literature shows that antimicrobial therapy does not resolve a potential infection or improve the prognosis. Antibiotics should therefore be used only for improving symptom management.

In practice, the most common infections in patients receiving end-of-life care are in the urinary and respiratory tracts. Antibiotics are beneficial in the short term in managing symptoms associated with urinary tract infections (effective in 60%-92% of cases), so they should be considered if the patient is not in the agonal or pre-agonal phase of death.

Antibiotics are also beneficial in managing symptoms associated with respiratory tract infections (effective in up to 53% of cases), so they should be considered if the patient is not in the agonal or pre-agonal phase of death. However, the risk of futility is high. As an alternative, opioids and antitussives could provide greater benefit for patients with dyspnea and cough.

No benefit has been observed with the use of antibiotics to treat symptoms associated with sepsis, abscesses, and deep and complicated infections. Antibiotics are therefore deemed futile in these cases.

In unclear cases, the “2-day rule” is useful. This involves waiting for 2 days, and if the patient remains clinically stable, prescribing antibiotics. If the patient’s condition deteriorates rapidly and progressively, antibiotics should not be prescribed.

Alternatively, one can prescribe antibiotics immediately. If no clinical improvement is observed after 2 days, the antibiotics should be stopped, especially if deterioration of the patient’s condition is rapid and progressive.

Increased body temperature is somewhat common in the last days and hours of life and is not generally associated with symptoms. Fever in these cases is not an indication for the use of antimicrobial therapy.

The most common laboratory markers of infection (C-reactive protein level, erythrocyte sedimentation rate, leukocyte level) are not particularly useful in this patient population, because they are affected by the baseline condition as well as by any treatments given and the state of systemic inflammation, which is associated with the decline in overall health in the last few weeks of life.

The choice should be individualized and shared with patients and family members so that the clinical appropriateness of the therapeutic strategy is evident and that decisions regarding antibiotic treatment are not regarded as a failure to treat the patient.
 

The longer term

In deciding to start antibiotic therapy, consideration must be given to the patient’s overall health, the treatment objectives, the possibility that the antibiotic will resolve the infection or improve the patient’s symptoms, and the estimated prognosis, which must be sufficiently long to allow the antibiotic time to take effect.

This article was translated from Univadis Italy, which is part of the Medscape Professional Network. A version of this article appeared on Medscape.com.

A recent study published in the journal Academic Pediatrics suggests that during health maintenance visits clinicians are giving too little attention to their patients’ sleep problems. Using a questionnaire, researchers surveyed patients’ caregivers’ concerns and observations regarding a variety of sleep problems. The investigators then reviewed the clinicians’ documentation of what transpired at the visit and found that while over 90% of the caregivers reported their child had at least one sleep related problem, only 20% of the clinicians documented the problem. And, only 12% documented a management plan regarding the sleep concerns.

I am always bit skeptical about studies that rely on clinicians’ “documentation” because clinicians are busy people and don’t always remember to record things they’ve discussed. You and I know that the lawyers’ dictum “if it wasn’t documented it didn’t happen” is rubbish. However, I still find the basic finding of this study concerning. If we are failing to ask about or even listen to caregivers’ concerns about something as important as sleep, we are missing the boat ... a very large boat.

How could this be happening? First, sleep may have fallen victim to the bloated list of topics that well-intentioned single-issue preventive health advocates have tacked on to the health maintenance visit. It’s a burden that few of us can manage without cutting corners.

However, it is more troubling to me that so many clinicians have chosen sleep as one of those corners to cut. This oversight suggests to me that too many of us have failed to realize from our own observations that sleep is incredibly important to the health of our patients ... and to ourselves.

I will admit that I am extremely sensitive to the importance of sleep. Some might say my sensitivity borders on an obsession. But, the literature is clear and becoming more voluminous every year that sleep is important to the mental health of our patients and their caregivers to things like obesity, to symptoms that suggest an attention-deficit/hyperactivity disorder, to school success, and to migraine ... to name just a few.

It may be that most of us realize the importance of sleep but feel our society has allowed itself to become so sleep deprived that there is little chance we can turn the ship around by spending just a few minutes trying help a family undo their deeply ingrained sleep unfriendly habits.

I am tempted to join those of you who see sleep depravation as a “why bother” issue. But, I’m not ready to throw in the towel. There are things that we as clinicians can do to help families address poor sleep hygiene. Even simply sharing your observations about the importance of sleep in the whole wellness picture may have an effect.

One of the benefits of retiring in the same community in which I practiced for over 40 years is that at least every month or two I encounter a parent who thanks me for sharing my views on the importance of sleep. They may not recall the little tip or two I gave them, but it seems that urging them to put sleep near the top of their lifestyle priority list has made the difference for them.

If I have failed in getting you to join me in my crusade against sleep deprivation, at least take to heart the most basic message of this study. That is that the investigators found only 20% of clinicians were addressing a concern that 90% of the caregivers shared. It happened to be sleep, but it could have been anything.

The authors of the study suggest that we need to be more assiduous in our screening for sleep problems. On the contrary. You and I know we don’t need more screening. We just need to be better listeners.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

A recent study published in the journal Academic Pediatrics suggests that during health maintenance visits clinicians are giving too little attention to their patients’ sleep problems. Using a questionnaire, researchers surveyed patients’ caregivers’ concerns and observations regarding a variety of sleep problems. The investigators then reviewed the clinicians’ documentation of what transpired at the visit and found that while over 90% of the caregivers reported their child had at least one sleep related problem, only 20% of the clinicians documented the problem. And, only 12% documented a management plan regarding the sleep concerns.

I am always bit skeptical about studies that rely on clinicians’ “documentation” because clinicians are busy people and don’t always remember to record things they’ve discussed. You and I know that the lawyers’ dictum “if it wasn’t documented it didn’t happen” is rubbish. However, I still find the basic finding of this study concerning. If we are failing to ask about or even listen to caregivers’ concerns about something as important as sleep, we are missing the boat ... a very large boat.

How could this be happening? First, sleep may have fallen victim to the bloated list of topics that well-intentioned single-issue preventive health advocates have tacked on to the health maintenance visit. It’s a burden that few of us can manage without cutting corners.

However, it is more troubling to me that so many clinicians have chosen sleep as one of those corners to cut. This oversight suggests to me that too many of us have failed to realize from our own observations that sleep is incredibly important to the health of our patients ... and to ourselves.

I will admit that I am extremely sensitive to the importance of sleep. Some might say my sensitivity borders on an obsession. But, the literature is clear and becoming more voluminous every year that sleep is important to the mental health of our patients and their caregivers to things like obesity, to symptoms that suggest an attention-deficit/hyperactivity disorder, to school success, and to migraine ... to name just a few.

It may be that most of us realize the importance of sleep but feel our society has allowed itself to become so sleep deprived that there is little chance we can turn the ship around by spending just a few minutes trying help a family undo their deeply ingrained sleep unfriendly habits.

I am tempted to join those of you who see sleep depravation as a “why bother” issue. But, I’m not ready to throw in the towel. There are things that we as clinicians can do to help families address poor sleep hygiene. Even simply sharing your observations about the importance of sleep in the whole wellness picture may have an effect.

One of the benefits of retiring in the same community in which I practiced for over 40 years is that at least every month or two I encounter a parent who thanks me for sharing my views on the importance of sleep. They may not recall the little tip or two I gave them, but it seems that urging them to put sleep near the top of their lifestyle priority list has made the difference for them.

If I have failed in getting you to join me in my crusade against sleep deprivation, at least take to heart the most basic message of this study. That is that the investigators found only 20% of clinicians were addressing a concern that 90% of the caregivers shared. It happened to be sleep, but it could have been anything.

The authors of the study suggest that we need to be more assiduous in our screening for sleep problems. On the contrary. You and I know we don’t need more screening. We just need to be better listeners.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

A recent study published in the journal Academic Pediatrics suggests that during health maintenance visits clinicians are giving too little attention to their patients’ sleep problems. Using a questionnaire, researchers surveyed patients’ caregivers’ concerns and observations regarding a variety of sleep problems. The investigators then reviewed the clinicians’ documentation of what transpired at the visit and found that while over 90% of the caregivers reported their child had at least one sleep related problem, only 20% of the clinicians documented the problem. And, only 12% documented a management plan regarding the sleep concerns.

I am always bit skeptical about studies that rely on clinicians’ “documentation” because clinicians are busy people and don’t always remember to record things they’ve discussed. You and I know that the lawyers’ dictum “if it wasn’t documented it didn’t happen” is rubbish. However, I still find the basic finding of this study concerning. If we are failing to ask about or even listen to caregivers’ concerns about something as important as sleep, we are missing the boat ... a very large boat.

How could this be happening? First, sleep may have fallen victim to the bloated list of topics that well-intentioned single-issue preventive health advocates have tacked on to the health maintenance visit. It’s a burden that few of us can manage without cutting corners.

However, it is more troubling to me that so many clinicians have chosen sleep as one of those corners to cut. This oversight suggests to me that too many of us have failed to realize from our own observations that sleep is incredibly important to the health of our patients ... and to ourselves.

I will admit that I am extremely sensitive to the importance of sleep. Some might say my sensitivity borders on an obsession. But, the literature is clear and becoming more voluminous every year that sleep is important to the mental health of our patients and their caregivers to things like obesity, to symptoms that suggest an attention-deficit/hyperactivity disorder, to school success, and to migraine ... to name just a few.

It may be that most of us realize the importance of sleep but feel our society has allowed itself to become so sleep deprived that there is little chance we can turn the ship around by spending just a few minutes trying help a family undo their deeply ingrained sleep unfriendly habits.

I am tempted to join those of you who see sleep depravation as a “why bother” issue. But, I’m not ready to throw in the towel. There are things that we as clinicians can do to help families address poor sleep hygiene. Even simply sharing your observations about the importance of sleep in the whole wellness picture may have an effect.

One of the benefits of retiring in the same community in which I practiced for over 40 years is that at least every month or two I encounter a parent who thanks me for sharing my views on the importance of sleep. They may not recall the little tip or two I gave them, but it seems that urging them to put sleep near the top of their lifestyle priority list has made the difference for them.

If I have failed in getting you to join me in my crusade against sleep deprivation, at least take to heart the most basic message of this study. That is that the investigators found only 20% of clinicians were addressing a concern that 90% of the caregivers shared. It happened to be sleep, but it could have been anything.

The authors of the study suggest that we need to be more assiduous in our screening for sleep problems. On the contrary. You and I know we don’t need more screening. We just need to be better listeners.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

MILAN – Rheumatic disease is not considered a significant risk factor for long COVID, according to the findings of a Dutch prospective cohort study presented at the annual European Congress of Rheumatology.

Although more patients with inflammatory rheumatic diseases (iRD) report symptoms resembling long COVID, the data suggest that many of these symptoms can be attributed to the underlying rheumatic disease. “Overall, we find the data quite reassuring,” said Laura Boekel, Amsterdam Rheumatology and Immunology Center, Amsterdam University Medical Center.

The results were also published in The Lancet Rheumatology.

The risk of developing long COVID after infection with the Omicron variant appeared to be higher in patients with iRD, with 21% meeting the criteria set by the World Health Organization, compared with 13% of healthy individuals (odds ratio, 1.58; P = .037). Fatigue and loss of fitness were the most common long COVID symptoms reported by both iRD patients and controls. However, the difference in risk decreased after accounting for factors that are significantly associated with an increased risk for long COVID, such as body mass index and the severity of the acute COVID-19 infection (adjusted OR, 1.46; P = .081). The duration of symptoms did not show a statistically significant difference.

Kim Lauper, MD, University of Geneva, who chaired the session in which Ms. Boekel reported the study, said in an interview that the data should be interpreted with caution. “The data demonstrate that rheumatic disease itself is not a risk factor for long COVID. However, patients with rheumatic diseases are at a higher risk of severe disease, which in turn increases the likelihood of long COVID. Therefore, as a population, these patients are more susceptible to long COVID overall.”

Moreover, irrespective of their previous COVID-19 infection status, iRD patients often exhibit symptoms similar to those of long COVID even without a prior COVID-19 infection. (There was no history of COVID-19 in 21% of iRD patients vs. 11% of controls.) This suggests that some of the reported long COVID symptoms may actually be clinical manifestations of the underlying rheumatic disease, thereby complicating the diagnosis of long COVID in this population. The study employed the WHO definition of long COVID, which includes persistent symptoms lasting at least 8 weeks, beginning within 3 months of a confirmed SARS-CoV-2 infection, and that cannot be attributed to an alternative diagnosis. However, the data presented in Milan indicate that the WHO definition “is not well suited for patients with iRD due to significant overlap in symptoms and features,” Ms. Boekel concluded.

The cases of Omicron COVID-19 were identified during Jan. 1–April 25, 2022, among iRD patients recruited from the Amsterdam Rheumatology and Immunology Center. The population with confirmed SARS-CoV-2 Omicron infection during this period was monitored for long COVID. The total number of patients included in the study consisted of 77 iRD patients and 23 healthy controls. When asked about the potential risk of selection bias in the survey, Ms. Boekel stated that only approximately 8% of participants declined to respond, and the nonresponders were comparable with the respondents. She concluded that “the risk of selection bias is minimal.”

In an editorial published in The Lancet Rheumatology, Leonard H. Calabrese, DO, Cleveland Clinic, provided his insights on the findings. He emphasized that, “at present, long COVID remains an important reality that significantly impacts the lives of millions of individuals, yet it remains incompletely defined. ... These limitations in defining cases should not in any way undermine the experiences of those suffering from long COVID. Instead, they should serve as a reminder that, at this stage of the pandemic, we unfortunately still lack validated classification criteria for long COVID. It is crucial to include non–SARS-CoV-2–infected controls in all studies to further enhance our understanding.”

Ms. Boekel and coauthors, as well as Dr. Lauper and Dr. Calabrese, reported no relevant financial relationships.

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

MILAN – Rheumatic disease is not considered a significant risk factor for long COVID, according to the findings of a Dutch prospective cohort study presented at the annual European Congress of Rheumatology.

Although more patients with inflammatory rheumatic diseases (iRD) report symptoms resembling long COVID, the data suggest that many of these symptoms can be attributed to the underlying rheumatic disease. “Overall, we find the data quite reassuring,” said Laura Boekel, Amsterdam Rheumatology and Immunology Center, Amsterdam University Medical Center.

The results were also published in The Lancet Rheumatology.

The risk of developing long COVID after infection with the Omicron variant appeared to be higher in patients with iRD, with 21% meeting the criteria set by the World Health Organization, compared with 13% of healthy individuals (odds ratio, 1.58; P = .037). Fatigue and loss of fitness were the most common long COVID symptoms reported by both iRD patients and controls. However, the difference in risk decreased after accounting for factors that are significantly associated with an increased risk for long COVID, such as body mass index and the severity of the acute COVID-19 infection (adjusted OR, 1.46; P = .081). The duration of symptoms did not show a statistically significant difference.

Kim Lauper, MD, University of Geneva, who chaired the session in which Ms. Boekel reported the study, said in an interview that the data should be interpreted with caution. “The data demonstrate that rheumatic disease itself is not a risk factor for long COVID. However, patients with rheumatic diseases are at a higher risk of severe disease, which in turn increases the likelihood of long COVID. Therefore, as a population, these patients are more susceptible to long COVID overall.”

Moreover, irrespective of their previous COVID-19 infection status, iRD patients often exhibit symptoms similar to those of long COVID even without a prior COVID-19 infection. (There was no history of COVID-19 in 21% of iRD patients vs. 11% of controls.) This suggests that some of the reported long COVID symptoms may actually be clinical manifestations of the underlying rheumatic disease, thereby complicating the diagnosis of long COVID in this population. The study employed the WHO definition of long COVID, which includes persistent symptoms lasting at least 8 weeks, beginning within 3 months of a confirmed SARS-CoV-2 infection, and that cannot be attributed to an alternative diagnosis. However, the data presented in Milan indicate that the WHO definition “is not well suited for patients with iRD due to significant overlap in symptoms and features,” Ms. Boekel concluded.

The cases of Omicron COVID-19 were identified during Jan. 1–April 25, 2022, among iRD patients recruited from the Amsterdam Rheumatology and Immunology Center. The population with confirmed SARS-CoV-2 Omicron infection during this period was monitored for long COVID. The total number of patients included in the study consisted of 77 iRD patients and 23 healthy controls. When asked about the potential risk of selection bias in the survey, Ms. Boekel stated that only approximately 8% of participants declined to respond, and the nonresponders were comparable with the respondents. She concluded that “the risk of selection bias is minimal.”

In an editorial published in The Lancet Rheumatology, Leonard H. Calabrese, DO, Cleveland Clinic, provided his insights on the findings. He emphasized that, “at present, long COVID remains an important reality that significantly impacts the lives of millions of individuals, yet it remains incompletely defined. ... These limitations in defining cases should not in any way undermine the experiences of those suffering from long COVID. Instead, they should serve as a reminder that, at this stage of the pandemic, we unfortunately still lack validated classification criteria for long COVID. It is crucial to include non–SARS-CoV-2–infected controls in all studies to further enhance our understanding.”

Ms. Boekel and coauthors, as well as Dr. Lauper and Dr. Calabrese, reported no relevant financial relationships.

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

MILAN – Rheumatic disease is not considered a significant risk factor for long COVID, according to the findings of a Dutch prospective cohort study presented at the annual European Congress of Rheumatology.

Although more patients with inflammatory rheumatic diseases (iRD) report symptoms resembling long COVID, the data suggest that many of these symptoms can be attributed to the underlying rheumatic disease. “Overall, we find the data quite reassuring,” said Laura Boekel, Amsterdam Rheumatology and Immunology Center, Amsterdam University Medical Center.

The results were also published in The Lancet Rheumatology.

The risk of developing long COVID after infection with the Omicron variant appeared to be higher in patients with iRD, with 21% meeting the criteria set by the World Health Organization, compared with 13% of healthy individuals (odds ratio, 1.58; P = .037). Fatigue and loss of fitness were the most common long COVID symptoms reported by both iRD patients and controls. However, the difference in risk decreased after accounting for factors that are significantly associated with an increased risk for long COVID, such as body mass index and the severity of the acute COVID-19 infection (adjusted OR, 1.46; P = .081). The duration of symptoms did not show a statistically significant difference.

Kim Lauper, MD, University of Geneva, who chaired the session in which Ms. Boekel reported the study, said in an interview that the data should be interpreted with caution. “The data demonstrate that rheumatic disease itself is not a risk factor for long COVID. However, patients with rheumatic diseases are at a higher risk of severe disease, which in turn increases the likelihood of long COVID. Therefore, as a population, these patients are more susceptible to long COVID overall.”

Moreover, irrespective of their previous COVID-19 infection status, iRD patients often exhibit symptoms similar to those of long COVID even without a prior COVID-19 infection. (There was no history of COVID-19 in 21% of iRD patients vs. 11% of controls.) This suggests that some of the reported long COVID symptoms may actually be clinical manifestations of the underlying rheumatic disease, thereby complicating the diagnosis of long COVID in this population. The study employed the WHO definition of long COVID, which includes persistent symptoms lasting at least 8 weeks, beginning within 3 months of a confirmed SARS-CoV-2 infection, and that cannot be attributed to an alternative diagnosis. However, the data presented in Milan indicate that the WHO definition “is not well suited for patients with iRD due to significant overlap in symptoms and features,” Ms. Boekel concluded.

The cases of Omicron COVID-19 were identified during Jan. 1–April 25, 2022, among iRD patients recruited from the Amsterdam Rheumatology and Immunology Center. The population with confirmed SARS-CoV-2 Omicron infection during this period was monitored for long COVID. The total number of patients included in the study consisted of 77 iRD patients and 23 healthy controls. When asked about the potential risk of selection bias in the survey, Ms. Boekel stated that only approximately 8% of participants declined to respond, and the nonresponders were comparable with the respondents. She concluded that “the risk of selection bias is minimal.”

In an editorial published in The Lancet Rheumatology, Leonard H. Calabrese, DO, Cleveland Clinic, provided his insights on the findings. He emphasized that, “at present, long COVID remains an important reality that significantly impacts the lives of millions of individuals, yet it remains incompletely defined. ... These limitations in defining cases should not in any way undermine the experiences of those suffering from long COVID. Instead, they should serve as a reminder that, at this stage of the pandemic, we unfortunately still lack validated classification criteria for long COVID. It is crucial to include non–SARS-CoV-2–infected controls in all studies to further enhance our understanding.”

Ms. Boekel and coauthors, as well as Dr. Lauper and Dr. Calabrese, reported no relevant financial relationships.

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

AURORA, COLO. – Long-term use of ozanimod for multiple sclerosis (MS) was well-tolerated across multiple age groups, though risk of certain infections and other treatment-emergent adverse events (TEAE) did increase with age, according to research presented at the annual meeting of the Consortium of Multiple Sclerosis Centers.

Research from the phase 3 DAYBREAK trial had already shown the safety of ozanimod, and the Food and Drug Administration approved the drug as an oral disease-modifying therapy for relapsing forms of MS in 2020.

“In the DAYBREAK study, we already have shown that the clinical and radiological disease was quite low in these patients who received the higher dose of ozanimod, and those who switched from the lower dose of the interferon to this active treatment also had decreases in their annualized relapse rate and their MRI lesion counts,” Sarah Morrow, MD, associate professor of neurology at Western University in London, Ontario, told attendees. She presented the data on behalf of senior author Bruce Cree, MD, PhD, professor of neurology and clinical research director at the University of California, San Francisco, Multiple Sclerosis Center, and the other authors. “But what was not known was whether there’s a difference in efficacy based on age, and we know that disease activity can differ based on age in person with relapsing multiple sclerosis.”
 

Examining efficacy by age

Analysis of data from DAYBREAK and an open-label extension study revealed that respiratory infections were more common in patients younger than 35, and urinary tract infections, dizziness, and treatment-emergent depressive symptoms became were common in patients age 50 and older. “Serious infections did not vary by age, and there were too few serious events to identify any age-related trends by specific TEAE,” the authors reported. During the open-label extension of the study, no new adverse events emerged, “confirming the ozanimod safety profile reported in the parent trials,” SUNBEAM and RADIANCE, the authors reported.

The phase 3 parent trials compared 30 mcg once weekly of intramuscular interferon beta-1a to 0.92 mg of once-daily oral ozanimod and 0.46 mg of once-daily oral ozanimod. In the DAYBREAK open-label extension, 2,256 participants underwent a dose escalation over 1 week until all reached 0.92 mg of ozanimod, where they remained for approximately 5 years of follow-up. The researchers then analyzed TEAEs, serious adverse events, and TEAEs leading to discontinuation in four age categories: 18-25, 26-35, 36-49, and 50 and older.

Respiratory infections occurred more often in those aged 18-25 (10.9%) and 26-35 (6.1%) than in those 36-49 (5.8%) and 50 and older (3.4%). However, UTIs occurred most in those age 50 and older (9.2%), versus occurring in 6.6% of those 36-49, 4.3% of those aged 26-35, and 4.6% of those 18-25.

High cholesterol occurred significantly less often in those 18-25 (1.4%) and 26-35 (2%) than in those 36-49 (5%) and 50 and older (8%), and hypertension showed a similar pattern: 2% in the youngest group, 4.7% in those aged 26-35, 12.8% in those aged 36-49, and 16.7% in those aged 50 and older.

Other TEAEs that occurred more often in older patients included depression/depressive symptoms, dizziness, back pain, joint pain, osteoarthritis, and high gamma-glutamyl transferase (GGT) levels. Overall cardiac and vascular disorders and malignancies were also more common as participants’ age increased.
 

Bigger concerns?

The increase in malignancy risk by age surprised Shailee Shah, MD, assistant professor of neuroimmunology and neurology at Vanderbilt University Medical Center, Nashville, Tenn., who was not involved in the research. This increase in risk was “not expanded upon much in this abstract or compared to population estimates, as this may ultimately be one of the bigger concerns with long-term use of this drug,” Dr. Shah said.

She further noted that “older patients may be at higher risk of infections and multiple cardiovascular risk factors, and so if patients already have comorbid disease, I may be less inclined to use this agent and likely less so in older individuals.”

Dr. Shah said these drugs are often recommended to individuals in their 20s and 30s at time of diagnosis. “If a patient is given this drug and tolerates it and finds it efficacious, we might continue this indefinitely, so looking at how the risk profile of young patients on this drug changes over time will be important,” Dr. Shah said. “I am also concerned about the malignancy risk and would want this elaborated upon.”
 

Overall efficacy across age groups

Serious infections occurred at relatively similar rates across all age groups. Incidence of any serious adverse event was 27 per 1,000 people per year in the youngest group compared with 24 events in the 26-35 group, 35 events in the 36-49 group, and 62 events per 1,000 people per year in those 50 and older.

“Patients in the 50 and older age group had a numerically lower adjusted annualized relapse rate and less gadolinium-enhancing lesions and new or enlarging T2 lesions per scan and were generally more likely to be free of gadolinium-enhancing lesions or new or enlarging T2 lesions than the 25 and younger age group,” Dr. Morrow told attendees, “but we feel that that’s more in keeping with the natural history of disease. And, overall, ozanimod, regardless of the age group, showed decreasing disease activity in the inflammatory part of disease, showing with annualized relapse rate, gad-enhancing lesions, and T2 lesions.”

Older participants were substantially more likely to withdraw from the trial because of adverse events. While 8% of the youngest group and 7.6% of participants aged 26-35 withdrew because of adverse events, 24.5% of those aged 36-49 and 18.5% of those aged 50 and older withdrew because of adverse events.

Dr. Shah said it was reassuring that no new safety signals emerged, “but based on this data, you would be concerned that long-term risk of cardiovascular disease may result in more serious adverse events over a longer period of time and will need to be considered as we see people increasingly on this drug.”

The research was funded by Bristol-Myers Squibb. The authors reported a wide range of financial disclosures, including personal fees, research funding, advisory board, and speakers fees, for multiple pharmaceutical companies, including Bristol-Myers Squibb, and five authors are employees and/or shareholders of the company. Dr. Shah has served on advisory boards for Alexion, Genentech, and Horizon.

AURORA, COLO. – Long-term use of ozanimod for multiple sclerosis (MS) was well-tolerated across multiple age groups, though risk of certain infections and other treatment-emergent adverse events (TEAE) did increase with age, according to research presented at the annual meeting of the Consortium of Multiple Sclerosis Centers.

Research from the phase 3 DAYBREAK trial had already shown the safety of ozanimod, and the Food and Drug Administration approved the drug as an oral disease-modifying therapy for relapsing forms of MS in 2020.

“In the DAYBREAK study, we already have shown that the clinical and radiological disease was quite low in these patients who received the higher dose of ozanimod, and those who switched from the lower dose of the interferon to this active treatment also had decreases in their annualized relapse rate and their MRI lesion counts,” Sarah Morrow, MD, associate professor of neurology at Western University in London, Ontario, told attendees. She presented the data on behalf of senior author Bruce Cree, MD, PhD, professor of neurology and clinical research director at the University of California, San Francisco, Multiple Sclerosis Center, and the other authors. “But what was not known was whether there’s a difference in efficacy based on age, and we know that disease activity can differ based on age in person with relapsing multiple sclerosis.”
 

Examining efficacy by age

Analysis of data from DAYBREAK and an open-label extension study revealed that respiratory infections were more common in patients younger than 35, and urinary tract infections, dizziness, and treatment-emergent depressive symptoms became were common in patients age 50 and older. “Serious infections did not vary by age, and there were too few serious events to identify any age-related trends by specific TEAE,” the authors reported. During the open-label extension of the study, no new adverse events emerged, “confirming the ozanimod safety profile reported in the parent trials,” SUNBEAM and RADIANCE, the authors reported.

The phase 3 parent trials compared 30 mcg once weekly of intramuscular interferon beta-1a to 0.92 mg of once-daily oral ozanimod and 0.46 mg of once-daily oral ozanimod. In the DAYBREAK open-label extension, 2,256 participants underwent a dose escalation over 1 week until all reached 0.92 mg of ozanimod, where they remained for approximately 5 years of follow-up. The researchers then analyzed TEAEs, serious adverse events, and TEAEs leading to discontinuation in four age categories: 18-25, 26-35, 36-49, and 50 and older.

Respiratory infections occurred more often in those aged 18-25 (10.9%) and 26-35 (6.1%) than in those 36-49 (5.8%) and 50 and older (3.4%). However, UTIs occurred most in those age 50 and older (9.2%), versus occurring in 6.6% of those 36-49, 4.3% of those aged 26-35, and 4.6% of those 18-25.

High cholesterol occurred significantly less often in those 18-25 (1.4%) and 26-35 (2%) than in those 36-49 (5%) and 50 and older (8%), and hypertension showed a similar pattern: 2% in the youngest group, 4.7% in those aged 26-35, 12.8% in those aged 36-49, and 16.7% in those aged 50 and older.

Other TEAEs that occurred more often in older patients included depression/depressive symptoms, dizziness, back pain, joint pain, osteoarthritis, and high gamma-glutamyl transferase (GGT) levels. Overall cardiac and vascular disorders and malignancies were also more common as participants’ age increased.
 

Bigger concerns?

The increase in malignancy risk by age surprised Shailee Shah, MD, assistant professor of neuroimmunology and neurology at Vanderbilt University Medical Center, Nashville, Tenn., who was not involved in the research. This increase in risk was “not expanded upon much in this abstract or compared to population estimates, as this may ultimately be one of the bigger concerns with long-term use of this drug,” Dr. Shah said.

She further noted that “older patients may be at higher risk of infections and multiple cardiovascular risk factors, and so if patients already have comorbid disease, I may be less inclined to use this agent and likely less so in older individuals.”

Dr. Shah said these drugs are often recommended to individuals in their 20s and 30s at time of diagnosis. “If a patient is given this drug and tolerates it and finds it efficacious, we might continue this indefinitely, so looking at how the risk profile of young patients on this drug changes over time will be important,” Dr. Shah said. “I am also concerned about the malignancy risk and would want this elaborated upon.”
 

Overall efficacy across age groups

Serious infections occurred at relatively similar rates across all age groups. Incidence of any serious adverse event was 27 per 1,000 people per year in the youngest group compared with 24 events in the 26-35 group, 35 events in the 36-49 group, and 62 events per 1,000 people per year in those 50 and older.

“Patients in the 50 and older age group had a numerically lower adjusted annualized relapse rate and less gadolinium-enhancing lesions and new or enlarging T2 lesions per scan and were generally more likely to be free of gadolinium-enhancing lesions or new or enlarging T2 lesions than the 25 and younger age group,” Dr. Morrow told attendees, “but we feel that that’s more in keeping with the natural history of disease. And, overall, ozanimod, regardless of the age group, showed decreasing disease activity in the inflammatory part of disease, showing with annualized relapse rate, gad-enhancing lesions, and T2 lesions.”

Older participants were substantially more likely to withdraw from the trial because of adverse events. While 8% of the youngest group and 7.6% of participants aged 26-35 withdrew because of adverse events, 24.5% of those aged 36-49 and 18.5% of those aged 50 and older withdrew because of adverse events.

Dr. Shah said it was reassuring that no new safety signals emerged, “but based on this data, you would be concerned that long-term risk of cardiovascular disease may result in more serious adverse events over a longer period of time and will need to be considered as we see people increasingly on this drug.”

The research was funded by Bristol-Myers Squibb. The authors reported a wide range of financial disclosures, including personal fees, research funding, advisory board, and speakers fees, for multiple pharmaceutical companies, including Bristol-Myers Squibb, and five authors are employees and/or shareholders of the company. Dr. Shah has served on advisory boards for Alexion, Genentech, and Horizon.

AURORA, COLO. – Long-term use of ozanimod for multiple sclerosis (MS) was well-tolerated across multiple age groups, though risk of certain infections and other treatment-emergent adverse events (TEAE) did increase with age, according to research presented at the annual meeting of the Consortium of Multiple Sclerosis Centers.

Research from the phase 3 DAYBREAK trial had already shown the safety of ozanimod, and the Food and Drug Administration approved the drug as an oral disease-modifying therapy for relapsing forms of MS in 2020.

“In the DAYBREAK study, we already have shown that the clinical and radiological disease was quite low in these patients who received the higher dose of ozanimod, and those who switched from the lower dose of the interferon to this active treatment also had decreases in their annualized relapse rate and their MRI lesion counts,” Sarah Morrow, MD, associate professor of neurology at Western University in London, Ontario, told attendees. She presented the data on behalf of senior author Bruce Cree, MD, PhD, professor of neurology and clinical research director at the University of California, San Francisco, Multiple Sclerosis Center, and the other authors. “But what was not known was whether there’s a difference in efficacy based on age, and we know that disease activity can differ based on age in person with relapsing multiple sclerosis.”
 

Examining efficacy by age

Analysis of data from DAYBREAK and an open-label extension study revealed that respiratory infections were more common in patients younger than 35, and urinary tract infections, dizziness, and treatment-emergent depressive symptoms became were common in patients age 50 and older. “Serious infections did not vary by age, and there were too few serious events to identify any age-related trends by specific TEAE,” the authors reported. During the open-label extension of the study, no new adverse events emerged, “confirming the ozanimod safety profile reported in the parent trials,” SUNBEAM and RADIANCE, the authors reported.

The phase 3 parent trials compared 30 mcg once weekly of intramuscular interferon beta-1a to 0.92 mg of once-daily oral ozanimod and 0.46 mg of once-daily oral ozanimod. In the DAYBREAK open-label extension, 2,256 participants underwent a dose escalation over 1 week until all reached 0.92 mg of ozanimod, where they remained for approximately 5 years of follow-up. The researchers then analyzed TEAEs, serious adverse events, and TEAEs leading to discontinuation in four age categories: 18-25, 26-35, 36-49, and 50 and older.

Respiratory infections occurred more often in those aged 18-25 (10.9%) and 26-35 (6.1%) than in those 36-49 (5.8%) and 50 and older (3.4%). However, UTIs occurred most in those age 50 and older (9.2%), versus occurring in 6.6% of those 36-49, 4.3% of those aged 26-35, and 4.6% of those 18-25.

High cholesterol occurred significantly less often in those 18-25 (1.4%) and 26-35 (2%) than in those 36-49 (5%) and 50 and older (8%), and hypertension showed a similar pattern: 2% in the youngest group, 4.7% in those aged 26-35, 12.8% in those aged 36-49, and 16.7% in those aged 50 and older.

Other TEAEs that occurred more often in older patients included depression/depressive symptoms, dizziness, back pain, joint pain, osteoarthritis, and high gamma-glutamyl transferase (GGT) levels. Overall cardiac and vascular disorders and malignancies were also more common as participants’ age increased.
 

Bigger concerns?

The increase in malignancy risk by age surprised Shailee Shah, MD, assistant professor of neuroimmunology and neurology at Vanderbilt University Medical Center, Nashville, Tenn., who was not involved in the research. This increase in risk was “not expanded upon much in this abstract or compared to population estimates, as this may ultimately be one of the bigger concerns with long-term use of this drug,” Dr. Shah said.

She further noted that “older patients may be at higher risk of infections and multiple cardiovascular risk factors, and so if patients already have comorbid disease, I may be less inclined to use this agent and likely less so in older individuals.”

Dr. Shah said these drugs are often recommended to individuals in their 20s and 30s at time of diagnosis. “If a patient is given this drug and tolerates it and finds it efficacious, we might continue this indefinitely, so looking at how the risk profile of young patients on this drug changes over time will be important,” Dr. Shah said. “I am also concerned about the malignancy risk and would want this elaborated upon.”
 

Overall efficacy across age groups

Serious infections occurred at relatively similar rates across all age groups. Incidence of any serious adverse event was 27 per 1,000 people per year in the youngest group compared with 24 events in the 26-35 group, 35 events in the 36-49 group, and 62 events per 1,000 people per year in those 50 and older.

“Patients in the 50 and older age group had a numerically lower adjusted annualized relapse rate and less gadolinium-enhancing lesions and new or enlarging T2 lesions per scan and were generally more likely to be free of gadolinium-enhancing lesions or new or enlarging T2 lesions than the 25 and younger age group,” Dr. Morrow told attendees, “but we feel that that’s more in keeping with the natural history of disease. And, overall, ozanimod, regardless of the age group, showed decreasing disease activity in the inflammatory part of disease, showing with annualized relapse rate, gad-enhancing lesions, and T2 lesions.”

Older participants were substantially more likely to withdraw from the trial because of adverse events. While 8% of the youngest group and 7.6% of participants aged 26-35 withdrew because of adverse events, 24.5% of those aged 36-49 and 18.5% of those aged 50 and older withdrew because of adverse events.

Dr. Shah said it was reassuring that no new safety signals emerged, “but based on this data, you would be concerned that long-term risk of cardiovascular disease may result in more serious adverse events over a longer period of time and will need to be considered as we see people increasingly on this drug.”

The research was funded by Bristol-Myers Squibb. The authors reported a wide range of financial disclosures, including personal fees, research funding, advisory board, and speakers fees, for multiple pharmaceutical companies, including Bristol-Myers Squibb, and five authors are employees and/or shareholders of the company. Dr. Shah has served on advisory boards for Alexion, Genentech, and Horizon.

Insufficient blood pressure measurement during medical consultation, use of an inadequate technique for its determination, and lack of validated automatic sphygmomanometers are three problems that convergently complicate the diagnosis and control of arterial hypertension in the Americas, a silent disease that affects 180 million people in the region and is the main risk factor for cardiovascular diseases, said the Pan American Health Organization.

Jarbas Barbosa, MD, MPH, PhD, director of PAHO, said in an interview: “We don’t have specific data for each of these scenarios, but unfortunately, all three doubtless work together to make the situation worse.

“Often, the staff members at our primary care clinics are not prepared to diagnose and treat hypertension, because there aren’t national protocols to raise awareness and prepare them to provide this care to the correct standard. Also, they are often unqualified to take blood pressure readings properly,” he added.

This concern is reflected in the theme the organization chose for World Hypertension Day, which was observed on May 17: Measure your blood pressure accurately, control it, live longer! “We shouldn’t underestimate the importance of taking blood pressure,” warned Silvana Luciani, chief of PAHO’s noncommunicable diseases, violence, and injury prevention unit. But, the experts stressed, it must be done correctly.
 

Time no problem

It’s important to raise awareness of the value of blood pressure measurement for the general population. However, as multiple studies have shown, one barrier to detecting and controlling hypertension is that doctors and other health care professionals measure blood pressure less frequently in clinic than expected, or they use inappropriate techniques or obsolete or uncalibrated measurement devices.

“The importance of clinic blood pressure measurement has been recognized for many decades, but adherence to guidelines on proper, standardized blood pressure measurement remains uncommon in clinical practice,” concluded a consensus document signed by 25 experts from 13 institutions in the United States, Australia, Germany, the United Kingdom, Canada, Italy, Belgium, and Greece.

The first problem lies in the low quantity of measurements. A recent study in Argentina of nearly 3,000 visits to the doctor’s office at nine health care centers showed that doctors took blood pressure readings in only once in every seven encounters. Even cardiologists, the specialists with the best performance, did so only half of the time.

“Several factors can come into play: lack of awareness, medical inertia, or lack of appropriate equipment. But it is not for lack of time. How long does it take to take blood pressure three times within a 1-minute interval, with the patient seated and their back supported, as indicated? Four minutes. That’s not very much,” said Judith Zilberman, MD, PhD, said in an interview. Dr. Zilberman leads the department of hypertension and the women’s cardiovascular disease area at the Argerich Hospital in Buenos Aires, and is the former chair of the Argentinian Society of Hypertension.

Patricio López-Jaramillo, MD, PhD, said in an interview that the greatest obstacle is the lack of awareness among physicians and other health care staff about the importance of taking proper blood pressure measurements. Dr. López-Jaramillo is president and scientific director of the MASIRA Research Institute at the University of Santander in Bucaramanga, Colombia, and first author of the Manual Práctico de Diagnóstico y Manejo de la Hipertensión Arterial (Practice Guidelines for Diagnosing and Managing Hypertension), published by the Latin American Hypertension Society.

“Medical schools are also responsible for this. They go over this topic very superficially during undergraduate and, even worse, postgraduate training. The lack of time to take correct measurements, or the lack of appropriate instruments, is secondary to this lack of awareness among most health care staff members,” added Dr. López-Jaramillo, who is one of the researchers of the PURE epidemiologic study. Since 2002, it has followed a cohort of 225,000 participants from 27 high-, mid-, and low-income countries.

Dr. Zilberman added that it would be good practice for all primary care physicians to take blood pressure readings regardless of the reason for the visit and whether patients have been diagnosed with hypertension or not. “If a woman goes to her gynecologist because she wants to get pregnant, her blood pressure should also be taken! And any other specialist should interview the patient, ascertain her history, what medications she’s on, and then ask if her blood pressure has been taken recently,” she recommended.
 

Measure well

The second factor to consider is that a correct technique should be used to take blood pressure readings in the doctor’s office or clinic so as not to produce inaccurate results that could lead to underdiagnosis, overdiagnosis, or a poor assessment of the patient’s response to prescribed treatments. An observational study performed in Uruguay in 2017 showed that only 5% of 302 blood pressure measurements followed appropriate procedures.

A new fact sheet from the PAHO lists the following eight requirements for obtaining an accurate reading: don’t have a conversation, support the arm at heart level, put the cuff on a bare arm, use the correct cuff size, support the feet, keep the legs uncrossed, ensure the patient has an empty bladder, and support the back.

Though most guidelines recommend taking three readings, the “pragmatic” focus proposed in the international consensus accepts at least two readings separated by a minimum of 30 seconds. The two readings should then be averaged out. There is evidence that simplified protocols can be used, at least for population screening.

The authors of the new document also recommend preparing the patient before taking the measurement. The patient should be asked not to smoke, exercise, or consume alcohol or caffeine for at least 30 minutes beforehand. He or she should rest for a period of 3-5 minutes without speaking or being spoken to before the measurement is taken.

Lastly, clinically validated automated measurement devices should be used, as called for by the PAHO HEARTS initiative in the Americas. “The sphygmomanometer or classic aneroid tensiometer for the auscultatory method, which is still used way too often at doctor’s office visits in the region, has many weaknesses – not only the device itself but also the way it’s used (human error). This produces a rounded, approximate reading,” stressed Dr. Zilberman.

Automated devices also minimize interactions with the patient by reducing distractions during the preparation and measurement phases and freeing up time for the health care professional. “To [check for a] fever, we use the appropriate thermometer in the appropriate location. We should do the same for blood pressure,” she added.

The STRIDE-BP database, which is affiliated with the European Society of Hypertension, the International Society of Hypertension, and the World Hypertension League, contains an updated list of validated devices for measuring blood pressure.

The signers of the consensus likewise recognized that, beyond taking blood pressure measurements during office visits, the best measurements are those taken at home outside the context of medical care (doctor’s office or clinic) and that the same recommendations are directly applicable. “Few diseases can be detected so easily as with a simple at-home assessment performed by the individual himself or herself. If after three consecutive measurements, readings above 140/90 mm Hg are obtained, the individual should see the doctor to set up a comprehensive treatment program,” said Pablo Rodríguez, MD, secretary of the Argentinian Society of Hypertension. From now through September 14 (Day for Patients With Hypertension), the society is conducting a campaign to take blood pressure measurements at different locations across the country.

Dr. Zilberman and Dr. López-Jiménez disclosed no relevant financial relationships.

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

Insufficient blood pressure measurement during medical consultation, use of an inadequate technique for its determination, and lack of validated automatic sphygmomanometers are three problems that convergently complicate the diagnosis and control of arterial hypertension in the Americas, a silent disease that affects 180 million people in the region and is the main risk factor for cardiovascular diseases, said the Pan American Health Organization.

Jarbas Barbosa, MD, MPH, PhD, director of PAHO, said in an interview: “We don’t have specific data for each of these scenarios, but unfortunately, all three doubtless work together to make the situation worse.

“Often, the staff members at our primary care clinics are not prepared to diagnose and treat hypertension, because there aren’t national protocols to raise awareness and prepare them to provide this care to the correct standard. Also, they are often unqualified to take blood pressure readings properly,” he added.

This concern is reflected in the theme the organization chose for World Hypertension Day, which was observed on May 17: Measure your blood pressure accurately, control it, live longer! “We shouldn’t underestimate the importance of taking blood pressure,” warned Silvana Luciani, chief of PAHO’s noncommunicable diseases, violence, and injury prevention unit. But, the experts stressed, it must be done correctly.
 

Time no problem

It’s important to raise awareness of the value of blood pressure measurement for the general population. However, as multiple studies have shown, one barrier to detecting and controlling hypertension is that doctors and other health care professionals measure blood pressure less frequently in clinic than expected, or they use inappropriate techniques or obsolete or uncalibrated measurement devices.

“The importance of clinic blood pressure measurement has been recognized for many decades, but adherence to guidelines on proper, standardized blood pressure measurement remains uncommon in clinical practice,” concluded a consensus document signed by 25 experts from 13 institutions in the United States, Australia, Germany, the United Kingdom, Canada, Italy, Belgium, and Greece.

The first problem lies in the low quantity of measurements. A recent study in Argentina of nearly 3,000 visits to the doctor’s office at nine health care centers showed that doctors took blood pressure readings in only once in every seven encounters. Even cardiologists, the specialists with the best performance, did so only half of the time.

“Several factors can come into play: lack of awareness, medical inertia, or lack of appropriate equipment. But it is not for lack of time. How long does it take to take blood pressure three times within a 1-minute interval, with the patient seated and their back supported, as indicated? Four minutes. That’s not very much,” said Judith Zilberman, MD, PhD, said in an interview. Dr. Zilberman leads the department of hypertension and the women’s cardiovascular disease area at the Argerich Hospital in Buenos Aires, and is the former chair of the Argentinian Society of Hypertension.

Patricio López-Jaramillo, MD, PhD, said in an interview that the greatest obstacle is the lack of awareness among physicians and other health care staff about the importance of taking proper blood pressure measurements. Dr. López-Jaramillo is president and scientific director of the MASIRA Research Institute at the University of Santander in Bucaramanga, Colombia, and first author of the Manual Práctico de Diagnóstico y Manejo de la Hipertensión Arterial (Practice Guidelines for Diagnosing and Managing Hypertension), published by the Latin American Hypertension Society.

“Medical schools are also responsible for this. They go over this topic very superficially during undergraduate and, even worse, postgraduate training. The lack of time to take correct measurements, or the lack of appropriate instruments, is secondary to this lack of awareness among most health care staff members,” added Dr. López-Jaramillo, who is one of the researchers of the PURE epidemiologic study. Since 2002, it has followed a cohort of 225,000 participants from 27 high-, mid-, and low-income countries.

Dr. Zilberman added that it would be good practice for all primary care physicians to take blood pressure readings regardless of the reason for the visit and whether patients have been diagnosed with hypertension or not. “If a woman goes to her gynecologist because she wants to get pregnant, her blood pressure should also be taken! And any other specialist should interview the patient, ascertain her history, what medications she’s on, and then ask if her blood pressure has been taken recently,” she recommended.
 

Measure well

The second factor to consider is that a correct technique should be used to take blood pressure readings in the doctor’s office or clinic so as not to produce inaccurate results that could lead to underdiagnosis, overdiagnosis, or a poor assessment of the patient’s response to prescribed treatments. An observational study performed in Uruguay in 2017 showed that only 5% of 302 blood pressure measurements followed appropriate procedures.

A new fact sheet from the PAHO lists the following eight requirements for obtaining an accurate reading: don’t have a conversation, support the arm at heart level, put the cuff on a bare arm, use the correct cuff size, support the feet, keep the legs uncrossed, ensure the patient has an empty bladder, and support the back.

Though most guidelines recommend taking three readings, the “pragmatic” focus proposed in the international consensus accepts at least two readings separated by a minimum of 30 seconds. The two readings should then be averaged out. There is evidence that simplified protocols can be used, at least for population screening.

The authors of the new document also recommend preparing the patient before taking the measurement. The patient should be asked not to smoke, exercise, or consume alcohol or caffeine for at least 30 minutes beforehand. He or she should rest for a period of 3-5 minutes without speaking or being spoken to before the measurement is taken.

Lastly, clinically validated automated measurement devices should be used, as called for by the PAHO HEARTS initiative in the Americas. “The sphygmomanometer or classic aneroid tensiometer for the auscultatory method, which is still used way too often at doctor’s office visits in the region, has many weaknesses – not only the device itself but also the way it’s used (human error). This produces a rounded, approximate reading,” stressed Dr. Zilberman.

Automated devices also minimize interactions with the patient by reducing distractions during the preparation and measurement phases and freeing up time for the health care professional. “To [check for a] fever, we use the appropriate thermometer in the appropriate location. We should do the same for blood pressure,” she added.

The STRIDE-BP database, which is affiliated with the European Society of Hypertension, the International Society of Hypertension, and the World Hypertension League, contains an updated list of validated devices for measuring blood pressure.

The signers of the consensus likewise recognized that, beyond taking blood pressure measurements during office visits, the best measurements are those taken at home outside the context of medical care (doctor’s office or clinic) and that the same recommendations are directly applicable. “Few diseases can be detected so easily as with a simple at-home assessment performed by the individual himself or herself. If after three consecutive measurements, readings above 140/90 mm Hg are obtained, the individual should see the doctor to set up a comprehensive treatment program,” said Pablo Rodríguez, MD, secretary of the Argentinian Society of Hypertension. From now through September 14 (Day for Patients With Hypertension), the society is conducting a campaign to take blood pressure measurements at different locations across the country.

Dr. Zilberman and Dr. López-Jiménez disclosed no relevant financial relationships.

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

Insufficient blood pressure measurement during medical consultation, use of an inadequate technique for its determination, and lack of validated automatic sphygmomanometers are three problems that convergently complicate the diagnosis and control of arterial hypertension in the Americas, a silent disease that affects 180 million people in the region and is the main risk factor for cardiovascular diseases, said the Pan American Health Organization.

Jarbas Barbosa, MD, MPH, PhD, director of PAHO, said in an interview: “We don’t have specific data for each of these scenarios, but unfortunately, all three doubtless work together to make the situation worse.

“Often, the staff members at our primary care clinics are not prepared to diagnose and treat hypertension, because there aren’t national protocols to raise awareness and prepare them to provide this care to the correct standard. Also, they are often unqualified to take blood pressure readings properly,” he added.

This concern is reflected in the theme the organization chose for World Hypertension Day, which was observed on May 17: Measure your blood pressure accurately, control it, live longer! “We shouldn’t underestimate the importance of taking blood pressure,” warned Silvana Luciani, chief of PAHO’s noncommunicable diseases, violence, and injury prevention unit. But, the experts stressed, it must be done correctly.
 

Time no problem

It’s important to raise awareness of the value of blood pressure measurement for the general population. However, as multiple studies have shown, one barrier to detecting and controlling hypertension is that doctors and other health care professionals measure blood pressure less frequently in clinic than expected, or they use inappropriate techniques or obsolete or uncalibrated measurement devices.

“The importance of clinic blood pressure measurement has been recognized for many decades, but adherence to guidelines on proper, standardized blood pressure measurement remains uncommon in clinical practice,” concluded a consensus document signed by 25 experts from 13 institutions in the United States, Australia, Germany, the United Kingdom, Canada, Italy, Belgium, and Greece.

The first problem lies in the low quantity of measurements. A recent study in Argentina of nearly 3,000 visits to the doctor’s office at nine health care centers showed that doctors took blood pressure readings in only once in every seven encounters. Even cardiologists, the specialists with the best performance, did so only half of the time.

“Several factors can come into play: lack of awareness, medical inertia, or lack of appropriate equipment. But it is not for lack of time. How long does it take to take blood pressure three times within a 1-minute interval, with the patient seated and their back supported, as indicated? Four minutes. That’s not very much,” said Judith Zilberman, MD, PhD, said in an interview. Dr. Zilberman leads the department of hypertension and the women’s cardiovascular disease area at the Argerich Hospital in Buenos Aires, and is the former chair of the Argentinian Society of Hypertension.

Patricio López-Jaramillo, MD, PhD, said in an interview that the greatest obstacle is the lack of awareness among physicians and other health care staff about the importance of taking proper blood pressure measurements. Dr. López-Jaramillo is president and scientific director of the MASIRA Research Institute at the University of Santander in Bucaramanga, Colombia, and first author of the Manual Práctico de Diagnóstico y Manejo de la Hipertensión Arterial (Practice Guidelines for Diagnosing and Managing Hypertension), published by the Latin American Hypertension Society.

“Medical schools are also responsible for this. They go over this topic very superficially during undergraduate and, even worse, postgraduate training. The lack of time to take correct measurements, or the lack of appropriate instruments, is secondary to this lack of awareness among most health care staff members,” added Dr. López-Jaramillo, who is one of the researchers of the PURE epidemiologic study. Since 2002, it has followed a cohort of 225,000 participants from 27 high-, mid-, and low-income countries.

Dr. Zilberman added that it would be good practice for all primary care physicians to take blood pressure readings regardless of the reason for the visit and whether patients have been diagnosed with hypertension or not. “If a woman goes to her gynecologist because she wants to get pregnant, her blood pressure should also be taken! And any other specialist should interview the patient, ascertain her history, what medications she’s on, and then ask if her blood pressure has been taken recently,” she recommended.
 

Measure well

The second factor to consider is that a correct technique should be used to take blood pressure readings in the doctor’s office or clinic so as not to produce inaccurate results that could lead to underdiagnosis, overdiagnosis, or a poor assessment of the patient’s response to prescribed treatments. An observational study performed in Uruguay in 2017 showed that only 5% of 302 blood pressure measurements followed appropriate procedures.

A new fact sheet from the PAHO lists the following eight requirements for obtaining an accurate reading: don’t have a conversation, support the arm at heart level, put the cuff on a bare arm, use the correct cuff size, support the feet, keep the legs uncrossed, ensure the patient has an empty bladder, and support the back.

Though most guidelines recommend taking three readings, the “pragmatic” focus proposed in the international consensus accepts at least two readings separated by a minimum of 30 seconds. The two readings should then be averaged out. There is evidence that simplified protocols can be used, at least for population screening.

The authors of the new document also recommend preparing the patient before taking the measurement. The patient should be asked not to smoke, exercise, or consume alcohol or caffeine for at least 30 minutes beforehand. He or she should rest for a period of 3-5 minutes without speaking or being spoken to before the measurement is taken.

Lastly, clinically validated automated measurement devices should be used, as called for by the PAHO HEARTS initiative in the Americas. “The sphygmomanometer or classic aneroid tensiometer for the auscultatory method, which is still used way too often at doctor’s office visits in the region, has many weaknesses – not only the device itself but also the way it’s used (human error). This produces a rounded, approximate reading,” stressed Dr. Zilberman.

Automated devices also minimize interactions with the patient by reducing distractions during the preparation and measurement phases and freeing up time for the health care professional. “To [check for a] fever, we use the appropriate thermometer in the appropriate location. We should do the same for blood pressure,” she added.

The STRIDE-BP database, which is affiliated with the European Society of Hypertension, the International Society of Hypertension, and the World Hypertension League, contains an updated list of validated devices for measuring blood pressure.

The signers of the consensus likewise recognized that, beyond taking blood pressure measurements during office visits, the best measurements are those taken at home outside the context of medical care (doctor’s office or clinic) and that the same recommendations are directly applicable. “Few diseases can be detected so easily as with a simple at-home assessment performed by the individual himself or herself. If after three consecutive measurements, readings above 140/90 mm Hg are obtained, the individual should see the doctor to set up a comprehensive treatment program,” said Pablo Rodríguez, MD, secretary of the Argentinian Society of Hypertension. From now through September 14 (Day for Patients With Hypertension), the society is conducting a campaign to take blood pressure measurements at different locations across the country.

Dr. Zilberman and Dr. López-Jiménez disclosed no relevant financial relationships.

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

The ways in which artificial intelligence (AI) may transform the future of medicine is making headlines across the globe. But chances are, you’re already using AI in your practice every day – you may just not realize it.
 

And whether you recognize the presence of AI or not, the technology could be putting you in danger of a lawsuit, legal experts say.

The use of AI in your daily practice can come with hidden liabilities, say legal experts, and as hospitals and medical groups deploy AI into more areas of health care, new liability exposures may be on the horizon.

“For physicians, AI has also not yet drastically changed or improved the way care is provided or consumed,” said Michael LeTang, chief nursing informatics officer and vice president of risk management and patient safety at Healthcare Risk Advisors, part of TDC Group. “Consequently, it may seem like AI is not present in their work streams, but in reality, it has been utilized in health care for several years. As AI technologies continue to develop and become more sophisticated, we can expect them to play an increasingly significant role in health care.”

Today, most AI applications in health care use narrow AI, which is designed to complete a single task without human assistance, as opposed to artificial general intelligence (AGI), which pertains to human-level reasoning and problem solving across a broad spectrum. Here are some ways doctors are using AI throughout the day – sometimes being aware of its assistance, and sometimes being unaware:

• Many doctors use electronic health records (EHRs) with integrated AI that include computerized clinical decision support tools designed to reduce the risk of diagnostic error and to integrate decision-making in the medication ordering function.
• Cardiologists, pathologists, and dermatologists use AI in the interpretation of vast amounts of images, tracings, and complex patterns.
• Surgeons are using AI-enhanced surgical robotics for orthopedic surgeries, such as joint replacement and spine surgery.
• A growing number of doctors are using ChatGPT to assist in drafting prior authorization letters for insurers. Experts say more doctors are also experimenting with ChatGPT to support medical decision-making.
• Within oncology, physicians use machine learning techniques in the form of computer-aided detection systems for early breast cancer detection.
• AI algorithms are often used by health systems for workflow, staffing optimization, population management, and care coordination.
• Some systems within EHRs use AI to indicate high-risk patients.
• Physicians are using AI applications for the early recognition of sepsis, including EHR-integrated decision tools, such as the Hospital Corporation of America Healthcare’s Sepsis Prediction and Optimization Therapy and the Sepsis Early Risk Assessment algorithm.
• About 30% of radiologists use AI in their practice to analyze x-rays and CT scans.
• Epic Systems recently announced a partnership with Microsoft to integrate ChatGPT into MyChart, Epic’s patient portal system. Pilot hospitals will utilize ChatGPT to automatically generate responses to patient-generated questions sent via the portal.

The growth of AI in health care has been enormous, and it’s only going to continue, said Ravi B. Parikh, MD, an assistant professor in the department of medical ethics and health policy and medicine at the University of Pennsylvania, Philadelphia.

“What’s really critical is that physicians, clinicians, and nurses using AI are provided with the tools to understand how artificial intelligence works and, most importantly, understand that they are still accountable for making the ultimate decision,” Mr. LeTang said, “The information is not always going to be the right thing to do or the most accurate thing to do. They’re still liable for making a bad decision, even if AI is driving that.”
 

What are the top AI legal dangers of today?

A pressing legal risk is becoming too reliant on the suggestions that AI-based systems provide, which can lead to poor care decisions, said Kenneth Rashbaum, a New York–based cybersecurity attorney with more than 25 years of experience in medical malpractice defense.

This can occur, for example, when using clinical support systems that leverage AI, machine learning, or statistical pattern recognition. Today, clinical support systems are commonly administered through EHRs and other computerized clinical workflows. In general, such systems match a patient’s characteristics to a computerized clinical knowledge base. An assessment or recommendation is then presented to the physician for a decision.

“If the clinician blindly accepts it without considering whether it’s appropriate for this patient at this time with this presentation, the clinician may bear some responsibility if there is an untoward result,” Mr. Rashbaum said.

“A common claim even in the days before the EMR [electronic medical record] and AI, was that the clinician did not take all available information into account in rendering treatment, including history of past and present condition, as reflected in the records, communication with past and other present treating clinicians, lab and radiology results, discussions with the patient, and physical examination findings,” he said. “So, if the clinician relied upon the support prompt to the exclusion of these other sources of information, that could be a very strong argument for the plaintiff.”

Chatbots, such OpenAI’s ChatGPT, are another form of AI raising legal red flags. ChatGPT, trained on a massive set of text data, can carry out conversations, write code, draft emails, and answer any question posed. The chatbot has gained considerable credibility for accurately diagnosing rare conditions in seconds, and it recently passed the U.S. Medical Licensing Examination.

It’s unclear how many doctors are signing onto the ChatGPT website daily, but physicians are actively using the chatbot, particularly for assistance with prior authorization letters and to support decision-making processes in their practices, said Mr. LeTang.

When physicians ask ChatGPT a question, however, they should be mindful that ChatGPT could “hallucinate,” a term that refers to a generated response that sounds plausible but is factually incorrect or is unrelated to the context, explains Harvey Castro, MD, an emergency physician, ChatGPT health care expert, and author of the 2023 book “ChatGPT and Healthcare: Unlocking the Potential of Patient Empowerment.”

Acting on ChatGPT’s response without vetting the information places doctors at serious risk of a lawsuit, he said.

“Sometimes, the response is half true and half false,” he said. “Say, I go outside my specialty of emergency medicine and ask it about a pediatric surgical procedure. It could give me a response that sounds medically correct, but then I ask a pediatric cardiologist, and he says, ‘We don’t even do this. This doesn’t even exist!’ Physicians really have to make sure they are vetting the information provided.”

In response to ChatGPT’s growing usage by health care professionals, hospitals and practices are quickly implementing guidelines, policies, and restrictions that caution physicians about the accuracy of ChatGPT-generated information, adds Mr. LeTang.

Emerging best practices include avoiding the input of patient health information, personally identifiable information, or any data that could be commercially valuable or considered the intellectual property of a hospital or health system, he said.

“Another crucial guideline is not to rely solely on ChatGPT as a definitive source for clinical decision-making; physicians must exercise their professional judgment,” he said. “If best practices are not adhered to, the associated risks are present today. However, these risks may become more significant as AI technologies continue to evolve and become increasingly integrated into health care.”

The potential for misdiagnosis by AI systems and the risk of unnecessary procedures if physicians do not thoroughly evaluate and validate AI predictions are other dangers.

As an example, Mr. LeTang described a case in which a physician documents in the EHR that a patient has presented to the emergency department with chest pains and other signs of a heart attack, and an AI algorithm predicts that the patient is experiencing an active myocardial infarction. If the physician then sends the patient for stenting or an angioplasty without other concrete evidence or tests to confirm the diagnosis, the doctor could later face a misdiagnosis complaint if the costly procedures were unnecessary.

“That’s one of the risks of using artificial intelligence,” he said. “A large percentage of malpractice claims is failure to diagnose, delayed diagnosis, or inaccurate diagnosis. What falls in the category of failure to diagnose is sending a patient for an unnecessary procedure or having an adverse event or bad outcome because of the failure to diagnose.”

So far, no AI lawsuits have been filed, but they may make an appearance soon, said Sue Boisvert, senior patient safety risk manager at The Doctors Company, a national medical liability insurer.

“There are hundreds of AI programs currently in use in health care,” she said. “At some point, a provider will make a decision that is contrary to what the AI recommended. The AI may be wrong, or the provider may be wrong. Either way, the provider will neglect to document their clinical reasoning, a patient will be harmed, and we will have the first AI claim.”
 

Upcoming AI legal risks to watch for

Lawsuits that allege biased patient care by physicians on the basis of algorithmic bias may also be forthcoming, analysts warn.

Much has been written about algorithmic bias that compounds and worsens inequities in socioeconomic status, ethnicity, sexual orientation, and gender in health systems. In 2019, a groundbreaking article in Science shed light on commonly used algorithms that are considered racially biased and how health care professionals often use such information to make medical decisions.

No claims involving AI bias have come down the pipeline yet, but it’s an area to watch, said Ms. Boisvert. She noted a website that highlights complaints and accusations of AI bias, including in health care.

“We need to be sure the training of the AI is appropriate, current, and broad enough so that there is no bias in the AI when it’s participating in the decision-making,” said Ms. Boisvert. “Imagine if the AI is diagnosing based on a dataset that is not local. It doesn’t represent the population at that particular hospital, and it’s providing inaccurate information to the physicians who are then making decisions about treatment.”

In pain management, for example, there are known differences in how patients experience pain, Ms. Boisvert said. If AI was being used to develop an algorithm for how a particular patient’s postoperative pain should be managed, and the algorithm did not include the differences, the pain control for a certain patient could be inappropriate. A poor outcome resulting from the treatment could lead to a claim against the physician or hospital that used the biased AI system, she said.

In the future, as AI becomes more integrated and accepted in medicine, there may be a risk of legal complaints against doctors for not using AI, said Saurabh Jha, MD, an associate professor of radiology at the University of Pennsylvania, Philadelphia, and a scholar of AI in radiology.

“Ultimately, we might get to a place where AI starts helping physicians detect more or reduce the miss of certain conditions, and it becomes the standard of care,” Dr. Jha said. “For example, if it became part of the standard of care for pulmonary embolism [PE] detection, and you didn’t use it for PE detection, and there was a miss. That could put you at legal risk. We’re not at that stage yet, but that is one future possibility.”

Dr. Parikh envisions an even cloudier liability landscape as the potential grows for AI to control patient care decisions. In such a scenario, rather than just issuing an alert or prediction to a physician, the AI system could trigger an action.

For instance, if an algorithm is trained to predict sepsis and, once triggered, the AI could initiate a nurse-led rapid response or a change in patient care outside the clinician’s control, said Dr. Parikh, who coauthored a recent article on AI and medical liability in The Milbank Quarterly.

“That’s still very much the minority of how AI is being used, but as evidence is growing that AI-based diagnostic tools perform equivalent or even superior to physicians, these autonomous workflows are being considered,” Dr. Parikh said. “When the ultimate action upon the patient is more determined by the AI than what the clinician does, then I think the liability picture gets murkier, and we should be thinking about how we can respond to that from a liability framework.”
 

How you can prevent AI-related lawsuits

The first step to preventing an AI-related claim is being aware of when and how you are using AI.

Ensure you’re informed about how the AI was trained, Ms. Boisvert stresses.

“Ask questions!” she said. “Is the AI safe? Are the recommendations accurate? Does the AI perform better than current systems? In what way? What databases were used, and did the programmers consider bias? Do I understand how to use the results?”

Never blindly trust the AI but rather view it as a data point in a medical decision, said Dr. Parikh. Ensure that other sources of medical information are properly accessed and that best practices for your specialty are still being followed.

When using any form of AI, document your usage, adds Mr. Rashbaum. A record that clearly outlines how the physician incorporated the AI is critical if a claim later arises in which the doctor is accused of AI-related malpractice, he said.

“Indicating how the AI tool was used, why it was used, and that it was used in conjunction with available clinical information and the clinician’s best judgment could reduce the risk of being found responsible as a result of AI use in a particular case,” he said.

Use chatbots, such as ChatGPT, the way they were intended, as support tools, rather than definitive diagnostic instruments, adds Dr. Castro.

“Doctors should also be well-trained in interpreting and understanding the suggestions provided by ChatGPT and should use their clinical judgment and experience alongside the AI tool for more accurate decision-making,” he said.

In addition, because no AI insurance product exists on the market, physicians and organizations using AI – particularly for direct health care – should evaluate their current insurance or insurance-like products to determine where a claim involving AI might fall and whether the policy would respond, said Ms. Boisvert. The AI vendor/manufacturer will likely have indemnified themselves in the purchase and sale agreement or contract, she said.

It will also become increasingly important for medical practices, hospitals, and health systems to put in place strong data governance strategies, Mr. LeTang said.

“AI relies on good data,” he said. “A data governance strategy is a key component to making sure we understand where the data is coming from, what is represents, how accurate it is, if it’s reproducible, what controls are in place to ensure the right people have the right access, and that if we’re starting to use it to build algorithms, that it’s deidentified.”

While no malpractice claims associated with the use of AI have yet surfaced, this may change as legal courts catch up on the backlog of malpractice claims that were delayed because of COVID-19, and even more so as AI becomes more prevalent in health care, Mr. LeTang said.

“Similar to the attention that autonomous driving systems, like Tesla, receive when the system fails and accidents occur, we can be assured that media outlets will widely publicize AI-related medical adverse events,” he said. “It is crucial for health care professionals, AI developers, and regulatory authorities to work together to ensure the responsible use of AI in health care, with patient safety as the top priority. By doing so, they can mitigate the risks associated with AI implementation and minimize the potential for legal disputes arising from AI-related medical errors.”

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

The ways in which artificial intelligence (AI) may transform the future of medicine is making headlines across the globe. But chances are, you’re already using AI in your practice every day – you may just not realize it.
 

And whether you recognize the presence of AI or not, the technology could be putting you in danger of a lawsuit, legal experts say.

The use of AI in your daily practice can come with hidden liabilities, say legal experts, and as hospitals and medical groups deploy AI into more areas of health care, new liability exposures may be on the horizon.

“For physicians, AI has also not yet drastically changed or improved the way care is provided or consumed,” said Michael LeTang, chief nursing informatics officer and vice president of risk management and patient safety at Healthcare Risk Advisors, part of TDC Group. “Consequently, it may seem like AI is not present in their work streams, but in reality, it has been utilized in health care for several years. As AI technologies continue to develop and become more sophisticated, we can expect them to play an increasingly significant role in health care.”

Today, most AI applications in health care use narrow AI, which is designed to complete a single task without human assistance, as opposed to artificial general intelligence (AGI), which pertains to human-level reasoning and problem solving across a broad spectrum. Here are some ways doctors are using AI throughout the day – sometimes being aware of its assistance, and sometimes being unaware:

• Many doctors use electronic health records (EHRs) with integrated AI that include computerized clinical decision support tools designed to reduce the risk of diagnostic error and to integrate decision-making in the medication ordering function.
• Cardiologists, pathologists, and dermatologists use AI in the interpretation of vast amounts of images, tracings, and complex patterns.
• Surgeons are using AI-enhanced surgical robotics for orthopedic surgeries, such as joint replacement and spine surgery.
• A growing number of doctors are using ChatGPT to assist in drafting prior authorization letters for insurers. Experts say more doctors are also experimenting with ChatGPT to support medical decision-making.
• Within oncology, physicians use machine learning techniques in the form of computer-aided detection systems for early breast cancer detection.
• AI algorithms are often used by health systems for workflow, staffing optimization, population management, and care coordination.
• Some systems within EHRs use AI to indicate high-risk patients.
• Physicians are using AI applications for the early recognition of sepsis, including EHR-integrated decision tools, such as the Hospital Corporation of America Healthcare’s Sepsis Prediction and Optimization Therapy and the Sepsis Early Risk Assessment algorithm.
• About 30% of radiologists use AI in their practice to analyze x-rays and CT scans.
• Epic Systems recently announced a partnership with Microsoft to integrate ChatGPT into MyChart, Epic’s patient portal system. Pilot hospitals will utilize ChatGPT to automatically generate responses to patient-generated questions sent via the portal.

The growth of AI in health care has been enormous, and it’s only going to continue, said Ravi B. Parikh, MD, an assistant professor in the department of medical ethics and health policy and medicine at the University of Pennsylvania, Philadelphia.

“What’s really critical is that physicians, clinicians, and nurses using AI are provided with the tools to understand how artificial intelligence works and, most importantly, understand that they are still accountable for making the ultimate decision,” Mr. LeTang said, “The information is not always going to be the right thing to do or the most accurate thing to do. They’re still liable for making a bad decision, even if AI is driving that.”
 

What are the top AI legal dangers of today?

A pressing legal risk is becoming too reliant on the suggestions that AI-based systems provide, which can lead to poor care decisions, said Kenneth Rashbaum, a New York–based cybersecurity attorney with more than 25 years of experience in medical malpractice defense.

This can occur, for example, when using clinical support systems that leverage AI, machine learning, or statistical pattern recognition. Today, clinical support systems are commonly administered through EHRs and other computerized clinical workflows. In general, such systems match a patient’s characteristics to a computerized clinical knowledge base. An assessment or recommendation is then presented to the physician for a decision.

“If the clinician blindly accepts it without considering whether it’s appropriate for this patient at this time with this presentation, the clinician may bear some responsibility if there is an untoward result,” Mr. Rashbaum said.

“A common claim even in the days before the EMR [electronic medical record] and AI, was that the clinician did not take all available information into account in rendering treatment, including history of past and present condition, as reflected in the records, communication with past and other present treating clinicians, lab and radiology results, discussions with the patient, and physical examination findings,” he said. “So, if the clinician relied upon the support prompt to the exclusion of these other sources of information, that could be a very strong argument for the plaintiff.”

Chatbots, such OpenAI’s ChatGPT, are another form of AI raising legal red flags. ChatGPT, trained on a massive set of text data, can carry out conversations, write code, draft emails, and answer any question posed. The chatbot has gained considerable credibility for accurately diagnosing rare conditions in seconds, and it recently passed the U.S. Medical Licensing Examination.

It’s unclear how many doctors are signing onto the ChatGPT website daily, but physicians are actively using the chatbot, particularly for assistance with prior authorization letters and to support decision-making processes in their practices, said Mr. LeTang.

When physicians ask ChatGPT a question, however, they should be mindful that ChatGPT could “hallucinate,” a term that refers to a generated response that sounds plausible but is factually incorrect or is unrelated to the context, explains Harvey Castro, MD, an emergency physician, ChatGPT health care expert, and author of the 2023 book “ChatGPT and Healthcare: Unlocking the Potential of Patient Empowerment.”

Acting on ChatGPT’s response without vetting the information places doctors at serious risk of a lawsuit, he said.

“Sometimes, the response is half true and half false,” he said. “Say, I go outside my specialty of emergency medicine and ask it about a pediatric surgical procedure. It could give me a response that sounds medically correct, but then I ask a pediatric cardiologist, and he says, ‘We don’t even do this. This doesn’t even exist!’ Physicians really have to make sure they are vetting the information provided.”

In response to ChatGPT’s growing usage by health care professionals, hospitals and practices are quickly implementing guidelines, policies, and restrictions that caution physicians about the accuracy of ChatGPT-generated information, adds Mr. LeTang.

Emerging best practices include avoiding the input of patient health information, personally identifiable information, or any data that could be commercially valuable or considered the intellectual property of a hospital or health system, he said.

“Another crucial guideline is not to rely solely on ChatGPT as a definitive source for clinical decision-making; physicians must exercise their professional judgment,” he said. “If best practices are not adhered to, the associated risks are present today. However, these risks may become more significant as AI technologies continue to evolve and become increasingly integrated into health care.”

The potential for misdiagnosis by AI systems and the risk of unnecessary procedures if physicians do not thoroughly evaluate and validate AI predictions are other dangers.

As an example, Mr. LeTang described a case in which a physician documents in the EHR that a patient has presented to the emergency department with chest pains and other signs of a heart attack, and an AI algorithm predicts that the patient is experiencing an active myocardial infarction. If the physician then sends the patient for stenting or an angioplasty without other concrete evidence or tests to confirm the diagnosis, the doctor could later face a misdiagnosis complaint if the costly procedures were unnecessary.

“That’s one of the risks of using artificial intelligence,” he said. “A large percentage of malpractice claims is failure to diagnose, delayed diagnosis, or inaccurate diagnosis. What falls in the category of failure to diagnose is sending a patient for an unnecessary procedure or having an adverse event or bad outcome because of the failure to diagnose.”

So far, no AI lawsuits have been filed, but they may make an appearance soon, said Sue Boisvert, senior patient safety risk manager at The Doctors Company, a national medical liability insurer.

“There are hundreds of AI programs currently in use in health care,” she said. “At some point, a provider will make a decision that is contrary to what the AI recommended. The AI may be wrong, or the provider may be wrong. Either way, the provider will neglect to document their clinical reasoning, a patient will be harmed, and we will have the first AI claim.”
 

Upcoming AI legal risks to watch for

Lawsuits that allege biased patient care by physicians on the basis of algorithmic bias may also be forthcoming, analysts warn.

Much has been written about algorithmic bias that compounds and worsens inequities in socioeconomic status, ethnicity, sexual orientation, and gender in health systems. In 2019, a groundbreaking article in Science shed light on commonly used algorithms that are considered racially biased and how health care professionals often use such information to make medical decisions.

No claims involving AI bias have come down the pipeline yet, but it’s an area to watch, said Ms. Boisvert. She noted a website that highlights complaints and accusations of AI bias, including in health care.

“We need to be sure the training of the AI is appropriate, current, and broad enough so that there is no bias in the AI when it’s participating in the decision-making,” said Ms. Boisvert. “Imagine if the AI is diagnosing based on a dataset that is not local. It doesn’t represent the population at that particular hospital, and it’s providing inaccurate information to the physicians who are then making decisions about treatment.”

In pain management, for example, there are known differences in how patients experience pain, Ms. Boisvert said. If AI was being used to develop an algorithm for how a particular patient’s postoperative pain should be managed, and the algorithm did not include the differences, the pain control for a certain patient could be inappropriate. A poor outcome resulting from the treatment could lead to a claim against the physician or hospital that used the biased AI system, she said.

In the future, as AI becomes more integrated and accepted in medicine, there may be a risk of legal complaints against doctors for not using AI, said Saurabh Jha, MD, an associate professor of radiology at the University of Pennsylvania, Philadelphia, and a scholar of AI in radiology.

“Ultimately, we might get to a place where AI starts helping physicians detect more or reduce the miss of certain conditions, and it becomes the standard of care,” Dr. Jha said. “For example, if it became part of the standard of care for pulmonary embolism [PE] detection, and you didn’t use it for PE detection, and there was a miss. That could put you at legal risk. We’re not at that stage yet, but that is one future possibility.”

Dr. Parikh envisions an even cloudier liability landscape as the potential grows for AI to control patient care decisions. In such a scenario, rather than just issuing an alert or prediction to a physician, the AI system could trigger an action.

For instance, if an algorithm is trained to predict sepsis and, once triggered, the AI could initiate a nurse-led rapid response or a change in patient care outside the clinician’s control, said Dr. Parikh, who coauthored a recent article on AI and medical liability in The Milbank Quarterly.

“That’s still very much the minority of how AI is being used, but as evidence is growing that AI-based diagnostic tools perform equivalent or even superior to physicians, these autonomous workflows are being considered,” Dr. Parikh said. “When the ultimate action upon the patient is more determined by the AI than what the clinician does, then I think the liability picture gets murkier, and we should be thinking about how we can respond to that from a liability framework.”
 

How you can prevent AI-related lawsuits

The first step to preventing an AI-related claim is being aware of when and how you are using AI.

Ensure you’re informed about how the AI was trained, Ms. Boisvert stresses.

“Ask questions!” she said. “Is the AI safe? Are the recommendations accurate? Does the AI perform better than current systems? In what way? What databases were used, and did the programmers consider bias? Do I understand how to use the results?”

Never blindly trust the AI but rather view it as a data point in a medical decision, said Dr. Parikh. Ensure that other sources of medical information are properly accessed and that best practices for your specialty are still being followed.

When using any form of AI, document your usage, adds Mr. Rashbaum. A record that clearly outlines how the physician incorporated the AI is critical if a claim later arises in which the doctor is accused of AI-related malpractice, he said.

“Indicating how the AI tool was used, why it was used, and that it was used in conjunction with available clinical information and the clinician’s best judgment could reduce the risk of being found responsible as a result of AI use in a particular case,” he said.

Use chatbots, such as ChatGPT, the way they were intended, as support tools, rather than definitive diagnostic instruments, adds Dr. Castro.

“Doctors should also be well-trained in interpreting and understanding the suggestions provided by ChatGPT and should use their clinical judgment and experience alongside the AI tool for more accurate decision-making,” he said.

In addition, because no AI insurance product exists on the market, physicians and organizations using AI – particularly for direct health care – should evaluate their current insurance or insurance-like products to determine where a claim involving AI might fall and whether the policy would respond, said Ms. Boisvert. The AI vendor/manufacturer will likely have indemnified themselves in the purchase and sale agreement or contract, she said.

It will also become increasingly important for medical practices, hospitals, and health systems to put in place strong data governance strategies, Mr. LeTang said.

“AI relies on good data,” he said. “A data governance strategy is a key component to making sure we understand where the data is coming from, what is represents, how accurate it is, if it’s reproducible, what controls are in place to ensure the right people have the right access, and that if we’re starting to use it to build algorithms, that it’s deidentified.”

While no malpractice claims associated with the use of AI have yet surfaced, this may change as legal courts catch up on the backlog of malpractice claims that were delayed because of COVID-19, and even more so as AI becomes more prevalent in health care, Mr. LeTang said.

“Similar to the attention that autonomous driving systems, like Tesla, receive when the system fails and accidents occur, we can be assured that media outlets will widely publicize AI-related medical adverse events,” he said. “It is crucial for health care professionals, AI developers, and regulatory authorities to work together to ensure the responsible use of AI in health care, with patient safety as the top priority. By doing so, they can mitigate the risks associated with AI implementation and minimize the potential for legal disputes arising from AI-related medical errors.”

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

The ways in which artificial intelligence (AI) may transform the future of medicine is making headlines across the globe. But chances are, you’re already using AI in your practice every day – you may just not realize it.
 

And whether you recognize the presence of AI or not, the technology could be putting you in danger of a lawsuit, legal experts say.

The use of AI in your daily practice can come with hidden liabilities, say legal experts, and as hospitals and medical groups deploy AI into more areas of health care, new liability exposures may be on the horizon.

“For physicians, AI has also not yet drastically changed or improved the way care is provided or consumed,” said Michael LeTang, chief nursing informatics officer and vice president of risk management and patient safety at Healthcare Risk Advisors, part of TDC Group. “Consequently, it may seem like AI is not present in their work streams, but in reality, it has been utilized in health care for several years. As AI technologies continue to develop and become more sophisticated, we can expect them to play an increasingly significant role in health care.”

Today, most AI applications in health care use narrow AI, which is designed to complete a single task without human assistance, as opposed to artificial general intelligence (AGI), which pertains to human-level reasoning and problem solving across a broad spectrum. Here are some ways doctors are using AI throughout the day – sometimes being aware of its assistance, and sometimes being unaware:

• Many doctors use electronic health records (EHRs) with integrated AI that include computerized clinical decision support tools designed to reduce the risk of diagnostic error and to integrate decision-making in the medication ordering function.
• Cardiologists, pathologists, and dermatologists use AI in the interpretation of vast amounts of images, tracings, and complex patterns.
• Surgeons are using AI-enhanced surgical robotics for orthopedic surgeries, such as joint replacement and spine surgery.
• A growing number of doctors are using ChatGPT to assist in drafting prior authorization letters for insurers. Experts say more doctors are also experimenting with ChatGPT to support medical decision-making.
• Within oncology, physicians use machine learning techniques in the form of computer-aided detection systems for early breast cancer detection.
• AI algorithms are often used by health systems for workflow, staffing optimization, population management, and care coordination.
• Some systems within EHRs use AI to indicate high-risk patients.
• Physicians are using AI applications for the early recognition of sepsis, including EHR-integrated decision tools, such as the Hospital Corporation of America Healthcare’s Sepsis Prediction and Optimization Therapy and the Sepsis Early Risk Assessment algorithm.
• About 30% of radiologists use AI in their practice to analyze x-rays and CT scans.
• Epic Systems recently announced a partnership with Microsoft to integrate ChatGPT into MyChart, Epic’s patient portal system. Pilot hospitals will utilize ChatGPT to automatically generate responses to patient-generated questions sent via the portal.

The growth of AI in health care has been enormous, and it’s only going to continue, said Ravi B. Parikh, MD, an assistant professor in the department of medical ethics and health policy and medicine at the University of Pennsylvania, Philadelphia.

“What’s really critical is that physicians, clinicians, and nurses using AI are provided with the tools to understand how artificial intelligence works and, most importantly, understand that they are still accountable for making the ultimate decision,” Mr. LeTang said, “The information is not always going to be the right thing to do or the most accurate thing to do. They’re still liable for making a bad decision, even if AI is driving that.”
 

What are the top AI legal dangers of today?

A pressing legal risk is becoming too reliant on the suggestions that AI-based systems provide, which can lead to poor care decisions, said Kenneth Rashbaum, a New York–based cybersecurity attorney with more than 25 years of experience in medical malpractice defense.

This can occur, for example, when using clinical support systems that leverage AI, machine learning, or statistical pattern recognition. Today, clinical support systems are commonly administered through EHRs and other computerized clinical workflows. In general, such systems match a patient’s characteristics to a computerized clinical knowledge base. An assessment or recommendation is then presented to the physician for a decision.

“If the clinician blindly accepts it without considering whether it’s appropriate for this patient at this time with this presentation, the clinician may bear some responsibility if there is an untoward result,” Mr. Rashbaum said.

“A common claim even in the days before the EMR [electronic medical record] and AI, was that the clinician did not take all available information into account in rendering treatment, including history of past and present condition, as reflected in the records, communication with past and other present treating clinicians, lab and radiology results, discussions with the patient, and physical examination findings,” he said. “So, if the clinician relied upon the support prompt to the exclusion of these other sources of information, that could be a very strong argument for the plaintiff.”

Chatbots, such OpenAI’s ChatGPT, are another form of AI raising legal red flags. ChatGPT, trained on a massive set of text data, can carry out conversations, write code, draft emails, and answer any question posed. The chatbot has gained considerable credibility for accurately diagnosing rare conditions in seconds, and it recently passed the U.S. Medical Licensing Examination.

It’s unclear how many doctors are signing onto the ChatGPT website daily, but physicians are actively using the chatbot, particularly for assistance with prior authorization letters and to support decision-making processes in their practices, said Mr. LeTang.

When physicians ask ChatGPT a question, however, they should be mindful that ChatGPT could “hallucinate,” a term that refers to a generated response that sounds plausible but is factually incorrect or is unrelated to the context, explains Harvey Castro, MD, an emergency physician, ChatGPT health care expert, and author of the 2023 book “ChatGPT and Healthcare: Unlocking the Potential of Patient Empowerment.”

Acting on ChatGPT’s response without vetting the information places doctors at serious risk of a lawsuit, he said.

“Sometimes, the response is half true and half false,” he said. “Say, I go outside my specialty of emergency medicine and ask it about a pediatric surgical procedure. It could give me a response that sounds medically correct, but then I ask a pediatric cardiologist, and he says, ‘We don’t even do this. This doesn’t even exist!’ Physicians really have to make sure they are vetting the information provided.”

In response to ChatGPT’s growing usage by health care professionals, hospitals and practices are quickly implementing guidelines, policies, and restrictions that caution physicians about the accuracy of ChatGPT-generated information, adds Mr. LeTang.

Emerging best practices include avoiding the input of patient health information, personally identifiable information, or any data that could be commercially valuable or considered the intellectual property of a hospital or health system, he said.

“Another crucial guideline is not to rely solely on ChatGPT as a definitive source for clinical decision-making; physicians must exercise their professional judgment,” he said. “If best practices are not adhered to, the associated risks are present today. However, these risks may become more significant as AI technologies continue to evolve and become increasingly integrated into health care.”

The potential for misdiagnosis by AI systems and the risk of unnecessary procedures if physicians do not thoroughly evaluate and validate AI predictions are other dangers.

As an example, Mr. LeTang described a case in which a physician documents in the EHR that a patient has presented to the emergency department with chest pains and other signs of a heart attack, and an AI algorithm predicts that the patient is experiencing an active myocardial infarction. If the physician then sends the patient for stenting or an angioplasty without other concrete evidence or tests to confirm the diagnosis, the doctor could later face a misdiagnosis complaint if the costly procedures were unnecessary.

“That’s one of the risks of using artificial intelligence,” he said. “A large percentage of malpractice claims is failure to diagnose, delayed diagnosis, or inaccurate diagnosis. What falls in the category of failure to diagnose is sending a patient for an unnecessary procedure or having an adverse event or bad outcome because of the failure to diagnose.”

So far, no AI lawsuits have been filed, but they may make an appearance soon, said Sue Boisvert, senior patient safety risk manager at The Doctors Company, a national medical liability insurer.

“There are hundreds of AI programs currently in use in health care,” she said. “At some point, a provider will make a decision that is contrary to what the AI recommended. The AI may be wrong, or the provider may be wrong. Either way, the provider will neglect to document their clinical reasoning, a patient will be harmed, and we will have the first AI claim.”
 

Upcoming AI legal risks to watch for

Lawsuits that allege biased patient care by physicians on the basis of algorithmic bias may also be forthcoming, analysts warn.

Much has been written about algorithmic bias that compounds and worsens inequities in socioeconomic status, ethnicity, sexual orientation, and gender in health systems. In 2019, a groundbreaking article in Science shed light on commonly used algorithms that are considered racially biased and how health care professionals often use such information to make medical decisions.

No claims involving AI bias have come down the pipeline yet, but it’s an area to watch, said Ms. Boisvert. She noted a website that highlights complaints and accusations of AI bias, including in health care.

“We need to be sure the training of the AI is appropriate, current, and broad enough so that there is no bias in the AI when it’s participating in the decision-making,” said Ms. Boisvert. “Imagine if the AI is diagnosing based on a dataset that is not local. It doesn’t represent the population at that particular hospital, and it’s providing inaccurate information to the physicians who are then making decisions about treatment.”

In pain management, for example, there are known differences in how patients experience pain, Ms. Boisvert said. If AI was being used to develop an algorithm for how a particular patient’s postoperative pain should be managed, and the algorithm did not include the differences, the pain control for a certain patient could be inappropriate. A poor outcome resulting from the treatment could lead to a claim against the physician or hospital that used the biased AI system, she said.

In the future, as AI becomes more integrated and accepted in medicine, there may be a risk of legal complaints against doctors for not using AI, said Saurabh Jha, MD, an associate professor of radiology at the University of Pennsylvania, Philadelphia, and a scholar of AI in radiology.

“Ultimately, we might get to a place where AI starts helping physicians detect more or reduce the miss of certain conditions, and it becomes the standard of care,” Dr. Jha said. “For example, if it became part of the standard of care for pulmonary embolism [PE] detection, and you didn’t use it for PE detection, and there was a miss. That could put you at legal risk. We’re not at that stage yet, but that is one future possibility.”

Dr. Parikh envisions an even cloudier liability landscape as the potential grows for AI to control patient care decisions. In such a scenario, rather than just issuing an alert or prediction to a physician, the AI system could trigger an action.

For instance, if an algorithm is trained to predict sepsis and, once triggered, the AI could initiate a nurse-led rapid response or a change in patient care outside the clinician’s control, said Dr. Parikh, who coauthored a recent article on AI and medical liability in The Milbank Quarterly.

“That’s still very much the minority of how AI is being used, but as evidence is growing that AI-based diagnostic tools perform equivalent or even superior to physicians, these autonomous workflows are being considered,” Dr. Parikh said. “When the ultimate action upon the patient is more determined by the AI than what the clinician does, then I think the liability picture gets murkier, and we should be thinking about how we can respond to that from a liability framework.”
 

How you can prevent AI-related lawsuits

The first step to preventing an AI-related claim is being aware of when and how you are using AI.

Ensure you’re informed about how the AI was trained, Ms. Boisvert stresses.

“Ask questions!” she said. “Is the AI safe? Are the recommendations accurate? Does the AI perform better than current systems? In what way? What databases were used, and did the programmers consider bias? Do I understand how to use the results?”

Never blindly trust the AI but rather view it as a data point in a medical decision, said Dr. Parikh. Ensure that other sources of medical information are properly accessed and that best practices for your specialty are still being followed.

When using any form of AI, document your usage, adds Mr. Rashbaum. A record that clearly outlines how the physician incorporated the AI is critical if a claim later arises in which the doctor is accused of AI-related malpractice, he said.

“Indicating how the AI tool was used, why it was used, and that it was used in conjunction with available clinical information and the clinician’s best judgment could reduce the risk of being found responsible as a result of AI use in a particular case,” he said.

Use chatbots, such as ChatGPT, the way they were intended, as support tools, rather than definitive diagnostic instruments, adds Dr. Castro.

“Doctors should also be well-trained in interpreting and understanding the suggestions provided by ChatGPT and should use their clinical judgment and experience alongside the AI tool for more accurate decision-making,” he said.

In addition, because no AI insurance product exists on the market, physicians and organizations using AI – particularly for direct health care – should evaluate their current insurance or insurance-like products to determine where a claim involving AI might fall and whether the policy would respond, said Ms. Boisvert. The AI vendor/manufacturer will likely have indemnified themselves in the purchase and sale agreement or contract, she said.

It will also become increasingly important for medical practices, hospitals, and health systems to put in place strong data governance strategies, Mr. LeTang said.

“AI relies on good data,” he said. “A data governance strategy is a key component to making sure we understand where the data is coming from, what is represents, how accurate it is, if it’s reproducible, what controls are in place to ensure the right people have the right access, and that if we’re starting to use it to build algorithms, that it’s deidentified.”

While no malpractice claims associated with the use of AI have yet surfaced, this may change as legal courts catch up on the backlog of malpractice claims that were delayed because of COVID-19, and even more so as AI becomes more prevalent in health care, Mr. LeTang said.

“Similar to the attention that autonomous driving systems, like Tesla, receive when the system fails and accidents occur, we can be assured that media outlets will widely publicize AI-related medical adverse events,” he said. “It is crucial for health care professionals, AI developers, and regulatory authorities to work together to ensure the responsible use of AI in health care, with patient safety as the top priority. By doing so, they can mitigate the risks associated with AI implementation and minimize the potential for legal disputes arising from AI-related medical errors.”

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

In late 2021, the Rome Proposal for diagnosing acute exacerbations of chronic obstructive pulmonary disease (AECOPD) and grading their severity was published. The 2023 Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Lung Disease (GOLD) Report has adopted the Rome Proposal criteria. Given that an endorsement by GOLD is tantamount to acceptance by clinicians, researchers, and policymakers alike, I guess we’re all using them now.

Anyone who’s ever cared for patients with COPD knows that treatment and reduction of exacerbations is how we improve outcomes. AECOPD are associated with considerable morbidity, greater health care utilization and costs, and a long-term decline in lung function. While we hope our pharmacotherapies improve symptoms, we know they reduce AECOPD. If our pharmacotherapies have any impact on mortality, it’s probably via AECOPD prevention.

Methods for reducing AECOPD are not controversial, but the approach to AECOPD treatment is, particularly decisions about who gets an antibiotic and who doesn’t. Since antibiotic indications are tied to severity, using the Rome Proposal criteria may affect management in unpredictable ways. As such, it’s worth reviewing the data on antibiotics for AECOPD.
 

What do the data reveal?

To start, it’s important to note that GOLD doesn’t equate having an AECOPD with needing an antibiotic. I myself have conflated the diagnosis with the indication and thereby overprescribed. The bar for diagnosis is quite low. In previous GOLD summaries, any “change in respiratory symptoms” would warrant the AECOPD label. Although the Rome Proposal definition is more specific, it leaves room for liberal interpretation. It’s likely to have a greater effect on research than on clinical practice. My guess is that AECOPD prevalence doesn’t change.

The antibiotic hurdle is slightly higher than that for diagnosis but is equally open to interpretation. In part, that’s related to the inherent subjectivity of judging symptoms, sputum production, and changes in color, but it’s also because the data are so poor. The meta-analyses that have been used to establish the indications include fewer than 1000 patients spread across 10 to 11 trials. Thus, the individual trials are small, and the sample size remains nominal even after adding them together. The addition of antibiotics – and it doesn’t seem to matter which class, type, or duration – will decrease mortality and hospital length of stay. One study says these effects are limited to inpatients while the other does not. After reading GOLD 2013, GOLD 2023, and both the meta-analyses they used to support their recommendations, I’m still not sure who benefits. Do you have to be hospitalized? Is some sort of ventilatory support required? Does C-reactive protein help or not?

In accordance with the classic Anthonisen criteria, GOLD relies on sputum volume and color as evidence of a bacterial infection. Soon after GOLD 2023 was published, a meta-analysis found that sputum color isn’t particularly accurate for detecting bacterial infection. Because it doesn’t seem to matter which antibiotic class is used, I always thought we were using antibiotics for their magical, pleiotropic anti-inflammatory effects anyway. I didn’t think the presence of an actual bacterial infection was important. If I saw an infiltrate on chest x-ray, I’d change my diagnosis from AECOPD to community-acquired pneumonia (CAP) and switch to CAP coverage. I’ve been doing this so long that I swear it’s in a guideline somewhere, though admittedly I couldn’t find said guideline while reading for this piece.
 

Key takeaways

In summary, I believe that the guidance reflects the data, which is muddy. The Rome Proposal should be seen as just that – a framework for moving forward with AECOPD classification and antibiotic indications that will need to be refined over time as better data become available. In fact, they allow for a more objective, point-of-care assessment of severity that can be validated and tied to antibiotic benefits. The Rome criteria aren’t evidence-based; they’re a necessary first step toward creating the evidence.

In the meantime, if your AECOPD patients are hospitalized, they probably warrant an antibiotic. If they’re not, sputum changes may be a reasonable surrogate for a bacterial infection. Considerable uncertainty remains.

Aaron B. Holley, MD, is a professor of medicine at Uniformed Services University in Bethesda, Md., and a pulmonary/sleep and critical care medicine physician at MedStar Washington Hospital Center in Washington. He reported conflicts of interest with Metapharm, CHEST College, and WebMD.

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

In late 2021, the Rome Proposal for diagnosing acute exacerbations of chronic obstructive pulmonary disease (AECOPD) and grading their severity was published. The 2023 Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Lung Disease (GOLD) Report has adopted the Rome Proposal criteria. Given that an endorsement by GOLD is tantamount to acceptance by clinicians, researchers, and policymakers alike, I guess we’re all using them now.

Anyone who’s ever cared for patients with COPD knows that treatment and reduction of exacerbations is how we improve outcomes. AECOPD are associated with considerable morbidity, greater health care utilization and costs, and a long-term decline in lung function. While we hope our pharmacotherapies improve symptoms, we know they reduce AECOPD. If our pharmacotherapies have any impact on mortality, it’s probably via AECOPD prevention.

Methods for reducing AECOPD are not controversial, but the approach to AECOPD treatment is, particularly decisions about who gets an antibiotic and who doesn’t. Since antibiotic indications are tied to severity, using the Rome Proposal criteria may affect management in unpredictable ways. As such, it’s worth reviewing the data on antibiotics for AECOPD.
 

What do the data reveal?

To start, it’s important to note that GOLD doesn’t equate having an AECOPD with needing an antibiotic. I myself have conflated the diagnosis with the indication and thereby overprescribed. The bar for diagnosis is quite low. In previous GOLD summaries, any “change in respiratory symptoms” would warrant the AECOPD label. Although the Rome Proposal definition is more specific, it leaves room for liberal interpretation. It’s likely to have a greater effect on research than on clinical practice. My guess is that AECOPD prevalence doesn’t change.

The antibiotic hurdle is slightly higher than that for diagnosis but is equally open to interpretation. In part, that’s related to the inherent subjectivity of judging symptoms, sputum production, and changes in color, but it’s also because the data are so poor. The meta-analyses that have been used to establish the indications include fewer than 1000 patients spread across 10 to 11 trials. Thus, the individual trials are small, and the sample size remains nominal even after adding them together. The addition of antibiotics – and it doesn’t seem to matter which class, type, or duration – will decrease mortality and hospital length of stay. One study says these effects are limited to inpatients while the other does not. After reading GOLD 2013, GOLD 2023, and both the meta-analyses they used to support their recommendations, I’m still not sure who benefits. Do you have to be hospitalized? Is some sort of ventilatory support required? Does C-reactive protein help or not?

In accordance with the classic Anthonisen criteria, GOLD relies on sputum volume and color as evidence of a bacterial infection. Soon after GOLD 2023 was published, a meta-analysis found that sputum color isn’t particularly accurate for detecting bacterial infection. Because it doesn’t seem to matter which antibiotic class is used, I always thought we were using antibiotics for their magical, pleiotropic anti-inflammatory effects anyway. I didn’t think the presence of an actual bacterial infection was important. If I saw an infiltrate on chest x-ray, I’d change my diagnosis from AECOPD to community-acquired pneumonia (CAP) and switch to CAP coverage. I’ve been doing this so long that I swear it’s in a guideline somewhere, though admittedly I couldn’t find said guideline while reading for this piece.
 

Key takeaways

In summary, I believe that the guidance reflects the data, which is muddy. The Rome Proposal should be seen as just that – a framework for moving forward with AECOPD classification and antibiotic indications that will need to be refined over time as better data become available. In fact, they allow for a more objective, point-of-care assessment of severity that can be validated and tied to antibiotic benefits. The Rome criteria aren’t evidence-based; they’re a necessary first step toward creating the evidence.

In the meantime, if your AECOPD patients are hospitalized, they probably warrant an antibiotic. If they’re not, sputum changes may be a reasonable surrogate for a bacterial infection. Considerable uncertainty remains.

Aaron B. Holley, MD, is a professor of medicine at Uniformed Services University in Bethesda, Md., and a pulmonary/sleep and critical care medicine physician at MedStar Washington Hospital Center in Washington. He reported conflicts of interest with Metapharm, CHEST College, and WebMD.

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

In late 2021, the Rome Proposal for diagnosing acute exacerbations of chronic obstructive pulmonary disease (AECOPD) and grading their severity was published. The 2023 Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Lung Disease (GOLD) Report has adopted the Rome Proposal criteria. Given that an endorsement by GOLD is tantamount to acceptance by clinicians, researchers, and policymakers alike, I guess we’re all using them now.

Anyone who’s ever cared for patients with COPD knows that treatment and reduction of exacerbations is how we improve outcomes. AECOPD are associated with considerable morbidity, greater health care utilization and costs, and a long-term decline in lung function. While we hope our pharmacotherapies improve symptoms, we know they reduce AECOPD. If our pharmacotherapies have any impact on mortality, it’s probably via AECOPD prevention.

Methods for reducing AECOPD are not controversial, but the approach to AECOPD treatment is, particularly decisions about who gets an antibiotic and who doesn’t. Since antibiotic indications are tied to severity, using the Rome Proposal criteria may affect management in unpredictable ways. As such, it’s worth reviewing the data on antibiotics for AECOPD.
 

What do the data reveal?

To start, it’s important to note that GOLD doesn’t equate having an AECOPD with needing an antibiotic. I myself have conflated the diagnosis with the indication and thereby overprescribed. The bar for diagnosis is quite low. In previous GOLD summaries, any “change in respiratory symptoms” would warrant the AECOPD label. Although the Rome Proposal definition is more specific, it leaves room for liberal interpretation. It’s likely to have a greater effect on research than on clinical practice. My guess is that AECOPD prevalence doesn’t change.

The antibiotic hurdle is slightly higher than that for diagnosis but is equally open to interpretation. In part, that’s related to the inherent subjectivity of judging symptoms, sputum production, and changes in color, but it’s also because the data are so poor. The meta-analyses that have been used to establish the indications include fewer than 1000 patients spread across 10 to 11 trials. Thus, the individual trials are small, and the sample size remains nominal even after adding them together. The addition of antibiotics – and it doesn’t seem to matter which class, type, or duration – will decrease mortality and hospital length of stay. One study says these effects are limited to inpatients while the other does not. After reading GOLD 2013, GOLD 2023, and both the meta-analyses they used to support their recommendations, I’m still not sure who benefits. Do you have to be hospitalized? Is some sort of ventilatory support required? Does C-reactive protein help or not?

In accordance with the classic Anthonisen criteria, GOLD relies on sputum volume and color as evidence of a bacterial infection. Soon after GOLD 2023 was published, a meta-analysis found that sputum color isn’t particularly accurate for detecting bacterial infection. Because it doesn’t seem to matter which antibiotic class is used, I always thought we were using antibiotics for their magical, pleiotropic anti-inflammatory effects anyway. I didn’t think the presence of an actual bacterial infection was important. If I saw an infiltrate on chest x-ray, I’d change my diagnosis from AECOPD to community-acquired pneumonia (CAP) and switch to CAP coverage. I’ve been doing this so long that I swear it’s in a guideline somewhere, though admittedly I couldn’t find said guideline while reading for this piece.
 

Key takeaways

In summary, I believe that the guidance reflects the data, which is muddy. The Rome Proposal should be seen as just that – a framework for moving forward with AECOPD classification and antibiotic indications that will need to be refined over time as better data become available. In fact, they allow for a more objective, point-of-care assessment of severity that can be validated and tied to antibiotic benefits. The Rome criteria aren’t evidence-based; they’re a necessary first step toward creating the evidence.

In the meantime, if your AECOPD patients are hospitalized, they probably warrant an antibiotic. If they’re not, sputum changes may be a reasonable surrogate for a bacterial infection. Considerable uncertainty remains.

Aaron B. Holley, MD, is a professor of medicine at Uniformed Services University in Bethesda, Md., and a pulmonary/sleep and critical care medicine physician at MedStar Washington Hospital Center in Washington. He reported conflicts of interest with Metapharm, CHEST College, and WebMD.

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

The real-world Zephyr 2 study, which assessed benralizumab for effectiveness in treating severe eosinophilic asthma, was extended with an analysis of a larger population stratified into three cohorts of participants who were aged 12 years or older. Pre- and posttreatment data showed an improvement in asthma control for each group.

Immunotherapy with monoclonal antibodies designed to block specific inflammatory pathways is a recommended add-on treatment option for adults to manage severe, uncontrolled eosinophilic-dependent (> 150 cells/µl) and corticosteroid-dependent asthma. One such biologic, benralizumab, targets the interleukin-5 receptor alpha chain (IL-5Rα).

For asthma patients who had previously been treated with benralizumab, there were significant reductions in exacerbation rates in the ZEPHYR 1 study. However, information regarding benefit associated with specific profiles was limited, warranting a larger study to address effectiveness when considering various blood eosinophil counts, prior treatments with other biologics, or benralizumab use for up to 24 months, Donna Carstens, MD, of AstraZeneca, Wilmington, Del., and colleagues write.
 

Study details

In the retrospective cohort Zephyr 2 study, which was published in the Journal of Allergy and Clinical Immunology: In Practice, the researchers retrieved deidentified patient information from medical, laboratory, and pharmacy U.S. insurance claims records from the PatientSource and DiagnosticSource databases and compared asthma exacerbation rates before and after treatment with benralizumab.

Age, asthma diagnosis, number of exacerbations, and number of benralizumab treatment records within specified periods were used to identify a total of 1,795 participants for inclusion in the study. The index date for establishing before-treatment and after-treatment index time intervals of 12 months each was defined as the day after the initial benralizumab treatment occurring between November 2017 and June 2019.

The cohort was stratified into three nonmutually exclusive groups consisting of 349 patients who had switched primarily from either omalizumab or mepolizumab biologics to benralizumab; 429 patients subdivided by closest to the index date blood eosinophil counts of less than 150, greater than or equal to 150, 150-299, less than 300, and greater than or equal to 300, and 419 patients with post data collection extended beyond 12 months to 18 or 24 months.

Similarities in baseline patient characteristics that were were observed across the three cohorts included a mean age range of 51-53 years, preponderance of women (67%-69%), obesity diagnosis (31.5%-32.9%), and a mean Charlson Comorbidity Index of 1.47-1.52. Allergic rhinitis was the most frequently reported (60%-67%) comorbidity, followed by hypertension and gastroesophageal reflex.
 

Effectiveness

Benralizumab was found to be a significantly effective treatment for managing severe eosinophilic asthma for all three evaluated cohorts, as evidenced by reductions in asthma exacerbations post-index, compared with pre-index. Specifically, the exacerbation rate for all five subgroups of the blood eosinophil cohort significantly decreased from the pre-index 3.10-3.55 person per year (PPY) rate to a 1.11-1.72 PPY post-index rate, equivalent to a 52%-64% decrease in exacerbations (P < .001 for all pre-index vs. post-index comparisons).

Comparable reductions also occurred with the cohort in which the biologic treatment was changed to benralizumab. A greater effect was observed when the switch was made from omalizumab to benralizumab with a pre-post PPY rate reduction of 3.25-1.25 (62%) than when the switch was made from mepolizumab (pre-post PPY rate reduction was 3.81-1.78 [53%], but both resulted in significant post-treatment improvements (P < .001).

Results from the extended follow-up analysis cohort showed consistency for significant exacerbation rate decline going from a pre-index rate of 3.38 PPY down to 1.34 PPY (60% rate reduction vs. pre-index) in the first 12 post-index months, continuing to decline to 1.18 PPY (65% reduction) over the following six months (both significant at P < .001).

Likewise, the results from the extended follow-up 24-month subgroup presented significant down trending exacerbation rates from pre-index 3.38 PPY to 1.38 (comparative 59% reduction) for the first 12 months continuing down to 1.08 PPY (68% reduction) over the 12-24 month post-index period (both P < .001). In the first and second 12 post-index months for the 24-month subgroup, 39% and 49% of the patients, respectively, experienced no exacerbations.

Following treatment with benralizumab, in addition to the observed decline in asthma exacerbation rates, the need for concomitant asthma medications was also significantly reduced for all three cohorts.

This retrospective ZEPHYR 2 study contributes evidence supporting the significant effectiveness of benralizumab in improving disease management for “specific subsets of severe asthma patients that are frequently seen in real-world practice and may be excluded from clinical trials,” according to the authors. The treatment resulted in reduced rates of asthma exacerbations with defined standards for hospitalizations, visits to emergency department or urgent care, or outpatient visits with separate exacerbations occurring at greater than or equal to 14 days, as reported in database records. Reduction in the rate of asthma exacerbations when benralizumab is switched for another biologic increases the disease management options for achieving optimal patient care, the authors add.

The authors have financial relationships with AstraZeneca, the source of funding for the study.

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

The real-world Zephyr 2 study, which assessed benralizumab for effectiveness in treating severe eosinophilic asthma, was extended with an analysis of a larger population stratified into three cohorts of participants who were aged 12 years or older. Pre- and posttreatment data showed an improvement in asthma control for each group.

Immunotherapy with monoclonal antibodies designed to block specific inflammatory pathways is a recommended add-on treatment option for adults to manage severe, uncontrolled eosinophilic-dependent (> 150 cells/µl) and corticosteroid-dependent asthma. One such biologic, benralizumab, targets the interleukin-5 receptor alpha chain (IL-5Rα).

For asthma patients who had previously been treated with benralizumab, there were significant reductions in exacerbation rates in the ZEPHYR 1 study. However, information regarding benefit associated with specific profiles was limited, warranting a larger study to address effectiveness when considering various blood eosinophil counts, prior treatments with other biologics, or benralizumab use for up to 24 months, Donna Carstens, MD, of AstraZeneca, Wilmington, Del., and colleagues write.
 

Study details

In the retrospective cohort Zephyr 2 study, which was published in the Journal of Allergy and Clinical Immunology: In Practice, the researchers retrieved deidentified patient information from medical, laboratory, and pharmacy U.S. insurance claims records from the PatientSource and DiagnosticSource databases and compared asthma exacerbation rates before and after treatment with benralizumab.

Age, asthma diagnosis, number of exacerbations, and number of benralizumab treatment records within specified periods were used to identify a total of 1,795 participants for inclusion in the study. The index date for establishing before-treatment and after-treatment index time intervals of 12 months each was defined as the day after the initial benralizumab treatment occurring between November 2017 and June 2019.

The cohort was stratified into three nonmutually exclusive groups consisting of 349 patients who had switched primarily from either omalizumab or mepolizumab biologics to benralizumab; 429 patients subdivided by closest to the index date blood eosinophil counts of less than 150, greater than or equal to 150, 150-299, less than 300, and greater than or equal to 300, and 419 patients with post data collection extended beyond 12 months to 18 or 24 months.

Similarities in baseline patient characteristics that were were observed across the three cohorts included a mean age range of 51-53 years, preponderance of women (67%-69%), obesity diagnosis (31.5%-32.9%), and a mean Charlson Comorbidity Index of 1.47-1.52. Allergic rhinitis was the most frequently reported (60%-67%) comorbidity, followed by hypertension and gastroesophageal reflex.
 

Effectiveness

Benralizumab was found to be a significantly effective treatment for managing severe eosinophilic asthma for all three evaluated cohorts, as evidenced by reductions in asthma exacerbations post-index, compared with pre-index. Specifically, the exacerbation rate for all five subgroups of the blood eosinophil cohort significantly decreased from the pre-index 3.10-3.55 person per year (PPY) rate to a 1.11-1.72 PPY post-index rate, equivalent to a 52%-64% decrease in exacerbations (P < .001 for all pre-index vs. post-index comparisons).

Comparable reductions also occurred with the cohort in which the biologic treatment was changed to benralizumab. A greater effect was observed when the switch was made from omalizumab to benralizumab with a pre-post PPY rate reduction of 3.25-1.25 (62%) than when the switch was made from mepolizumab (pre-post PPY rate reduction was 3.81-1.78 [53%], but both resulted in significant post-treatment improvements (P < .001).

Results from the extended follow-up analysis cohort showed consistency for significant exacerbation rate decline going from a pre-index rate of 3.38 PPY down to 1.34 PPY (60% rate reduction vs. pre-index) in the first 12 post-index months, continuing to decline to 1.18 PPY (65% reduction) over the following six months (both significant at P < .001).

Likewise, the results from the extended follow-up 24-month subgroup presented significant down trending exacerbation rates from pre-index 3.38 PPY to 1.38 (comparative 59% reduction) for the first 12 months continuing down to 1.08 PPY (68% reduction) over the 12-24 month post-index period (both P < .001). In the first and second 12 post-index months for the 24-month subgroup, 39% and 49% of the patients, respectively, experienced no exacerbations.

Following treatment with benralizumab, in addition to the observed decline in asthma exacerbation rates, the need for concomitant asthma medications was also significantly reduced for all three cohorts.

This retrospective ZEPHYR 2 study contributes evidence supporting the significant effectiveness of benralizumab in improving disease management for “specific subsets of severe asthma patients that are frequently seen in real-world practice and may be excluded from clinical trials,” according to the authors. The treatment resulted in reduced rates of asthma exacerbations with defined standards for hospitalizations, visits to emergency department or urgent care, or outpatient visits with separate exacerbations occurring at greater than or equal to 14 days, as reported in database records. Reduction in the rate of asthma exacerbations when benralizumab is switched for another biologic increases the disease management options for achieving optimal patient care, the authors add.

The authors have financial relationships with AstraZeneca, the source of funding for the study.

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

The real-world Zephyr 2 study, which assessed benralizumab for effectiveness in treating severe eosinophilic asthma, was extended with an analysis of a larger population stratified into three cohorts of participants who were aged 12 years or older. Pre- and posttreatment data showed an improvement in asthma control for each group.

Immunotherapy with monoclonal antibodies designed to block specific inflammatory pathways is a recommended add-on treatment option for adults to manage severe, uncontrolled eosinophilic-dependent (> 150 cells/µl) and corticosteroid-dependent asthma. One such biologic, benralizumab, targets the interleukin-5 receptor alpha chain (IL-5Rα).

For asthma patients who had previously been treated with benralizumab, there were significant reductions in exacerbation rates in the ZEPHYR 1 study. However, information regarding benefit associated with specific profiles was limited, warranting a larger study to address effectiveness when considering various blood eosinophil counts, prior treatments with other biologics, or benralizumab use for up to 24 months, Donna Carstens, MD, of AstraZeneca, Wilmington, Del., and colleagues write.
 

Study details

In the retrospective cohort Zephyr 2 study, which was published in the Journal of Allergy and Clinical Immunology: In Practice, the researchers retrieved deidentified patient information from medical, laboratory, and pharmacy U.S. insurance claims records from the PatientSource and DiagnosticSource databases and compared asthma exacerbation rates before and after treatment with benralizumab.

Age, asthma diagnosis, number of exacerbations, and number of benralizumab treatment records within specified periods were used to identify a total of 1,795 participants for inclusion in the study. The index date for establishing before-treatment and after-treatment index time intervals of 12 months each was defined as the day after the initial benralizumab treatment occurring between November 2017 and June 2019.

The cohort was stratified into three nonmutually exclusive groups consisting of 349 patients who had switched primarily from either omalizumab or mepolizumab biologics to benralizumab; 429 patients subdivided by closest to the index date blood eosinophil counts of less than 150, greater than or equal to 150, 150-299, less than 300, and greater than or equal to 300, and 419 patients with post data collection extended beyond 12 months to 18 or 24 months.

Similarities in baseline patient characteristics that were were observed across the three cohorts included a mean age range of 51-53 years, preponderance of women (67%-69%), obesity diagnosis (31.5%-32.9%), and a mean Charlson Comorbidity Index of 1.47-1.52. Allergic rhinitis was the most frequently reported (60%-67%) comorbidity, followed by hypertension and gastroesophageal reflex.
 

Effectiveness

Benralizumab was found to be a significantly effective treatment for managing severe eosinophilic asthma for all three evaluated cohorts, as evidenced by reductions in asthma exacerbations post-index, compared with pre-index. Specifically, the exacerbation rate for all five subgroups of the blood eosinophil cohort significantly decreased from the pre-index 3.10-3.55 person per year (PPY) rate to a 1.11-1.72 PPY post-index rate, equivalent to a 52%-64% decrease in exacerbations (P < .001 for all pre-index vs. post-index comparisons).

Comparable reductions also occurred with the cohort in which the biologic treatment was changed to benralizumab. A greater effect was observed when the switch was made from omalizumab to benralizumab with a pre-post PPY rate reduction of 3.25-1.25 (62%) than when the switch was made from mepolizumab (pre-post PPY rate reduction was 3.81-1.78 [53%], but both resulted in significant post-treatment improvements (P < .001).

Results from the extended follow-up analysis cohort showed consistency for significant exacerbation rate decline going from a pre-index rate of 3.38 PPY down to 1.34 PPY (60% rate reduction vs. pre-index) in the first 12 post-index months, continuing to decline to 1.18 PPY (65% reduction) over the following six months (both significant at P < .001).

Likewise, the results from the extended follow-up 24-month subgroup presented significant down trending exacerbation rates from pre-index 3.38 PPY to 1.38 (comparative 59% reduction) for the first 12 months continuing down to 1.08 PPY (68% reduction) over the 12-24 month post-index period (both P < .001). In the first and second 12 post-index months for the 24-month subgroup, 39% and 49% of the patients, respectively, experienced no exacerbations.

Following treatment with benralizumab, in addition to the observed decline in asthma exacerbation rates, the need for concomitant asthma medications was also significantly reduced for all three cohorts.

This retrospective ZEPHYR 2 study contributes evidence supporting the significant effectiveness of benralizumab in improving disease management for “specific subsets of severe asthma patients that are frequently seen in real-world practice and may be excluded from clinical trials,” according to the authors. The treatment resulted in reduced rates of asthma exacerbations with defined standards for hospitalizations, visits to emergency department or urgent care, or outpatient visits with separate exacerbations occurring at greater than or equal to 14 days, as reported in database records. Reduction in the rate of asthma exacerbations when benralizumab is switched for another biologic increases the disease management options for achieving optimal patient care, the authors add.

The authors have financial relationships with AstraZeneca, the source of funding for the study.

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

A blood biomarker that measures astrocyte reactivity may help determine who, among cognitively unimpaired older adults with amyloid-beta, will go on to develop Alzheimer’s disease (AD), new research suggests.

Investigators tested the blood of 1,000 cognitively healthy individuals with and without amyloid-beta pathology and found that only those with a combination of amyloid-beta burden and abnormal astrocyte activation subsequently progressed to AD.

“Our study argues that testing for the presence of brain amyloid along with blood biomarkers of astrocyte reactivity is the optimal screening to identify patients who are most at risk for progressing to Alzheimer’s disease,” senior investigator Tharick A. Pascoal, MD, PhD, associate professor of psychiatry and neurology, University of Pittsburgh, said in a release.

At this point, the biomarker is a research tool, but its application in clinical practice “is not very far away,” Dr. Pascoal told this news organization.

The study was published online  in Nature Medicine.  
 

Multicenter study

In AD, accumulation of amyloid-beta in the brain precedes tau pathology, but not everyone with amyloid-beta develops tau, and, consequently, clinical symptoms. Approximately 30% of older adults have brain amyloid but many never progress to AD, said Dr. Pascoal.

This suggests other biological processes may trigger the deleterious effects of amyloid-beta in the early stages of AD.

Finding predictive markers of early amyloid-beta–related tau pathology would help identify cognitively normal individuals who are more likely to develop AD.

Post-mortem studies show astrocyte reactivity – changes in glial cells in the brain and spinal cord because of an insult in the brain – is an early AD abnormality. Other research suggests a close link between amyloid-beta, astrocyte reactivity, and tau.

In addition, evidence suggests plasma measures of glial fibrillary acidic protein (GFAP) could be a strong proxy of astrocyte reactivity in the brain. Dr. Pascoal explained that when astrocytes are changed or become bigger, more GFAP is released.

The study included 1,016 cognitively normal individuals from three centers; some had amyloid pathology, some did not. Participants’ mean age was 69.6 years, and all were deemed negative or positive for astrocyte reactivity based on plasma GFAP levels.

Results showed amyloid-beta is associated with increased plasma phosphorylated tau only in individuals positive for astrocyte reactivity. In addition, analyses using PET scans showed an AD-like pattern of tau tangle accumulation as a function of amyloid-beta exclusively in those same individuals.
 

Early upstream event

The findings suggest abnormalities in astrocyte reactivity is an early upstream event that likely occurs prior to tau pathology, which is closely related to the development of neurodegeneration and cognitive decline.

It’s likely many types of insults or processes can lead to astrocyte reactivity, possibly including COVID, but more research in this area is needed, said Dr. Pascoal.

“Our study only looked at the consequence of having both amyloid and astrocyte reactivity; it did not elucidate what is causing either of them,” he said.

Although “we were able to have very good results” in the current study, additional studies are needed to better establish the cut-off for GFAP levels that signal progression, said Dr. Pascoal.

The effect of astrocyte reactivity on the association between amyloid-beta and tau phosphorylation was greater in men than women. Dr. Pascoal noted anti-amyloid therapies, which might be modifying the amyloid-beta-astrocyte-tau pathway, tend to have a much larger effect in men than women.

Further studies that measure amyloid-beta, tau, and GFAP biomarkers at multiple timepoints, and with long follow-up, are needed, the investigators note.

The results may have implications for clinical trials, which have increasingly focused on individuals in the earliest preclinical phases of AD. Future studies should include cognitively normal patients who are positive for both amyloid pathology and astrocyte reactivity but have no overt p-tau abnormality, said Dr. Pascoal.

This may provide a time window for interventions very early in the disease process in those at increased risk for AD-related progression.

The study did not determine whether participants with both amyloid and astrocyte reactivity will inevitably develop AD, and to do so would require a longer follow up. “Our outcome was correlation to tau in the brain, which is something we know will lead to AD.”

Although the cohort represents significant socioeconomic diversity, a main limitation of the study was that subjects were mainly White, which limits the generalizability of the findings to a more diverse population.

The study received support from the National Institute of Aging; National Heart Lung and Blood Institute; Alzheimer’s Association; Fonds de Recherche du Québec-Santé; Canadian Consortium of Neurodegeneration in Aging; Weston Brain Institute; Colin Adair Charitable Foundation; Swedish Research Council; Wallenberg Scholar; BrightFocus Foundation; Swedish Alzheimer Foundation; Swedish Brain Foundation; Agneta Prytz-Folkes & Gösta Folkes Foundation; European Union; Swedish State Support for Clinical Research; Alzheimer Drug Discovery Foundation; Bluefield Project, the Olav Thon Foundation, the Erling-Persson Family Foundation, Stiftelsen för Gamla Tjänarinnor, Hjärnfonden, Sweden; the UK Dementia Research Institute at UCL; National Academy of Neuropsychology; Fundação de Amparo a pesquisa do Rio Grande do Sul; Instituto Serrapilheira; and Hjärnfonden.

Dr. Pascoal reports no relevant financial relationships.

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

A blood biomarker that measures astrocyte reactivity may help determine who, among cognitively unimpaired older adults with amyloid-beta, will go on to develop Alzheimer’s disease (AD), new research suggests.

Investigators tested the blood of 1,000 cognitively healthy individuals with and without amyloid-beta pathology and found that only those with a combination of amyloid-beta burden and abnormal astrocyte activation subsequently progressed to AD.

“Our study argues that testing for the presence of brain amyloid along with blood biomarkers of astrocyte reactivity is the optimal screening to identify patients who are most at risk for progressing to Alzheimer’s disease,” senior investigator Tharick A. Pascoal, MD, PhD, associate professor of psychiatry and neurology, University of Pittsburgh, said in a release.

At this point, the biomarker is a research tool, but its application in clinical practice “is not very far away,” Dr. Pascoal told this news organization.

The study was published online  in Nature Medicine.  
 

Multicenter study

In AD, accumulation of amyloid-beta in the brain precedes tau pathology, but not everyone with amyloid-beta develops tau, and, consequently, clinical symptoms. Approximately 30% of older adults have brain amyloid but many never progress to AD, said Dr. Pascoal.

This suggests other biological processes may trigger the deleterious effects of amyloid-beta in the early stages of AD.

Finding predictive markers of early amyloid-beta–related tau pathology would help identify cognitively normal individuals who are more likely to develop AD.

Post-mortem studies show astrocyte reactivity – changes in glial cells in the brain and spinal cord because of an insult in the brain – is an early AD abnormality. Other research suggests a close link between amyloid-beta, astrocyte reactivity, and tau.

In addition, evidence suggests plasma measures of glial fibrillary acidic protein (GFAP) could be a strong proxy of astrocyte reactivity in the brain. Dr. Pascoal explained that when astrocytes are changed or become bigger, more GFAP is released.

The study included 1,016 cognitively normal individuals from three centers; some had amyloid pathology, some did not. Participants’ mean age was 69.6 years, and all were deemed negative or positive for astrocyte reactivity based on plasma GFAP levels.

Results showed amyloid-beta is associated with increased plasma phosphorylated tau only in individuals positive for astrocyte reactivity. In addition, analyses using PET scans showed an AD-like pattern of tau tangle accumulation as a function of amyloid-beta exclusively in those same individuals.
 

Early upstream event

The findings suggest abnormalities in astrocyte reactivity is an early upstream event that likely occurs prior to tau pathology, which is closely related to the development of neurodegeneration and cognitive decline.

It’s likely many types of insults or processes can lead to astrocyte reactivity, possibly including COVID, but more research in this area is needed, said Dr. Pascoal.

“Our study only looked at the consequence of having both amyloid and astrocyte reactivity; it did not elucidate what is causing either of them,” he said.

Although “we were able to have very good results” in the current study, additional studies are needed to better establish the cut-off for GFAP levels that signal progression, said Dr. Pascoal.

The effect of astrocyte reactivity on the association between amyloid-beta and tau phosphorylation was greater in men than women. Dr. Pascoal noted anti-amyloid therapies, which might be modifying the amyloid-beta-astrocyte-tau pathway, tend to have a much larger effect in men than women.

Further studies that measure amyloid-beta, tau, and GFAP biomarkers at multiple timepoints, and with long follow-up, are needed, the investigators note.

The results may have implications for clinical trials, which have increasingly focused on individuals in the earliest preclinical phases of AD. Future studies should include cognitively normal patients who are positive for both amyloid pathology and astrocyte reactivity but have no overt p-tau abnormality, said Dr. Pascoal.

This may provide a time window for interventions very early in the disease process in those at increased risk for AD-related progression.

The study did not determine whether participants with both amyloid and astrocyte reactivity will inevitably develop AD, and to do so would require a longer follow up. “Our outcome was correlation to tau in the brain, which is something we know will lead to AD.”

Although the cohort represents significant socioeconomic diversity, a main limitation of the study was that subjects were mainly White, which limits the generalizability of the findings to a more diverse population.

The study received support from the National Institute of Aging; National Heart Lung and Blood Institute; Alzheimer’s Association; Fonds de Recherche du Québec-Santé; Canadian Consortium of Neurodegeneration in Aging; Weston Brain Institute; Colin Adair Charitable Foundation; Swedish Research Council; Wallenberg Scholar; BrightFocus Foundation; Swedish Alzheimer Foundation; Swedish Brain Foundation; Agneta Prytz-Folkes & Gösta Folkes Foundation; European Union; Swedish State Support for Clinical Research; Alzheimer Drug Discovery Foundation; Bluefield Project, the Olav Thon Foundation, the Erling-Persson Family Foundation, Stiftelsen för Gamla Tjänarinnor, Hjärnfonden, Sweden; the UK Dementia Research Institute at UCL; National Academy of Neuropsychology; Fundação de Amparo a pesquisa do Rio Grande do Sul; Instituto Serrapilheira; and Hjärnfonden.

Dr. Pascoal reports no relevant financial relationships.

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

A blood biomarker that measures astrocyte reactivity may help determine who, among cognitively unimpaired older adults with amyloid-beta, will go on to develop Alzheimer’s disease (AD), new research suggests.

Investigators tested the blood of 1,000 cognitively healthy individuals with and without amyloid-beta pathology and found that only those with a combination of amyloid-beta burden and abnormal astrocyte activation subsequently progressed to AD.

“Our study argues that testing for the presence of brain amyloid along with blood biomarkers of astrocyte reactivity is the optimal screening to identify patients who are most at risk for progressing to Alzheimer’s disease,” senior investigator Tharick A. Pascoal, MD, PhD, associate professor of psychiatry and neurology, University of Pittsburgh, said in a release.

At this point, the biomarker is a research tool, but its application in clinical practice “is not very far away,” Dr. Pascoal told this news organization.

The study was published online  in Nature Medicine.  
 

Multicenter study

In AD, accumulation of amyloid-beta in the brain precedes tau pathology, but not everyone with amyloid-beta develops tau, and, consequently, clinical symptoms. Approximately 30% of older adults have brain amyloid but many never progress to AD, said Dr. Pascoal.

This suggests other biological processes may trigger the deleterious effects of amyloid-beta in the early stages of AD.

Finding predictive markers of early amyloid-beta–related tau pathology would help identify cognitively normal individuals who are more likely to develop AD.

Post-mortem studies show astrocyte reactivity – changes in glial cells in the brain and spinal cord because of an insult in the brain – is an early AD abnormality. Other research suggests a close link between amyloid-beta, astrocyte reactivity, and tau.

In addition, evidence suggests plasma measures of glial fibrillary acidic protein (GFAP) could be a strong proxy of astrocyte reactivity in the brain. Dr. Pascoal explained that when astrocytes are changed or become bigger, more GFAP is released.

The study included 1,016 cognitively normal individuals from three centers; some had amyloid pathology, some did not. Participants’ mean age was 69.6 years, and all were deemed negative or positive for astrocyte reactivity based on plasma GFAP levels.

Results showed amyloid-beta is associated with increased plasma phosphorylated tau only in individuals positive for astrocyte reactivity. In addition, analyses using PET scans showed an AD-like pattern of tau tangle accumulation as a function of amyloid-beta exclusively in those same individuals.
 

Early upstream event

The findings suggest abnormalities in astrocyte reactivity is an early upstream event that likely occurs prior to tau pathology, which is closely related to the development of neurodegeneration and cognitive decline.

It’s likely many types of insults or processes can lead to astrocyte reactivity, possibly including COVID, but more research in this area is needed, said Dr. Pascoal.

“Our study only looked at the consequence of having both amyloid and astrocyte reactivity; it did not elucidate what is causing either of them,” he said.

Although “we were able to have very good results” in the current study, additional studies are needed to better establish the cut-off for GFAP levels that signal progression, said Dr. Pascoal.

The effect of astrocyte reactivity on the association between amyloid-beta and tau phosphorylation was greater in men than women. Dr. Pascoal noted anti-amyloid therapies, which might be modifying the amyloid-beta-astrocyte-tau pathway, tend to have a much larger effect in men than women.

Further studies that measure amyloid-beta, tau, and GFAP biomarkers at multiple timepoints, and with long follow-up, are needed, the investigators note.

The results may have implications for clinical trials, which have increasingly focused on individuals in the earliest preclinical phases of AD. Future studies should include cognitively normal patients who are positive for both amyloid pathology and astrocyte reactivity but have no overt p-tau abnormality, said Dr. Pascoal.

This may provide a time window for interventions very early in the disease process in those at increased risk for AD-related progression.

The study did not determine whether participants with both amyloid and astrocyte reactivity will inevitably develop AD, and to do so would require a longer follow up. “Our outcome was correlation to tau in the brain, which is something we know will lead to AD.”

Although the cohort represents significant socioeconomic diversity, a main limitation of the study was that subjects were mainly White, which limits the generalizability of the findings to a more diverse population.

The study received support from the National Institute of Aging; National Heart Lung and Blood Institute; Alzheimer’s Association; Fonds de Recherche du Québec-Santé; Canadian Consortium of Neurodegeneration in Aging; Weston Brain Institute; Colin Adair Charitable Foundation; Swedish Research Council; Wallenberg Scholar; BrightFocus Foundation; Swedish Alzheimer Foundation; Swedish Brain Foundation; Agneta Prytz-Folkes & Gösta Folkes Foundation; European Union; Swedish State Support for Clinical Research; Alzheimer Drug Discovery Foundation; Bluefield Project, the Olav Thon Foundation, the Erling-Persson Family Foundation, Stiftelsen för Gamla Tjänarinnor, Hjärnfonden, Sweden; the UK Dementia Research Institute at UCL; National Academy of Neuropsychology; Fundação de Amparo a pesquisa do Rio Grande do Sul; Instituto Serrapilheira; and Hjärnfonden.

Dr. Pascoal reports no relevant financial relationships.

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

Sowing the seeds of cancer prevention

Are you looking to add to your quality of life, even though pets are not your speed? Might we suggest something with lower maintenance? Something a little greener?

Indoor plants can purify the air that comes from outside. Researchers at the University of Technology Sydney, in partnership with the plantscaping company Ambius, showed that a “green wall” made up of mixed indoor plants was able to suck up 97% of “the most toxic compounds” from the air in just 8 hours. We’re talking about lung-irritating, headache-inducing, cancer risk–boosting compounds from gasoline fumes, including benzene.

Fraser Torpy/University of Technology Sydney

Public health initiatives often strive to reduce cardiovascular and obesity risks, but breathing seems pretty important too. According to the World Health Organization, household air pollution is responsible for about 2.5 million global premature deaths each year. And since 2020 we’ve become accustomed to spending more time inside and at home.

“This new research proves that plants should not just be seen as ‘nice to have,’ but rather a crucial part of every workplace wellness plan,” Ambius General Manager Johan Hodgson said in statement released by the university.

So don’t spend hundreds of dollars on a fancy air filtration system when a wall of plants can do that for next to nothing. Find what works for you and your space and become a plant parent today! Your lungs will thank you.
 

But officer, I had to swerve to miss the duodenal ampulla

Tiny video capsule endoscopes have been around for many years, but they have one big weakness: The ingestible cameras’ journey through the GI tract is passively driven by gravity and the natural movement of the body, so they often miss potential problem areas.

AnX Robotica

Not anymore. That flaw has been addressed by medical technology company AnX Robotica, which has taken endoscopy to the next level by adding that wondrous directional control device of the modern electronic age, a joystick.

The new system “uses an external magnet and hand-held video game style joysticks to move the capsule in three dimensions,” which allows physicians to “remotely drive a miniature video capsule to all regions of the stomach to visualize and photograph potential problem areas,” according to Andrew C. Meltzer, MD, of George Washington University and associates, who conducted a pilot study funded by AnX Robotica.

The video capsule provided a 95% rate of visualization in the stomachs of 40 patients who were examined at a medical office building by an emergency medicine physician who had no previous specialty training in endoscopy. “Capsules were driven by the ER physician and then the study reports were reviewed by an attending gastroenterologist who was physically off site,” the investigators said in a written statement.

The capsule operator did receive some additional training, and development of artificial intelligence to self-drive the capsule is in the works, but for now, we’re talking about a device controlled by a human using a joystick. And we all know that 50-year-olds are not especially known for their joystick skills. For that we need real experts. Yup, we need to put those joystick-controlled capsule endoscopes in the hands of teenage gamers. Who wants to go first?
 

Maybe AI isn’t ready for the big time after all

“How long before some intrepid stockholder says: ‘Hey, instead of paying doctors, why don’t we just use the free robot instead?’ ” Those words appeared on LOTME but a month ago. After all, the AI is supposed to be smarter and more empathetic than a doctor. And did we mention it’s free? Or at least extremely cheap. Cheaper than, say, a group of recently unionized health care workers.

maewjpho/Thinkstock

In early May, the paid employees manning the National Eating Disorders Association emergency hotline voted to unionize, as they felt overwhelmed and underpaid. Apparently, paying six people an extra few thousand a year was too much for NEDA’s leadership, as they decided a few weeks later to fire those workers, fully closing down the hotline. Instead of talking to a real person, people “calling in” for support would be met with Tessa, a wellness chatbot that would hopefully guide them through their crisis. Key word, hopefully.

In perhaps the least surprising twist of the year, NEDA was forced to walk back its decision about a week after its initial announcement. It all started with a viral Instagram post from a woman who called in and received the following advice from Tessa: Lose 1-2 pounds a week, count calories and work for a 500- to 1,000-calorie deficit, weigh herself weekly, and restrict her diet. Unfortunately, all of these suggestions were things that led to the development of the woman’s eating disorder.

Naturally, NEDA responded in good grace, accusing the woman of lying. A NEDA vice president even left some nasty comments on the post, but hastily deleted them a day later when NEDA announced it was shutting down Tessa “until further notice for a complete investigation.” NEDA’s CEO insisted they hadn’t seen that behavior from Tessa before, calling it a “bug” and insisting the bot would only be down temporarily until the triggers causing the bug were fixed.

In the aftermath, several doctors and psychologists chimed in, terming the rush to automate human roles dangerous and risky. After all, much of what makes these hotlines effective is the volunteers speaking from their own experience. An unsupervised bot doesn’t seem to have what it takes to deal with a mental health crisis, but we’re betting that Tessa will be back. As a wise cephalopod once said: Nobody gives a care about the fate of labor as long as they can get their instant gratification.
 

You can’t spell existential without s-t-e-n-t

This week, we’re including a special “bonus” item that, to be honest, has nothing to do with stents. That’s why our editor is making us call this a “bonus” (and making us use quote marks, too): It doesn’t really have anything to do with stents or health care or those who practice health care. Actually, his exact words were, “You can’t just give the readers someone else’s ****ing list and expect to get paid for it.” Did we mention that he looks like Jack Nicklaus but acts like BoJack Horseman?

Anywaaay, we’re pretty sure that the list in question – “America’s Top 10 Most Googled Existential Questions” – says something about the human condition, just not about stents:

1. Why is the sky blue?

2. What do dreams mean?

3. What is the meaning of life?

4. Why am I so tired?

5. Who am I?

6. What is love?

7. Is a hot dog a sandwich?

8. What came first, the chicken or the egg?

9. What should I do?

10. Do animals have souls?

Sowing the seeds of cancer prevention

Are you looking to add to your quality of life, even though pets are not your speed? Might we suggest something with lower maintenance? Something a little greener?

Indoor plants can purify the air that comes from outside. Researchers at the University of Technology Sydney, in partnership with the plantscaping company Ambius, showed that a “green wall” made up of mixed indoor plants was able to suck up 97% of “the most toxic compounds” from the air in just 8 hours. We’re talking about lung-irritating, headache-inducing, cancer risk–boosting compounds from gasoline fumes, including benzene.

Fraser Torpy/University of Technology Sydney

Public health initiatives often strive to reduce cardiovascular and obesity risks, but breathing seems pretty important too. According to the World Health Organization, household air pollution is responsible for about 2.5 million global premature deaths each year. And since 2020 we’ve become accustomed to spending more time inside and at home.

“This new research proves that plants should not just be seen as ‘nice to have,’ but rather a crucial part of every workplace wellness plan,” Ambius General Manager Johan Hodgson said in statement released by the university.

So don’t spend hundreds of dollars on a fancy air filtration system when a wall of plants can do that for next to nothing. Find what works for you and your space and become a plant parent today! Your lungs will thank you.
 

But officer, I had to swerve to miss the duodenal ampulla

Tiny video capsule endoscopes have been around for many years, but they have one big weakness: The ingestible cameras’ journey through the GI tract is passively driven by gravity and the natural movement of the body, so they often miss potential problem areas.

AnX Robotica

Not anymore. That flaw has been addressed by medical technology company AnX Robotica, which has taken endoscopy to the next level by adding that wondrous directional control device of the modern electronic age, a joystick.

The new system “uses an external magnet and hand-held video game style joysticks to move the capsule in three dimensions,” which allows physicians to “remotely drive a miniature video capsule to all regions of the stomach to visualize and photograph potential problem areas,” according to Andrew C. Meltzer, MD, of George Washington University and associates, who conducted a pilot study funded by AnX Robotica.

The video capsule provided a 95% rate of visualization in the stomachs of 40 patients who were examined at a medical office building by an emergency medicine physician who had no previous specialty training in endoscopy. “Capsules were driven by the ER physician and then the study reports were reviewed by an attending gastroenterologist who was physically off site,” the investigators said in a written statement.

The capsule operator did receive some additional training, and development of artificial intelligence to self-drive the capsule is in the works, but for now, we’re talking about a device controlled by a human using a joystick. And we all know that 50-year-olds are not especially known for their joystick skills. For that we need real experts. Yup, we need to put those joystick-controlled capsule endoscopes in the hands of teenage gamers. Who wants to go first?
 

Maybe AI isn’t ready for the big time after all

“How long before some intrepid stockholder says: ‘Hey, instead of paying doctors, why don’t we just use the free robot instead?’ ” Those words appeared on LOTME but a month ago. After all, the AI is supposed to be smarter and more empathetic than a doctor. And did we mention it’s free? Or at least extremely cheap. Cheaper than, say, a group of recently unionized health care workers.

maewjpho/Thinkstock

In early May, the paid employees manning the National Eating Disorders Association emergency hotline voted to unionize, as they felt overwhelmed and underpaid. Apparently, paying six people an extra few thousand a year was too much for NEDA’s leadership, as they decided a few weeks later to fire those workers, fully closing down the hotline. Instead of talking to a real person, people “calling in” for support would be met with Tessa, a wellness chatbot that would hopefully guide them through their crisis. Key word, hopefully.

In perhaps the least surprising twist of the year, NEDA was forced to walk back its decision about a week after its initial announcement. It all started with a viral Instagram post from a woman who called in and received the following advice from Tessa: Lose 1-2 pounds a week, count calories and work for a 500- to 1,000-calorie deficit, weigh herself weekly, and restrict her diet. Unfortunately, all of these suggestions were things that led to the development of the woman’s eating disorder.

Naturally, NEDA responded in good grace, accusing the woman of lying. A NEDA vice president even left some nasty comments on the post, but hastily deleted them a day later when NEDA announced it was shutting down Tessa “until further notice for a complete investigation.” NEDA’s CEO insisted they hadn’t seen that behavior from Tessa before, calling it a “bug” and insisting the bot would only be down temporarily until the triggers causing the bug were fixed.

In the aftermath, several doctors and psychologists chimed in, terming the rush to automate human roles dangerous and risky. After all, much of what makes these hotlines effective is the volunteers speaking from their own experience. An unsupervised bot doesn’t seem to have what it takes to deal with a mental health crisis, but we’re betting that Tessa will be back. As a wise cephalopod once said: Nobody gives a care about the fate of labor as long as they can get their instant gratification.
 

You can’t spell existential without s-t-e-n-t

This week, we’re including a special “bonus” item that, to be honest, has nothing to do with stents. That’s why our editor is making us call this a “bonus” (and making us use quote marks, too): It doesn’t really have anything to do with stents or health care or those who practice health care. Actually, his exact words were, “You can’t just give the readers someone else’s ****ing list and expect to get paid for it.” Did we mention that he looks like Jack Nicklaus but acts like BoJack Horseman?

Anywaaay, we’re pretty sure that the list in question – “America’s Top 10 Most Googled Existential Questions” – says something about the human condition, just not about stents:

1. Why is the sky blue?

2. What do dreams mean?

3. What is the meaning of life?

4. Why am I so tired?

5. Who am I?

6. What is love?

7. Is a hot dog a sandwich?

8. What came first, the chicken or the egg?

9. What should I do?

10. Do animals have souls?

Sowing the seeds of cancer prevention

Are you looking to add to your quality of life, even though pets are not your speed? Might we suggest something with lower maintenance? Something a little greener?

Indoor plants can purify the air that comes from outside. Researchers at the University of Technology Sydney, in partnership with the plantscaping company Ambius, showed that a “green wall” made up of mixed indoor plants was able to suck up 97% of “the most toxic compounds” from the air in just 8 hours. We’re talking about lung-irritating, headache-inducing, cancer risk–boosting compounds from gasoline fumes, including benzene.

Fraser Torpy/University of Technology Sydney

Public health initiatives often strive to reduce cardiovascular and obesity risks, but breathing seems pretty important too. According to the World Health Organization, household air pollution is responsible for about 2.5 million global premature deaths each year. And since 2020 we’ve become accustomed to spending more time inside and at home.

“This new research proves that plants should not just be seen as ‘nice to have,’ but rather a crucial part of every workplace wellness plan,” Ambius General Manager Johan Hodgson said in statement released by the university.

So don’t spend hundreds of dollars on a fancy air filtration system when a wall of plants can do that for next to nothing. Find what works for you and your space and become a plant parent today! Your lungs will thank you.
 

But officer, I had to swerve to miss the duodenal ampulla

Tiny video capsule endoscopes have been around for many years, but they have one big weakness: The ingestible cameras’ journey through the GI tract is passively driven by gravity and the natural movement of the body, so they often miss potential problem areas.

AnX Robotica

Not anymore. That flaw has been addressed by medical technology company AnX Robotica, which has taken endoscopy to the next level by adding that wondrous directional control device of the modern electronic age, a joystick.

The new system “uses an external magnet and hand-held video game style joysticks to move the capsule in three dimensions,” which allows physicians to “remotely drive a miniature video capsule to all regions of the stomach to visualize and photograph potential problem areas,” according to Andrew C. Meltzer, MD, of George Washington University and associates, who conducted a pilot study funded by AnX Robotica.

The video capsule provided a 95% rate of visualization in the stomachs of 40 patients who were examined at a medical office building by an emergency medicine physician who had no previous specialty training in endoscopy. “Capsules were driven by the ER physician and then the study reports were reviewed by an attending gastroenterologist who was physically off site,” the investigators said in a written statement.

The capsule operator did receive some additional training, and development of artificial intelligence to self-drive the capsule is in the works, but for now, we’re talking about a device controlled by a human using a joystick. And we all know that 50-year-olds are not especially known for their joystick skills. For that we need real experts. Yup, we need to put those joystick-controlled capsule endoscopes in the hands of teenage gamers. Who wants to go first?
 

Maybe AI isn’t ready for the big time after all

“How long before some intrepid stockholder says: ‘Hey, instead of paying doctors, why don’t we just use the free robot instead?’ ” Those words appeared on LOTME but a month ago. After all, the AI is supposed to be smarter and more empathetic than a doctor. And did we mention it’s free? Or at least extremely cheap. Cheaper than, say, a group of recently unionized health care workers.

maewjpho/Thinkstock

In early May, the paid employees manning the National Eating Disorders Association emergency hotline voted to unionize, as they felt overwhelmed and underpaid. Apparently, paying six people an extra few thousand a year was too much for NEDA’s leadership, as they decided a few weeks later to fire those workers, fully closing down the hotline. Instead of talking to a real person, people “calling in” for support would be met with Tessa, a wellness chatbot that would hopefully guide them through their crisis. Key word, hopefully.

In perhaps the least surprising twist of the year, NEDA was forced to walk back its decision about a week after its initial announcement. It all started with a viral Instagram post from a woman who called in and received the following advice from Tessa: Lose 1-2 pounds a week, count calories and work for a 500- to 1,000-calorie deficit, weigh herself weekly, and restrict her diet. Unfortunately, all of these suggestions were things that led to the development of the woman’s eating disorder.

Naturally, NEDA responded in good grace, accusing the woman of lying. A NEDA vice president even left some nasty comments on the post, but hastily deleted them a day later when NEDA announced it was shutting down Tessa “until further notice for a complete investigation.” NEDA’s CEO insisted they hadn’t seen that behavior from Tessa before, calling it a “bug” and insisting the bot would only be down temporarily until the triggers causing the bug were fixed.

In the aftermath, several doctors and psychologists chimed in, terming the rush to automate human roles dangerous and risky. After all, much of what makes these hotlines effective is the volunteers speaking from their own experience. An unsupervised bot doesn’t seem to have what it takes to deal with a mental health crisis, but we’re betting that Tessa will be back. As a wise cephalopod once said: Nobody gives a care about the fate of labor as long as they can get their instant gratification.
 

You can’t spell existential without s-t-e-n-t

This week, we’re including a special “bonus” item that, to be honest, has nothing to do with stents. That’s why our editor is making us call this a “bonus” (and making us use quote marks, too): It doesn’t really have anything to do with stents or health care or those who practice health care. Actually, his exact words were, “You can’t just give the readers someone else’s ****ing list and expect to get paid for it.” Did we mention that he looks like Jack Nicklaus but acts like BoJack Horseman?

Anywaaay, we’re pretty sure that the list in question – “America’s Top 10 Most Googled Existential Questions” – says something about the human condition, just not about stents:

1. Why is the sky blue?

2. What do dreams mean?

3. What is the meaning of life?

4. Why am I so tired?

5. Who am I?

6. What is love?

7. Is a hot dog a sandwich?

8. What came first, the chicken or the egg?

9. What should I do?

10. Do animals have souls?