News

Sandra Hong, MD, chair of allergy and immunology and director of the Food Allergy Center of Excellence at Cleveland Clinic, in Ohio, sees firsthand how situations that feel ordinary to most people strike fear in the hearts of her patients with food allergies. 

Not only do some experience reactions to milk when they eat a cheese pizza — they can’t be in the same room with someone enjoying a slice nearby. “That would be terrifying,” Dr. Hong said.

Omalizumab (Xolair), recently approved by the US Food and Drug Administration as monotherapy for the treatment of food allergies, may now bring peace of mind to these patients and their families by reducing their risk of dangerous allergic reactions to accidental exposure.

While the drug does not cure food allergies, a phase 3, placebo-controlled trial found that after 16 weeks of treatment, two thirds of participants were able to tolerate at least 600 mg of peanut protein — equal to about 2.5 peanuts — without experiencing moderate to severe reactions. 

An open-label extension trial also found the monoclonal antibody reduced the likelihood of serious reactions to eggs by 67%, milk by 66%, and cashews by 42%. The results of the study were published in The New England Journal of Medicine.

The treatment is approved for children as young as the age of 1 year and is the only treatment approved for multiple food allergies. It does not treat anaphylaxis or other emergency situations.

Patient Selection Key

While 8% of children and 10% of adults in the United States have a true food allergy, Brian Vickery, MD, chief of allergy and immunology and director of the Food Allergy Center at Children’s Healthcare of Atlanta, noted that a significantly higher proportion of the population restricts their diet based on perceived food intolerances.

“Most important for family doctors prior to prescribing the medication will be to be sure that the diagnosis is correct,” Kim said. “We know that allergy blood and skin testing is good but not perfect, and false positive results can occur,” said Edwin Kim, MD, chief of the Division of Pediatric Allergy and Immunology and director of the University of North Carolina Food Allergy Initiative at the University of North Carolina School of Medicine, Chapel Hill, who was a coauthor on the study in the New England Journal of Medicine. “ An allergist can conduct food challenges to confirm the diagnosis if results are unclear.”

Even for patients with confirmed IgE-mediated allergies, Dr. Hong said selecting patients who are good candidates for the therapy has “nuances.” 

Patients must be willing and able to commit to injections every 2-4 weeks. Dosing depends on body weight and the total IgE levels of each patient. Patients with IgE levels > 1850 UI/mL likely will be disqualified from treatment since the clinical trial did not enroll patients with total IgE above this level and the appropriate dose in those patients is unknown.

“My recommendation for family physicians who are counseling food-allergic patients interested in omalizumab treatment is to partner with an allergist-immunologist, if at all possible,” Dr. Vickery said. He added that patients should have a comprehensive workup before beginning treatment because starting omalizumab would reduce reactivity and alter the outcome a diagnostic oral food challenge.

Two populations Dr. Hong thinks might particularly benefit from the therapy are college students and preschoolers, who may be unable to completely avoid allergens because of poor impulse control and food sharing in group settings.

“The concerns we have about this age group are whether or not there might be other factors involved that may impede their ability to make good decisions.”

Less control of the environment in dorms or other group living situations also could increase the risk of accidental exposure to a food allergen.

For the right patients, the treatment regimen has significant advantages over oral immunotherapy treatment (OIT), including the fact that it’s not a daily medication and it has the potential to treat allergic asthma at the same time.

“The biggest pro for omalizumab is that it can treat all of your food allergies, whether you have one or many, and do it all in one medication,” Dr. Kim said. 

Managing Potential Harms

Omalizumab carries risks both primary care providers and patients must consider. First among them is that the drug carries a “black box” warning for an increased risk of anaphylaxis, Dr. Hong said. 

Although patients with multiple food allergies typically already have prescriptions for epinephrine, primary care physicians (PCPs) considering offering omalizumab must be comfortable treating severe systemic reactions and their offices capable of post-dose monitoring, Dr. Hong said. 

Anaphylaxis “can occur after the first dose or it can be delayed,” she said. “Typically, allergists will give these in our offices and we’ll actually have people wait for delayed amounts of time, for hours.”

The drug has been available since 2003 as a treatment for allergic asthma and urticaria. In addition to the warning for anaphylaxis, common reactions include joint pain and injection-site reactions. It also increases the risk for parasitic infection, and some studies show an increase in the risk for cancer.

Still, Dr. Kim said omalizumab’s safety profile is reassuring and noted it has advantages over OIT. “Since the patient is not exposing themselves to the food they are allergic to like in OIT, the safety is expected to be far better,” he said.

Lifelong Treatment 

Dr. Vickery, Dr. Hong, and Dr. Kim all cautioned that patients should understand that, while omalizumab offers protection against accidental exposure and can meaningfully improve quality of life, it won’t allow them to loosen their allergen-avoidant diets.

Further, maintaining protection requires receiving injections every 2-4 weeks for life. For those without insurance, or whose insurance does not cover the treatment, costs could reach thousands of dollars each month, Dr. Hong said.

Omalizumab “has been well covered by insurance for asthma and chronic hives, but we will have to see what it looks like for food allergy. The range of plans and out-of-pocket deductibles available to patients will also play a big role,” Dr. Kim said. 

Other novel approaches to food allergies are currently in clinical trials, and both Dr. Hong and Dr. Vickery are optimistic about potential options in the pipeline.

“We’re just on the brink of really exciting therapies coming forward in the future,” Dr. Hong said.

The study was supported by the National Institute of Allergy and Infectious Diseases and the National Center for Advancing Translational Sciences, both part of the National Institutes of Health; the Claudia and Steve Stange Family Fund; Genentech; and Novartis. Dr. Hong, Dr. Kim, and Dr. Vickery reported no relevant financial relationships.

A version of this article appeared on Medscape.com.

Sandra Hong, MD, chair of allergy and immunology and director of the Food Allergy Center of Excellence at Cleveland Clinic, in Ohio, sees firsthand how situations that feel ordinary to most people strike fear in the hearts of her patients with food allergies. 

Not only do some experience reactions to milk when they eat a cheese pizza — they can’t be in the same room with someone enjoying a slice nearby. “That would be terrifying,” Dr. Hong said.

Omalizumab (Xolair), recently approved by the US Food and Drug Administration as monotherapy for the treatment of food allergies, may now bring peace of mind to these patients and their families by reducing their risk of dangerous allergic reactions to accidental exposure.

While the drug does not cure food allergies, a phase 3, placebo-controlled trial found that after 16 weeks of treatment, two thirds of participants were able to tolerate at least 600 mg of peanut protein — equal to about 2.5 peanuts — without experiencing moderate to severe reactions. 

An open-label extension trial also found the monoclonal antibody reduced the likelihood of serious reactions to eggs by 67%, milk by 66%, and cashews by 42%. The results of the study were published in The New England Journal of Medicine.

The treatment is approved for children as young as the age of 1 year and is the only treatment approved for multiple food allergies. It does not treat anaphylaxis or other emergency situations.

Patient Selection Key

While 8% of children and 10% of adults in the United States have a true food allergy, Brian Vickery, MD, chief of allergy and immunology and director of the Food Allergy Center at Children’s Healthcare of Atlanta, noted that a significantly higher proportion of the population restricts their diet based on perceived food intolerances.

“Most important for family doctors prior to prescribing the medication will be to be sure that the diagnosis is correct,” Kim said. “We know that allergy blood and skin testing is good but not perfect, and false positive results can occur,” said Edwin Kim, MD, chief of the Division of Pediatric Allergy and Immunology and director of the University of North Carolina Food Allergy Initiative at the University of North Carolina School of Medicine, Chapel Hill, who was a coauthor on the study in the New England Journal of Medicine. “ An allergist can conduct food challenges to confirm the diagnosis if results are unclear.”

Even for patients with confirmed IgE-mediated allergies, Dr. Hong said selecting patients who are good candidates for the therapy has “nuances.” 

Patients must be willing and able to commit to injections every 2-4 weeks. Dosing depends on body weight and the total IgE levels of each patient. Patients with IgE levels > 1850 UI/mL likely will be disqualified from treatment since the clinical trial did not enroll patients with total IgE above this level and the appropriate dose in those patients is unknown.

“My recommendation for family physicians who are counseling food-allergic patients interested in omalizumab treatment is to partner with an allergist-immunologist, if at all possible,” Dr. Vickery said. He added that patients should have a comprehensive workup before beginning treatment because starting omalizumab would reduce reactivity and alter the outcome a diagnostic oral food challenge.

Two populations Dr. Hong thinks might particularly benefit from the therapy are college students and preschoolers, who may be unable to completely avoid allergens because of poor impulse control and food sharing in group settings.

“The concerns we have about this age group are whether or not there might be other factors involved that may impede their ability to make good decisions.”

Less control of the environment in dorms or other group living situations also could increase the risk of accidental exposure to a food allergen.

For the right patients, the treatment regimen has significant advantages over oral immunotherapy treatment (OIT), including the fact that it’s not a daily medication and it has the potential to treat allergic asthma at the same time.

“The biggest pro for omalizumab is that it can treat all of your food allergies, whether you have one or many, and do it all in one medication,” Dr. Kim said. 

Managing Potential Harms

Omalizumab carries risks both primary care providers and patients must consider. First among them is that the drug carries a “black box” warning for an increased risk of anaphylaxis, Dr. Hong said. 

Although patients with multiple food allergies typically already have prescriptions for epinephrine, primary care physicians (PCPs) considering offering omalizumab must be comfortable treating severe systemic reactions and their offices capable of post-dose monitoring, Dr. Hong said. 

Anaphylaxis “can occur after the first dose or it can be delayed,” she said. “Typically, allergists will give these in our offices and we’ll actually have people wait for delayed amounts of time, for hours.”

The drug has been available since 2003 as a treatment for allergic asthma and urticaria. In addition to the warning for anaphylaxis, common reactions include joint pain and injection-site reactions. It also increases the risk for parasitic infection, and some studies show an increase in the risk for cancer.

Still, Dr. Kim said omalizumab’s safety profile is reassuring and noted it has advantages over OIT. “Since the patient is not exposing themselves to the food they are allergic to like in OIT, the safety is expected to be far better,” he said.

Lifelong Treatment 

Dr. Vickery, Dr. Hong, and Dr. Kim all cautioned that patients should understand that, while omalizumab offers protection against accidental exposure and can meaningfully improve quality of life, it won’t allow them to loosen their allergen-avoidant diets.

Further, maintaining protection requires receiving injections every 2-4 weeks for life. For those without insurance, or whose insurance does not cover the treatment, costs could reach thousands of dollars each month, Dr. Hong said.

Omalizumab “has been well covered by insurance for asthma and chronic hives, but we will have to see what it looks like for food allergy. The range of plans and out-of-pocket deductibles available to patients will also play a big role,” Dr. Kim said. 

Other novel approaches to food allergies are currently in clinical trials, and both Dr. Hong and Dr. Vickery are optimistic about potential options in the pipeline.

“We’re just on the brink of really exciting therapies coming forward in the future,” Dr. Hong said.

The study was supported by the National Institute of Allergy and Infectious Diseases and the National Center for Advancing Translational Sciences, both part of the National Institutes of Health; the Claudia and Steve Stange Family Fund; Genentech; and Novartis. Dr. Hong, Dr. Kim, and Dr. Vickery reported no relevant financial relationships.

A version of this article appeared on Medscape.com.

Sandra Hong, MD, chair of allergy and immunology and director of the Food Allergy Center of Excellence at Cleveland Clinic, in Ohio, sees firsthand how situations that feel ordinary to most people strike fear in the hearts of her patients with food allergies. 

Not only do some experience reactions to milk when they eat a cheese pizza — they can’t be in the same room with someone enjoying a slice nearby. “That would be terrifying,” Dr. Hong said.

Omalizumab (Xolair), recently approved by the US Food and Drug Administration as monotherapy for the treatment of food allergies, may now bring peace of mind to these patients and their families by reducing their risk of dangerous allergic reactions to accidental exposure.

While the drug does not cure food allergies, a phase 3, placebo-controlled trial found that after 16 weeks of treatment, two thirds of participants were able to tolerate at least 600 mg of peanut protein — equal to about 2.5 peanuts — without experiencing moderate to severe reactions. 

An open-label extension trial also found the monoclonal antibody reduced the likelihood of serious reactions to eggs by 67%, milk by 66%, and cashews by 42%. The results of the study were published in The New England Journal of Medicine.

The treatment is approved for children as young as the age of 1 year and is the only treatment approved for multiple food allergies. It does not treat anaphylaxis or other emergency situations.

Patient Selection Key

While 8% of children and 10% of adults in the United States have a true food allergy, Brian Vickery, MD, chief of allergy and immunology and director of the Food Allergy Center at Children’s Healthcare of Atlanta, noted that a significantly higher proportion of the population restricts their diet based on perceived food intolerances.

“Most important for family doctors prior to prescribing the medication will be to be sure that the diagnosis is correct,” Kim said. “We know that allergy blood and skin testing is good but not perfect, and false positive results can occur,” said Edwin Kim, MD, chief of the Division of Pediatric Allergy and Immunology and director of the University of North Carolina Food Allergy Initiative at the University of North Carolina School of Medicine, Chapel Hill, who was a coauthor on the study in the New England Journal of Medicine. “ An allergist can conduct food challenges to confirm the diagnosis if results are unclear.”

Even for patients with confirmed IgE-mediated allergies, Dr. Hong said selecting patients who are good candidates for the therapy has “nuances.” 

Patients must be willing and able to commit to injections every 2-4 weeks. Dosing depends on body weight and the total IgE levels of each patient. Patients with IgE levels > 1850 UI/mL likely will be disqualified from treatment since the clinical trial did not enroll patients with total IgE above this level and the appropriate dose in those patients is unknown.

“My recommendation for family physicians who are counseling food-allergic patients interested in omalizumab treatment is to partner with an allergist-immunologist, if at all possible,” Dr. Vickery said. He added that patients should have a comprehensive workup before beginning treatment because starting omalizumab would reduce reactivity and alter the outcome a diagnostic oral food challenge.

Two populations Dr. Hong thinks might particularly benefit from the therapy are college students and preschoolers, who may be unable to completely avoid allergens because of poor impulse control and food sharing in group settings.

“The concerns we have about this age group are whether or not there might be other factors involved that may impede their ability to make good decisions.”

Less control of the environment in dorms or other group living situations also could increase the risk of accidental exposure to a food allergen.

For the right patients, the treatment regimen has significant advantages over oral immunotherapy treatment (OIT), including the fact that it’s not a daily medication and it has the potential to treat allergic asthma at the same time.

“The biggest pro for omalizumab is that it can treat all of your food allergies, whether you have one or many, and do it all in one medication,” Dr. Kim said. 

Managing Potential Harms

Omalizumab carries risks both primary care providers and patients must consider. First among them is that the drug carries a “black box” warning for an increased risk of anaphylaxis, Dr. Hong said. 

Although patients with multiple food allergies typically already have prescriptions for epinephrine, primary care physicians (PCPs) considering offering omalizumab must be comfortable treating severe systemic reactions and their offices capable of post-dose monitoring, Dr. Hong said. 

Anaphylaxis “can occur after the first dose or it can be delayed,” she said. “Typically, allergists will give these in our offices and we’ll actually have people wait for delayed amounts of time, for hours.”

The drug has been available since 2003 as a treatment for allergic asthma and urticaria. In addition to the warning for anaphylaxis, common reactions include joint pain and injection-site reactions. It also increases the risk for parasitic infection, and some studies show an increase in the risk for cancer.

Still, Dr. Kim said omalizumab’s safety profile is reassuring and noted it has advantages over OIT. “Since the patient is not exposing themselves to the food they are allergic to like in OIT, the safety is expected to be far better,” he said.

Lifelong Treatment 

Dr. Vickery, Dr. Hong, and Dr. Kim all cautioned that patients should understand that, while omalizumab offers protection against accidental exposure and can meaningfully improve quality of life, it won’t allow them to loosen their allergen-avoidant diets.

Further, maintaining protection requires receiving injections every 2-4 weeks for life. For those without insurance, or whose insurance does not cover the treatment, costs could reach thousands of dollars each month, Dr. Hong said.

Omalizumab “has been well covered by insurance for asthma and chronic hives, but we will have to see what it looks like for food allergy. The range of plans and out-of-pocket deductibles available to patients will also play a big role,” Dr. Kim said. 

Other novel approaches to food allergies are currently in clinical trials, and both Dr. Hong and Dr. Vickery are optimistic about potential options in the pipeline.

“We’re just on the brink of really exciting therapies coming forward in the future,” Dr. Hong said.

The study was supported by the National Institute of Allergy and Infectious Diseases and the National Center for Advancing Translational Sciences, both part of the National Institutes of Health; the Claudia and Steve Stange Family Fund; Genentech; and Novartis. Dr. Hong, Dr. Kim, and Dr. Vickery reported no relevant financial relationships.

A version of this article appeared on Medscape.com.

“Fingers, toes, ears, and nose are places where epinephrine never goes,” Thomas Ehlers, DPM, wrote in Podiatry Today. “That is an adage I heard during podiatry school, my clerkships, and from various attendings throughout my training.”

But as Dr. Ehlers added, epinephrine gets a bad rap. The catchy admonition “has been proven a myth time and time again.”

So why do many clinicians believe the combination of epinephrine and lidocaine to be off-limits in surgical interventions involving the digits and other regions with low blood flow? Although medical trainees across multiple disciplines are taught to fear the practice, citing the potential for gangrene, its reputation for harm is not supported by the evidence.
 

Lack of Feeling Doesn’t Care About Your Facts

The debate surfaced anew in response to a recent column by Kenny Lin, MD, MPH, family physician and associate director of the Lancaster General Hospital Family Medicine Residency, in Lancaster, Pennsylvania, about the rather pedestrian topic of why he no longer performs surgery to correct ingrown toenails. Dr. Lin’s admission that he used to do the procedure with a combination of epinephrine and lidocaine turned into a major focus of the comments — many of them harshly critical of the practice:

“Epinephrine is not an appropriate drug to use for podiatry or use in any peripheral area. Gangrene?” one commenter posted.

“Leave epi out of lidocaine to fingers, toes, nose, and ear lobes,” another wrote.

“No lido with epi, whether or not it is contraindicated, because: If there’s any adverse outcome, a lawyer will find plenty of references saying it was contraindicated,” a reader chimed in.

Other commenters disagreed, with one saying, “Please, folks, don’t show that you trained 50 years ago and haven’t changed practice since…”

For Dr. Lin, the response was surprising given what he believes to be the lack of evidence supporting the purported dangers.

“When I think about this, it’s something that was taught to me during residency — that they should not be used on certain areas,” Dr. Lin said. “But since then, studies have been published looking at thousands of cases of people using epinephrine with lidocaine and haven’t found any cases of necrosis.”

Many doctors, like Dr. Lin, say they were cautioned against this in their training. Others don’t remember exactly where they’ve heard it but recognize the idea has a nebulous hold on practice.

Combining epinephrine with lidocaine helps make the numbing last longer, stops bleeding, and reduces the use of lidocaine required, all of which improve the chances of an effective and comfortable intervention for the patient, Dr. Lin said. The approach also reduces the use of tourniquets, which come with their own risks including nerve injury.

However, in areas with limited circulation, this vasoconstrictive effect may be more pronounced, potentially leading to complications for patients with complicating factors.

Clinicians who regularly use the combination of epinephrine and lidocaine for surgery do concede that it can pose certain hazards and considerations in areas without robust blood flow.

But the literature largely points to its safety.

In 2001, California-based plastic and reconstructive surgeon Keith Denkler, MD, published a deep dive on the topic starting in the 19th century, including a review of Index Medicus from 1880 to 1966, a computer review of the National Library of Medicine database from 1966 to 2000, and major textbooks from 1900 to 2000.

He found a total of 48 cases of digital gangrene — but most involved the use of cocaine or procaine. Of the 48 cases, 21 involved the use of epinephrine, and 17 used an unknown concentration based on manual dilution.

“Multiple other concurrent conditions (hot soaks, tight tourniquets, and infection) existed in these case reports, making it difficult to determine the exact cause of the tissue insult,” Dr. Denkler wrote.

In a 2010 retrospective review in the Journal of the American Society of Plastic Surgeons, authors examined 1111 cases involving digital and hand surgery. Of the 611 patients who received injections of 1% lidocaine with epinephrine, none experienced digital necrosis.

Another review from 2003 touted the combination’s safety, in hopes to “help dispel the myth that epinephrine has no place in podiatric anesthesia.” But authors noted limitations of use, including “known sensitivity, thyrotoxicosis, and use of either tricyclic antidepressants or monoamine oxidase inhibitors.”

James Christina, DPM, executive director and CEO of the American Podiatric Medical Association, echoed that sentiment. He said he regularly used the combination to correct bunions, hammer toes, and ingrown toenails over his 20 years of practicing but acknowledged the technique is not appropriate for all such patients.

“There’s always been caution when using epinephrine with local anesthetic,” Dr. Christina told this news organization. “You need a healthy patient with normal circulation and no other complications; someone without vascular compromise.”

Marie Hanna, MD, MEHP, chief of regional anesthesia and acute pain management at Johns Hopkins University, Baltimore, counts herself among the cautious. Citing Principles of Office Anesthesia: Part I. Infiltrative Anesthesia, Dr. Hanna said epinephrine should never be used in digital and penile blocks or in skin flaps with marginal viability.

“It is perfectly fine in certain areas, like the wrist or the arm,” Dr. Hanna said. “But specifically for use in end organs like nose, fingers, ears, toes — all of these with tenuous blood supply — it is not good practice.”

The divide among doctors comes down to theoretical concern, rather than empirical basis, said Rebecca Johnson, MD, chair of the American Society of Anesthesiologists committee on Regional Anesthesia and Acute Pain Medicine and a faculty member at Mayo Clinic, in Rochester, Minnesota.

“It’s just one of those myths we have in practice,” she said.

And legally, Dr. Johnson noted, the mere existence of a myth can be enough of a deterrent for medical practitioners: “Like anything, when you’re trying to do the right thing, if a complication would occur for another reason, you’d want to make sure a jury of your peers didn’t bring up that myth.”

The sources in this story reported no relevant financial conflicts of interest.
 

A version of this article appeared on Medscape.com.

“Fingers, toes, ears, and nose are places where epinephrine never goes,” Thomas Ehlers, DPM, wrote in Podiatry Today. “That is an adage I heard during podiatry school, my clerkships, and from various attendings throughout my training.”

But as Dr. Ehlers added, epinephrine gets a bad rap. The catchy admonition “has been proven a myth time and time again.”

So why do many clinicians believe the combination of epinephrine and lidocaine to be off-limits in surgical interventions involving the digits and other regions with low blood flow? Although medical trainees across multiple disciplines are taught to fear the practice, citing the potential for gangrene, its reputation for harm is not supported by the evidence.
 

Lack of Feeling Doesn’t Care About Your Facts

The debate surfaced anew in response to a recent column by Kenny Lin, MD, MPH, family physician and associate director of the Lancaster General Hospital Family Medicine Residency, in Lancaster, Pennsylvania, about the rather pedestrian topic of why he no longer performs surgery to correct ingrown toenails. Dr. Lin’s admission that he used to do the procedure with a combination of epinephrine and lidocaine turned into a major focus of the comments — many of them harshly critical of the practice:

“Epinephrine is not an appropriate drug to use for podiatry or use in any peripheral area. Gangrene?” one commenter posted.

“Leave epi out of lidocaine to fingers, toes, nose, and ear lobes,” another wrote.

“No lido with epi, whether or not it is contraindicated, because: If there’s any adverse outcome, a lawyer will find plenty of references saying it was contraindicated,” a reader chimed in.

Other commenters disagreed, with one saying, “Please, folks, don’t show that you trained 50 years ago and haven’t changed practice since…”

For Dr. Lin, the response was surprising given what he believes to be the lack of evidence supporting the purported dangers.

“When I think about this, it’s something that was taught to me during residency — that they should not be used on certain areas,” Dr. Lin said. “But since then, studies have been published looking at thousands of cases of people using epinephrine with lidocaine and haven’t found any cases of necrosis.”

Many doctors, like Dr. Lin, say they were cautioned against this in their training. Others don’t remember exactly where they’ve heard it but recognize the idea has a nebulous hold on practice.

Combining epinephrine with lidocaine helps make the numbing last longer, stops bleeding, and reduces the use of lidocaine required, all of which improve the chances of an effective and comfortable intervention for the patient, Dr. Lin said. The approach also reduces the use of tourniquets, which come with their own risks including nerve injury.

However, in areas with limited circulation, this vasoconstrictive effect may be more pronounced, potentially leading to complications for patients with complicating factors.

Clinicians who regularly use the combination of epinephrine and lidocaine for surgery do concede that it can pose certain hazards and considerations in areas without robust blood flow.

But the literature largely points to its safety.

In 2001, California-based plastic and reconstructive surgeon Keith Denkler, MD, published a deep dive on the topic starting in the 19th century, including a review of Index Medicus from 1880 to 1966, a computer review of the National Library of Medicine database from 1966 to 2000, and major textbooks from 1900 to 2000.

He found a total of 48 cases of digital gangrene — but most involved the use of cocaine or procaine. Of the 48 cases, 21 involved the use of epinephrine, and 17 used an unknown concentration based on manual dilution.

“Multiple other concurrent conditions (hot soaks, tight tourniquets, and infection) existed in these case reports, making it difficult to determine the exact cause of the tissue insult,” Dr. Denkler wrote.

In a 2010 retrospective review in the Journal of the American Society of Plastic Surgeons, authors examined 1111 cases involving digital and hand surgery. Of the 611 patients who received injections of 1% lidocaine with epinephrine, none experienced digital necrosis.

Another review from 2003 touted the combination’s safety, in hopes to “help dispel the myth that epinephrine has no place in podiatric anesthesia.” But authors noted limitations of use, including “known sensitivity, thyrotoxicosis, and use of either tricyclic antidepressants or monoamine oxidase inhibitors.”

James Christina, DPM, executive director and CEO of the American Podiatric Medical Association, echoed that sentiment. He said he regularly used the combination to correct bunions, hammer toes, and ingrown toenails over his 20 years of practicing but acknowledged the technique is not appropriate for all such patients.

“There’s always been caution when using epinephrine with local anesthetic,” Dr. Christina told this news organization. “You need a healthy patient with normal circulation and no other complications; someone without vascular compromise.”

Marie Hanna, MD, MEHP, chief of regional anesthesia and acute pain management at Johns Hopkins University, Baltimore, counts herself among the cautious. Citing Principles of Office Anesthesia: Part I. Infiltrative Anesthesia, Dr. Hanna said epinephrine should never be used in digital and penile blocks or in skin flaps with marginal viability.

“It is perfectly fine in certain areas, like the wrist or the arm,” Dr. Hanna said. “But specifically for use in end organs like nose, fingers, ears, toes — all of these with tenuous blood supply — it is not good practice.”

The divide among doctors comes down to theoretical concern, rather than empirical basis, said Rebecca Johnson, MD, chair of the American Society of Anesthesiologists committee on Regional Anesthesia and Acute Pain Medicine and a faculty member at Mayo Clinic, in Rochester, Minnesota.

“It’s just one of those myths we have in practice,” she said.

And legally, Dr. Johnson noted, the mere existence of a myth can be enough of a deterrent for medical practitioners: “Like anything, when you’re trying to do the right thing, if a complication would occur for another reason, you’d want to make sure a jury of your peers didn’t bring up that myth.”

The sources in this story reported no relevant financial conflicts of interest.
 

A version of this article appeared on Medscape.com.

“Fingers, toes, ears, and nose are places where epinephrine never goes,” Thomas Ehlers, DPM, wrote in Podiatry Today. “That is an adage I heard during podiatry school, my clerkships, and from various attendings throughout my training.”

But as Dr. Ehlers added, epinephrine gets a bad rap. The catchy admonition “has been proven a myth time and time again.”

So why do many clinicians believe the combination of epinephrine and lidocaine to be off-limits in surgical interventions involving the digits and other regions with low blood flow? Although medical trainees across multiple disciplines are taught to fear the practice, citing the potential for gangrene, its reputation for harm is not supported by the evidence.
 

Lack of Feeling Doesn’t Care About Your Facts

The debate surfaced anew in response to a recent column by Kenny Lin, MD, MPH, family physician and associate director of the Lancaster General Hospital Family Medicine Residency, in Lancaster, Pennsylvania, about the rather pedestrian topic of why he no longer performs surgery to correct ingrown toenails. Dr. Lin’s admission that he used to do the procedure with a combination of epinephrine and lidocaine turned into a major focus of the comments — many of them harshly critical of the practice:

“Epinephrine is not an appropriate drug to use for podiatry or use in any peripheral area. Gangrene?” one commenter posted.

“Leave epi out of lidocaine to fingers, toes, nose, and ear lobes,” another wrote.

“No lido with epi, whether or not it is contraindicated, because: If there’s any adverse outcome, a lawyer will find plenty of references saying it was contraindicated,” a reader chimed in.

Other commenters disagreed, with one saying, “Please, folks, don’t show that you trained 50 years ago and haven’t changed practice since…”

For Dr. Lin, the response was surprising given what he believes to be the lack of evidence supporting the purported dangers.

“When I think about this, it’s something that was taught to me during residency — that they should not be used on certain areas,” Dr. Lin said. “But since then, studies have been published looking at thousands of cases of people using epinephrine with lidocaine and haven’t found any cases of necrosis.”

Many doctors, like Dr. Lin, say they were cautioned against this in their training. Others don’t remember exactly where they’ve heard it but recognize the idea has a nebulous hold on practice.

Combining epinephrine with lidocaine helps make the numbing last longer, stops bleeding, and reduces the use of lidocaine required, all of which improve the chances of an effective and comfortable intervention for the patient, Dr. Lin said. The approach also reduces the use of tourniquets, which come with their own risks including nerve injury.

However, in areas with limited circulation, this vasoconstrictive effect may be more pronounced, potentially leading to complications for patients with complicating factors.

Clinicians who regularly use the combination of epinephrine and lidocaine for surgery do concede that it can pose certain hazards and considerations in areas without robust blood flow.

But the literature largely points to its safety.

In 2001, California-based plastic and reconstructive surgeon Keith Denkler, MD, published a deep dive on the topic starting in the 19th century, including a review of Index Medicus from 1880 to 1966, a computer review of the National Library of Medicine database from 1966 to 2000, and major textbooks from 1900 to 2000.

He found a total of 48 cases of digital gangrene — but most involved the use of cocaine or procaine. Of the 48 cases, 21 involved the use of epinephrine, and 17 used an unknown concentration based on manual dilution.

“Multiple other concurrent conditions (hot soaks, tight tourniquets, and infection) existed in these case reports, making it difficult to determine the exact cause of the tissue insult,” Dr. Denkler wrote.

In a 2010 retrospective review in the Journal of the American Society of Plastic Surgeons, authors examined 1111 cases involving digital and hand surgery. Of the 611 patients who received injections of 1% lidocaine with epinephrine, none experienced digital necrosis.

Another review from 2003 touted the combination’s safety, in hopes to “help dispel the myth that epinephrine has no place in podiatric anesthesia.” But authors noted limitations of use, including “known sensitivity, thyrotoxicosis, and use of either tricyclic antidepressants or monoamine oxidase inhibitors.”

James Christina, DPM, executive director and CEO of the American Podiatric Medical Association, echoed that sentiment. He said he regularly used the combination to correct bunions, hammer toes, and ingrown toenails over his 20 years of practicing but acknowledged the technique is not appropriate for all such patients.

“There’s always been caution when using epinephrine with local anesthetic,” Dr. Christina told this news organization. “You need a healthy patient with normal circulation and no other complications; someone without vascular compromise.”

Marie Hanna, MD, MEHP, chief of regional anesthesia and acute pain management at Johns Hopkins University, Baltimore, counts herself among the cautious. Citing Principles of Office Anesthesia: Part I. Infiltrative Anesthesia, Dr. Hanna said epinephrine should never be used in digital and penile blocks or in skin flaps with marginal viability.

“It is perfectly fine in certain areas, like the wrist or the arm,” Dr. Hanna said. “But specifically for use in end organs like nose, fingers, ears, toes — all of these with tenuous blood supply — it is not good practice.”

The divide among doctors comes down to theoretical concern, rather than empirical basis, said Rebecca Johnson, MD, chair of the American Society of Anesthesiologists committee on Regional Anesthesia and Acute Pain Medicine and a faculty member at Mayo Clinic, in Rochester, Minnesota.

“It’s just one of those myths we have in practice,” she said.

And legally, Dr. Johnson noted, the mere existence of a myth can be enough of a deterrent for medical practitioners: “Like anything, when you’re trying to do the right thing, if a complication would occur for another reason, you’d want to make sure a jury of your peers didn’t bring up that myth.”

The sources in this story reported no relevant financial conflicts of interest.
 

A version of this article appeared on Medscape.com.

TOPLINE:

A history of herpes simplex virus (HSV) is associated with a more than doubling of the risk for dementia in older people, results of a prospective epidemiological study showed. 

METHODOLOGY:

• The study included 1002 dementia-free 70-year-olds from the Prospective Investigation of Vasculature in Uppsala Seniors cohort who were assessed at baseline and at age 75 and 80 years and followed through medical records at age 85 years.
• Researchers collected and analyzed blood samples to detect anti-HSV and anti-HSV-1 immunoglobulin (Ig) G, anti-cytomegalovirus (CMV) IgG, anti-HSV IgM, and anti-HSV and anti-CMV IgG levels and apolipoprotein epsilon 4 (APOE 4) status of participants.
• Investigators collected information on anti-herpesvirus drug treatment and reviewed dementia diagnoses obtained from medical records to classify as established or probable dementia or Alzheimer’s disease (AD).

TAKEAWAY: 

• 82% of participants were anti-HSV IgG carriers, of which 6% had received drug treatment for herpes virus, and 7% of participants developed all-cause dementia and 4% AD during the median 15-year follow up.
• In HSV and HSV-1 subsamples, treatment for herpes virus was not significantly associated with lower risks for AD (HR, 1.46, P = .532 and HR, 1.64; P = .419, respectively) or dementia (HR 1.70; P = .222 and HR, 1.60; P = .320, respectively).
• There was no significant interaction between anti-HSV IgG seroprevalence and APOE 4 with regard to dementia risk, likely due to underpowering, and there were no associations between anti-CMV IgG positivity or anti-HSV IgM positivity and AD or dementia.

IN PRACTICE:

“What’s special about this particular study is that the participants are roughly the same age, which makes the results even more reliable since age differences, which are otherwise linked to the development of dementia, cannot confuse the results,” lead author Erika Vestin, a medical student in the Department of Public Health and Caring Sciences, Clinical Geriatrics, Uppsala University, Sweden, said in a press release. Findings may drive dementia research further towards treating the illness at an early stage using common anti-herpes virus drugs, Ms. Vestin added.

SOURCE:

The study, with Ms. Vestin as lead author, was published online on February 14, 2024, in the Journal of Alzheimer’s Disease.

LIMITATIONS:

The study underrepresented people with diabetes, heart failure, and stroke and lacked information on treatment compliance, dosage, and length and number of prescriptions, which prevented analysis of dose dependency. Since dementia data collection relied on medical records, dementia cases may be underreported. Some cases of AD could have been misclassified as vascular dementia or other dementia. 

DISCLOSURES:

The study was supported by the Gun and Bertil Stohne’s Foundation, Swedish Dementia Association, Swedish Society of Medicine, Märta Lundqvist Foundation, Thureus Foundation, Region Uppsala, Gamla Tjänarinnor Foundation, and Swedish Brain Foundation. The authors had no relevant conflicts of interest.
 

A version of this article appeared on Medscape.com.

TOPLINE:

A history of herpes simplex virus (HSV) is associated with a more than doubling of the risk for dementia in older people, results of a prospective epidemiological study showed. 

METHODOLOGY:

• The study included 1002 dementia-free 70-year-olds from the Prospective Investigation of Vasculature in Uppsala Seniors cohort who were assessed at baseline and at age 75 and 80 years and followed through medical records at age 85 years.
• Researchers collected and analyzed blood samples to detect anti-HSV and anti-HSV-1 immunoglobulin (Ig) G, anti-cytomegalovirus (CMV) IgG, anti-HSV IgM, and anti-HSV and anti-CMV IgG levels and apolipoprotein epsilon 4 (APOE 4) status of participants.
• Investigators collected information on anti-herpesvirus drug treatment and reviewed dementia diagnoses obtained from medical records to classify as established or probable dementia or Alzheimer’s disease (AD).

TAKEAWAY: 

• 82% of participants were anti-HSV IgG carriers, of which 6% had received drug treatment for herpes virus, and 7% of participants developed all-cause dementia and 4% AD during the median 15-year follow up.
• In HSV and HSV-1 subsamples, treatment for herpes virus was not significantly associated with lower risks for AD (HR, 1.46, P = .532 and HR, 1.64; P = .419, respectively) or dementia (HR 1.70; P = .222 and HR, 1.60; P = .320, respectively).
• There was no significant interaction between anti-HSV IgG seroprevalence and APOE 4 with regard to dementia risk, likely due to underpowering, and there were no associations between anti-CMV IgG positivity or anti-HSV IgM positivity and AD or dementia.

IN PRACTICE:

“What’s special about this particular study is that the participants are roughly the same age, which makes the results even more reliable since age differences, which are otherwise linked to the development of dementia, cannot confuse the results,” lead author Erika Vestin, a medical student in the Department of Public Health and Caring Sciences, Clinical Geriatrics, Uppsala University, Sweden, said in a press release. Findings may drive dementia research further towards treating the illness at an early stage using common anti-herpes virus drugs, Ms. Vestin added.

SOURCE:

The study, with Ms. Vestin as lead author, was published online on February 14, 2024, in the Journal of Alzheimer’s Disease.

LIMITATIONS:

The study underrepresented people with diabetes, heart failure, and stroke and lacked information on treatment compliance, dosage, and length and number of prescriptions, which prevented analysis of dose dependency. Since dementia data collection relied on medical records, dementia cases may be underreported. Some cases of AD could have been misclassified as vascular dementia or other dementia. 

DISCLOSURES:

The study was supported by the Gun and Bertil Stohne’s Foundation, Swedish Dementia Association, Swedish Society of Medicine, Märta Lundqvist Foundation, Thureus Foundation, Region Uppsala, Gamla Tjänarinnor Foundation, and Swedish Brain Foundation. The authors had no relevant conflicts of interest.
 

A version of this article appeared on Medscape.com.

TOPLINE:

A history of herpes simplex virus (HSV) is associated with a more than doubling of the risk for dementia in older people, results of a prospective epidemiological study showed. 

METHODOLOGY:

• The study included 1002 dementia-free 70-year-olds from the Prospective Investigation of Vasculature in Uppsala Seniors cohort who were assessed at baseline and at age 75 and 80 years and followed through medical records at age 85 years.
• Researchers collected and analyzed blood samples to detect anti-HSV and anti-HSV-1 immunoglobulin (Ig) G, anti-cytomegalovirus (CMV) IgG, anti-HSV IgM, and anti-HSV and anti-CMV IgG levels and apolipoprotein epsilon 4 (APOE 4) status of participants.
• Investigators collected information on anti-herpesvirus drug treatment and reviewed dementia diagnoses obtained from medical records to classify as established or probable dementia or Alzheimer’s disease (AD).

TAKEAWAY: 

• 82% of participants were anti-HSV IgG carriers, of which 6% had received drug treatment for herpes virus, and 7% of participants developed all-cause dementia and 4% AD during the median 15-year follow up.
• In HSV and HSV-1 subsamples, treatment for herpes virus was not significantly associated with lower risks for AD (HR, 1.46, P = .532 and HR, 1.64; P = .419, respectively) or dementia (HR 1.70; P = .222 and HR, 1.60; P = .320, respectively).
• There was no significant interaction between anti-HSV IgG seroprevalence and APOE 4 with regard to dementia risk, likely due to underpowering, and there were no associations between anti-CMV IgG positivity or anti-HSV IgM positivity and AD or dementia.

IN PRACTICE:

“What’s special about this particular study is that the participants are roughly the same age, which makes the results even more reliable since age differences, which are otherwise linked to the development of dementia, cannot confuse the results,” lead author Erika Vestin, a medical student in the Department of Public Health and Caring Sciences, Clinical Geriatrics, Uppsala University, Sweden, said in a press release. Findings may drive dementia research further towards treating the illness at an early stage using common anti-herpes virus drugs, Ms. Vestin added.

SOURCE:

The study, with Ms. Vestin as lead author, was published online on February 14, 2024, in the Journal of Alzheimer’s Disease.

LIMITATIONS:

The study underrepresented people with diabetes, heart failure, and stroke and lacked information on treatment compliance, dosage, and length and number of prescriptions, which prevented analysis of dose dependency. Since dementia data collection relied on medical records, dementia cases may be underreported. Some cases of AD could have been misclassified as vascular dementia or other dementia. 

DISCLOSURES:

The study was supported by the Gun and Bertil Stohne’s Foundation, Swedish Dementia Association, Swedish Society of Medicine, Märta Lundqvist Foundation, Thureus Foundation, Region Uppsala, Gamla Tjänarinnor Foundation, and Swedish Brain Foundation. The authors had no relevant conflicts of interest.
 

A version of this article appeared on Medscape.com.

A prognostic tool may facilitate the early identification of older adults in the community who would benefit from palliative care in their final years, new research from Canada suggested.

The analysis of data from close to a quarter million community-dwelling older adults in Ontario with at least one interRAI (Resident Assessment Instrument) home care assessment showed that only half of those with an estimated survival of fewer than 3 months received at least one palliative home care visit before death.

“One of the challenges and a barrier to accessing palliative home care is the difficulty of predicting survival,” Amy Hsu, PhD, an investigator at the Bruyère Research Institute in Ottawa, Ontario, Canada, told this news organization. “Clinicians are good at prognosticating when a patient might be entering their last 3-6 weeks of life, but they have a harder time predicting if someone will survive 6 months or longer.”

The team developed the Risk Evaluation for Support: Predictions for Elder-life in their Communities Tool (RESPECT) to see whether access to predicted survival data could inform conversations about a patient’s status and palliative care needs.

The study was published online in the Canadian Medical Association Journal.
 

Setting Care Goals

Researchers analyzed population health administrative data from Ontario involving home care clients who received at least one interRAI Home Care assessment between April 2018 and September 2019. The cohort included 247,377 adults (62% women) with a mean age of 80.1 years at the time of assessment. Comorbidities, including congestive heart failure, coronary artery disease, cancer, and chronic obstructive pulmonary disease, as well as symptoms of health instability, were more prevalent among those at higher risk of dying.

The team used an updated, validated version of RESPECT to predict survival.

Only 2.6% of home care clients had received a clinician diagnosis of an end-stage disease, which was more prevalent among those at highest mortality risk (77.9%). Most clients (74.5%) required extensive assistance in performing instrumental activities of daily living (ADLs, score ≤ 4), and half (50.3%) were less able to perform ADLs in the last 3 months of life.

Within the cohort, 75% of patients with a predicted median survival of fewer than 3 months, 55.4% of those with a predicted median survival between 3 and 6 months, and 40.7% of those with a predicted median survival between 6 and 12 months died within 6 months of the home care assessment.

Among decedents, 50.6% of those with a RESPECT-estimated median survival of fewer than 3 months received at least one nonphysician palliative home care visit before death. Less than a third (27.8%) received at least one palliative home care visit from a physician.

The proportion of those who received at least one nonphysician visit fell to 38.7% among those with a median survival of between 3 and 6 months and to 29.5% among those with a median survival of between 6 and 12 months.

Patients who received at least one palliative home care visit (from either physicians or nonphysician home care providers) within 6 months of an assessment had clinical characteristics similar to those who did not receive a visit. However, those who did not receive palliative home care were more likely to not have been identified by a clinician as being in their past 6 months of life.

“These results reinforce the role of clinicians in identifying older adults who may be in their last 6 months of life as an important component for the receipt of palliative home care and highlight the value of RESPECT in supplementing clinicians’ assessments of prognosis,” the authors wrote.

“Our goal is to use data and tools like RESPECT to help individuals living with a life-limiting illness have conversations about what their end-of-life care goals and wishes may be and discuss whether a referral to palliative care is appropriate or needed,” Dr. Hsu added. “Data about life expectancy could be helpful for framing these conversations.”

The researchers are working with partners in home, community care, and long-term care to implement RESPECT in their settings.
 

‘Valuable Tool’

Guohua Li, MD, DrPH, professor of epidemiology and anesthesiology at Columbia University Mailman School of Public Health and Vagelos College of Physicians and Surgeons in New York City, commented on the findings for this news organization. He noted that the study is “rigorously designed and meticulously analyzed. The findings are of high validity and population health significance.”

The findings are comparable with what is seen in the United States and Canada, he said, where about 50% of terminally ill patients die at home or in hospice. However, palliative care outside of North America “varies greatly, and in many developing countries, [it] is still in its infancy.”

As a mortality risk prediction algorithm, “RESPECT seems to perform reasonably well,” he said. “If incorporated into the electronic health record, it could be a valuable tool for clinicians to identify patients with less than 6 months of life expectancy and deliver palliative care to these patients. RESPECT appears to be particularly beneficial for home care patients without a clinically diagnosed terminal disease.”

That said, he added, “RESPECT should be viewed as a clinical decision support tool. It is no substitute for clinicians or clinical judgment. Based on the data presented in the paper, the algorithm tends to overestimate the short-term mortality risk for home care patients, therefore resulting in many false alarms.”

The study was supported by the Canadian Institutes of Health Research and the Associated Medical Services. Dr. Hsu is an executive lead on the steering committee of the Ontario Centres for Learning, Research, and Innovation in Long-Term Care. Funding for the centers comes from the Ontario Ministry of Health and Ministry of Long-Term Care and is partially administered by the Bruyère Research Institute. Dr. Li reported no relevant financial interests.

A version of this article appeared on Medscape.com.

A prognostic tool may facilitate the early identification of older adults in the community who would benefit from palliative care in their final years, new research from Canada suggested.

The analysis of data from close to a quarter million community-dwelling older adults in Ontario with at least one interRAI (Resident Assessment Instrument) home care assessment showed that only half of those with an estimated survival of fewer than 3 months received at least one palliative home care visit before death.

“One of the challenges and a barrier to accessing palliative home care is the difficulty of predicting survival,” Amy Hsu, PhD, an investigator at the Bruyère Research Institute in Ottawa, Ontario, Canada, told this news organization. “Clinicians are good at prognosticating when a patient might be entering their last 3-6 weeks of life, but they have a harder time predicting if someone will survive 6 months or longer.”

The team developed the Risk Evaluation for Support: Predictions for Elder-life in their Communities Tool (RESPECT) to see whether access to predicted survival data could inform conversations about a patient’s status and palliative care needs.

The study was published online in the Canadian Medical Association Journal.
 

Setting Care Goals

Researchers analyzed population health administrative data from Ontario involving home care clients who received at least one interRAI Home Care assessment between April 2018 and September 2019. The cohort included 247,377 adults (62% women) with a mean age of 80.1 years at the time of assessment. Comorbidities, including congestive heart failure, coronary artery disease, cancer, and chronic obstructive pulmonary disease, as well as symptoms of health instability, were more prevalent among those at higher risk of dying.

The team used an updated, validated version of RESPECT to predict survival.

Only 2.6% of home care clients had received a clinician diagnosis of an end-stage disease, which was more prevalent among those at highest mortality risk (77.9%). Most clients (74.5%) required extensive assistance in performing instrumental activities of daily living (ADLs, score ≤ 4), and half (50.3%) were less able to perform ADLs in the last 3 months of life.

Within the cohort, 75% of patients with a predicted median survival of fewer than 3 months, 55.4% of those with a predicted median survival between 3 and 6 months, and 40.7% of those with a predicted median survival between 6 and 12 months died within 6 months of the home care assessment.

Among decedents, 50.6% of those with a RESPECT-estimated median survival of fewer than 3 months received at least one nonphysician palliative home care visit before death. Less than a third (27.8%) received at least one palliative home care visit from a physician.

The proportion of those who received at least one nonphysician visit fell to 38.7% among those with a median survival of between 3 and 6 months and to 29.5% among those with a median survival of between 6 and 12 months.

Patients who received at least one palliative home care visit (from either physicians or nonphysician home care providers) within 6 months of an assessment had clinical characteristics similar to those who did not receive a visit. However, those who did not receive palliative home care were more likely to not have been identified by a clinician as being in their past 6 months of life.

“These results reinforce the role of clinicians in identifying older adults who may be in their last 6 months of life as an important component for the receipt of palliative home care and highlight the value of RESPECT in supplementing clinicians’ assessments of prognosis,” the authors wrote.

“Our goal is to use data and tools like RESPECT to help individuals living with a life-limiting illness have conversations about what their end-of-life care goals and wishes may be and discuss whether a referral to palliative care is appropriate or needed,” Dr. Hsu added. “Data about life expectancy could be helpful for framing these conversations.”

The researchers are working with partners in home, community care, and long-term care to implement RESPECT in their settings.
 

‘Valuable Tool’

Guohua Li, MD, DrPH, professor of epidemiology and anesthesiology at Columbia University Mailman School of Public Health and Vagelos College of Physicians and Surgeons in New York City, commented on the findings for this news organization. He noted that the study is “rigorously designed and meticulously analyzed. The findings are of high validity and population health significance.”

The findings are comparable with what is seen in the United States and Canada, he said, where about 50% of terminally ill patients die at home or in hospice. However, palliative care outside of North America “varies greatly, and in many developing countries, [it] is still in its infancy.”

As a mortality risk prediction algorithm, “RESPECT seems to perform reasonably well,” he said. “If incorporated into the electronic health record, it could be a valuable tool for clinicians to identify patients with less than 6 months of life expectancy and deliver palliative care to these patients. RESPECT appears to be particularly beneficial for home care patients without a clinically diagnosed terminal disease.”

That said, he added, “RESPECT should be viewed as a clinical decision support tool. It is no substitute for clinicians or clinical judgment. Based on the data presented in the paper, the algorithm tends to overestimate the short-term mortality risk for home care patients, therefore resulting in many false alarms.”

The study was supported by the Canadian Institutes of Health Research and the Associated Medical Services. Dr. Hsu is an executive lead on the steering committee of the Ontario Centres for Learning, Research, and Innovation in Long-Term Care. Funding for the centers comes from the Ontario Ministry of Health and Ministry of Long-Term Care and is partially administered by the Bruyère Research Institute. Dr. Li reported no relevant financial interests.

A version of this article appeared on Medscape.com.

A prognostic tool may facilitate the early identification of older adults in the community who would benefit from palliative care in their final years, new research from Canada suggested.

The analysis of data from close to a quarter million community-dwelling older adults in Ontario with at least one interRAI (Resident Assessment Instrument) home care assessment showed that only half of those with an estimated survival of fewer than 3 months received at least one palliative home care visit before death.

“One of the challenges and a barrier to accessing palliative home care is the difficulty of predicting survival,” Amy Hsu, PhD, an investigator at the Bruyère Research Institute in Ottawa, Ontario, Canada, told this news organization. “Clinicians are good at prognosticating when a patient might be entering their last 3-6 weeks of life, but they have a harder time predicting if someone will survive 6 months or longer.”

The team developed the Risk Evaluation for Support: Predictions for Elder-life in their Communities Tool (RESPECT) to see whether access to predicted survival data could inform conversations about a patient’s status and palliative care needs.

The study was published online in the Canadian Medical Association Journal.
 

Setting Care Goals

Researchers analyzed population health administrative data from Ontario involving home care clients who received at least one interRAI Home Care assessment between April 2018 and September 2019. The cohort included 247,377 adults (62% women) with a mean age of 80.1 years at the time of assessment. Comorbidities, including congestive heart failure, coronary artery disease, cancer, and chronic obstructive pulmonary disease, as well as symptoms of health instability, were more prevalent among those at higher risk of dying.

The team used an updated, validated version of RESPECT to predict survival.

Only 2.6% of home care clients had received a clinician diagnosis of an end-stage disease, which was more prevalent among those at highest mortality risk (77.9%). Most clients (74.5%) required extensive assistance in performing instrumental activities of daily living (ADLs, score ≤ 4), and half (50.3%) were less able to perform ADLs in the last 3 months of life.

Within the cohort, 75% of patients with a predicted median survival of fewer than 3 months, 55.4% of those with a predicted median survival between 3 and 6 months, and 40.7% of those with a predicted median survival between 6 and 12 months died within 6 months of the home care assessment.

Among decedents, 50.6% of those with a RESPECT-estimated median survival of fewer than 3 months received at least one nonphysician palliative home care visit before death. Less than a third (27.8%) received at least one palliative home care visit from a physician.

The proportion of those who received at least one nonphysician visit fell to 38.7% among those with a median survival of between 3 and 6 months and to 29.5% among those with a median survival of between 6 and 12 months.

Patients who received at least one palliative home care visit (from either physicians or nonphysician home care providers) within 6 months of an assessment had clinical characteristics similar to those who did not receive a visit. However, those who did not receive palliative home care were more likely to not have been identified by a clinician as being in their past 6 months of life.

“These results reinforce the role of clinicians in identifying older adults who may be in their last 6 months of life as an important component for the receipt of palliative home care and highlight the value of RESPECT in supplementing clinicians’ assessments of prognosis,” the authors wrote.

“Our goal is to use data and tools like RESPECT to help individuals living with a life-limiting illness have conversations about what their end-of-life care goals and wishes may be and discuss whether a referral to palliative care is appropriate or needed,” Dr. Hsu added. “Data about life expectancy could be helpful for framing these conversations.”

The researchers are working with partners in home, community care, and long-term care to implement RESPECT in their settings.
 

‘Valuable Tool’

Guohua Li, MD, DrPH, professor of epidemiology and anesthesiology at Columbia University Mailman School of Public Health and Vagelos College of Physicians and Surgeons in New York City, commented on the findings for this news organization. He noted that the study is “rigorously designed and meticulously analyzed. The findings are of high validity and population health significance.”

The findings are comparable with what is seen in the United States and Canada, he said, where about 50% of terminally ill patients die at home or in hospice. However, palliative care outside of North America “varies greatly, and in many developing countries, [it] is still in its infancy.”

As a mortality risk prediction algorithm, “RESPECT seems to perform reasonably well,” he said. “If incorporated into the electronic health record, it could be a valuable tool for clinicians to identify patients with less than 6 months of life expectancy and deliver palliative care to these patients. RESPECT appears to be particularly beneficial for home care patients without a clinically diagnosed terminal disease.”

That said, he added, “RESPECT should be viewed as a clinical decision support tool. It is no substitute for clinicians or clinical judgment. Based on the data presented in the paper, the algorithm tends to overestimate the short-term mortality risk for home care patients, therefore resulting in many false alarms.”

The study was supported by the Canadian Institutes of Health Research and the Associated Medical Services. Dr. Hsu is an executive lead on the steering committee of the Ontario Centres for Learning, Research, and Innovation in Long-Term Care. Funding for the centers comes from the Ontario Ministry of Health and Ministry of Long-Term Care and is partially administered by the Bruyère Research Institute. Dr. Li reported no relevant financial interests.

A version of this article appeared on Medscape.com.

In January 2023, Mark Lewis, MD, stood with the door slammed in his face. His partner in the practice had had enough. She accused him of sugarcoating prognoses and leaving her to tell patients the whole truth.

The reality was he just didn’t know how to grieve.

Dr. Lewis was well acquainted with cancer grief long before he became an oncologist. Dr. Lewis’ father died of a rare, hereditary cancer syndrome when he was only 14. The condition, which causes tumors to grow in the endocrine glands, can be hard to identify and, if found late, deadly.

In some ways, Dr. Lewis’ career caring for patients with advanced cancers was born out of that first loss. He centered his practice around helping patients diagnosed at late stages, like his father.

But that comes at a cost. Many patients will die.

Dr. Lewis’ encounter with his colleague led him to inventory his practice. He found that well over half of his patients died within 2 years following their advanced cancer diagnosis.

To stave off the grief of so many losses, Dr. Lewis became an eternal optimist in the clinic, in search of the Hail Mary chemotherapy, any way to eke out a few more months only to be ambushed by grief when a patient did finally pass.

At funerals — which he made every effort to attend — Dr. Lewis couldn’t help but think, “If I had done my job better, none of us with be here.” His grief started to mingle with this sense of guilt.

It became a cycle: Denial shrouded in optimism, grief, then a toxic guilt. The pattern became untenable for his colleagues. And his partner finally called him out.

Few medical specialties draw physicians as close to their patients as oncology. The long courses of treatment-spanning years can foster an intimacy that is comforting for patients and fulfilling for physicians. But that closeness can also set doctors up for an acute grief when the end of life comes.

Experts agree that no amount of training in medical school prepares an oncologist to navigate the grief that comes with losing patients. Five oncologists spoke with this news organization about the boundaries they rely on to sustain their careers.
 

Don’t Go to Funerals

Don Dizon, MD, who specializes in women’s cancers, established an essential boundary 20 years ago: Never go to funerals. In his early days at Memorial Sloan Kettering Cancer Center, the death of each patient dealt him a crushing blow. He’d go to the funerals in search of closure, but that only added to the weight of his grief.

“When I started in oncology, I just remember the most tragic cases were the ones I was taking care of,” recalled Dr. Dizon, now director of the Pelvic Malignancies Program at Lifespan Cancer Institute in Lincoln, Rhode Island.

Dr. Dizon recalled one young mother who was diagnosed with ovarian cancer. She responded to treatment, but it was short-lived, and her cancer progressed, he said. Multiple treatments followed, but none were effective. Eventually, Dr. Dizon had to tell her that “there’s nothing left to try.”

At her funeral, watching her grieving husband with their daughter who had just started to walk, Dr. Dizon was overwhelmed with despair.

“When you have to do this multiple times a year,” the grief becomes untenable, he said. Sensing the difficulty I was having as a new attending, “my boss stopped sending me patients because he knew I was in trouble emotionally.”

That’s when Dr. Dizon started looking for other ways to get closure.

Today, he tries to say his goodbyes before a patient dies. After the final treatment or before hospice, Dr. Dizon has a parting conversation with his patients to express the privilege of caring for them and all he learned from them. These talks help him and his patient connect in their last moments together.
 

The Price of Wildly Happy Days

Molly Taylor, MD, MS, a pediatric oncologist in Seattle, sees the deeply sad days as the price an oncologist pays to be witness to the “wildly happy ones.”

Dr. Taylor has gone to patients’ funerals, has even been asked to speak at them, but she has also attended patients’ weddings.

To some degree, doctors get good at compartmentalizing, and they become accustomed to tragedy, she said. But there are some patients who stick with you, “and that is a whole other level of grief,” Dr. Taylor said.

Several years into her practice, one of Dr. Taylor’s patients, someone who reminded her of her own child, died. The death came as a surprise, and the finality of it took her breath away, she said. The sadness only deepened as days went by. “I felt that mother’s grief and still do,” she said.

The patient’s funeral was one of the most difficult moments in her career as an oncologist. Even weeks later, she caught herself picturing the family huddled together that day.

Taking long walks, commiserating with colleagues who get it, and watching the occasional cat video can help take the immediate sting away. But the pain of losing a patient can be long lasting and processing that grief can be a lonely endeavor.

“We need space to recognize grief for all providers, all the people that touch these patients’ lives — the nurses, the translators, the cleaning staff,” Dr. Taylor said. Otherwise, you start to believe you’re the only one feeling the weight of the loss.

While it doesn’t make the losses any less poignant, Dr. Taylor finds solace in the good moments: Patient graduations and weddings, survivors who now volunteer at the hospital, and a patient who had a baby of her own this past year. If facing grief daily has taught Dr. Taylor anything, it is to not let the good moments pass unnoticed.
 

Towing the Line

Ten years ago, Tina Rizack, MD, walked into the ICU to see a young mother holding her 6-year-old daughter. The mother had necrotizing fasciitis that had gone undiagnosed.

As Dr. Rizack stood in the doorway watching the embrace, she saw a grim future: A child without her mother. This realization hit too close to home, she said. “I still think about that case.”

In her training, Dr. Rizack, now medical director of hematology/oncology at St. Anne’s in Fall River, Massachusetts, worked with a social worker who taught her how to deal with these tough cases — most importantly, how to not take them home with her.

Over the years, Dr. Rizack learned how to build and sustain a firm barrier between work and outside work.

She doesn’t go to funerals or give out her cell phone number. If charts need to be done, she prefers to stay late at the clinic instead of bringing them home.

And she invests in the simple moments that help her detach from the day-to-day in the clinic — rooting for her kids at their games, carving out time for family meals most days, and having relaxed movie nights on the couch.

“It’s hard sometimes,” she said. But “I really do need the line.” Because without it, she can’t show up for her patients the way she wants and needs to.

Establishing the work-life boundary means that when at work, Dr. Rizack can be all in for her patients. Even after her patients’ treatment ends, she makes sure to check on them at home or in hospice. For her, sticking with patients over the long term offers some closure.

“I want to love work, and if I’m there all the time, I’m not going to love it,” she said.
 

Trading Funerals for the Bedside

Like many other oncologists, Charles Blanke, MD, finds that going to patients’ funerals makes the loss seem more profound. Being at the bedside when they die is not as painful, he said. In fact, being there when his patients die offers him some comfort. He rarely misses a patient’s death because now Dr. Blanke’s patients can schedule their departure.

An oncologist at the Knight Cancer Institute in Portland, Oregon, Dr. Blanke specializes in end-of-life care with an emphasis on death with dignity, also known as medical aid in dying. He admits it’s not a role every physician is comfortable with.

“If you’re paralyzed by grief, you can’t do this for a living,” he said. But he’s able to do the work because he genuinely feels he’s helping patients get “the relief they so strongly desire” in their last moments.

When cancer care can’t give them the life they wanted, he can give them control over when and how they die. And the ability to honor their last wishes offers him some closure as well.

“You know what kind of end they have. You know it was peaceful. You see them achieve the thing that was the most important to them,” he said.

Despite this process, he still encounters some circumstances utterly heart-wrenching — the very young patients who have advanced disease. Some of these patients choose to die because they can’t afford to continue treatment. Others don’t have a support system. In these instances, Dr. Blanke is often the only one in the room.

Believe it or not, he said, the paperwork — and there’s a lot of it in his line of work — helps remind Dr. Blanke that patients’ last wishes are being honored.
 

Making Changes

After Dr. Lewis was confronted by his partner, he began to face the shortcomings of his own coping strategies. His practice hired a social worker to help staff process difficult experiences. After the loss of every patient, the practice comes together to share and process the loss.

For him, funerals remain helpful, providing a sort of solace, so he continues to go when he can. But how to grieve is something each doctor has to figure out, he said.

Deaths still hit hard, especially the ones he doesn’t see coming. The patients who remind him of his dad can also be hard. They restart a cycle of grief from his teenage years.

The difference now is he has space to voice those concerns and someone objective to help his process.

“It’s a privilege to prepare [patients for death] and help them build their legacy,” he said. But it’s also an unrelenting challenge to navigate that grief, he said.

Still, the grief lets Dr. Lewis know he’s still engaged.

“The day I don’t feel something is probably the day I need to take a break or walk away.”
 

A version of this article appeared on Medscape.com.

In January 2023, Mark Lewis, MD, stood with the door slammed in his face. His partner in the practice had had enough. She accused him of sugarcoating prognoses and leaving her to tell patients the whole truth.

The reality was he just didn’t know how to grieve.

Dr. Lewis was well acquainted with cancer grief long before he became an oncologist. Dr. Lewis’ father died of a rare, hereditary cancer syndrome when he was only 14. The condition, which causes tumors to grow in the endocrine glands, can be hard to identify and, if found late, deadly.

In some ways, Dr. Lewis’ career caring for patients with advanced cancers was born out of that first loss. He centered his practice around helping patients diagnosed at late stages, like his father.

But that comes at a cost. Many patients will die.

Dr. Lewis’ encounter with his colleague led him to inventory his practice. He found that well over half of his patients died within 2 years following their advanced cancer diagnosis.

To stave off the grief of so many losses, Dr. Lewis became an eternal optimist in the clinic, in search of the Hail Mary chemotherapy, any way to eke out a few more months only to be ambushed by grief when a patient did finally pass.

At funerals — which he made every effort to attend — Dr. Lewis couldn’t help but think, “If I had done my job better, none of us with be here.” His grief started to mingle with this sense of guilt.

It became a cycle: Denial shrouded in optimism, grief, then a toxic guilt. The pattern became untenable for his colleagues. And his partner finally called him out.

Few medical specialties draw physicians as close to their patients as oncology. The long courses of treatment-spanning years can foster an intimacy that is comforting for patients and fulfilling for physicians. But that closeness can also set doctors up for an acute grief when the end of life comes.

Experts agree that no amount of training in medical school prepares an oncologist to navigate the grief that comes with losing patients. Five oncologists spoke with this news organization about the boundaries they rely on to sustain their careers.
 

Don’t Go to Funerals

Don Dizon, MD, who specializes in women’s cancers, established an essential boundary 20 years ago: Never go to funerals. In his early days at Memorial Sloan Kettering Cancer Center, the death of each patient dealt him a crushing blow. He’d go to the funerals in search of closure, but that only added to the weight of his grief.

“When I started in oncology, I just remember the most tragic cases were the ones I was taking care of,” recalled Dr. Dizon, now director of the Pelvic Malignancies Program at Lifespan Cancer Institute in Lincoln, Rhode Island.

Dr. Dizon recalled one young mother who was diagnosed with ovarian cancer. She responded to treatment, but it was short-lived, and her cancer progressed, he said. Multiple treatments followed, but none were effective. Eventually, Dr. Dizon had to tell her that “there’s nothing left to try.”

At her funeral, watching her grieving husband with their daughter who had just started to walk, Dr. Dizon was overwhelmed with despair.

“When you have to do this multiple times a year,” the grief becomes untenable, he said. Sensing the difficulty I was having as a new attending, “my boss stopped sending me patients because he knew I was in trouble emotionally.”

That’s when Dr. Dizon started looking for other ways to get closure.

Today, he tries to say his goodbyes before a patient dies. After the final treatment or before hospice, Dr. Dizon has a parting conversation with his patients to express the privilege of caring for them and all he learned from them. These talks help him and his patient connect in their last moments together.
 

The Price of Wildly Happy Days

Molly Taylor, MD, MS, a pediatric oncologist in Seattle, sees the deeply sad days as the price an oncologist pays to be witness to the “wildly happy ones.”

Dr. Taylor has gone to patients’ funerals, has even been asked to speak at them, but she has also attended patients’ weddings.

To some degree, doctors get good at compartmentalizing, and they become accustomed to tragedy, she said. But there are some patients who stick with you, “and that is a whole other level of grief,” Dr. Taylor said.

Several years into her practice, one of Dr. Taylor’s patients, someone who reminded her of her own child, died. The death came as a surprise, and the finality of it took her breath away, she said. The sadness only deepened as days went by. “I felt that mother’s grief and still do,” she said.

The patient’s funeral was one of the most difficult moments in her career as an oncologist. Even weeks later, she caught herself picturing the family huddled together that day.

Taking long walks, commiserating with colleagues who get it, and watching the occasional cat video can help take the immediate sting away. But the pain of losing a patient can be long lasting and processing that grief can be a lonely endeavor.

“We need space to recognize grief for all providers, all the people that touch these patients’ lives — the nurses, the translators, the cleaning staff,” Dr. Taylor said. Otherwise, you start to believe you’re the only one feeling the weight of the loss.

While it doesn’t make the losses any less poignant, Dr. Taylor finds solace in the good moments: Patient graduations and weddings, survivors who now volunteer at the hospital, and a patient who had a baby of her own this past year. If facing grief daily has taught Dr. Taylor anything, it is to not let the good moments pass unnoticed.
 

Towing the Line

Ten years ago, Tina Rizack, MD, walked into the ICU to see a young mother holding her 6-year-old daughter. The mother had necrotizing fasciitis that had gone undiagnosed.

As Dr. Rizack stood in the doorway watching the embrace, she saw a grim future: A child without her mother. This realization hit too close to home, she said. “I still think about that case.”

In her training, Dr. Rizack, now medical director of hematology/oncology at St. Anne’s in Fall River, Massachusetts, worked with a social worker who taught her how to deal with these tough cases — most importantly, how to not take them home with her.

Over the years, Dr. Rizack learned how to build and sustain a firm barrier between work and outside work.

She doesn’t go to funerals or give out her cell phone number. If charts need to be done, she prefers to stay late at the clinic instead of bringing them home.

And she invests in the simple moments that help her detach from the day-to-day in the clinic — rooting for her kids at their games, carving out time for family meals most days, and having relaxed movie nights on the couch.

“It’s hard sometimes,” she said. But “I really do need the line.” Because without it, she can’t show up for her patients the way she wants and needs to.

Establishing the work-life boundary means that when at work, Dr. Rizack can be all in for her patients. Even after her patients’ treatment ends, she makes sure to check on them at home or in hospice. For her, sticking with patients over the long term offers some closure.

“I want to love work, and if I’m there all the time, I’m not going to love it,” she said.
 

Trading Funerals for the Bedside

Like many other oncologists, Charles Blanke, MD, finds that going to patients’ funerals makes the loss seem more profound. Being at the bedside when they die is not as painful, he said. In fact, being there when his patients die offers him some comfort. He rarely misses a patient’s death because now Dr. Blanke’s patients can schedule their departure.

An oncologist at the Knight Cancer Institute in Portland, Oregon, Dr. Blanke specializes in end-of-life care with an emphasis on death with dignity, also known as medical aid in dying. He admits it’s not a role every physician is comfortable with.

“If you’re paralyzed by grief, you can’t do this for a living,” he said. But he’s able to do the work because he genuinely feels he’s helping patients get “the relief they so strongly desire” in their last moments.

When cancer care can’t give them the life they wanted, he can give them control over when and how they die. And the ability to honor their last wishes offers him some closure as well.

“You know what kind of end they have. You know it was peaceful. You see them achieve the thing that was the most important to them,” he said.

Despite this process, he still encounters some circumstances utterly heart-wrenching — the very young patients who have advanced disease. Some of these patients choose to die because they can’t afford to continue treatment. Others don’t have a support system. In these instances, Dr. Blanke is often the only one in the room.

Believe it or not, he said, the paperwork — and there’s a lot of it in his line of work — helps remind Dr. Blanke that patients’ last wishes are being honored.
 

Making Changes

After Dr. Lewis was confronted by his partner, he began to face the shortcomings of his own coping strategies. His practice hired a social worker to help staff process difficult experiences. After the loss of every patient, the practice comes together to share and process the loss.

For him, funerals remain helpful, providing a sort of solace, so he continues to go when he can. But how to grieve is something each doctor has to figure out, he said.

Deaths still hit hard, especially the ones he doesn’t see coming. The patients who remind him of his dad can also be hard. They restart a cycle of grief from his teenage years.

The difference now is he has space to voice those concerns and someone objective to help his process.

“It’s a privilege to prepare [patients for death] and help them build their legacy,” he said. But it’s also an unrelenting challenge to navigate that grief, he said.

Still, the grief lets Dr. Lewis know he’s still engaged.

“The day I don’t feel something is probably the day I need to take a break or walk away.”
 

A version of this article appeared on Medscape.com.

In January 2023, Mark Lewis, MD, stood with the door slammed in his face. His partner in the practice had had enough. She accused him of sugarcoating prognoses and leaving her to tell patients the whole truth.

The reality was he just didn’t know how to grieve.

Dr. Lewis was well acquainted with cancer grief long before he became an oncologist. Dr. Lewis’ father died of a rare, hereditary cancer syndrome when he was only 14. The condition, which causes tumors to grow in the endocrine glands, can be hard to identify and, if found late, deadly.

In some ways, Dr. Lewis’ career caring for patients with advanced cancers was born out of that first loss. He centered his practice around helping patients diagnosed at late stages, like his father.

But that comes at a cost. Many patients will die.

Dr. Lewis’ encounter with his colleague led him to inventory his practice. He found that well over half of his patients died within 2 years following their advanced cancer diagnosis.

To stave off the grief of so many losses, Dr. Lewis became an eternal optimist in the clinic, in search of the Hail Mary chemotherapy, any way to eke out a few more months only to be ambushed by grief when a patient did finally pass.

At funerals — which he made every effort to attend — Dr. Lewis couldn’t help but think, “If I had done my job better, none of us with be here.” His grief started to mingle with this sense of guilt.

It became a cycle: Denial shrouded in optimism, grief, then a toxic guilt. The pattern became untenable for his colleagues. And his partner finally called him out.

Few medical specialties draw physicians as close to their patients as oncology. The long courses of treatment-spanning years can foster an intimacy that is comforting for patients and fulfilling for physicians. But that closeness can also set doctors up for an acute grief when the end of life comes.

Experts agree that no amount of training in medical school prepares an oncologist to navigate the grief that comes with losing patients. Five oncologists spoke with this news organization about the boundaries they rely on to sustain their careers.
 

Don’t Go to Funerals

Don Dizon, MD, who specializes in women’s cancers, established an essential boundary 20 years ago: Never go to funerals. In his early days at Memorial Sloan Kettering Cancer Center, the death of each patient dealt him a crushing blow. He’d go to the funerals in search of closure, but that only added to the weight of his grief.

“When I started in oncology, I just remember the most tragic cases were the ones I was taking care of,” recalled Dr. Dizon, now director of the Pelvic Malignancies Program at Lifespan Cancer Institute in Lincoln, Rhode Island.

Dr. Dizon recalled one young mother who was diagnosed with ovarian cancer. She responded to treatment, but it was short-lived, and her cancer progressed, he said. Multiple treatments followed, but none were effective. Eventually, Dr. Dizon had to tell her that “there’s nothing left to try.”

At her funeral, watching her grieving husband with their daughter who had just started to walk, Dr. Dizon was overwhelmed with despair.

“When you have to do this multiple times a year,” the grief becomes untenable, he said. Sensing the difficulty I was having as a new attending, “my boss stopped sending me patients because he knew I was in trouble emotionally.”

That’s when Dr. Dizon started looking for other ways to get closure.

Today, he tries to say his goodbyes before a patient dies. After the final treatment or before hospice, Dr. Dizon has a parting conversation with his patients to express the privilege of caring for them and all he learned from them. These talks help him and his patient connect in their last moments together.
 

The Price of Wildly Happy Days

Molly Taylor, MD, MS, a pediatric oncologist in Seattle, sees the deeply sad days as the price an oncologist pays to be witness to the “wildly happy ones.”

Dr. Taylor has gone to patients’ funerals, has even been asked to speak at them, but she has also attended patients’ weddings.

To some degree, doctors get good at compartmentalizing, and they become accustomed to tragedy, she said. But there are some patients who stick with you, “and that is a whole other level of grief,” Dr. Taylor said.

Several years into her practice, one of Dr. Taylor’s patients, someone who reminded her of her own child, died. The death came as a surprise, and the finality of it took her breath away, she said. The sadness only deepened as days went by. “I felt that mother’s grief and still do,” she said.

The patient’s funeral was one of the most difficult moments in her career as an oncologist. Even weeks later, she caught herself picturing the family huddled together that day.

Taking long walks, commiserating with colleagues who get it, and watching the occasional cat video can help take the immediate sting away. But the pain of losing a patient can be long lasting and processing that grief can be a lonely endeavor.

“We need space to recognize grief for all providers, all the people that touch these patients’ lives — the nurses, the translators, the cleaning staff,” Dr. Taylor said. Otherwise, you start to believe you’re the only one feeling the weight of the loss.

While it doesn’t make the losses any less poignant, Dr. Taylor finds solace in the good moments: Patient graduations and weddings, survivors who now volunteer at the hospital, and a patient who had a baby of her own this past year. If facing grief daily has taught Dr. Taylor anything, it is to not let the good moments pass unnoticed.
 

Towing the Line

Ten years ago, Tina Rizack, MD, walked into the ICU to see a young mother holding her 6-year-old daughter. The mother had necrotizing fasciitis that had gone undiagnosed.

As Dr. Rizack stood in the doorway watching the embrace, she saw a grim future: A child without her mother. This realization hit too close to home, she said. “I still think about that case.”

In her training, Dr. Rizack, now medical director of hematology/oncology at St. Anne’s in Fall River, Massachusetts, worked with a social worker who taught her how to deal with these tough cases — most importantly, how to not take them home with her.

Over the years, Dr. Rizack learned how to build and sustain a firm barrier between work and outside work.

She doesn’t go to funerals or give out her cell phone number. If charts need to be done, she prefers to stay late at the clinic instead of bringing them home.

And she invests in the simple moments that help her detach from the day-to-day in the clinic — rooting for her kids at their games, carving out time for family meals most days, and having relaxed movie nights on the couch.

“It’s hard sometimes,” she said. But “I really do need the line.” Because without it, she can’t show up for her patients the way she wants and needs to.

Establishing the work-life boundary means that when at work, Dr. Rizack can be all in for her patients. Even after her patients’ treatment ends, she makes sure to check on them at home or in hospice. For her, sticking with patients over the long term offers some closure.

“I want to love work, and if I’m there all the time, I’m not going to love it,” she said.
 

Trading Funerals for the Bedside

Like many other oncologists, Charles Blanke, MD, finds that going to patients’ funerals makes the loss seem more profound. Being at the bedside when they die is not as painful, he said. In fact, being there when his patients die offers him some comfort. He rarely misses a patient’s death because now Dr. Blanke’s patients can schedule their departure.

An oncologist at the Knight Cancer Institute in Portland, Oregon, Dr. Blanke specializes in end-of-life care with an emphasis on death with dignity, also known as medical aid in dying. He admits it’s not a role every physician is comfortable with.

“If you’re paralyzed by grief, you can’t do this for a living,” he said. But he’s able to do the work because he genuinely feels he’s helping patients get “the relief they so strongly desire” in their last moments.

When cancer care can’t give them the life they wanted, he can give them control over when and how they die. And the ability to honor their last wishes offers him some closure as well.

“You know what kind of end they have. You know it was peaceful. You see them achieve the thing that was the most important to them,” he said.

Despite this process, he still encounters some circumstances utterly heart-wrenching — the very young patients who have advanced disease. Some of these patients choose to die because they can’t afford to continue treatment. Others don’t have a support system. In these instances, Dr. Blanke is often the only one in the room.

Believe it or not, he said, the paperwork — and there’s a lot of it in his line of work — helps remind Dr. Blanke that patients’ last wishes are being honored.
 

Making Changes

After Dr. Lewis was confronted by his partner, he began to face the shortcomings of his own coping strategies. His practice hired a social worker to help staff process difficult experiences. After the loss of every patient, the practice comes together to share and process the loss.

For him, funerals remain helpful, providing a sort of solace, so he continues to go when he can. But how to grieve is something each doctor has to figure out, he said.

Deaths still hit hard, especially the ones he doesn’t see coming. The patients who remind him of his dad can also be hard. They restart a cycle of grief from his teenage years.

The difference now is he has space to voice those concerns and someone objective to help his process.

“It’s a privilege to prepare [patients for death] and help them build their legacy,” he said. But it’s also an unrelenting challenge to navigate that grief, he said.

Still, the grief lets Dr. Lewis know he’s still engaged.

“The day I don’t feel something is probably the day I need to take a break or walk away.”
 

A version of this article appeared on Medscape.com.

A new study from the United Kingdom provides greater clarity on how SARS-CoV-2 infection can affect cognition and memory, including novel data on how long brain fog may last after the illness resolves and which cognitive functions are most vulnerable. 

In a large community sample, researchers found that on average, people who had recovered from COVID-19 showed small cognitive deficits equivalent to a 3-point loss in IQ for up to 1 year or more after recovering from the acute illness compared with peers who never had COVID-19.

However, people who had more severe cases, requiring treatment in a hospital intensive care unit, had cognitive deficits equivalent to a 9-point drop in IQ.

“People with ongoing persistent symptoms, indicative of long COVID, had larger cognitive deficits than people whose symptoms had resolved,” first author Adam Hampshire, PhD, with Imperial College London, told this news organization. 

The largest deficits among cognitive tasks were in memory, reasoning, and executive function, he added.

“That is, people who had had COVID-19 were both slower and less accurate when performing tasks that measure those abilities,” Dr. Hampshire said. “The group with the largest cognitive deficits were patients who had been in intensive care for COVID-19.”

The study was published online in The New England Journal of Medicine. 

Lingering Brain Fog

Cognitive symptoms after SARS-CoV-2 infection are well recognized, but whether objectively measurable cognitive deficits exist and how long they persist remains unclear. 

To investigate, researchers invited 800,000 adults from the REACT study of SARS-CoV-2 transmission in England to complete an online assessment for cognitive function with eight domains.

Altogether, 141,583 participants started the cognitive battery by completing at least one task, and 112,964 completed all eight tasks.

The researchers estimated global cognitive scores among participants who had been previously infected with SARS-CoV-2 with symptoms that persisted for at least 12 weeks, whether or not resolved, and among uninfected participants. 

Compared with uninfected adults, those who had COVID-19 that resolved had a small cognitive deficit, corresponding to a 3-point loss in IQ, the researchers found. 

Adults with unresolved persistent COVID-19 symptoms had the equivalent of a 6-point loss in IQ, and those who had been admitted to the intensive care unit had the equivalent of a 9-point loss in IQ, in line with previous findings of cognitive deficits in patients hospitalized in a critical care unit, the researchers report. 

Larger cognitive deficits were evident in adults infected early in the pandemic by the original SARS-CoV-2 virus or the B.1.1.7 variant, whereas peers infected later in the pandemic (eg, in the Omicron period), showed smaller cognitive deficits. This finding is in line with other studies suggesting that the association between COVID-19–associated cognitive deficits attenuated as the pandemic progressed, the researchers noted. 

They also found that people who had COVID-19 after receiving two or more vaccinations showed better cognitive performance compared with those who had not been vaccinated. 

The memory, reasoning, and executive function tasks were among the most sensitive to COVID-19–related cognitive differences and performance on these tasks differed according to illness duration and hospitalization. 

Dr. Hampshire said that more research is needed to determine whether the cognitive deficits resolve with time. 

“The implications of longer-term persistence of cognitive deficits and their clinical relevance remain unclear and warrant ongoing surveillance,” he said. 

Larger Cognitive Deficits Likely?

These results are “a concern and the broader implications require evaluation,” wrote Ziyad Al-Aly, MD, with Washington University School of Medicine in St. Louis, and Clifford Rosen, MD, with Tufts University School of Medicine in Boston, in an accompanying editorial. 

In their view, several outstanding questions remain, including what the potential functional implications of a 3-point loss in IQ may be and whether COVID-19–related cognitive deficits predispose to a higher risk for dementia later in life. 

“A deeper understanding of the biology of cognitive dysfunction after SARS-CoV-2 infection and how best to prevent and treat it are critical for addressing the needs of affected persons and preserving the cognitive health of populations,” Drs. Al-Aly and Rosen concluded. 

Commenting on the study for this news organization, Jacqueline Becker, PhD, clinical neuropsychologist and assistant professor of medicine, Icahn School of Medicine at Mount Sinai, New York City, noted that “one important caveat” is that the study used an online assessment tool for cognitive function and therefore the findings should be taken with “a grain of salt.”

“That said, this is a large sample, and the findings are generally consistent with what we’ve seen in terms of cognitive deficits post-COVID,” Dr. Becker said. 

It’s likely that this study “underestimates” the degree of cognitive deficits that would be seen on validated neuropsychological tests, she added.

In a recent study, Dr. Becker and her colleagues investigated rates of cognitive impairment in 740 COVID-19 patients who recovered and were treated in outpatient, emergency department, or inpatient hospital settings. 

Using validated neuropsychological measures, they found a relatively high frequency of cognitive impairment several months after patients contracted COVID-19. Impairments in executive functioning, processing speed, category fluency, memory encoding, and recall were predominant among hospitalized patients. 

Dr. Becker noted that in her experience, cognition typically will improve in some patients 12-18 months post-COVID. 

Support for the study was provided by the National Institute for Health and Care Research and UK Research and Innovation and by the Department of Health and Social Care in England and the Huo Family Foundation. Disclosures for authors and editorial writers are available at NEJM.org. Dr. Becker has no relevant disclosures. 

A version of this article appeared on Medscape.com.

A new study from the United Kingdom provides greater clarity on how SARS-CoV-2 infection can affect cognition and memory, including novel data on how long brain fog may last after the illness resolves and which cognitive functions are most vulnerable. 

In a large community sample, researchers found that on average, people who had recovered from COVID-19 showed small cognitive deficits equivalent to a 3-point loss in IQ for up to 1 year or more after recovering from the acute illness compared with peers who never had COVID-19.

However, people who had more severe cases, requiring treatment in a hospital intensive care unit, had cognitive deficits equivalent to a 9-point drop in IQ.

“People with ongoing persistent symptoms, indicative of long COVID, had larger cognitive deficits than people whose symptoms had resolved,” first author Adam Hampshire, PhD, with Imperial College London, told this news organization. 

The largest deficits among cognitive tasks were in memory, reasoning, and executive function, he added.

“That is, people who had had COVID-19 were both slower and less accurate when performing tasks that measure those abilities,” Dr. Hampshire said. “The group with the largest cognitive deficits were patients who had been in intensive care for COVID-19.”

The study was published online in The New England Journal of Medicine. 

Lingering Brain Fog

Cognitive symptoms after SARS-CoV-2 infection are well recognized, but whether objectively measurable cognitive deficits exist and how long they persist remains unclear. 

To investigate, researchers invited 800,000 adults from the REACT study of SARS-CoV-2 transmission in England to complete an online assessment for cognitive function with eight domains.

Altogether, 141,583 participants started the cognitive battery by completing at least one task, and 112,964 completed all eight tasks.

The researchers estimated global cognitive scores among participants who had been previously infected with SARS-CoV-2 with symptoms that persisted for at least 12 weeks, whether or not resolved, and among uninfected participants. 

Compared with uninfected adults, those who had COVID-19 that resolved had a small cognitive deficit, corresponding to a 3-point loss in IQ, the researchers found. 

Adults with unresolved persistent COVID-19 symptoms had the equivalent of a 6-point loss in IQ, and those who had been admitted to the intensive care unit had the equivalent of a 9-point loss in IQ, in line with previous findings of cognitive deficits in patients hospitalized in a critical care unit, the researchers report. 

Larger cognitive deficits were evident in adults infected early in the pandemic by the original SARS-CoV-2 virus or the B.1.1.7 variant, whereas peers infected later in the pandemic (eg, in the Omicron period), showed smaller cognitive deficits. This finding is in line with other studies suggesting that the association between COVID-19–associated cognitive deficits attenuated as the pandemic progressed, the researchers noted. 

They also found that people who had COVID-19 after receiving two or more vaccinations showed better cognitive performance compared with those who had not been vaccinated. 

The memory, reasoning, and executive function tasks were among the most sensitive to COVID-19–related cognitive differences and performance on these tasks differed according to illness duration and hospitalization. 

Dr. Hampshire said that more research is needed to determine whether the cognitive deficits resolve with time. 

“The implications of longer-term persistence of cognitive deficits and their clinical relevance remain unclear and warrant ongoing surveillance,” he said. 

Larger Cognitive Deficits Likely?

These results are “a concern and the broader implications require evaluation,” wrote Ziyad Al-Aly, MD, with Washington University School of Medicine in St. Louis, and Clifford Rosen, MD, with Tufts University School of Medicine in Boston, in an accompanying editorial. 

In their view, several outstanding questions remain, including what the potential functional implications of a 3-point loss in IQ may be and whether COVID-19–related cognitive deficits predispose to a higher risk for dementia later in life. 

“A deeper understanding of the biology of cognitive dysfunction after SARS-CoV-2 infection and how best to prevent and treat it are critical for addressing the needs of affected persons and preserving the cognitive health of populations,” Drs. Al-Aly and Rosen concluded. 

Commenting on the study for this news organization, Jacqueline Becker, PhD, clinical neuropsychologist and assistant professor of medicine, Icahn School of Medicine at Mount Sinai, New York City, noted that “one important caveat” is that the study used an online assessment tool for cognitive function and therefore the findings should be taken with “a grain of salt.”

“That said, this is a large sample, and the findings are generally consistent with what we’ve seen in terms of cognitive deficits post-COVID,” Dr. Becker said. 

It’s likely that this study “underestimates” the degree of cognitive deficits that would be seen on validated neuropsychological tests, she added.

In a recent study, Dr. Becker and her colleagues investigated rates of cognitive impairment in 740 COVID-19 patients who recovered and were treated in outpatient, emergency department, or inpatient hospital settings. 

Using validated neuropsychological measures, they found a relatively high frequency of cognitive impairment several months after patients contracted COVID-19. Impairments in executive functioning, processing speed, category fluency, memory encoding, and recall were predominant among hospitalized patients. 

Dr. Becker noted that in her experience, cognition typically will improve in some patients 12-18 months post-COVID. 

Support for the study was provided by the National Institute for Health and Care Research and UK Research and Innovation and by the Department of Health and Social Care in England and the Huo Family Foundation. Disclosures for authors and editorial writers are available at NEJM.org. Dr. Becker has no relevant disclosures. 

A version of this article appeared on Medscape.com.

A new study from the United Kingdom provides greater clarity on how SARS-CoV-2 infection can affect cognition and memory, including novel data on how long brain fog may last after the illness resolves and which cognitive functions are most vulnerable. 

In a large community sample, researchers found that on average, people who had recovered from COVID-19 showed small cognitive deficits equivalent to a 3-point loss in IQ for up to 1 year or more after recovering from the acute illness compared with peers who never had COVID-19.

However, people who had more severe cases, requiring treatment in a hospital intensive care unit, had cognitive deficits equivalent to a 9-point drop in IQ.

“People with ongoing persistent symptoms, indicative of long COVID, had larger cognitive deficits than people whose symptoms had resolved,” first author Adam Hampshire, PhD, with Imperial College London, told this news organization. 

The largest deficits among cognitive tasks were in memory, reasoning, and executive function, he added.

“That is, people who had had COVID-19 were both slower and less accurate when performing tasks that measure those abilities,” Dr. Hampshire said. “The group with the largest cognitive deficits were patients who had been in intensive care for COVID-19.”

The study was published online in The New England Journal of Medicine. 

Lingering Brain Fog

Cognitive symptoms after SARS-CoV-2 infection are well recognized, but whether objectively measurable cognitive deficits exist and how long they persist remains unclear. 

To investigate, researchers invited 800,000 adults from the REACT study of SARS-CoV-2 transmission in England to complete an online assessment for cognitive function with eight domains.

Altogether, 141,583 participants started the cognitive battery by completing at least one task, and 112,964 completed all eight tasks.

The researchers estimated global cognitive scores among participants who had been previously infected with SARS-CoV-2 with symptoms that persisted for at least 12 weeks, whether or not resolved, and among uninfected participants. 

Compared with uninfected adults, those who had COVID-19 that resolved had a small cognitive deficit, corresponding to a 3-point loss in IQ, the researchers found. 

Adults with unresolved persistent COVID-19 symptoms had the equivalent of a 6-point loss in IQ, and those who had been admitted to the intensive care unit had the equivalent of a 9-point loss in IQ, in line with previous findings of cognitive deficits in patients hospitalized in a critical care unit, the researchers report. 

Larger cognitive deficits were evident in adults infected early in the pandemic by the original SARS-CoV-2 virus or the B.1.1.7 variant, whereas peers infected later in the pandemic (eg, in the Omicron period), showed smaller cognitive deficits. This finding is in line with other studies suggesting that the association between COVID-19–associated cognitive deficits attenuated as the pandemic progressed, the researchers noted. 

They also found that people who had COVID-19 after receiving two or more vaccinations showed better cognitive performance compared with those who had not been vaccinated. 

The memory, reasoning, and executive function tasks were among the most sensitive to COVID-19–related cognitive differences and performance on these tasks differed according to illness duration and hospitalization. 

Dr. Hampshire said that more research is needed to determine whether the cognitive deficits resolve with time. 

“The implications of longer-term persistence of cognitive deficits and their clinical relevance remain unclear and warrant ongoing surveillance,” he said. 

Larger Cognitive Deficits Likely?

These results are “a concern and the broader implications require evaluation,” wrote Ziyad Al-Aly, MD, with Washington University School of Medicine in St. Louis, and Clifford Rosen, MD, with Tufts University School of Medicine in Boston, in an accompanying editorial. 

In their view, several outstanding questions remain, including what the potential functional implications of a 3-point loss in IQ may be and whether COVID-19–related cognitive deficits predispose to a higher risk for dementia later in life. 

“A deeper understanding of the biology of cognitive dysfunction after SARS-CoV-2 infection and how best to prevent and treat it are critical for addressing the needs of affected persons and preserving the cognitive health of populations,” Drs. Al-Aly and Rosen concluded. 

Commenting on the study for this news organization, Jacqueline Becker, PhD, clinical neuropsychologist and assistant professor of medicine, Icahn School of Medicine at Mount Sinai, New York City, noted that “one important caveat” is that the study used an online assessment tool for cognitive function and therefore the findings should be taken with “a grain of salt.”

“That said, this is a large sample, and the findings are generally consistent with what we’ve seen in terms of cognitive deficits post-COVID,” Dr. Becker said. 

It’s likely that this study “underestimates” the degree of cognitive deficits that would be seen on validated neuropsychological tests, she added.

In a recent study, Dr. Becker and her colleagues investigated rates of cognitive impairment in 740 COVID-19 patients who recovered and were treated in outpatient, emergency department, or inpatient hospital settings. 

Using validated neuropsychological measures, they found a relatively high frequency of cognitive impairment several months after patients contracted COVID-19. Impairments in executive functioning, processing speed, category fluency, memory encoding, and recall were predominant among hospitalized patients. 

Dr. Becker noted that in her experience, cognition typically will improve in some patients 12-18 months post-COVID. 

Support for the study was provided by the National Institute for Health and Care Research and UK Research and Innovation and by the Department of Health and Social Care in England and the Huo Family Foundation. Disclosures for authors and editorial writers are available at NEJM.org. Dr. Becker has no relevant disclosures. 

A version of this article appeared on Medscape.com.

TOPLINE:

Low-dose aspirin use is associated with a reduced risk for colorectal cancer (CRC), confirms a large-scale cohort study, which also suggests that the risk reduction is greatest for metastatic disease and in individuals who take the drug for at least 5 years.

METHODOLOGY:

• Researchers used several population-based registries to identify individuals aged ≥ 50 years living in Norway between 2014 and 2018, excluding those with a prior history of invasive cancer or who had lived in Norway for less than 6 months before study commencement.
• Sociodemographic information was obtained, as well as low-dose aspirin prescription data to determine the prescription date, number of dispensed packages, and defined daily dose.
• Follow-up began 6 months after entering the cohort and continued until CRC diagnosis, another cancer diagnosis, death, emigration, or the end of follow-up on December 31, 2018.
• CRC cases were categorized by site as well as by clinical stage.

TAKEAWAY:

• Of 2,186,390 individuals included, 38,577 (1.8%) were diagnosed with CRC after a median follow-up of 10.9 years. Low-dose aspirin was used at least once by 579,196 (26.5%) individuals.
• Low-dose aspirin use was more common among males, older individuals, those with a lower education or lower income, those of Norwegian origin, and individuals using other medications, including those targeting cardiovascular conditions.
• Compared with never-use, current aspirin use was associated with a lower CRC risk (hazard ratio [HR], 0.87), an association that was more pronounced for metastatic CRC (HR, 0.79) than for regionally advanced (HR, 0.89) and localized disease (HR, 0.93).
• Duration of current aspirin use was also associated with the degree of CRC risk, at HRs of 0.91 for < 3 years, 0.85 for ≥ 3 and < 5 years, and 0.84 for ≥ 5 years.
• It was estimated that aspirin use averted 1073 cases of CRC over the study period.

IN PRACTICE:

“We believe that new randomized controlled trials are urgently needed to confirm the potential protective effect of aspirin against CRC and to identify subgroups in the population who might benefit the most from the use of aspirin,” the authors wrote.

SOURCE:

The research, led by Edoardo Botteri, PhD, Department of Research, Cancer Registry of Norway, National Institute of Public Health, Oslo, Norway, was published online in The American Journal of Gastroenterology.

LIMITATIONS:

This study is limited by its observational nature. Users and nonusers are also “incomparable,” as aspirin is used for the primary prevention of cardiovascular events. Moreover, information was lacking in the registries about “several known risk factors for CRC,” and so the link between aspirin and CRC risk could have been over- or underestimated. Finally, the defined daily dose may not necessarily reflect the dose actually taken by the individual or how often it was taken.

DISCLOSURES:

No relevant financial relationships were declared. The study was funded by the Norwegian Research Council.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Low-dose aspirin use is associated with a reduced risk for colorectal cancer (CRC), confirms a large-scale cohort study, which also suggests that the risk reduction is greatest for metastatic disease and in individuals who take the drug for at least 5 years.

METHODOLOGY:

• Researchers used several population-based registries to identify individuals aged ≥ 50 years living in Norway between 2014 and 2018, excluding those with a prior history of invasive cancer or who had lived in Norway for less than 6 months before study commencement.
• Sociodemographic information was obtained, as well as low-dose aspirin prescription data to determine the prescription date, number of dispensed packages, and defined daily dose.
• Follow-up began 6 months after entering the cohort and continued until CRC diagnosis, another cancer diagnosis, death, emigration, or the end of follow-up on December 31, 2018.
• CRC cases were categorized by site as well as by clinical stage.

TAKEAWAY:

• Of 2,186,390 individuals included, 38,577 (1.8%) were diagnosed with CRC after a median follow-up of 10.9 years. Low-dose aspirin was used at least once by 579,196 (26.5%) individuals.
• Low-dose aspirin use was more common among males, older individuals, those with a lower education or lower income, those of Norwegian origin, and individuals using other medications, including those targeting cardiovascular conditions.
• Compared with never-use, current aspirin use was associated with a lower CRC risk (hazard ratio [HR], 0.87), an association that was more pronounced for metastatic CRC (HR, 0.79) than for regionally advanced (HR, 0.89) and localized disease (HR, 0.93).
• Duration of current aspirin use was also associated with the degree of CRC risk, at HRs of 0.91 for < 3 years, 0.85 for ≥ 3 and < 5 years, and 0.84 for ≥ 5 years.
• It was estimated that aspirin use averted 1073 cases of CRC over the study period.

IN PRACTICE:

“We believe that new randomized controlled trials are urgently needed to confirm the potential protective effect of aspirin against CRC and to identify subgroups in the population who might benefit the most from the use of aspirin,” the authors wrote.

SOURCE:

The research, led by Edoardo Botteri, PhD, Department of Research, Cancer Registry of Norway, National Institute of Public Health, Oslo, Norway, was published online in The American Journal of Gastroenterology.

LIMITATIONS:

This study is limited by its observational nature. Users and nonusers are also “incomparable,” as aspirin is used for the primary prevention of cardiovascular events. Moreover, information was lacking in the registries about “several known risk factors for CRC,” and so the link between aspirin and CRC risk could have been over- or underestimated. Finally, the defined daily dose may not necessarily reflect the dose actually taken by the individual or how often it was taken.

DISCLOSURES:

No relevant financial relationships were declared. The study was funded by the Norwegian Research Council.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Low-dose aspirin use is associated with a reduced risk for colorectal cancer (CRC), confirms a large-scale cohort study, which also suggests that the risk reduction is greatest for metastatic disease and in individuals who take the drug for at least 5 years.

METHODOLOGY:

• Researchers used several population-based registries to identify individuals aged ≥ 50 years living in Norway between 2014 and 2018, excluding those with a prior history of invasive cancer or who had lived in Norway for less than 6 months before study commencement.
• Sociodemographic information was obtained, as well as low-dose aspirin prescription data to determine the prescription date, number of dispensed packages, and defined daily dose.
• Follow-up began 6 months after entering the cohort and continued until CRC diagnosis, another cancer diagnosis, death, emigration, or the end of follow-up on December 31, 2018.
• CRC cases were categorized by site as well as by clinical stage.

TAKEAWAY:

• Of 2,186,390 individuals included, 38,577 (1.8%) were diagnosed with CRC after a median follow-up of 10.9 years. Low-dose aspirin was used at least once by 579,196 (26.5%) individuals.
• Low-dose aspirin use was more common among males, older individuals, those with a lower education or lower income, those of Norwegian origin, and individuals using other medications, including those targeting cardiovascular conditions.
• Compared with never-use, current aspirin use was associated with a lower CRC risk (hazard ratio [HR], 0.87), an association that was more pronounced for metastatic CRC (HR, 0.79) than for regionally advanced (HR, 0.89) and localized disease (HR, 0.93).
• Duration of current aspirin use was also associated with the degree of CRC risk, at HRs of 0.91 for < 3 years, 0.85 for ≥ 3 and < 5 years, and 0.84 for ≥ 5 years.
• It was estimated that aspirin use averted 1073 cases of CRC over the study period.

IN PRACTICE:

“We believe that new randomized controlled trials are urgently needed to confirm the potential protective effect of aspirin against CRC and to identify subgroups in the population who might benefit the most from the use of aspirin,” the authors wrote.

SOURCE:

The research, led by Edoardo Botteri, PhD, Department of Research, Cancer Registry of Norway, National Institute of Public Health, Oslo, Norway, was published online in The American Journal of Gastroenterology.

LIMITATIONS:

This study is limited by its observational nature. Users and nonusers are also “incomparable,” as aspirin is used for the primary prevention of cardiovascular events. Moreover, information was lacking in the registries about “several known risk factors for CRC,” and so the link between aspirin and CRC risk could have been over- or underestimated. Finally, the defined daily dose may not necessarily reflect the dose actually taken by the individual or how often it was taken.

DISCLOSURES:

No relevant financial relationships were declared. The study was funded by the Norwegian Research Council.
 

A version of this article appeared on Medscape.com.

Long-term adherence to a plant-based diet was not tied to a greater risk of hip fracture and some plant-based regimens may actually reduce the risk, a large cohort study of postmenopausal women in the United States suggested.

Not all plant-centered regimens are healthful, however, and this study factored dietary quality into risk.

Writing in JAMA Network Open, the study authors compared the lowest to highest quintiles of Plant-Based Diet Index scores. They found the most recent intake of a healthy plant-based diet (hPDI) to be associated with a somewhat lower (21%) risk of fracture while the most recent intake of its unhealthy counterpart (uPDI) was linked to a somewhat higher (28%) risk.

“In addition, higher baseline scores in the uPDI were associated with higher risk of hip fracture,” wrote the researchers, led by Mercedes Sotos Prieto, PhD, a nutritional epidemiologist in the Department of Preventive Medicine and Public Health at the Autonomous University of Madrid.

Plant-based diets, characterized by higher consumption of plant foods and lower or no intake of animal foods, have raised concerns about their potential harm to bone health. In a recent meta-analysis, vegetarians, but particularly vegans with no consumption of any animal food, had a higher fracture risk and lower bone mineral density compared with omnivores.

Another study found that compared with meat eaters, fish eaters and vegetarians had a higher risk of hip fractures. These analyses, however, did not assess the quality of the plant-based diets.

Courtesy Dr. Sotos Prieto

“We hypothesized that the differences in the quality of the plant-based diets — whole grains, fruits, and vegetables vs refined carbohydrates or snacks, which are both plant-based but very different, would be important in the association for the risk of hip fracture,” Dr. Sotos Prieto said in an interview.
 

Study details

Her study drew on data from 70,285 postmenopausal White women who were in the US Nurses’ Health Study from 1984 through 2014; data were analyzed from Jan. 1 to July 31, 2023.

The mean age of the nurses was 54.92 years, and 2038 cases of hip fracture were reported during the study over as long as 30 years of follow-up.

Healthy plant foods included whole grains, fruits, vegetables, nuts, legumes, vegetable oils, and tea or coffee and received positive scores, whereas less healthy plant foods such as fruit juices, sweetened beverages, refined grains, potatoes, sweets, or desserts and animal foods received reversed scores. Dietary and lifestyle information was collected by self-reported questionnaires.

Individuals with higher hPDI scores were leaner, more physically active, less likely to be smokers, and more likely to use vitamin and calcium supplements. Not surprisingly, they also had higher intakes of dietary calcium and healthy plant foods and had lower intake of less healthy plant foods. “It’s plausible that reverse causation may account for the risk associations, as individuals with underlying health conditions that predisposed them to higher fracture risk may have changed their diet,” Dr. Sotos Prieto said. “In addition, baseline diet may reflect diet early on, which could be an important predictor of bone mineral density when there was more active bone turnover.”

Lack of information precluded adjustment for the use of anti-osteoporotic medication.

Neither the hPDI, with a hazard ratio (HR) for highest vs lowest quintile of 0.97 (95% confidence interval, 0.83-1.14) nor the uPDI, with an HR for highest vs lowest quintile of 1.02 (95% CI, 0.87-1.20) for diet adherence over the long term was associated with hip fracture risk.

For recent dietary intake in the highest vs lowest quintiles, however, the hPDI was associated with a 21% lower risk of hip fracture: HR, 0.79 (95% CI, 0.68-0.92; P = .02 for trend). In contrast, the uPDI was associated with a 28% higher risk: HR, 1.28 (95% CI, 1.09-1.51; P = .008 for trend).

Future studies in other populations are needed to confirm the results and enhance their generalizability, Dr. Sotos Prieto said. “Investigating the temporal dynamics of dietary patterns and their effects by examining how recent dietary changes may impact health outcomes over different timeframes is important.” In the meantime, people wishing to follow a plant-based diet should make sure it features high-quality foods.

This work was supported by Instituto de Salud Carlos III, State Secretary of Research, Development and Innovation of Spain, and the European Research Funds and European Social Fund, the Agencia Estatal de Investigación, the National Institutes of Health, and a Ramón y Cajal contract from the Ministry of Science, Innovation, and Universities. A coauthor reported a patent pending. No other disclosures were reported.

Long-term adherence to a plant-based diet was not tied to a greater risk of hip fracture and some plant-based regimens may actually reduce the risk, a large cohort study of postmenopausal women in the United States suggested.

Not all plant-centered regimens are healthful, however, and this study factored dietary quality into risk.

Writing in JAMA Network Open, the study authors compared the lowest to highest quintiles of Plant-Based Diet Index scores. They found the most recent intake of a healthy plant-based diet (hPDI) to be associated with a somewhat lower (21%) risk of fracture while the most recent intake of its unhealthy counterpart (uPDI) was linked to a somewhat higher (28%) risk.

“In addition, higher baseline scores in the uPDI were associated with higher risk of hip fracture,” wrote the researchers, led by Mercedes Sotos Prieto, PhD, a nutritional epidemiologist in the Department of Preventive Medicine and Public Health at the Autonomous University of Madrid.

Plant-based diets, characterized by higher consumption of plant foods and lower or no intake of animal foods, have raised concerns about their potential harm to bone health. In a recent meta-analysis, vegetarians, but particularly vegans with no consumption of any animal food, had a higher fracture risk and lower bone mineral density compared with omnivores.

Another study found that compared with meat eaters, fish eaters and vegetarians had a higher risk of hip fractures. These analyses, however, did not assess the quality of the plant-based diets.

Courtesy Dr. Sotos Prieto

“We hypothesized that the differences in the quality of the plant-based diets — whole grains, fruits, and vegetables vs refined carbohydrates or snacks, which are both plant-based but very different, would be important in the association for the risk of hip fracture,” Dr. Sotos Prieto said in an interview.
 

Study details

Her study drew on data from 70,285 postmenopausal White women who were in the US Nurses’ Health Study from 1984 through 2014; data were analyzed from Jan. 1 to July 31, 2023.

The mean age of the nurses was 54.92 years, and 2038 cases of hip fracture were reported during the study over as long as 30 years of follow-up.

Healthy plant foods included whole grains, fruits, vegetables, nuts, legumes, vegetable oils, and tea or coffee and received positive scores, whereas less healthy plant foods such as fruit juices, sweetened beverages, refined grains, potatoes, sweets, or desserts and animal foods received reversed scores. Dietary and lifestyle information was collected by self-reported questionnaires.

Individuals with higher hPDI scores were leaner, more physically active, less likely to be smokers, and more likely to use vitamin and calcium supplements. Not surprisingly, they also had higher intakes of dietary calcium and healthy plant foods and had lower intake of less healthy plant foods. “It’s plausible that reverse causation may account for the risk associations, as individuals with underlying health conditions that predisposed them to higher fracture risk may have changed their diet,” Dr. Sotos Prieto said. “In addition, baseline diet may reflect diet early on, which could be an important predictor of bone mineral density when there was more active bone turnover.”

Lack of information precluded adjustment for the use of anti-osteoporotic medication.

Neither the hPDI, with a hazard ratio (HR) for highest vs lowest quintile of 0.97 (95% confidence interval, 0.83-1.14) nor the uPDI, with an HR for highest vs lowest quintile of 1.02 (95% CI, 0.87-1.20) for diet adherence over the long term was associated with hip fracture risk.

For recent dietary intake in the highest vs lowest quintiles, however, the hPDI was associated with a 21% lower risk of hip fracture: HR, 0.79 (95% CI, 0.68-0.92; P = .02 for trend). In contrast, the uPDI was associated with a 28% higher risk: HR, 1.28 (95% CI, 1.09-1.51; P = .008 for trend).

Future studies in other populations are needed to confirm the results and enhance their generalizability, Dr. Sotos Prieto said. “Investigating the temporal dynamics of dietary patterns and their effects by examining how recent dietary changes may impact health outcomes over different timeframes is important.” In the meantime, people wishing to follow a plant-based diet should make sure it features high-quality foods.

This work was supported by Instituto de Salud Carlos III, State Secretary of Research, Development and Innovation of Spain, and the European Research Funds and European Social Fund, the Agencia Estatal de Investigación, the National Institutes of Health, and a Ramón y Cajal contract from the Ministry of Science, Innovation, and Universities. A coauthor reported a patent pending. No other disclosures were reported.

Long-term adherence to a plant-based diet was not tied to a greater risk of hip fracture and some plant-based regimens may actually reduce the risk, a large cohort study of postmenopausal women in the United States suggested.

Not all plant-centered regimens are healthful, however, and this study factored dietary quality into risk.

Writing in JAMA Network Open, the study authors compared the lowest to highest quintiles of Plant-Based Diet Index scores. They found the most recent intake of a healthy plant-based diet (hPDI) to be associated with a somewhat lower (21%) risk of fracture while the most recent intake of its unhealthy counterpart (uPDI) was linked to a somewhat higher (28%) risk.

“In addition, higher baseline scores in the uPDI were associated with higher risk of hip fracture,” wrote the researchers, led by Mercedes Sotos Prieto, PhD, a nutritional epidemiologist in the Department of Preventive Medicine and Public Health at the Autonomous University of Madrid.

Plant-based diets, characterized by higher consumption of plant foods and lower or no intake of animal foods, have raised concerns about their potential harm to bone health. In a recent meta-analysis, vegetarians, but particularly vegans with no consumption of any animal food, had a higher fracture risk and lower bone mineral density compared with omnivores.

Another study found that compared with meat eaters, fish eaters and vegetarians had a higher risk of hip fractures. These analyses, however, did not assess the quality of the plant-based diets.

Courtesy Dr. Sotos Prieto

“We hypothesized that the differences in the quality of the plant-based diets — whole grains, fruits, and vegetables vs refined carbohydrates or snacks, which are both plant-based but very different, would be important in the association for the risk of hip fracture,” Dr. Sotos Prieto said in an interview.
 

Study details

Her study drew on data from 70,285 postmenopausal White women who were in the US Nurses’ Health Study from 1984 through 2014; data were analyzed from Jan. 1 to July 31, 2023.

The mean age of the nurses was 54.92 years, and 2038 cases of hip fracture were reported during the study over as long as 30 years of follow-up.

Healthy plant foods included whole grains, fruits, vegetables, nuts, legumes, vegetable oils, and tea or coffee and received positive scores, whereas less healthy plant foods such as fruit juices, sweetened beverages, refined grains, potatoes, sweets, or desserts and animal foods received reversed scores. Dietary and lifestyle information was collected by self-reported questionnaires.

Individuals with higher hPDI scores were leaner, more physically active, less likely to be smokers, and more likely to use vitamin and calcium supplements. Not surprisingly, they also had higher intakes of dietary calcium and healthy plant foods and had lower intake of less healthy plant foods. “It’s plausible that reverse causation may account for the risk associations, as individuals with underlying health conditions that predisposed them to higher fracture risk may have changed their diet,” Dr. Sotos Prieto said. “In addition, baseline diet may reflect diet early on, which could be an important predictor of bone mineral density when there was more active bone turnover.”

Lack of information precluded adjustment for the use of anti-osteoporotic medication.

Neither the hPDI, with a hazard ratio (HR) for highest vs lowest quintile of 0.97 (95% confidence interval, 0.83-1.14) nor the uPDI, with an HR for highest vs lowest quintile of 1.02 (95% CI, 0.87-1.20) for diet adherence over the long term was associated with hip fracture risk.

For recent dietary intake in the highest vs lowest quintiles, however, the hPDI was associated with a 21% lower risk of hip fracture: HR, 0.79 (95% CI, 0.68-0.92; P = .02 for trend). In contrast, the uPDI was associated with a 28% higher risk: HR, 1.28 (95% CI, 1.09-1.51; P = .008 for trend).

Future studies in other populations are needed to confirm the results and enhance their generalizability, Dr. Sotos Prieto said. “Investigating the temporal dynamics of dietary patterns and their effects by examining how recent dietary changes may impact health outcomes over different timeframes is important.” In the meantime, people wishing to follow a plant-based diet should make sure it features high-quality foods.

This work was supported by Instituto de Salud Carlos III, State Secretary of Research, Development and Innovation of Spain, and the European Research Funds and European Social Fund, the Agencia Estatal de Investigación, the National Institutes of Health, and a Ramón y Cajal contract from the Ministry of Science, Innovation, and Universities. A coauthor reported a patent pending. No other disclosures were reported.

TOPLINE:

Galantamine purchased as a dietary supplement may be more likely to contain bacterial contaminants and an incorrect amount of the product vs when it is prescribed as a generic drug, new research showed.

METHODOLOGY:

• Galantamine, a plant alkaloid, is approved for treating mild to moderate Alzheimer’s dementia but is also marketed as a dietary supplement for cognitive enhancement.
• In June 2023, researchers purchased all 10 galantamine dietary supplements available on Amazon.com that had a Supplement Facts panel.
• In September 2023, they acquired all 11 generic immediate-release formulations of prescription galantamine available in the United States.
• They analyzed the content of galantamine in each product using ultrahigh-performance liquid chromatography-mass spectrometry and quantified any microorganisms present.

TAKEAWAY:

• Generic galantamine drugs were found to contain 97.5%-104.2% of the labeled content, with no microbial contamination.
• Galantamine dietary supplements, however, showed a wide variance in content, ranging from less than 2% to 110% of the labeled amount, and 30% were contaminated with Bacillus cereus sensu stricto. The amount of bacteria present would not have been expected to harm consumers, according to the authors of the study.

IN PRACTICE:

“Clinicians should query patients with memory concerns about the use of dietary supplements and advise patients not to use galantamine supplements,” the researchers wrote.

SOURCE:

The corresponding author of the study was Pieter A. Cohen, MD, with Broadway Clinic, Cambridge Health Alliance, in Somerville, Massachusetts. The paper was published online as a research letter in JAMA.

LIMITATIONS:

The products were purchased at a single point in time and may not reflect current options, the researchers noted. The generalizability of the findings to other supplement ingredients or generic drugs is unknown.

DISCLOSURES:

Dr. Cohen has received grants from the Consumers Union and PEW Charitable Trust and personal fees from UpToDate and the Centers for Disease Control and Prevention. He has been sued by a supplement company in a case where the jury found in his favor.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

A version of this article appeared on Medscape.com.

TOPLINE:

Galantamine purchased as a dietary supplement may be more likely to contain bacterial contaminants and an incorrect amount of the product vs when it is prescribed as a generic drug, new research showed.

METHODOLOGY:

• Galantamine, a plant alkaloid, is approved for treating mild to moderate Alzheimer’s dementia but is also marketed as a dietary supplement for cognitive enhancement.
• In June 2023, researchers purchased all 10 galantamine dietary supplements available on Amazon.com that had a Supplement Facts panel.
• In September 2023, they acquired all 11 generic immediate-release formulations of prescription galantamine available in the United States.
• They analyzed the content of galantamine in each product using ultrahigh-performance liquid chromatography-mass spectrometry and quantified any microorganisms present.

TAKEAWAY:

• Generic galantamine drugs were found to contain 97.5%-104.2% of the labeled content, with no microbial contamination.
• Galantamine dietary supplements, however, showed a wide variance in content, ranging from less than 2% to 110% of the labeled amount, and 30% were contaminated with Bacillus cereus sensu stricto. The amount of bacteria present would not have been expected to harm consumers, according to the authors of the study.

IN PRACTICE:

“Clinicians should query patients with memory concerns about the use of dietary supplements and advise patients not to use galantamine supplements,” the researchers wrote.

SOURCE:

The corresponding author of the study was Pieter A. Cohen, MD, with Broadway Clinic, Cambridge Health Alliance, in Somerville, Massachusetts. The paper was published online as a research letter in JAMA.

LIMITATIONS:

The products were purchased at a single point in time and may not reflect current options, the researchers noted. The generalizability of the findings to other supplement ingredients or generic drugs is unknown.

DISCLOSURES:

Dr. Cohen has received grants from the Consumers Union and PEW Charitable Trust and personal fees from UpToDate and the Centers for Disease Control and Prevention. He has been sued by a supplement company in a case where the jury found in his favor.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

A version of this article appeared on Medscape.com.

TOPLINE:

Galantamine purchased as a dietary supplement may be more likely to contain bacterial contaminants and an incorrect amount of the product vs when it is prescribed as a generic drug, new research showed.

METHODOLOGY:

• Galantamine, a plant alkaloid, is approved for treating mild to moderate Alzheimer’s dementia but is also marketed as a dietary supplement for cognitive enhancement.
• In June 2023, researchers purchased all 10 galantamine dietary supplements available on Amazon.com that had a Supplement Facts panel.
• In September 2023, they acquired all 11 generic immediate-release formulations of prescription galantamine available in the United States.
• They analyzed the content of galantamine in each product using ultrahigh-performance liquid chromatography-mass spectrometry and quantified any microorganisms present.

TAKEAWAY:

• Generic galantamine drugs were found to contain 97.5%-104.2% of the labeled content, with no microbial contamination.
• Galantamine dietary supplements, however, showed a wide variance in content, ranging from less than 2% to 110% of the labeled amount, and 30% were contaminated with Bacillus cereus sensu stricto. The amount of bacteria present would not have been expected to harm consumers, according to the authors of the study.

IN PRACTICE:

“Clinicians should query patients with memory concerns about the use of dietary supplements and advise patients not to use galantamine supplements,” the researchers wrote.

SOURCE:

The corresponding author of the study was Pieter A. Cohen, MD, with Broadway Clinic, Cambridge Health Alliance, in Somerville, Massachusetts. The paper was published online as a research letter in JAMA.

LIMITATIONS:

The products were purchased at a single point in time and may not reflect current options, the researchers noted. The generalizability of the findings to other supplement ingredients or generic drugs is unknown.

DISCLOSURES:

Dr. Cohen has received grants from the Consumers Union and PEW Charitable Trust and personal fees from UpToDate and the Centers for Disease Control and Prevention. He has been sued by a supplement company in a case where the jury found in his favor.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

A version of this article appeared on Medscape.com.

Will the new US Department of Veterans Affairs (VA) pharmacy software be safe and effective? That was the topic when David Case, the VA Deputy Inspector General, spoke in the US House of Representatives Veterans Affairs Committee technology modernization subcommittee hearing on February 15.

Questions like that have dogged the project since 2018, when the VA began rolling out the Oracle Cerner electronic health record (EHR) system as the successor to ViSTA.

The Oracle system has been beset by one glitch after another since its arrival. And in that time, Case said, the VA Office of Inspector General (OIG) has been engaging with VA employees at sites in Washington, Oregon, Ohio, Illinois, and other locations where the modernization program has been piloted.

The most recent OIG investigation of pharmacy-related patient safety issues began with a review of an allegation of a prescription backlog at Columbus, Ohio, where the system went live on April 30, 2022. The OIG found that facility leaders took “timely and sustainable steps” to manage that issue. However, other unresolved patient safety issues came to light, such as medication inaccuracies, inaccurate medication data, and insufficient staffing. The OIG also found staff were creating “numerous work arounds” to provide patient care, and that the volume of staff educational materials for pharmacy-related functions was “overwhelming.”

Those problems were just the latest in a long queue. In May 2021, after the first VA deployment of the new EHR at the Mann-Grandstaff VA Medical Center in Spokane, Washington, a pharmacy patient safety team under the VA National Center for Patient Safety (NCPS) also had identified patient safety issues and “multiple” concerns regarding the system’s usability. For example, updates to a patient’s active medication list were not routinely reflected at the patient’s next appointment. Despite knowing about such challenges, Case noted in his report, VA leaders deployed the new EHR at 4 more VA medical centers.

Cerner/ViSTA Communication

One major cause of the current problems is the way the systems “talk” to each other. EHR information is communicated between VHA facilities through channels that include the Joint Longitudinal Viewer (JLV) and the Health Data Repository, which stores patient-specific clinical information from both the legacy and the new EHR systems. The JLV application allows clinicians to access a read only version of a patient’s EHR from both systems.

Every medication used in VHA has a VA Unique Identifier (VUID). When a patient is prescribed a medication at a new EHR site, that medication’s VUID is sent to the Health Data Repository. If that patient seeks care from a legacy health care practitioner (HCP), and that HCP enters a medication order, a software interface accesses the VUID from the Health Data Repository to verify that the medication being prescribed is safe and compatible with the medications and allergies previously documented in the patient’s record.

However, on March 31, 2023, staff from a ViSTA site found an incorrect medication order when prescribing a new medication to a patient who had received care and medications at a new EHR site. This in turn led to the discovery that an error in Oracle software coding had resulted in the “widespread transmission” of incorrect VUIDs from new EHR sites to legacy EHR sites, the OIG found. VA leaders and HCPs were notified of the potential clinical impact and were given specific instructions on how to mitigate the issue. They were asked to “please share widely.”

On top of that, days later, patient safety managers across the Veterans Health Administration (VHA) were told that drug-to-drug interactions, duplicate medication orders, and allergy checks were not functioning as expected, and they too were provided with remedial actions.

Oracle applied a successful software patch on in April 2023, to ensure accurate VUIDs were attached to all mail order pharmacy–processed prescriptions from that date forward. However, the OIG learned the incorrect VUIDs sent from new EHR sites and stored in the Health Data Repository from as far back as October 2020 had not been corrected. Case told the subcommittee that on November 29, 2023, the VHA Pharmacy Council reported withdrawing a request for Oracle to send corrected medication VUID data to the Health Data Repository, on the presumption that remaining inaccurate VUIDs would expire in early April 2024, and the data would be corrected at that time.

The OIG is concerned, Case said, that patient medication data remains inaccurate almost a year after VA learned of the issue. The mail order pharmacy-related data generated from approximately 120,000 patients served by new EHR sites are still incorrect. These patients face an ongoing risk of an adverse medication-related event if they receive care and medications from a VA medical center using the legacy EHR system.

The OIG also learned of other problems associated with transmission of medication and allergy information, which could have consequences such as:

• Patient medications being discontinued or stopped by new HCPs using Cerner that appear in ViSTA as active and current prescriptions;
• Allergy-warning messages not appearing when intended or inappropriately appearing for the wrong medication;
• Duplicate medication order checks not appearing when intended or inappropriately appearing for the wrong drug;
• Patient active medication lists having incomplete or inaccurate information, such as missing prescriptions, duplicate prescriptions, or incorrect medication order statuses.

The OIG warned VHA employees about the risks, although it wasn’t possible to determine who might actually be at risk. A VHA leader told the OIG that all patients who have been prescribed any medications or have medication allergies documented at a at a Cerner site are at risk. That could mean as many as 250,000 patients: As of September 2023, approximately 190,000 patients had a medication prescribed and 126,000 had an allergy documented at a new EHR site.

Case Example

Not surprisingly, “the OIG is not confident in [EHRM-Integration Office] leaders’ oversight and control of the new systems’ Health Data Repository interface programming,” Case said. He cited the case of a patient with posttraumatic stress disorder and traumatic brain injury with adrenal insufficiency. Four days prior to admission, a ViSTA site pharmacist used the EHR to perform a medication reconciliation for the patient. The data available did not include the patient’s most recent prednisone prescription, which had been ordered by an HCP at a facility using Cerner.

A nurse practitioner performed another reconciliation when the patient was admitted to the residential program, but the patient was unsure of all their medications. Because the most recent prednisone prescription was not visible in ViSTA, the prednisone appeared to have been completed at least 3 months prior to admission and was therefore not prescribed in the admission medication orders.

Five days into the residential program, the patient began exhibiting unusual behaviors associated with the lack of prednisone. The patient realized they needed more prednisone, but the nurse explained there was no prednisone on the patient’s medication list. Eventually, the patient found the active prednisone order on their personal cell phone and was transferred to a local emergency department for care.

Work Arounds

The VHA’s efforts to forestall or mitigate system errors have in some cases had a cascade effect. For example, HCPs must essentially back up what the automated software is intended to do, with “complex, time-consuming” multistep manual safety checks when prescribing new medications for patients previously cared for at a Cerner site. The OIG is concerned that this increased vigilance is “unsustainable” by pharmacists and frontline staff and could lead to burnout and medication-related patient safety events. After the new EHR launched, the OIG found, burnout symptoms for pharmacy staff increased. Nonetheless, Case told the committee, OIG staff “have observed [employees’] unwavering commitment to prioritizing the care of patients while mitigating implementation challenges.”

EHR-related workload burdens have necessitated other adjustments. Columbus, for instance, hired 9 full-time clinical pharmacists—a 62% staffing increase—to help reduce the backlog. Pharmacy leaders created approximately 29 additional work-arounds to support pharmacy staff and prevent delays. Facility pharmacy leaders also developed approximately 25 educational materials, such as tip sheets, reference guides, and job aids. The OIG’s concern—apart from the overwhelming amount of information for staff to implement—is that such prophylactic measures may in fact give rise to inconsistent practices, which increase risks to patient safety.

Committed to Working With the VA

Mike Sicilia, executive vice president of Oracle Corporation, told lawmakers in the hearing, “After the initial deployments, it became clear that the pharmacy system needed to be enhanced to better meet VA’s needs. To that end, in August 2022, shortly after Oracle completed its acquisition of Cerner, VA contracted with us for seven enhancements that overall would adapt the pharmacy system to a more bidirectional system between VA providers placing prescription orders and VA pharmacists fulfilling and dispensing them.” Those enhancements are all live for VA providers and pharmacists to use now, he said, except for one that is undergoing additional testing.

He added, “As with any healthcare technology system, there is a need for continuous improvements but that does not mean the system is not safe and effective in its current state. Oracle is committed to working with VA … throughout the reset period to identify workflows and other items that can be simplified or streamlined to improve the overall user and pharmacy experience.”

Standardizing workflows and ensuring training and communications to pharmacists about the latest updates will discourage use of work-arounds, Sicilia said, and “help with improving morale and satisfaction with the system.” During a visit in early February by VA and the Oracle team to the Lovell Federal Health Care Center in North Chicago, “feedback from pharmacists was positive about the training and readiness for using the new pharmacy system.”

The backlog, at least, may be resolved. Sicilia said on average more than 215,000 outpatient prescriptions are being filled each month. “The current live sites do not have a backlog in filling prescriptions. Recent data from this month show that three of the five live sites have zero prescriptions waiting to be processed that are older than seven days. The two other live sites have an average of two prescriptions older than seven days,” he said.

Although Oracle Health has since resolved some of the identified issues, the OIG is concerned that the new EHR will continue to be deployed at medical facilities despite “myriad” as-yet unresolved issues related to inaccurate medication ordering, reconciliation, and dispensing. The VHA has paused Cerner deployments multiple times.

“It is unclear whether identified problems are being adequately resolved before additional deployments,” Case said. “There is also the question of whether there is sufficient transparency and communication among EHRM-IO, VHA and facility leaders, VA leaders, and Oracle Health needed for quality control and critical coordination. Trust in VA is also dependent on patients being fully and quickly advised when issues affecting them are identified and addressed. As VA moves toward its deployment next month at a complex facility jointly operated with the Department of Defense, transparency, communication, and program management will be essential to getting it right. Failures in these areas risk cascading problems.”

Will the new US Department of Veterans Affairs (VA) pharmacy software be safe and effective? That was the topic when David Case, the VA Deputy Inspector General, spoke in the US House of Representatives Veterans Affairs Committee technology modernization subcommittee hearing on February 15.

Questions like that have dogged the project since 2018, when the VA began rolling out the Oracle Cerner electronic health record (EHR) system as the successor to ViSTA.

The Oracle system has been beset by one glitch after another since its arrival. And in that time, Case said, the VA Office of Inspector General (OIG) has been engaging with VA employees at sites in Washington, Oregon, Ohio, Illinois, and other locations where the modernization program has been piloted.

The most recent OIG investigation of pharmacy-related patient safety issues began with a review of an allegation of a prescription backlog at Columbus, Ohio, where the system went live on April 30, 2022. The OIG found that facility leaders took “timely and sustainable steps” to manage that issue. However, other unresolved patient safety issues came to light, such as medication inaccuracies, inaccurate medication data, and insufficient staffing. The OIG also found staff were creating “numerous work arounds” to provide patient care, and that the volume of staff educational materials for pharmacy-related functions was “overwhelming.”

Those problems were just the latest in a long queue. In May 2021, after the first VA deployment of the new EHR at the Mann-Grandstaff VA Medical Center in Spokane, Washington, a pharmacy patient safety team under the VA National Center for Patient Safety (NCPS) also had identified patient safety issues and “multiple” concerns regarding the system’s usability. For example, updates to a patient’s active medication list were not routinely reflected at the patient’s next appointment. Despite knowing about such challenges, Case noted in his report, VA leaders deployed the new EHR at 4 more VA medical centers.

Cerner/ViSTA Communication

One major cause of the current problems is the way the systems “talk” to each other. EHR information is communicated between VHA facilities through channels that include the Joint Longitudinal Viewer (JLV) and the Health Data Repository, which stores patient-specific clinical information from both the legacy and the new EHR systems. The JLV application allows clinicians to access a read only version of a patient’s EHR from both systems.

Every medication used in VHA has a VA Unique Identifier (VUID). When a patient is prescribed a medication at a new EHR site, that medication’s VUID is sent to the Health Data Repository. If that patient seeks care from a legacy health care practitioner (HCP), and that HCP enters a medication order, a software interface accesses the VUID from the Health Data Repository to verify that the medication being prescribed is safe and compatible with the medications and allergies previously documented in the patient’s record.

However, on March 31, 2023, staff from a ViSTA site found an incorrect medication order when prescribing a new medication to a patient who had received care and medications at a new EHR site. This in turn led to the discovery that an error in Oracle software coding had resulted in the “widespread transmission” of incorrect VUIDs from new EHR sites to legacy EHR sites, the OIG found. VA leaders and HCPs were notified of the potential clinical impact and were given specific instructions on how to mitigate the issue. They were asked to “please share widely.”

On top of that, days later, patient safety managers across the Veterans Health Administration (VHA) were told that drug-to-drug interactions, duplicate medication orders, and allergy checks were not functioning as expected, and they too were provided with remedial actions.

Oracle applied a successful software patch on in April 2023, to ensure accurate VUIDs were attached to all mail order pharmacy–processed prescriptions from that date forward. However, the OIG learned the incorrect VUIDs sent from new EHR sites and stored in the Health Data Repository from as far back as October 2020 had not been corrected. Case told the subcommittee that on November 29, 2023, the VHA Pharmacy Council reported withdrawing a request for Oracle to send corrected medication VUID data to the Health Data Repository, on the presumption that remaining inaccurate VUIDs would expire in early April 2024, and the data would be corrected at that time.

The OIG is concerned, Case said, that patient medication data remains inaccurate almost a year after VA learned of the issue. The mail order pharmacy-related data generated from approximately 120,000 patients served by new EHR sites are still incorrect. These patients face an ongoing risk of an adverse medication-related event if they receive care and medications from a VA medical center using the legacy EHR system.

The OIG also learned of other problems associated with transmission of medication and allergy information, which could have consequences such as:

• Patient medications being discontinued or stopped by new HCPs using Cerner that appear in ViSTA as active and current prescriptions;
• Allergy-warning messages not appearing when intended or inappropriately appearing for the wrong medication;
• Duplicate medication order checks not appearing when intended or inappropriately appearing for the wrong drug;
• Patient active medication lists having incomplete or inaccurate information, such as missing prescriptions, duplicate prescriptions, or incorrect medication order statuses.

The OIG warned VHA employees about the risks, although it wasn’t possible to determine who might actually be at risk. A VHA leader told the OIG that all patients who have been prescribed any medications or have medication allergies documented at a at a Cerner site are at risk. That could mean as many as 250,000 patients: As of September 2023, approximately 190,000 patients had a medication prescribed and 126,000 had an allergy documented at a new EHR site.

Case Example

Not surprisingly, “the OIG is not confident in [EHRM-Integration Office] leaders’ oversight and control of the new systems’ Health Data Repository interface programming,” Case said. He cited the case of a patient with posttraumatic stress disorder and traumatic brain injury with adrenal insufficiency. Four days prior to admission, a ViSTA site pharmacist used the EHR to perform a medication reconciliation for the patient. The data available did not include the patient’s most recent prednisone prescription, which had been ordered by an HCP at a facility using Cerner.

A nurse practitioner performed another reconciliation when the patient was admitted to the residential program, but the patient was unsure of all their medications. Because the most recent prednisone prescription was not visible in ViSTA, the prednisone appeared to have been completed at least 3 months prior to admission and was therefore not prescribed in the admission medication orders.

Five days into the residential program, the patient began exhibiting unusual behaviors associated with the lack of prednisone. The patient realized they needed more prednisone, but the nurse explained there was no prednisone on the patient’s medication list. Eventually, the patient found the active prednisone order on their personal cell phone and was transferred to a local emergency department for care.

Work Arounds

The VHA’s efforts to forestall or mitigate system errors have in some cases had a cascade effect. For example, HCPs must essentially back up what the automated software is intended to do, with “complex, time-consuming” multistep manual safety checks when prescribing new medications for patients previously cared for at a Cerner site. The OIG is concerned that this increased vigilance is “unsustainable” by pharmacists and frontline staff and could lead to burnout and medication-related patient safety events. After the new EHR launched, the OIG found, burnout symptoms for pharmacy staff increased. Nonetheless, Case told the committee, OIG staff “have observed [employees’] unwavering commitment to prioritizing the care of patients while mitigating implementation challenges.”

EHR-related workload burdens have necessitated other adjustments. Columbus, for instance, hired 9 full-time clinical pharmacists—a 62% staffing increase—to help reduce the backlog. Pharmacy leaders created approximately 29 additional work-arounds to support pharmacy staff and prevent delays. Facility pharmacy leaders also developed approximately 25 educational materials, such as tip sheets, reference guides, and job aids. The OIG’s concern—apart from the overwhelming amount of information for staff to implement—is that such prophylactic measures may in fact give rise to inconsistent practices, which increase risks to patient safety.

Committed to Working With the VA

Mike Sicilia, executive vice president of Oracle Corporation, told lawmakers in the hearing, “After the initial deployments, it became clear that the pharmacy system needed to be enhanced to better meet VA’s needs. To that end, in August 2022, shortly after Oracle completed its acquisition of Cerner, VA contracted with us for seven enhancements that overall would adapt the pharmacy system to a more bidirectional system between VA providers placing prescription orders and VA pharmacists fulfilling and dispensing them.” Those enhancements are all live for VA providers and pharmacists to use now, he said, except for one that is undergoing additional testing.

He added, “As with any healthcare technology system, there is a need for continuous improvements but that does not mean the system is not safe and effective in its current state. Oracle is committed to working with VA … throughout the reset period to identify workflows and other items that can be simplified or streamlined to improve the overall user and pharmacy experience.”

Standardizing workflows and ensuring training and communications to pharmacists about the latest updates will discourage use of work-arounds, Sicilia said, and “help with improving morale and satisfaction with the system.” During a visit in early February by VA and the Oracle team to the Lovell Federal Health Care Center in North Chicago, “feedback from pharmacists was positive about the training and readiness for using the new pharmacy system.”

The backlog, at least, may be resolved. Sicilia said on average more than 215,000 outpatient prescriptions are being filled each month. “The current live sites do not have a backlog in filling prescriptions. Recent data from this month show that three of the five live sites have zero prescriptions waiting to be processed that are older than seven days. The two other live sites have an average of two prescriptions older than seven days,” he said.

Although Oracle Health has since resolved some of the identified issues, the OIG is concerned that the new EHR will continue to be deployed at medical facilities despite “myriad” as-yet unresolved issues related to inaccurate medication ordering, reconciliation, and dispensing. The VHA has paused Cerner deployments multiple times.

“It is unclear whether identified problems are being adequately resolved before additional deployments,” Case said. “There is also the question of whether there is sufficient transparency and communication among EHRM-IO, VHA and facility leaders, VA leaders, and Oracle Health needed for quality control and critical coordination. Trust in VA is also dependent on patients being fully and quickly advised when issues affecting them are identified and addressed. As VA moves toward its deployment next month at a complex facility jointly operated with the Department of Defense, transparency, communication, and program management will be essential to getting it right. Failures in these areas risk cascading problems.”

Will the new US Department of Veterans Affairs (VA) pharmacy software be safe and effective? That was the topic when David Case, the VA Deputy Inspector General, spoke in the US House of Representatives Veterans Affairs Committee technology modernization subcommittee hearing on February 15.

Questions like that have dogged the project since 2018, when the VA began rolling out the Oracle Cerner electronic health record (EHR) system as the successor to ViSTA.

The Oracle system has been beset by one glitch after another since its arrival. And in that time, Case said, the VA Office of Inspector General (OIG) has been engaging with VA employees at sites in Washington, Oregon, Ohio, Illinois, and other locations where the modernization program has been piloted.

The most recent OIG investigation of pharmacy-related patient safety issues began with a review of an allegation of a prescription backlog at Columbus, Ohio, where the system went live on April 30, 2022. The OIG found that facility leaders took “timely and sustainable steps” to manage that issue. However, other unresolved patient safety issues came to light, such as medication inaccuracies, inaccurate medication data, and insufficient staffing. The OIG also found staff were creating “numerous work arounds” to provide patient care, and that the volume of staff educational materials for pharmacy-related functions was “overwhelming.”

Those problems were just the latest in a long queue. In May 2021, after the first VA deployment of the new EHR at the Mann-Grandstaff VA Medical Center in Spokane, Washington, a pharmacy patient safety team under the VA National Center for Patient Safety (NCPS) also had identified patient safety issues and “multiple” concerns regarding the system’s usability. For example, updates to a patient’s active medication list were not routinely reflected at the patient’s next appointment. Despite knowing about such challenges, Case noted in his report, VA leaders deployed the new EHR at 4 more VA medical centers.

Cerner/ViSTA Communication

One major cause of the current problems is the way the systems “talk” to each other. EHR information is communicated between VHA facilities through channels that include the Joint Longitudinal Viewer (JLV) and the Health Data Repository, which stores patient-specific clinical information from both the legacy and the new EHR systems. The JLV application allows clinicians to access a read only version of a patient’s EHR from both systems.

Every medication used in VHA has a VA Unique Identifier (VUID). When a patient is prescribed a medication at a new EHR site, that medication’s VUID is sent to the Health Data Repository. If that patient seeks care from a legacy health care practitioner (HCP), and that HCP enters a medication order, a software interface accesses the VUID from the Health Data Repository to verify that the medication being prescribed is safe and compatible with the medications and allergies previously documented in the patient’s record.

However, on March 31, 2023, staff from a ViSTA site found an incorrect medication order when prescribing a new medication to a patient who had received care and medications at a new EHR site. This in turn led to the discovery that an error in Oracle software coding had resulted in the “widespread transmission” of incorrect VUIDs from new EHR sites to legacy EHR sites, the OIG found. VA leaders and HCPs were notified of the potential clinical impact and were given specific instructions on how to mitigate the issue. They were asked to “please share widely.”

On top of that, days later, patient safety managers across the Veterans Health Administration (VHA) were told that drug-to-drug interactions, duplicate medication orders, and allergy checks were not functioning as expected, and they too were provided with remedial actions.

Oracle applied a successful software patch on in April 2023, to ensure accurate VUIDs were attached to all mail order pharmacy–processed prescriptions from that date forward. However, the OIG learned the incorrect VUIDs sent from new EHR sites and stored in the Health Data Repository from as far back as October 2020 had not been corrected. Case told the subcommittee that on November 29, 2023, the VHA Pharmacy Council reported withdrawing a request for Oracle to send corrected medication VUID data to the Health Data Repository, on the presumption that remaining inaccurate VUIDs would expire in early April 2024, and the data would be corrected at that time.

The OIG is concerned, Case said, that patient medication data remains inaccurate almost a year after VA learned of the issue. The mail order pharmacy-related data generated from approximately 120,000 patients served by new EHR sites are still incorrect. These patients face an ongoing risk of an adverse medication-related event if they receive care and medications from a VA medical center using the legacy EHR system.

The OIG also learned of other problems associated with transmission of medication and allergy information, which could have consequences such as:

• Patient medications being discontinued or stopped by new HCPs using Cerner that appear in ViSTA as active and current prescriptions;
• Allergy-warning messages not appearing when intended or inappropriately appearing for the wrong medication;
• Duplicate medication order checks not appearing when intended or inappropriately appearing for the wrong drug;
• Patient active medication lists having incomplete or inaccurate information, such as missing prescriptions, duplicate prescriptions, or incorrect medication order statuses.

The OIG warned VHA employees about the risks, although it wasn’t possible to determine who might actually be at risk. A VHA leader told the OIG that all patients who have been prescribed any medications or have medication allergies documented at a at a Cerner site are at risk. That could mean as many as 250,000 patients: As of September 2023, approximately 190,000 patients had a medication prescribed and 126,000 had an allergy documented at a new EHR site.

Case Example

Not surprisingly, “the OIG is not confident in [EHRM-Integration Office] leaders’ oversight and control of the new systems’ Health Data Repository interface programming,” Case said. He cited the case of a patient with posttraumatic stress disorder and traumatic brain injury with adrenal insufficiency. Four days prior to admission, a ViSTA site pharmacist used the EHR to perform a medication reconciliation for the patient. The data available did not include the patient’s most recent prednisone prescription, which had been ordered by an HCP at a facility using Cerner.

A nurse practitioner performed another reconciliation when the patient was admitted to the residential program, but the patient was unsure of all their medications. Because the most recent prednisone prescription was not visible in ViSTA, the prednisone appeared to have been completed at least 3 months prior to admission and was therefore not prescribed in the admission medication orders.

Five days into the residential program, the patient began exhibiting unusual behaviors associated with the lack of prednisone. The patient realized they needed more prednisone, but the nurse explained there was no prednisone on the patient’s medication list. Eventually, the patient found the active prednisone order on their personal cell phone and was transferred to a local emergency department for care.

Work Arounds

The VHA’s efforts to forestall or mitigate system errors have in some cases had a cascade effect. For example, HCPs must essentially back up what the automated software is intended to do, with “complex, time-consuming” multistep manual safety checks when prescribing new medications for patients previously cared for at a Cerner site. The OIG is concerned that this increased vigilance is “unsustainable” by pharmacists and frontline staff and could lead to burnout and medication-related patient safety events. After the new EHR launched, the OIG found, burnout symptoms for pharmacy staff increased. Nonetheless, Case told the committee, OIG staff “have observed [employees’] unwavering commitment to prioritizing the care of patients while mitigating implementation challenges.”

EHR-related workload burdens have necessitated other adjustments. Columbus, for instance, hired 9 full-time clinical pharmacists—a 62% staffing increase—to help reduce the backlog. Pharmacy leaders created approximately 29 additional work-arounds to support pharmacy staff and prevent delays. Facility pharmacy leaders also developed approximately 25 educational materials, such as tip sheets, reference guides, and job aids. The OIG’s concern—apart from the overwhelming amount of information for staff to implement—is that such prophylactic measures may in fact give rise to inconsistent practices, which increase risks to patient safety.

Committed to Working With the VA

Mike Sicilia, executive vice president of Oracle Corporation, told lawmakers in the hearing, “After the initial deployments, it became clear that the pharmacy system needed to be enhanced to better meet VA’s needs. To that end, in August 2022, shortly after Oracle completed its acquisition of Cerner, VA contracted with us for seven enhancements that overall would adapt the pharmacy system to a more bidirectional system between VA providers placing prescription orders and VA pharmacists fulfilling and dispensing them.” Those enhancements are all live for VA providers and pharmacists to use now, he said, except for one that is undergoing additional testing.

He added, “As with any healthcare technology system, there is a need for continuous improvements but that does not mean the system is not safe and effective in its current state. Oracle is committed to working with VA … throughout the reset period to identify workflows and other items that can be simplified or streamlined to improve the overall user and pharmacy experience.”

Standardizing workflows and ensuring training and communications to pharmacists about the latest updates will discourage use of work-arounds, Sicilia said, and “help with improving morale and satisfaction with the system.” During a visit in early February by VA and the Oracle team to the Lovell Federal Health Care Center in North Chicago, “feedback from pharmacists was positive about the training and readiness for using the new pharmacy system.”

The backlog, at least, may be resolved. Sicilia said on average more than 215,000 outpatient prescriptions are being filled each month. “The current live sites do not have a backlog in filling prescriptions. Recent data from this month show that three of the five live sites have zero prescriptions waiting to be processed that are older than seven days. The two other live sites have an average of two prescriptions older than seven days,” he said.

Although Oracle Health has since resolved some of the identified issues, the OIG is concerned that the new EHR will continue to be deployed at medical facilities despite “myriad” as-yet unresolved issues related to inaccurate medication ordering, reconciliation, and dispensing. The VHA has paused Cerner deployments multiple times.

“It is unclear whether identified problems are being adequately resolved before additional deployments,” Case said. “There is also the question of whether there is sufficient transparency and communication among EHRM-IO, VHA and facility leaders, VA leaders, and Oracle Health needed for quality control and critical coordination. Trust in VA is also dependent on patients being fully and quickly advised when issues affecting them are identified and addressed. As VA moves toward its deployment next month at a complex facility jointly operated with the Department of Defense, transparency, communication, and program management will be essential to getting it right. Failures in these areas risk cascading problems.”