Infectious Disease Practitioner

A rapid point-of-care test meant to help clinicians avoid overprescribing antibiotics can successfully distinguish biomarkers of bacterial infection from those of viral infection, a new study finds.

The fingerstick test, FebriDx, works by detecting myxovirus resistance protein A, which the body generates in response to viral infections, and C-reactive protein (CRP), which is associated with systemic bacterial or viral infection.

In a study of 520 adults and children with symptoms of acute respiratory illness who were treated in outpatient settings, the test correctly classified bacterial infections 93.2% of the time (95% confidence interval [CI], 84.9-97.0). The negative predictive value (NPV), or probability that a person with a negative test result was truly free of a bacterial infection, was 98.7% (95% CI, 96.9-99.4).

The findings of the study, which was sponsored by the test’s manufacturer, were published in JAMA Network Open).

The ability to rule out a bacterial cause “may provide clinicians with reassurance to withhold antibiotics when supported by the clinical assessment,” the researchers wrote.

They added that the ability to identify infections that may benefit from antibiotics and confidently rule out those that will not “is essential to optimizing clinical management and addressing global antimicrobial resistance.”
 

FDA concerned about false negative viral infection results

FebriDx has been cleared for sale in the United Kingdom, Europe, Canada, United Arab Emirates, Brazil, and Australia, according to the manufacturer, Australia-based Lumos Diagnostics.

However, the product is not available in the United States, where the Food and Drug Administration denied marketing clearance in July. In a news release, Lumos said the FDA determined that FebriDx did not demonstrate “substantial equivalence” to a predicate device and expressed concern that false negative viral infection results could lead to missed cases of COVID-19.

In the newly published study, FebriDx identified individuals with viral infections 70.3% of the time (95% CI, 64.8-75.2). The probability that a person who tested negative for a viral infection was truly negative was 66.7% (95%CI, 60.8-72.1).

The study included patients with respiratory symptoms and recent fever who were enrolled from October 2019 to April 2021 at nine emergency departments, six urgent care clinics, and five primary care clinics in the United States. All patients were tested with FebriDx and underwent separate laboratory testing to determine a final diagnosis.

In addition, researchers recruited a control group of 120 individuals without symptoms.

Among 496 symptomatic individuals who had a final diagnosis, 73 (14.7%) were classified as having a response associated with a bacterial infection, 296 (59.7%) as having a viral-associated response, and 127 (25.6%) as negative.

FebriDx correctly ruled out a bacterial infection 88.4% of the time (95% CI, 85.0-91.1). The probability that a patient with a positive result for bacterial infection actually had a bacterial infection was 58.1% (95%CI, 49.1-66.7).

The findings bolster those of a previous study on the same test. This research included 220 patients who reported having a fever within the prior 3 days or had a measurable fever at the time of enrollment. In that study, the test correctly identified bacterial infections 85% of the time and correctly ruled out bacterial infection 93% of the time, with a NPV of 97%.
 

Too early to say test will be useful in practice

The idea of a test to guide the prescribing of antibiotics isn’t new, according to an expert who was not involved in FebriDx research.

Noah Ivers, MD, PhD, a family physician and associate professor at the University of Toronto who studies strategies to optimize primary care delivery, said, “many such point-of-care tests have been tried” to detect biomarkers such as CRP or procalcitonin, which is associated with bacterial infections.

A rapid point-of-care test meant to help clinicians avoid overprescribing antibiotics can successfully distinguish biomarkers of bacterial infection from those of viral infection, a new study finds.

The fingerstick test, FebriDx, works by detecting myxovirus resistance protein A, which the body generates in response to viral infections, and C-reactive protein (CRP), which is associated with systemic bacterial or viral infection.

In a study of 520 adults and children with symptoms of acute respiratory illness who were treated in outpatient settings, the test correctly classified bacterial infections 93.2% of the time (95% confidence interval [CI], 84.9-97.0). The negative predictive value (NPV), or probability that a person with a negative test result was truly free of a bacterial infection, was 98.7% (95% CI, 96.9-99.4).

The findings of the study, which was sponsored by the test’s manufacturer, were published in JAMA Network Open).

The ability to rule out a bacterial cause “may provide clinicians with reassurance to withhold antibiotics when supported by the clinical assessment,” the researchers wrote.

They added that the ability to identify infections that may benefit from antibiotics and confidently rule out those that will not “is essential to optimizing clinical management and addressing global antimicrobial resistance.”
 

FDA concerned about false negative viral infection results

FebriDx has been cleared for sale in the United Kingdom, Europe, Canada, United Arab Emirates, Brazil, and Australia, according to the manufacturer, Australia-based Lumos Diagnostics.

However, the product is not available in the United States, where the Food and Drug Administration denied marketing clearance in July. In a news release, Lumos said the FDA determined that FebriDx did not demonstrate “substantial equivalence” to a predicate device and expressed concern that false negative viral infection results could lead to missed cases of COVID-19.

In the newly published study, FebriDx identified individuals with viral infections 70.3% of the time (95% CI, 64.8-75.2). The probability that a person who tested negative for a viral infection was truly negative was 66.7% (95%CI, 60.8-72.1).

The study included patients with respiratory symptoms and recent fever who were enrolled from October 2019 to April 2021 at nine emergency departments, six urgent care clinics, and five primary care clinics in the United States. All patients were tested with FebriDx and underwent separate laboratory testing to determine a final diagnosis.

In addition, researchers recruited a control group of 120 individuals without symptoms.

Among 496 symptomatic individuals who had a final diagnosis, 73 (14.7%) were classified as having a response associated with a bacterial infection, 296 (59.7%) as having a viral-associated response, and 127 (25.6%) as negative.

FebriDx correctly ruled out a bacterial infection 88.4% of the time (95% CI, 85.0-91.1). The probability that a patient with a positive result for bacterial infection actually had a bacterial infection was 58.1% (95%CI, 49.1-66.7).

The findings bolster those of a previous study on the same test. This research included 220 patients who reported having a fever within the prior 3 days or had a measurable fever at the time of enrollment. In that study, the test correctly identified bacterial infections 85% of the time and correctly ruled out bacterial infection 93% of the time, with a NPV of 97%.
 

Too early to say test will be useful in practice

The idea of a test to guide the prescribing of antibiotics isn’t new, according to an expert who was not involved in FebriDx research.

Noah Ivers, MD, PhD, a family physician and associate professor at the University of Toronto who studies strategies to optimize primary care delivery, said, “many such point-of-care tests have been tried” to detect biomarkers such as CRP or procalcitonin, which is associated with bacterial infections.

A rapid point-of-care test meant to help clinicians avoid overprescribing antibiotics can successfully distinguish biomarkers of bacterial infection from those of viral infection, a new study finds.

The fingerstick test, FebriDx, works by detecting myxovirus resistance protein A, which the body generates in response to viral infections, and C-reactive protein (CRP), which is associated with systemic bacterial or viral infection.

In a study of 520 adults and children with symptoms of acute respiratory illness who were treated in outpatient settings, the test correctly classified bacterial infections 93.2% of the time (95% confidence interval [CI], 84.9-97.0). The negative predictive value (NPV), or probability that a person with a negative test result was truly free of a bacterial infection, was 98.7% (95% CI, 96.9-99.4).

The findings of the study, which was sponsored by the test’s manufacturer, were published in JAMA Network Open).

The ability to rule out a bacterial cause “may provide clinicians with reassurance to withhold antibiotics when supported by the clinical assessment,” the researchers wrote.

They added that the ability to identify infections that may benefit from antibiotics and confidently rule out those that will not “is essential to optimizing clinical management and addressing global antimicrobial resistance.”
 

FDA concerned about false negative viral infection results

FebriDx has been cleared for sale in the United Kingdom, Europe, Canada, United Arab Emirates, Brazil, and Australia, according to the manufacturer, Australia-based Lumos Diagnostics.

However, the product is not available in the United States, where the Food and Drug Administration denied marketing clearance in July. In a news release, Lumos said the FDA determined that FebriDx did not demonstrate “substantial equivalence” to a predicate device and expressed concern that false negative viral infection results could lead to missed cases of COVID-19.

In the newly published study, FebriDx identified individuals with viral infections 70.3% of the time (95% CI, 64.8-75.2). The probability that a person who tested negative for a viral infection was truly negative was 66.7% (95%CI, 60.8-72.1).

The study included patients with respiratory symptoms and recent fever who were enrolled from October 2019 to April 2021 at nine emergency departments, six urgent care clinics, and five primary care clinics in the United States. All patients were tested with FebriDx and underwent separate laboratory testing to determine a final diagnosis.

In addition, researchers recruited a control group of 120 individuals without symptoms.

Among 496 symptomatic individuals who had a final diagnosis, 73 (14.7%) were classified as having a response associated with a bacterial infection, 296 (59.7%) as having a viral-associated response, and 127 (25.6%) as negative.

FebriDx correctly ruled out a bacterial infection 88.4% of the time (95% CI, 85.0-91.1). The probability that a patient with a positive result for bacterial infection actually had a bacterial infection was 58.1% (95%CI, 49.1-66.7).

The findings bolster those of a previous study on the same test. This research included 220 patients who reported having a fever within the prior 3 days or had a measurable fever at the time of enrollment. In that study, the test correctly identified bacterial infections 85% of the time and correctly ruled out bacterial infection 93% of the time, with a NPV of 97%.
 

Too early to say test will be useful in practice

The idea of a test to guide the prescribing of antibiotics isn’t new, according to an expert who was not involved in FebriDx research.

Noah Ivers, MD, PhD, a family physician and associate professor at the University of Toronto who studies strategies to optimize primary care delivery, said, “many such point-of-care tests have been tried” to detect biomarkers such as CRP or procalcitonin, which is associated with bacterial infections.

VIENNA – Fecal microbiota transplantation (FMT) into the small intestine led to a better response rate of longer duration in patients with irritable bowel syndrome (IBS), vs. it being administered into the large intestine, according to a new study.

Patients also reported an improvement in symptoms and quality of life with repeated doses of FMT (two doses, given 1 week apart), compared with a single dose in the small intestine, although statistical significance was not met.

“Administering a fecal transplant to the small intestine leads to long-term – up to 1 year in this analysis – colonization of beneficial bacteria, whereas administrating the fecal transplant to the large intestine results in the effect only lasting for the first 3 months,” said Magdy El-Salhy, MD, from the University of Bergen, Norway.

Dr. El-Salhy presented the results at the annual United European Gastroenterology Week meeting.

“It seems that bacteria in the small intestine play a more central role in IBS, as well as its associated fatigue, than bacteria in the large intestine,” Dr. El-Salhy said in an interview.

“Until now, we’ve been targeting the wrong part of the intestine,” he said.

The findings are the first to show that the small intestine is a more effective location for administering FMT than the large intestine for IBS. “It would be worthwhile doing similar [studies] in other diseases, especially in inflammatory bowel diseases,” said Dr. El-Salhy.

Researchers also didn’t expect the repeated dose to improve symptoms for a longer duration. “It really was revolutionary to see,” he added.

Some of Dr. El-Salhy’s patients have had up to 5 years of follow-up, although these results were not presented at this year’s UEG, he said.

“Around 75% of my patients have shown duration of response up to 3 years, and a few up to 5 years, on a 60-g dose from an earlier study group,” he said. “It’s an incredible result after a 10-minute treatment.”

In Dr. El-Salhy’s previous work, he found that increasing the dose from 30 g to 60 g increased the response from about 75% to about 90%. However, in this study presented, he found that increasing the dose to 90 g did not further increase the response. He also noted that while repeating the FMT dose improved symptoms and quality of life more than a single transplantation, it did not increase the response.
 

Targeting the small intestine

FMT has been widely investigated for the treatment of such conditions as psoriatic arthritis, Clostridioides difficile infection, and ulcerative colitis.

In this study, Dr. El-Salhy built on prior work (seven randomized controlled studies with varied outcomes) by asking whether the transplant dose increases FMT efficacy, which route of administration is more effective, and whether repeating FMT increases efficacy in patients with IBS.

A total of 186 patients were randomized to one of three groups: 90 g of frozen transplant into the large intestine (n = 62), 90 g of frozen transplant into the small intestine (n = 62), or 90 g of frozen transplant into the small intestine twice (with a 1-week interval; n = 62). FMT was administered via nasoduodenal tube and colonoscopy into the small and large intestines, respectively.

Outcomes were measured at 3, 6, and 12 months. The 12-month analysis of outcomes via patient questionnaire included 60, 61, and 60 patients, respectively.

The patient questionnaires included in the study were the IBS-SSS (a composite score of abdominal pain, duration of abdominal pain, bloating/distention, satisfaction with bowel habits, and IBS-related quality of life), the Birmingham IBS Symptom questionnaire, the Fatigue Assessment Scale questionnaire, the IBS-Quality of Life assessment, and the Short-Form Nepean Dyspepsia Index.

Fecal samples were taken and tested for bacterial loads. The bacterial profile and dysbiosis index were determined using the 16S rRNA gene.

At 3 months, patients had similar response rates, around 80%, across single dose in large intestine, single dose in small intestine, and repeat doses in small intestine.

At 6 months, the differences in response rates started to become noticeable, with 67.9% for single dose in large intestine, 71.4% for single dose in small intestine, and 86% for repeat doses in small intestine.

By 12 months, the difference in response rate between the single dose in the large and small intestines was statistically significant at 51.9% and 75.5%, respectively. The response rate to the repeat doses in the small intestine at 12 months (80.9%) was similar to that at 3 months (80.8%).

Side effects, including mild abdominal pain, diarrhea, and constipation, after FMT were seen for the first 5 days after treatment. “People who generally suffer from constipation get diarrhea after FMT and vice versa,” Dr. El-Salhy reported.

“Long-term side effects, as monitored up to 3 years, were not observed,” he added.

Treatment reduced IBS symptoms in all patient groups as measured by IBS-SSS scores. By 12 months, the score fell from around 350 to around 220 in patients who received a single dose in the large intestine, from around 300 to around 200 in patients who received a single dose in the small intestine, and from around 350 to around 170 in patients who received repeat doses in the small intestine.

Quality of life showed a statistically significant difference at 3 months between single and repeated doses in the small intestine and similarly at 6 and 12 months.

Chronic fatigue, experienced by many patients with IBS, was substantially reduced after FMT, Dr. El-Salhy noted. “This surge in energy is often more important to them than the gastrointestinal symptoms.”
 

Location affects bacterial success

Certain beneficial bacteria were found to thrive more when the donor transplant was administered to the small intestine than to the large intestine.

Of note, Lactobacillus species and Holdemanella biformis grew and then dropped off sharply after 3 months in patients who received a single-dose fecal transplant in the large intestine, while they grew after 3 months and continued to grow after 6 and 12 months in the groups who received a fecal transplant in the small intestine.

“We think bacteria in the small intestine have different characteristics to those in the large intestine,” Dr. El-Salhy said. “This is relatively new, because many years ago it was thought that bile acids prevented bacterial survival. Now we know lots can thrive in the small intestine.”

“It might be viral or some other component that is most effective here. We don’t know yet, but so far we have identified 11 bacteria of interest,” he added.
 

Broader questions

“Rather than focusing on a specific, single strain microbe as a predictor of success in a disease, the global equilibrium of microbiota is more important, and microbial ecology parameters would be interesting to assess,” remarked Gianluca Ianiro, MD, from the Università Cattolica del Sacro Cuore, Rome, who comoderated the session. “Selected survival of some bacteria through the gut may be the response.”

FMT emerged in response to the challenges posed by recurrent C. difficile infections, noted Alexander Khoruts, MD, a professor of medicine in the division of gastroenterology, hepatology, and nutrition at the University of Minnesota, Minneapolis, who was not involved in the research.

“It is much harder to achieve remodeling of the gut microbiome in non–C. difficile conditions where there is an intact and resilient indigenous microbiota,” he said in an interview. “Therefore, regimens using antibiotic preconditioning and repeated administrations of microbiota are generally more efficacious in achieving this objective.”

The specificity of the bacteria according to disease type targeted was important, said Dr. Khoruts, who has a special interest in gut microbiota.

“The big question in non–C. difficile indications is the composition of donor microbiota. It is critical that we understand the mechanisms involved in each target disease to design appropriate microbiota-based therapeutics,” he said.

Dr. Khoruts sounded a note of caution with respect to establishing the pharmacokinetic and dynamic data related to FMT, which is classified as a drug in the United States.

“It’s imperative that we develop the pharmacology discipline appropriate for this class of therapeutics, including their pharmacokinetics and pharmacodynamics, and an understanding of their potential toxicity and drug-drug interactions,” he said.

Drug distribution data are needed to determine host-microbiota interactions.

“This includes the small bowel microbiome, which continues to be woefully understudied,” Dr. Khoruts said.

Dr. El-Salhy reports no relevant financial relationships. Dr. Ianiro reports receiving personal fees for acting as speaker for Biocodex, Sofar, Malesci, and Tillotts Pharma, and for acting as consultant/advisor for Ferring Therapeutics, Biocodex, Tillotts Pharma, and Zambon. Dr. Khoruts reports he has patents pertaining to fecal microbiota separation from stool and their cryopreservation and lyopreservation.

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

VIENNA – Fecal microbiota transplantation (FMT) into the small intestine led to a better response rate of longer duration in patients with irritable bowel syndrome (IBS), vs. it being administered into the large intestine, according to a new study.

Patients also reported an improvement in symptoms and quality of life with repeated doses of FMT (two doses, given 1 week apart), compared with a single dose in the small intestine, although statistical significance was not met.

“Administering a fecal transplant to the small intestine leads to long-term – up to 1 year in this analysis – colonization of beneficial bacteria, whereas administrating the fecal transplant to the large intestine results in the effect only lasting for the first 3 months,” said Magdy El-Salhy, MD, from the University of Bergen, Norway.

Dr. El-Salhy presented the results at the annual United European Gastroenterology Week meeting.

“It seems that bacteria in the small intestine play a more central role in IBS, as well as its associated fatigue, than bacteria in the large intestine,” Dr. El-Salhy said in an interview.

“Until now, we’ve been targeting the wrong part of the intestine,” he said.

The findings are the first to show that the small intestine is a more effective location for administering FMT than the large intestine for IBS. “It would be worthwhile doing similar [studies] in other diseases, especially in inflammatory bowel diseases,” said Dr. El-Salhy.

Researchers also didn’t expect the repeated dose to improve symptoms for a longer duration. “It really was revolutionary to see,” he added.

Some of Dr. El-Salhy’s patients have had up to 5 years of follow-up, although these results were not presented at this year’s UEG, he said.

“Around 75% of my patients have shown duration of response up to 3 years, and a few up to 5 years, on a 60-g dose from an earlier study group,” he said. “It’s an incredible result after a 10-minute treatment.”

In Dr. El-Salhy’s previous work, he found that increasing the dose from 30 g to 60 g increased the response from about 75% to about 90%. However, in this study presented, he found that increasing the dose to 90 g did not further increase the response. He also noted that while repeating the FMT dose improved symptoms and quality of life more than a single transplantation, it did not increase the response.
 

Targeting the small intestine

FMT has been widely investigated for the treatment of such conditions as psoriatic arthritis, Clostridioides difficile infection, and ulcerative colitis.

In this study, Dr. El-Salhy built on prior work (seven randomized controlled studies with varied outcomes) by asking whether the transplant dose increases FMT efficacy, which route of administration is more effective, and whether repeating FMT increases efficacy in patients with IBS.

A total of 186 patients were randomized to one of three groups: 90 g of frozen transplant into the large intestine (n = 62), 90 g of frozen transplant into the small intestine (n = 62), or 90 g of frozen transplant into the small intestine twice (with a 1-week interval; n = 62). FMT was administered via nasoduodenal tube and colonoscopy into the small and large intestines, respectively.

Outcomes were measured at 3, 6, and 12 months. The 12-month analysis of outcomes via patient questionnaire included 60, 61, and 60 patients, respectively.

The patient questionnaires included in the study were the IBS-SSS (a composite score of abdominal pain, duration of abdominal pain, bloating/distention, satisfaction with bowel habits, and IBS-related quality of life), the Birmingham IBS Symptom questionnaire, the Fatigue Assessment Scale questionnaire, the IBS-Quality of Life assessment, and the Short-Form Nepean Dyspepsia Index.

Fecal samples were taken and tested for bacterial loads. The bacterial profile and dysbiosis index were determined using the 16S rRNA gene.

At 3 months, patients had similar response rates, around 80%, across single dose in large intestine, single dose in small intestine, and repeat doses in small intestine.

At 6 months, the differences in response rates started to become noticeable, with 67.9% for single dose in large intestine, 71.4% for single dose in small intestine, and 86% for repeat doses in small intestine.

By 12 months, the difference in response rate between the single dose in the large and small intestines was statistically significant at 51.9% and 75.5%, respectively. The response rate to the repeat doses in the small intestine at 12 months (80.9%) was similar to that at 3 months (80.8%).

Side effects, including mild abdominal pain, diarrhea, and constipation, after FMT were seen for the first 5 days after treatment. “People who generally suffer from constipation get diarrhea after FMT and vice versa,” Dr. El-Salhy reported.

“Long-term side effects, as monitored up to 3 years, were not observed,” he added.

Treatment reduced IBS symptoms in all patient groups as measured by IBS-SSS scores. By 12 months, the score fell from around 350 to around 220 in patients who received a single dose in the large intestine, from around 300 to around 200 in patients who received a single dose in the small intestine, and from around 350 to around 170 in patients who received repeat doses in the small intestine.

Quality of life showed a statistically significant difference at 3 months between single and repeated doses in the small intestine and similarly at 6 and 12 months.

Chronic fatigue, experienced by many patients with IBS, was substantially reduced after FMT, Dr. El-Salhy noted. “This surge in energy is often more important to them than the gastrointestinal symptoms.”
 

Location affects bacterial success

Certain beneficial bacteria were found to thrive more when the donor transplant was administered to the small intestine than to the large intestine.

Of note, Lactobacillus species and Holdemanella biformis grew and then dropped off sharply after 3 months in patients who received a single-dose fecal transplant in the large intestine, while they grew after 3 months and continued to grow after 6 and 12 months in the groups who received a fecal transplant in the small intestine.

“We think bacteria in the small intestine have different characteristics to those in the large intestine,” Dr. El-Salhy said. “This is relatively new, because many years ago it was thought that bile acids prevented bacterial survival. Now we know lots can thrive in the small intestine.”

“It might be viral or some other component that is most effective here. We don’t know yet, but so far we have identified 11 bacteria of interest,” he added.
 

Broader questions

“Rather than focusing on a specific, single strain microbe as a predictor of success in a disease, the global equilibrium of microbiota is more important, and microbial ecology parameters would be interesting to assess,” remarked Gianluca Ianiro, MD, from the Università Cattolica del Sacro Cuore, Rome, who comoderated the session. “Selected survival of some bacteria through the gut may be the response.”

FMT emerged in response to the challenges posed by recurrent C. difficile infections, noted Alexander Khoruts, MD, a professor of medicine in the division of gastroenterology, hepatology, and nutrition at the University of Minnesota, Minneapolis, who was not involved in the research.

“It is much harder to achieve remodeling of the gut microbiome in non–C. difficile conditions where there is an intact and resilient indigenous microbiota,” he said in an interview. “Therefore, regimens using antibiotic preconditioning and repeated administrations of microbiota are generally more efficacious in achieving this objective.”

The specificity of the bacteria according to disease type targeted was important, said Dr. Khoruts, who has a special interest in gut microbiota.

“The big question in non–C. difficile indications is the composition of donor microbiota. It is critical that we understand the mechanisms involved in each target disease to design appropriate microbiota-based therapeutics,” he said.

Dr. Khoruts sounded a note of caution with respect to establishing the pharmacokinetic and dynamic data related to FMT, which is classified as a drug in the United States.

“It’s imperative that we develop the pharmacology discipline appropriate for this class of therapeutics, including their pharmacokinetics and pharmacodynamics, and an understanding of their potential toxicity and drug-drug interactions,” he said.

Drug distribution data are needed to determine host-microbiota interactions.

“This includes the small bowel microbiome, which continues to be woefully understudied,” Dr. Khoruts said.

Dr. El-Salhy reports no relevant financial relationships. Dr. Ianiro reports receiving personal fees for acting as speaker for Biocodex, Sofar, Malesci, and Tillotts Pharma, and for acting as consultant/advisor for Ferring Therapeutics, Biocodex, Tillotts Pharma, and Zambon. Dr. Khoruts reports he has patents pertaining to fecal microbiota separation from stool and their cryopreservation and lyopreservation.

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

VIENNA – Fecal microbiota transplantation (FMT) into the small intestine led to a better response rate of longer duration in patients with irritable bowel syndrome (IBS), vs. it being administered into the large intestine, according to a new study.

Patients also reported an improvement in symptoms and quality of life with repeated doses of FMT (two doses, given 1 week apart), compared with a single dose in the small intestine, although statistical significance was not met.

“Administering a fecal transplant to the small intestine leads to long-term – up to 1 year in this analysis – colonization of beneficial bacteria, whereas administrating the fecal transplant to the large intestine results in the effect only lasting for the first 3 months,” said Magdy El-Salhy, MD, from the University of Bergen, Norway.

Dr. El-Salhy presented the results at the annual United European Gastroenterology Week meeting.

“It seems that bacteria in the small intestine play a more central role in IBS, as well as its associated fatigue, than bacteria in the large intestine,” Dr. El-Salhy said in an interview.

“Until now, we’ve been targeting the wrong part of the intestine,” he said.

The findings are the first to show that the small intestine is a more effective location for administering FMT than the large intestine for IBS. “It would be worthwhile doing similar [studies] in other diseases, especially in inflammatory bowel diseases,” said Dr. El-Salhy.

Researchers also didn’t expect the repeated dose to improve symptoms for a longer duration. “It really was revolutionary to see,” he added.

Some of Dr. El-Salhy’s patients have had up to 5 years of follow-up, although these results were not presented at this year’s UEG, he said.

“Around 75% of my patients have shown duration of response up to 3 years, and a few up to 5 years, on a 60-g dose from an earlier study group,” he said. “It’s an incredible result after a 10-minute treatment.”

In Dr. El-Salhy’s previous work, he found that increasing the dose from 30 g to 60 g increased the response from about 75% to about 90%. However, in this study presented, he found that increasing the dose to 90 g did not further increase the response. He also noted that while repeating the FMT dose improved symptoms and quality of life more than a single transplantation, it did not increase the response.
 

Targeting the small intestine

FMT has been widely investigated for the treatment of such conditions as psoriatic arthritis, Clostridioides difficile infection, and ulcerative colitis.

In this study, Dr. El-Salhy built on prior work (seven randomized controlled studies with varied outcomes) by asking whether the transplant dose increases FMT efficacy, which route of administration is more effective, and whether repeating FMT increases efficacy in patients with IBS.

A total of 186 patients were randomized to one of three groups: 90 g of frozen transplant into the large intestine (n = 62), 90 g of frozen transplant into the small intestine (n = 62), or 90 g of frozen transplant into the small intestine twice (with a 1-week interval; n = 62). FMT was administered via nasoduodenal tube and colonoscopy into the small and large intestines, respectively.

Outcomes were measured at 3, 6, and 12 months. The 12-month analysis of outcomes via patient questionnaire included 60, 61, and 60 patients, respectively.

The patient questionnaires included in the study were the IBS-SSS (a composite score of abdominal pain, duration of abdominal pain, bloating/distention, satisfaction with bowel habits, and IBS-related quality of life), the Birmingham IBS Symptom questionnaire, the Fatigue Assessment Scale questionnaire, the IBS-Quality of Life assessment, and the Short-Form Nepean Dyspepsia Index.

Fecal samples were taken and tested for bacterial loads. The bacterial profile and dysbiosis index were determined using the 16S rRNA gene.

At 3 months, patients had similar response rates, around 80%, across single dose in large intestine, single dose in small intestine, and repeat doses in small intestine.

At 6 months, the differences in response rates started to become noticeable, with 67.9% for single dose in large intestine, 71.4% for single dose in small intestine, and 86% for repeat doses in small intestine.

By 12 months, the difference in response rate between the single dose in the large and small intestines was statistically significant at 51.9% and 75.5%, respectively. The response rate to the repeat doses in the small intestine at 12 months (80.9%) was similar to that at 3 months (80.8%).

Side effects, including mild abdominal pain, diarrhea, and constipation, after FMT were seen for the first 5 days after treatment. “People who generally suffer from constipation get diarrhea after FMT and vice versa,” Dr. El-Salhy reported.

“Long-term side effects, as monitored up to 3 years, were not observed,” he added.

Treatment reduced IBS symptoms in all patient groups as measured by IBS-SSS scores. By 12 months, the score fell from around 350 to around 220 in patients who received a single dose in the large intestine, from around 300 to around 200 in patients who received a single dose in the small intestine, and from around 350 to around 170 in patients who received repeat doses in the small intestine.

Quality of life showed a statistically significant difference at 3 months between single and repeated doses in the small intestine and similarly at 6 and 12 months.

Chronic fatigue, experienced by many patients with IBS, was substantially reduced after FMT, Dr. El-Salhy noted. “This surge in energy is often more important to them than the gastrointestinal symptoms.”
 

Location affects bacterial success

Certain beneficial bacteria were found to thrive more when the donor transplant was administered to the small intestine than to the large intestine.

Of note, Lactobacillus species and Holdemanella biformis grew and then dropped off sharply after 3 months in patients who received a single-dose fecal transplant in the large intestine, while they grew after 3 months and continued to grow after 6 and 12 months in the groups who received a fecal transplant in the small intestine.

“We think bacteria in the small intestine have different characteristics to those in the large intestine,” Dr. El-Salhy said. “This is relatively new, because many years ago it was thought that bile acids prevented bacterial survival. Now we know lots can thrive in the small intestine.”

“It might be viral or some other component that is most effective here. We don’t know yet, but so far we have identified 11 bacteria of interest,” he added.
 

Broader questions

“Rather than focusing on a specific, single strain microbe as a predictor of success in a disease, the global equilibrium of microbiota is more important, and microbial ecology parameters would be interesting to assess,” remarked Gianluca Ianiro, MD, from the Università Cattolica del Sacro Cuore, Rome, who comoderated the session. “Selected survival of some bacteria through the gut may be the response.”

FMT emerged in response to the challenges posed by recurrent C. difficile infections, noted Alexander Khoruts, MD, a professor of medicine in the division of gastroenterology, hepatology, and nutrition at the University of Minnesota, Minneapolis, who was not involved in the research.

“It is much harder to achieve remodeling of the gut microbiome in non–C. difficile conditions where there is an intact and resilient indigenous microbiota,” he said in an interview. “Therefore, regimens using antibiotic preconditioning and repeated administrations of microbiota are generally more efficacious in achieving this objective.”

The specificity of the bacteria according to disease type targeted was important, said Dr. Khoruts, who has a special interest in gut microbiota.

“The big question in non–C. difficile indications is the composition of donor microbiota. It is critical that we understand the mechanisms involved in each target disease to design appropriate microbiota-based therapeutics,” he said.

Dr. Khoruts sounded a note of caution with respect to establishing the pharmacokinetic and dynamic data related to FMT, which is classified as a drug in the United States.

“It’s imperative that we develop the pharmacology discipline appropriate for this class of therapeutics, including their pharmacokinetics and pharmacodynamics, and an understanding of their potential toxicity and drug-drug interactions,” he said.

Drug distribution data are needed to determine host-microbiota interactions.

“This includes the small bowel microbiome, which continues to be woefully understudied,” Dr. Khoruts said.

Dr. El-Salhy reports no relevant financial relationships. Dr. Ianiro reports receiving personal fees for acting as speaker for Biocodex, Sofar, Malesci, and Tillotts Pharma, and for acting as consultant/advisor for Ferring Therapeutics, Biocodex, Tillotts Pharma, and Zambon. Dr. Khoruts reports he has patents pertaining to fecal microbiota separation from stool and their cryopreservation and lyopreservation.

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

Do doctors, who typically earn a high salary, focus on living in the moment or saving for the future, or a financially healthy combination of both? In a poll that ran from August 30 to Sept. 21, conducted by Medscape, physicians were asked if they lived within their means. They were asked whether they pay their bills on time, save at least 20% of their monthly income toward retirement, pay down student loan debt, and contribute to their kids’ college savings or a rainy-day emergency fund.

Medscape polled 468 U.S. physicians and 159 living outside of the United States. Eighty-nine percent of U.S. respondents report living within their means, while only 11% said they don’t.

Medscape’s Physician Wealth & Debt Report 2022 similarly reported that of 13,000 physicians in more than 29 specialties, 94% said they live at or below their means.

For example, over half of physicians have a net worth above $1 million. In contrast, according to Credit Suisse’s Global Wealth Report, less than 7% of the general population has a seven-figure net worth.

So just how do physicians stack up financially?
 

Habits of physician super savers

Physicians who consider themselves savers likely have money habits that correlate. They buy things on sale, are DIYers for home projects and maintenance, and wait to buy luxury or large expenses when the timing is right, an item is on sale, or they’ve saved for it.

For example, when it comes to life’s luxuries like buying a new car or dining out, overall, physicians seem to be more frugal, as 43% of those who buy cars said they only buy a new car every 10 years; 30% said they buy a new vehicle every 6-7 years, and 22% said every 4-5 years.

When asked about weekly dine-out or delivery habits, 82% of those polled who said they dine out, or order takeout, do so a nominal 1-2 times per week. That’s on par with the Centers for Disease Control, which reports that 3 in 5 Americans eat out once weekly. Another 14% of polled physicians said they dine out 3-5 nights per week. Only 4% revealed they eat out or grab to-go food more than 5 nights a week.

When hiring for essential home maintenance, like house cleaning and pool or lawn service, almost a third of physicians we polled who require such maintenance employ a service for these tasks, and 23% hire out often while 21% hire out only sometimes. However, 14% say they rarely hire out for home maintenance, and 11% never do.

Since physicians are typically tight on time, they tend to favor outsourcing things like housecleaning, lawn service, landscaping, maintenance, and even cooking. So, the fact that a quarter of physicians polled rarely or never hire out for household help is somewhat surprising.

Most physicians also prioritize saving. When asked how important it is to save money consistently, 93% think it’s either extremely or very important, while only 6% think it’s somewhat important.
 

Barriers to wealth

When asked what barriers prevent them from saving at least 20% of their monthly income, physician respondents who said they live within their means and encountered barriers reported that family necessities (35%), student loan debt (19%), and mortgage sizes (18%) were the top reasons. The average doctor earns five times as much as the average American, according to the Global Wealth Report.

“What prevents me from saving is holding too much debt, responsibilities at home, bills, being unprepared for what is coming, and making excuses to spend even when it’s not necessary,” says Sean Ormond, MD, a dual board-certified physician in Anesthesiology and Pain Management in Phoenix.

When physician respondents who said they didn’t live within their means were asked about the barriers preventing them from saving at least 20% of their monthly income, they cited the cost of family necessities (49%), the size of their mortgage (47%), credit card debt (30%), student loan debt (21%), other loans (15%), and car lease/loan (13%).

“My most significant financial splurge is vacation, since I always choose the best, and the best comes at an extra cost,” says Dr. Ormond.
 

What’s your financial grade?

Finally, physicians were asked who they considered better at saving money, themselves or their spouse/domestic partner. Forty-four percent think they are the better saver, whereas 41% said that both they and their partner were equally good at saving. Thirteen percent credited their partner with better saving habits, and 2% said neither themselves nor their partner were good at saving money.

More than half (63%) of physicians polled pay off their credit card balance monthly, but 18% carry a $1,000-$5,000 balance, 10% have $5,000-$10,000 in credit card debt, and 6% hold more than $10,000 of credit card debt.

“I would grade myself with a B, because however much I love having the best, I still have a budget, and I always ensure that I follow it to the dot,” says Dr. Ormond.

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

Do doctors, who typically earn a high salary, focus on living in the moment or saving for the future, or a financially healthy combination of both? In a poll that ran from August 30 to Sept. 21, conducted by Medscape, physicians were asked if they lived within their means. They were asked whether they pay their bills on time, save at least 20% of their monthly income toward retirement, pay down student loan debt, and contribute to their kids’ college savings or a rainy-day emergency fund.

Medscape polled 468 U.S. physicians and 159 living outside of the United States. Eighty-nine percent of U.S. respondents report living within their means, while only 11% said they don’t.

Medscape’s Physician Wealth & Debt Report 2022 similarly reported that of 13,000 physicians in more than 29 specialties, 94% said they live at or below their means.

For example, over half of physicians have a net worth above $1 million. In contrast, according to Credit Suisse’s Global Wealth Report, less than 7% of the general population has a seven-figure net worth.

So just how do physicians stack up financially?
 

Habits of physician super savers

Physicians who consider themselves savers likely have money habits that correlate. They buy things on sale, are DIYers for home projects and maintenance, and wait to buy luxury or large expenses when the timing is right, an item is on sale, or they’ve saved for it.

For example, when it comes to life’s luxuries like buying a new car or dining out, overall, physicians seem to be more frugal, as 43% of those who buy cars said they only buy a new car every 10 years; 30% said they buy a new vehicle every 6-7 years, and 22% said every 4-5 years.

When asked about weekly dine-out or delivery habits, 82% of those polled who said they dine out, or order takeout, do so a nominal 1-2 times per week. That’s on par with the Centers for Disease Control, which reports that 3 in 5 Americans eat out once weekly. Another 14% of polled physicians said they dine out 3-5 nights per week. Only 4% revealed they eat out or grab to-go food more than 5 nights a week.

When hiring for essential home maintenance, like house cleaning and pool or lawn service, almost a third of physicians we polled who require such maintenance employ a service for these tasks, and 23% hire out often while 21% hire out only sometimes. However, 14% say they rarely hire out for home maintenance, and 11% never do.

Since physicians are typically tight on time, they tend to favor outsourcing things like housecleaning, lawn service, landscaping, maintenance, and even cooking. So, the fact that a quarter of physicians polled rarely or never hire out for household help is somewhat surprising.

Most physicians also prioritize saving. When asked how important it is to save money consistently, 93% think it’s either extremely or very important, while only 6% think it’s somewhat important.
 

Barriers to wealth

When asked what barriers prevent them from saving at least 20% of their monthly income, physician respondents who said they live within their means and encountered barriers reported that family necessities (35%), student loan debt (19%), and mortgage sizes (18%) were the top reasons. The average doctor earns five times as much as the average American, according to the Global Wealth Report.

“What prevents me from saving is holding too much debt, responsibilities at home, bills, being unprepared for what is coming, and making excuses to spend even when it’s not necessary,” says Sean Ormond, MD, a dual board-certified physician in Anesthesiology and Pain Management in Phoenix.

When physician respondents who said they didn’t live within their means were asked about the barriers preventing them from saving at least 20% of their monthly income, they cited the cost of family necessities (49%), the size of their mortgage (47%), credit card debt (30%), student loan debt (21%), other loans (15%), and car lease/loan (13%).

“My most significant financial splurge is vacation, since I always choose the best, and the best comes at an extra cost,” says Dr. Ormond.
 

What’s your financial grade?

Finally, physicians were asked who they considered better at saving money, themselves or their spouse/domestic partner. Forty-four percent think they are the better saver, whereas 41% said that both they and their partner were equally good at saving. Thirteen percent credited their partner with better saving habits, and 2% said neither themselves nor their partner were good at saving money.

More than half (63%) of physicians polled pay off their credit card balance monthly, but 18% carry a $1,000-$5,000 balance, 10% have $5,000-$10,000 in credit card debt, and 6% hold more than $10,000 of credit card debt.

“I would grade myself with a B, because however much I love having the best, I still have a budget, and I always ensure that I follow it to the dot,” says Dr. Ormond.

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

Do doctors, who typically earn a high salary, focus on living in the moment or saving for the future, or a financially healthy combination of both? In a poll that ran from August 30 to Sept. 21, conducted by Medscape, physicians were asked if they lived within their means. They were asked whether they pay their bills on time, save at least 20% of their monthly income toward retirement, pay down student loan debt, and contribute to their kids’ college savings or a rainy-day emergency fund.

Medscape polled 468 U.S. physicians and 159 living outside of the United States. Eighty-nine percent of U.S. respondents report living within their means, while only 11% said they don’t.

Medscape’s Physician Wealth & Debt Report 2022 similarly reported that of 13,000 physicians in more than 29 specialties, 94% said they live at or below their means.

For example, over half of physicians have a net worth above $1 million. In contrast, according to Credit Suisse’s Global Wealth Report, less than 7% of the general population has a seven-figure net worth.

So just how do physicians stack up financially?
 

Habits of physician super savers

Physicians who consider themselves savers likely have money habits that correlate. They buy things on sale, are DIYers for home projects and maintenance, and wait to buy luxury or large expenses when the timing is right, an item is on sale, or they’ve saved for it.

For example, when it comes to life’s luxuries like buying a new car or dining out, overall, physicians seem to be more frugal, as 43% of those who buy cars said they only buy a new car every 10 years; 30% said they buy a new vehicle every 6-7 years, and 22% said every 4-5 years.

When asked about weekly dine-out or delivery habits, 82% of those polled who said they dine out, or order takeout, do so a nominal 1-2 times per week. That’s on par with the Centers for Disease Control, which reports that 3 in 5 Americans eat out once weekly. Another 14% of polled physicians said they dine out 3-5 nights per week. Only 4% revealed they eat out or grab to-go food more than 5 nights a week.

When hiring for essential home maintenance, like house cleaning and pool or lawn service, almost a third of physicians we polled who require such maintenance employ a service for these tasks, and 23% hire out often while 21% hire out only sometimes. However, 14% say they rarely hire out for home maintenance, and 11% never do.

Since physicians are typically tight on time, they tend to favor outsourcing things like housecleaning, lawn service, landscaping, maintenance, and even cooking. So, the fact that a quarter of physicians polled rarely or never hire out for household help is somewhat surprising.

Most physicians also prioritize saving. When asked how important it is to save money consistently, 93% think it’s either extremely or very important, while only 6% think it’s somewhat important.
 

Barriers to wealth

When asked what barriers prevent them from saving at least 20% of their monthly income, physician respondents who said they live within their means and encountered barriers reported that family necessities (35%), student loan debt (19%), and mortgage sizes (18%) were the top reasons. The average doctor earns five times as much as the average American, according to the Global Wealth Report.

“What prevents me from saving is holding too much debt, responsibilities at home, bills, being unprepared for what is coming, and making excuses to spend even when it’s not necessary,” says Sean Ormond, MD, a dual board-certified physician in Anesthesiology and Pain Management in Phoenix.

When physician respondents who said they didn’t live within their means were asked about the barriers preventing them from saving at least 20% of their monthly income, they cited the cost of family necessities (49%), the size of their mortgage (47%), credit card debt (30%), student loan debt (21%), other loans (15%), and car lease/loan (13%).

“My most significant financial splurge is vacation, since I always choose the best, and the best comes at an extra cost,” says Dr. Ormond.
 

What’s your financial grade?

Finally, physicians were asked who they considered better at saving money, themselves or their spouse/domestic partner. Forty-four percent think they are the better saver, whereas 41% said that both they and their partner were equally good at saving. Thirteen percent credited their partner with better saving habits, and 2% said neither themselves nor their partner were good at saving money.

More than half (63%) of physicians polled pay off their credit card balance monthly, but 18% carry a $1,000-$5,000 balance, 10% have $5,000-$10,000 in credit card debt, and 6% hold more than $10,000 of credit card debt.

“I would grade myself with a B, because however much I love having the best, I still have a budget, and I always ensure that I follow it to the dot,” says Dr. Ormond.

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

The emerging COVID-19 variant BQ.1 and one of its descendants now account for more than 1 in 10 cases in the United States, according to the CDC’s latest data.

Just 1 month ago, the variant accounted for less than 1% of cases.

“When you get variants like that, you look at what their rate of increase is as a relative proportion of the variants, and this has a pretty troublesome doubling time,” Anthony Fauci, MD, said in an interview with CBS News. Dr. Fauci is the director of the National Institute of Allergy and Infectious Diseases and also the chief medical adviser to President Joe Biden.

There are also concerning features of the BQ.1 variant, which include mutations that could potentially escape vaccines and treatments for COVID-19. 

Currently, the most widespread variant in the U.S. is the Omicron subvariant known as BA.5, which accounts for 68% of all infections. One of the go-to treatments for BA.5 infections is monoclonal antibodies, which may not be as effective when fighting the up-and-coming strains of BQ.1 and its descendant BQ.1.1, according to experts.  

“That’s the reason why people are concerned about BQ.1.1, for the double reason of its doubling time and the fact that it seems to elude important monoclonal antibodies,” Dr. Fauci told CBS News. 

Currently, BQ.1 and BQ.1.1 appear most widespread in the New York and New Jersey region, accounting for nearly 20% of infections there, according to the CDC. 

But because the new variant is a descendant of Omicron, Dr. Fauci said the currently available booster shots are still the best first line of protection against this up-and-coming threat.

“The bad news is that there’s a new variant that’s emerging and that has qualities or characteristics that could evade some of the interventions we have. But, the somewhat encouraging news is that it’s a BA.5 sub-lineage, so there is almost certainly going to be some cross-protection that you can boost up,” he said.

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

The emerging COVID-19 variant BQ.1 and one of its descendants now account for more than 1 in 10 cases in the United States, according to the CDC’s latest data.

Just 1 month ago, the variant accounted for less than 1% of cases.

“When you get variants like that, you look at what their rate of increase is as a relative proportion of the variants, and this has a pretty troublesome doubling time,” Anthony Fauci, MD, said in an interview with CBS News. Dr. Fauci is the director of the National Institute of Allergy and Infectious Diseases and also the chief medical adviser to President Joe Biden.

There are also concerning features of the BQ.1 variant, which include mutations that could potentially escape vaccines and treatments for COVID-19. 

Currently, the most widespread variant in the U.S. is the Omicron subvariant known as BA.5, which accounts for 68% of all infections. One of the go-to treatments for BA.5 infections is monoclonal antibodies, which may not be as effective when fighting the up-and-coming strains of BQ.1 and its descendant BQ.1.1, according to experts.  

“That’s the reason why people are concerned about BQ.1.1, for the double reason of its doubling time and the fact that it seems to elude important monoclonal antibodies,” Dr. Fauci told CBS News. 

Currently, BQ.1 and BQ.1.1 appear most widespread in the New York and New Jersey region, accounting for nearly 20% of infections there, according to the CDC. 

But because the new variant is a descendant of Omicron, Dr. Fauci said the currently available booster shots are still the best first line of protection against this up-and-coming threat.

“The bad news is that there’s a new variant that’s emerging and that has qualities or characteristics that could evade some of the interventions we have. But, the somewhat encouraging news is that it’s a BA.5 sub-lineage, so there is almost certainly going to be some cross-protection that you can boost up,” he said.

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

The emerging COVID-19 variant BQ.1 and one of its descendants now account for more than 1 in 10 cases in the United States, according to the CDC’s latest data.

Just 1 month ago, the variant accounted for less than 1% of cases.

“When you get variants like that, you look at what their rate of increase is as a relative proportion of the variants, and this has a pretty troublesome doubling time,” Anthony Fauci, MD, said in an interview with CBS News. Dr. Fauci is the director of the National Institute of Allergy and Infectious Diseases and also the chief medical adviser to President Joe Biden.

There are also concerning features of the BQ.1 variant, which include mutations that could potentially escape vaccines and treatments for COVID-19. 

Currently, the most widespread variant in the U.S. is the Omicron subvariant known as BA.5, which accounts for 68% of all infections. One of the go-to treatments for BA.5 infections is monoclonal antibodies, which may not be as effective when fighting the up-and-coming strains of BQ.1 and its descendant BQ.1.1, according to experts.  

“That’s the reason why people are concerned about BQ.1.1, for the double reason of its doubling time and the fact that it seems to elude important monoclonal antibodies,” Dr. Fauci told CBS News. 

Currently, BQ.1 and BQ.1.1 appear most widespread in the New York and New Jersey region, accounting for nearly 20% of infections there, according to the CDC. 

But because the new variant is a descendant of Omicron, Dr. Fauci said the currently available booster shots are still the best first line of protection against this up-and-coming threat.

“The bad news is that there’s a new variant that’s emerging and that has qualities or characteristics that could evade some of the interventions we have. But, the somewhat encouraging news is that it’s a BA.5 sub-lineage, so there is almost certainly going to be some cross-protection that you can boost up,” he said.

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

The number of adults hospitalized with ventilator-associated pneumonia (VAP) in the United States increased by 50% from 2013 to 2019, based on data from the National Inpatient Sample.

Health care–associated infections are a significant burden, and “ventilator associated-pneumonia is a contributor to that,” said Namratha S. Meda, MBBS, in a presentation at the annual meeting of the American College of Chest Physicians.

VAP can affect length of stay and other costs, but factors related to VAP hospitalization have not been well studied, said Dr. Meda, of Medstar Health/Georgetown University Hospital, Washington.

To examine trends in hospitalization for VAP, Dr. Meda and colleagues reviewed data from the National Inpatient Sample from January 2013 to December 2019. The study population included adult patients with VAP as a primary or secondary diagnosis based on ICD-9 or ICD-10 codes.

Overall, the trend in hospitalizations showed a consistent increase, said Dr. Meda.

The researchers identified 128,025 adult hospitalizations with VAP during the study period, with an increase from 50 VAP cases per 100,000 hospitalizations in 2013 to 75 cases per 100,000 hospitalizations in 2019.

A total of 42,120 hospitalizations were associated with tracheostomy, ventilator dependence, or both. Hospitalizations in these categories increased by 80% during the study period, from 15 cases per 100,000 hospitalizations in 2013 to 27 cases per 100,000 hospitalizations in 2019.

The median cost for each hospitalization was $83,311, and showed a 2.9% increase from 2013 to 2019. The estimated annual cost of VAP hospitalizations was approximately $2.8 billion in 2019, Dr. Meda emphasized. However, all-cause hospital mortality remained unchanged over the study period, at approximately 20%.

The mean age of the hospitalized VAP patients was 58 years across all VAP-related hospitalizations, and 36.5% were women. More than half (58%) were White, 21% were Black, and 12% were Hispanic.

The researchers noted some sex and racial disparities; the median age was lower for Black and Hispanic patients, compared with White patients, but all-cause mortality was lower. Men had a significantly longer median length of stay, compared with women (21 days vs. 19 days), and higher median costs ($87,981 vs. $74,889) with a P <.001 for both, but the all-cause in-hospital mortality was not significantly different between sexes.

The steady increase in hospitalization for VAP without a significant change in all-cause mortality, might be driven by hospitals with higher levels of tracheostomy and ventilator dependence, but more research is needed, Dr. Meda noted.

The study was limited by the observational design, which allowed the researchers to report an association, but not causality, said Dr. Meda. However, the results reflect the ongoing financial burden of VAP on the health care system, although “it would be interesting to see how the trend might change if we just looked at the clinical definition versus billing data,” she noted.

The study did not include data since the advent of COVID-19, but COVID is likely to drive the trend of increasing VAP hospitalization higher, Dr. Meda added.

The study received no outside funding. The researchers had no financial conflicts to disclose.

The number of adults hospitalized with ventilator-associated pneumonia (VAP) in the United States increased by 50% from 2013 to 2019, based on data from the National Inpatient Sample.

Health care–associated infections are a significant burden, and “ventilator associated-pneumonia is a contributor to that,” said Namratha S. Meda, MBBS, in a presentation at the annual meeting of the American College of Chest Physicians.

VAP can affect length of stay and other costs, but factors related to VAP hospitalization have not been well studied, said Dr. Meda, of Medstar Health/Georgetown University Hospital, Washington.

To examine trends in hospitalization for VAP, Dr. Meda and colleagues reviewed data from the National Inpatient Sample from January 2013 to December 2019. The study population included adult patients with VAP as a primary or secondary diagnosis based on ICD-9 or ICD-10 codes.

Overall, the trend in hospitalizations showed a consistent increase, said Dr. Meda.

The researchers identified 128,025 adult hospitalizations with VAP during the study period, with an increase from 50 VAP cases per 100,000 hospitalizations in 2013 to 75 cases per 100,000 hospitalizations in 2019.

A total of 42,120 hospitalizations were associated with tracheostomy, ventilator dependence, or both. Hospitalizations in these categories increased by 80% during the study period, from 15 cases per 100,000 hospitalizations in 2013 to 27 cases per 100,000 hospitalizations in 2019.

The median cost for each hospitalization was $83,311, and showed a 2.9% increase from 2013 to 2019. The estimated annual cost of VAP hospitalizations was approximately $2.8 billion in 2019, Dr. Meda emphasized. However, all-cause hospital mortality remained unchanged over the study period, at approximately 20%.

The mean age of the hospitalized VAP patients was 58 years across all VAP-related hospitalizations, and 36.5% were women. More than half (58%) were White, 21% were Black, and 12% were Hispanic.

The researchers noted some sex and racial disparities; the median age was lower for Black and Hispanic patients, compared with White patients, but all-cause mortality was lower. Men had a significantly longer median length of stay, compared with women (21 days vs. 19 days), and higher median costs ($87,981 vs. $74,889) with a P <.001 for both, but the all-cause in-hospital mortality was not significantly different between sexes.

The steady increase in hospitalization for VAP without a significant change in all-cause mortality, might be driven by hospitals with higher levels of tracheostomy and ventilator dependence, but more research is needed, Dr. Meda noted.

The study was limited by the observational design, which allowed the researchers to report an association, but not causality, said Dr. Meda. However, the results reflect the ongoing financial burden of VAP on the health care system, although “it would be interesting to see how the trend might change if we just looked at the clinical definition versus billing data,” she noted.

The study did not include data since the advent of COVID-19, but COVID is likely to drive the trend of increasing VAP hospitalization higher, Dr. Meda added.

The study received no outside funding. The researchers had no financial conflicts to disclose.

The number of adults hospitalized with ventilator-associated pneumonia (VAP) in the United States increased by 50% from 2013 to 2019, based on data from the National Inpatient Sample.

Health care–associated infections are a significant burden, and “ventilator associated-pneumonia is a contributor to that,” said Namratha S. Meda, MBBS, in a presentation at the annual meeting of the American College of Chest Physicians.

VAP can affect length of stay and other costs, but factors related to VAP hospitalization have not been well studied, said Dr. Meda, of Medstar Health/Georgetown University Hospital, Washington.

To examine trends in hospitalization for VAP, Dr. Meda and colleagues reviewed data from the National Inpatient Sample from January 2013 to December 2019. The study population included adult patients with VAP as a primary or secondary diagnosis based on ICD-9 or ICD-10 codes.

Overall, the trend in hospitalizations showed a consistent increase, said Dr. Meda.

The researchers identified 128,025 adult hospitalizations with VAP during the study period, with an increase from 50 VAP cases per 100,000 hospitalizations in 2013 to 75 cases per 100,000 hospitalizations in 2019.

A total of 42,120 hospitalizations were associated with tracheostomy, ventilator dependence, or both. Hospitalizations in these categories increased by 80% during the study period, from 15 cases per 100,000 hospitalizations in 2013 to 27 cases per 100,000 hospitalizations in 2019.

The median cost for each hospitalization was $83,311, and showed a 2.9% increase from 2013 to 2019. The estimated annual cost of VAP hospitalizations was approximately $2.8 billion in 2019, Dr. Meda emphasized. However, all-cause hospital mortality remained unchanged over the study period, at approximately 20%.

The mean age of the hospitalized VAP patients was 58 years across all VAP-related hospitalizations, and 36.5% were women. More than half (58%) were White, 21% were Black, and 12% were Hispanic.

The researchers noted some sex and racial disparities; the median age was lower for Black and Hispanic patients, compared with White patients, but all-cause mortality was lower. Men had a significantly longer median length of stay, compared with women (21 days vs. 19 days), and higher median costs ($87,981 vs. $74,889) with a P <.001 for both, but the all-cause in-hospital mortality was not significantly different between sexes.

The steady increase in hospitalization for VAP without a significant change in all-cause mortality, might be driven by hospitals with higher levels of tracheostomy and ventilator dependence, but more research is needed, Dr. Meda noted.

The study was limited by the observational design, which allowed the researchers to report an association, but not causality, said Dr. Meda. However, the results reflect the ongoing financial burden of VAP on the health care system, although “it would be interesting to see how the trend might change if we just looked at the clinical definition versus billing data,” she noted.

The study did not include data since the advent of COVID-19, but COVID is likely to drive the trend of increasing VAP hospitalization higher, Dr. Meda added.

The study received no outside funding. The researchers had no financial conflicts to disclose.

In the decade since the Sandy Hook Elementary School shootings, the United States has experienced more than 3,300 mass shootings, according to the Gun Violence Archive.

The latest NPR/PBS NewsHour/Marist poll shows that that the margin of public opinion in the United States is the widest that it has been during the past 10 years in favor of taking steps to control gun violence; 59% of U.S. adults said it’s more important to control gun violence than to protect gun rights, and 35% said the opposite.

Have physicians’ opinions about gun issues in our country shifted meaningfully during that period? That’s a complex question that can be informed with the basic snapshot provided by doctors› comments to New York University (and Medscape blogger) bioethicist Arthur L. Caplan’s four video blogs on whether physicians should discuss gun safety with their patients. Dr. Caplan’s video blogs appeared on the Medscape website in 2014, 2016, 2018, and 2022.

Hundreds of physicians have posted comments to Dr. Caplan’s arguments that doctors should bring up gun safety when talking to their patients. The great majority of comments opposed his position in 2014, and that remained the case through 2022, regardless of incidents of gun-related violence. Supportive comments have been a small minority that has grown only slightly over his four video blogs.
 

Physicians’ lack of qualifications

The most prevalent counterarguments expressed against Dr. Caplan’s position are that physicians lack the proper knowledge to discuss gun safety with patients; and the responsibility falls on family members, certified firearms instructors, teachers, and others – but not doctors – to educate people about firearm safety.

“Then there’s a third group that says, ‘I don’t want to do this because I am too busy trying to figure out what is wrong with the patient,’ ” Dr. Caplan says.

Here are a few on-point comments that were posted to his video blogs:

• “Unless physicians become certified firearms instructors like myself, they are not qualified to talk to patients on the subject and should advise patients to find a program and take a course.” – Dr. Ken Long, March 31, 2014
• “Gun safety should be taught in school, just like health and sex education.” – Patricia L., Feb. 11, 2016
• “None of my medical or surgical training or experience qualifies me as a policy expert on gun laws or regulations.” – Dr. Kelly Hyde, Dec. 23, 2018
• “I have the Constitution hanging in my office with an NRA plaque next to it. Most MDs can’t mow their own yard.” – Dr. Brian Anseeuw, June 21, 2022

Do mental health issues trump gun talks?

Another counterargument to discussing gun safety with patients involves mental health issues that many physicians may not be trained to address. Mental health entered comments to Dr. Caplan’s video blogs in 2016 and has shaped much of the discussion since.

• “First of all, two-thirds of gun deaths are suicides. It is foolish to talk about counseling patients about gun safety, etc, and ignore the mental health issues.” – Dr. Jeffrey Jennings, Jan. 25, 2016
• “Suicide victims and those committing mass shootings are mentally ill. ... Blame society, drugs, mental illness, easy access to illegal firearms, and poor recognition of SOS (signs of suicide).” – Dr. Alan DeCarlo, Dec. 24, 2018
• “Yes, we have gun violence, but what is the underlying problem? Bullying? Mental issues? Not enough parental supervision? These and others are the issues I feel need to be discussed.” – T. Deese, June 24, 2022
• “The causes of increased gun violence are mental health, problems with bullying, social media, and normalization of deviant behavior.” – Julie Johng, 2022

Added responsibility is too much

Another theme that has grown over time is that talks of gun safety just heap issues onto physicians’ treatment plates that are already too full.

• “Oh, for God’s sake, is there anything else I can do while I›m at it? Primary care has gotten to be more headache than it’s worth. Thanks for another reason to think about retiring.” – Dr. Kathleen Collins, March 31, 2014
• “THE JOB OF POLICE, COURTS, AND LAW-EDUCATED PROSECUTORS SHOULD NOT BE HANDLED BY PHYSICIANS.” – Dr. Sudarshan Singla, Jan. 25, 2016
• “This is a debate that only those at the academic/ivory tower–level of medicine even have time to lament. The frontline medical providers barely have enough time to adequately address the pertinent.” – Tobin Purslow, Jan. 15, 2016

Other ways to communicate

For his part, Dr. Caplan believes there is a variety of ways physicians can effectively discuss gun safety with patients to help minimize the potential of injury or death.

Acknowledging that other aspects of treatment are often more pressing, he suggested that the gun safety education could be done through educational videos that are shown in waiting rooms, through pamphlets available at the front desk, or throuigh a newsletter sent to patients.

“Everything doesn’t have to happen in conversation. The doctor’s office should become more of an educational site.

“I am 100% more passionate about this than when I first started down this road.”

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

In the decade since the Sandy Hook Elementary School shootings, the United States has experienced more than 3,300 mass shootings, according to the Gun Violence Archive.

The latest NPR/PBS NewsHour/Marist poll shows that that the margin of public opinion in the United States is the widest that it has been during the past 10 years in favor of taking steps to control gun violence; 59% of U.S. adults said it’s more important to control gun violence than to protect gun rights, and 35% said the opposite.

Have physicians’ opinions about gun issues in our country shifted meaningfully during that period? That’s a complex question that can be informed with the basic snapshot provided by doctors› comments to New York University (and Medscape blogger) bioethicist Arthur L. Caplan’s four video blogs on whether physicians should discuss gun safety with their patients. Dr. Caplan’s video blogs appeared on the Medscape website in 2014, 2016, 2018, and 2022.

Hundreds of physicians have posted comments to Dr. Caplan’s arguments that doctors should bring up gun safety when talking to their patients. The great majority of comments opposed his position in 2014, and that remained the case through 2022, regardless of incidents of gun-related violence. Supportive comments have been a small minority that has grown only slightly over his four video blogs.
 

Physicians’ lack of qualifications

The most prevalent counterarguments expressed against Dr. Caplan’s position are that physicians lack the proper knowledge to discuss gun safety with patients; and the responsibility falls on family members, certified firearms instructors, teachers, and others – but not doctors – to educate people about firearm safety.

“Then there’s a third group that says, ‘I don’t want to do this because I am too busy trying to figure out what is wrong with the patient,’ ” Dr. Caplan says.

Here are a few on-point comments that were posted to his video blogs:

• “Unless physicians become certified firearms instructors like myself, they are not qualified to talk to patients on the subject and should advise patients to find a program and take a course.” – Dr. Ken Long, March 31, 2014
• “Gun safety should be taught in school, just like health and sex education.” – Patricia L., Feb. 11, 2016
• “None of my medical or surgical training or experience qualifies me as a policy expert on gun laws or regulations.” – Dr. Kelly Hyde, Dec. 23, 2018
• “I have the Constitution hanging in my office with an NRA plaque next to it. Most MDs can’t mow their own yard.” – Dr. Brian Anseeuw, June 21, 2022

Do mental health issues trump gun talks?

Another counterargument to discussing gun safety with patients involves mental health issues that many physicians may not be trained to address. Mental health entered comments to Dr. Caplan’s video blogs in 2016 and has shaped much of the discussion since.

• “First of all, two-thirds of gun deaths are suicides. It is foolish to talk about counseling patients about gun safety, etc, and ignore the mental health issues.” – Dr. Jeffrey Jennings, Jan. 25, 2016
• “Suicide victims and those committing mass shootings are mentally ill. ... Blame society, drugs, mental illness, easy access to illegal firearms, and poor recognition of SOS (signs of suicide).” – Dr. Alan DeCarlo, Dec. 24, 2018
• “Yes, we have gun violence, but what is the underlying problem? Bullying? Mental issues? Not enough parental supervision? These and others are the issues I feel need to be discussed.” – T. Deese, June 24, 2022
• “The causes of increased gun violence are mental health, problems with bullying, social media, and normalization of deviant behavior.” – Julie Johng, 2022

Added responsibility is too much

Another theme that has grown over time is that talks of gun safety just heap issues onto physicians’ treatment plates that are already too full.

• “Oh, for God’s sake, is there anything else I can do while I›m at it? Primary care has gotten to be more headache than it’s worth. Thanks for another reason to think about retiring.” – Dr. Kathleen Collins, March 31, 2014
• “THE JOB OF POLICE, COURTS, AND LAW-EDUCATED PROSECUTORS SHOULD NOT BE HANDLED BY PHYSICIANS.” – Dr. Sudarshan Singla, Jan. 25, 2016
• “This is a debate that only those at the academic/ivory tower–level of medicine even have time to lament. The frontline medical providers barely have enough time to adequately address the pertinent.” – Tobin Purslow, Jan. 15, 2016

Other ways to communicate

For his part, Dr. Caplan believes there is a variety of ways physicians can effectively discuss gun safety with patients to help minimize the potential of injury or death.

Acknowledging that other aspects of treatment are often more pressing, he suggested that the gun safety education could be done through educational videos that are shown in waiting rooms, through pamphlets available at the front desk, or throuigh a newsletter sent to patients.

“Everything doesn’t have to happen in conversation. The doctor’s office should become more of an educational site.

“I am 100% more passionate about this than when I first started down this road.”

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

In the decade since the Sandy Hook Elementary School shootings, the United States has experienced more than 3,300 mass shootings, according to the Gun Violence Archive.

The latest NPR/PBS NewsHour/Marist poll shows that that the margin of public opinion in the United States is the widest that it has been during the past 10 years in favor of taking steps to control gun violence; 59% of U.S. adults said it’s more important to control gun violence than to protect gun rights, and 35% said the opposite.

Have physicians’ opinions about gun issues in our country shifted meaningfully during that period? That’s a complex question that can be informed with the basic snapshot provided by doctors› comments to New York University (and Medscape blogger) bioethicist Arthur L. Caplan’s four video blogs on whether physicians should discuss gun safety with their patients. Dr. Caplan’s video blogs appeared on the Medscape website in 2014, 2016, 2018, and 2022.

Hundreds of physicians have posted comments to Dr. Caplan’s arguments that doctors should bring up gun safety when talking to their patients. The great majority of comments opposed his position in 2014, and that remained the case through 2022, regardless of incidents of gun-related violence. Supportive comments have been a small minority that has grown only slightly over his four video blogs.
 

Physicians’ lack of qualifications

The most prevalent counterarguments expressed against Dr. Caplan’s position are that physicians lack the proper knowledge to discuss gun safety with patients; and the responsibility falls on family members, certified firearms instructors, teachers, and others – but not doctors – to educate people about firearm safety.

“Then there’s a third group that says, ‘I don’t want to do this because I am too busy trying to figure out what is wrong with the patient,’ ” Dr. Caplan says.

Here are a few on-point comments that were posted to his video blogs:

• “Unless physicians become certified firearms instructors like myself, they are not qualified to talk to patients on the subject and should advise patients to find a program and take a course.” – Dr. Ken Long, March 31, 2014
• “Gun safety should be taught in school, just like health and sex education.” – Patricia L., Feb. 11, 2016
• “None of my medical or surgical training or experience qualifies me as a policy expert on gun laws or regulations.” – Dr. Kelly Hyde, Dec. 23, 2018
• “I have the Constitution hanging in my office with an NRA plaque next to it. Most MDs can’t mow their own yard.” – Dr. Brian Anseeuw, June 21, 2022

Do mental health issues trump gun talks?

Another counterargument to discussing gun safety with patients involves mental health issues that many physicians may not be trained to address. Mental health entered comments to Dr. Caplan’s video blogs in 2016 and has shaped much of the discussion since.

• “First of all, two-thirds of gun deaths are suicides. It is foolish to talk about counseling patients about gun safety, etc, and ignore the mental health issues.” – Dr. Jeffrey Jennings, Jan. 25, 2016
• “Suicide victims and those committing mass shootings are mentally ill. ... Blame society, drugs, mental illness, easy access to illegal firearms, and poor recognition of SOS (signs of suicide).” – Dr. Alan DeCarlo, Dec. 24, 2018
• “Yes, we have gun violence, but what is the underlying problem? Bullying? Mental issues? Not enough parental supervision? These and others are the issues I feel need to be discussed.” – T. Deese, June 24, 2022
• “The causes of increased gun violence are mental health, problems with bullying, social media, and normalization of deviant behavior.” – Julie Johng, 2022

Added responsibility is too much

Another theme that has grown over time is that talks of gun safety just heap issues onto physicians’ treatment plates that are already too full.

• “Oh, for God’s sake, is there anything else I can do while I›m at it? Primary care has gotten to be more headache than it’s worth. Thanks for another reason to think about retiring.” – Dr. Kathleen Collins, March 31, 2014
• “THE JOB OF POLICE, COURTS, AND LAW-EDUCATED PROSECUTORS SHOULD NOT BE HANDLED BY PHYSICIANS.” – Dr. Sudarshan Singla, Jan. 25, 2016
• “This is a debate that only those at the academic/ivory tower–level of medicine even have time to lament. The frontline medical providers barely have enough time to adequately address the pertinent.” – Tobin Purslow, Jan. 15, 2016

Other ways to communicate

For his part, Dr. Caplan believes there is a variety of ways physicians can effectively discuss gun safety with patients to help minimize the potential of injury or death.

Acknowledging that other aspects of treatment are often more pressing, he suggested that the gun safety education could be done through educational videos that are shown in waiting rooms, through pamphlets available at the front desk, or throuigh a newsletter sent to patients.

“Everything doesn’t have to happen in conversation. The doctor’s office should become more of an educational site.

“I am 100% more passionate about this than when I first started down this road.”

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

Gregory A. Hood, MD, remembers a patient of his who was perpetually dubious about COVID-19 – and then couldn’t be saved.

“I spoke to him on many occasions about the dangers of COVID, but he just didn’t believe me,” said Dr. Hood, an internist in Lexington, Ky. “He just didn’t give me enough time to help him. He waited to let me know he was ill with COVID and took days to pick up the medicine. Unfortunately, he then passed away.”
 

The rise of the skeptical patient

It can be extremely frustrating for doctors when patients question or disbelieve their physician’s medical advice and explanations. And many physicians resent the amount of time they spend trying to explain or make their case, especially during a busy day. But patients’ skepticism about the validity of some treatments seems to be increasing.

“Patients are now more likely to have their own medical explanation for their complaint than they used to, and that can be bad for their health,” Dr. Hood said.

Dr. Hood sees medical cynicism as part of Americans’ growing distrust of experts, leveraged by easy access to the internet. “When people Google, they tend to look for support of their opinions, rather than arrive at a fully educated decision.”

Only about half of patients believe their physicians “provide fair and accurate treatment information all or most of the time,” according to a 2019 survey by the Pew Research Center.

Patients’ distrust has become more obvious during the COVID-19 pandemic, said John Schumann, MD, an internist with Oak Street Health, a practice with more than 500 physicians and other providers in 20 states, treating almost exclusively Medicare patients.

“The skeptics became more entrenched during the pandemic,” said Dr. Schumann, who is based in Tulsa, Okla. “They may think the COVID vaccines were approved too quickly, or believe the pandemic itself is a hoax.”

“There’s a lot of antiscience rhetoric now,” Dr. Schumann added. “I’d say about half of my patients are comfortable with science-based decisions and the other half are not.”
 

What are patients mistrustful about?

Patients’ suspicions of certain therapies began long before the pandemic. In dermatology, for example, some patients refuse to take topical steroids, said Steven R. Feldman, MD, a dermatologist in Winston-Salem, N.C.

“Their distrust is usually based on anecdotal stories they read about,” he noted. “Patients in other specialties are dead set against vaccinations.”

In addition to refusing treatments and inoculations, some patients ask for questionable regimens mentioned in the news. “Some patients have demanded hydroxychloroquine or Noromectin, drugs that are unproven in the treatment of COVID,” Dr. Schumann said. “We refuse to prescribe them.”

Dr. Hood said patients’ reluctance to follow medical advice can often be based on cost. “I have a patient who was more willing to save $20 than to save his life. But when the progression of his test results fit my predictions, he became more willing to take treatments. I had to wait for the opportune moment to convince him.”

Many naysayer patients keep their views to themselves, and physicians may be unaware that the patients are stonewalling. A 2006 study estimated that about 10%-16% of primary care patients actively resist medical authority.

Dr. Schumann cited patients who don’t want to hear an upsetting diagnosis. “Some patients might refuse to take a biopsy to see if they have cancer because they don’t want to know,” he said. “In many cases, they simply won’t get the biopsy and won’t tell the doctor that they didn’t.”
 

Sometimes skeptics’ arguments have merit

Some patients’ concerns can be valid, such as when they refuse to go on statins, said Zain Hakeem, DO, a physician in Austin, Tex.

“In some cases, I feel that statins are not necessary,” he said. “The science on statins for primary prevention is not strong, although they should be used for exceedingly high-risk patients.”

Certain patients, especially those with chronic conditions, do a great deal of research, using legitimate sources on the Web, and their research is well supported.

However, these patients can be overconfident in their conclusions. Several studies have shown that with just a little experience, people can replace beginners’ caution with a false sense of competence.

For example, “Patients may not weigh the risks correctly,” Dr. Hakeem said. “They can be more concerned about the risk of having their colon perforated during a colonoscopy, while the risk of cancer if they don’t have a colonoscopy is much higher.”

Some highly successful people may be more likely to trust their own medical instincts. When Steve Jobs, the founder of Apple, was diagnosed with pancreatic cancer in 2003, he put off surgery for 9 months while he tried to cure his disease with a vegan diet, acupuncture, herbs, bowel cleansings, and other remedies he read about. He died in 2011. Some experts believe that delay hastened his death.

Of course, not all physicians’ diagnoses or treatments are correct. One study indicated doctors’ diagnostic error rate could be as high as 15%. And just as patients can be overconfident in their conclusions, so can doctors. Another study found that physicians’ stated confidence in their diagnosis was only slightly affected by the inaccuracy of that diagnosis or the difficulty of the case.
 

Best ways to deal with cynical patients

Patients’ skepticism can frustrate doctors, reduce the efficiency of care delivery, and interfere with recovery. What can doctors do to deal with these problems?

1. Build the patient’s trust in you. “Getting patients to adhere to your advice involves making sure they feel they have a caring doctor whom they trust,” Dr. Feldman said.

“I want to show patients that I am entirely focused on them,” he added. “For example, I may rush to the door of the exam room from my last appointment, but I open the door very slowly and deliberately, because I want the patient to see that I won’t hurry with them.”

2. Spend time with the patient. Familiarity builds trust. Dr. Schumann said doctors at Oak Street Health see their patients an average of six to eight times a year, an unusually high number. “The more patients see their physicians, the more likely they are to trust them.”

3. Keep up to date. “I make sure I’m up to date with the literature, and I try to present a truthful message,” Dr. Hood said. “For instance, my research showed that inflammation played a strong role in developing complications from COVID, so I wrote a detailed treatment protocol aimed at the inflammation and the immune response, which has been very effective.”

4. Confront patients tactfully. Patients who do research on the Web don’t want to be scolded, Dr. Feldman said. In fact, he praises them, even if he doesn’t agree with their findings. “I might say: ‘What a relief to finally find patients who’ve taken the time to educate themselves before coming here.’ ”

Dr. Feldman is careful not to dispute patients’ conclusions. “Debating the issues is not an effective approach to get patients to trust you. The last thing you want to tell a patient is: ‘Listen to me! I’m an expert.’ People just dig in.”

However, it does help to give patients feedback. “I’m a big fan of patients arguing with me,” Dr. Hakeem said. “It means you can straighten out misunderstandings and improve decision-making.”

5. Explain your reasoning. “You need to communicate clearly and show them your thinking,” Dr. Hood said. “For instance, I’ll explain why a patient has a strong risk for heart attack.”

6. Acknowledge uncertainties. “The doctor may present the science as far more certain than it is,” Dr. Hakeem said. “If you don’t acknowledge the uncertainties, you could break the patient’s trust in you.”

7. Don’t use a lot of numbers. “Data is not a good tool to convince patients,” Dr. Feldman said. “The human brain isn’t designed to work that way.”

If you want to use numbers to show clinical risk, Dr. Hakeem advisd using natural frequencies, such as 10 out of 10,000, which is less confusing to the patient than the equivalent percentage of 0.1%.

It can be helpful to refer to familiar concepts. One way to understand a risk is to compare it with risks in daily life, such as the dangers of driving or falling in the shower, Dr. Hakeem added.

Dr. Feldman often refers to another person’s experience when presenting his medical advice. “I might say to the patient: ‘You remind me of another patient I had. They were sitting in the same chair you’re sitting in. They did really well on this drug, and I think it’s probably the best choice for you, too.’ ”

8. Adopt shared decision-making. This approach involves empowering the patient to become an equal partner in medical decisions. The patient is given information through portals and is encouraged to do research. Critics, however, say that most patients don’t want this degree of empowerment and would rather depend on the doctor’s advice.

Conclusion

It’s often impossible to get through to a skeptical patient, which can be disheartening for doctors. “Physicians want to do what is best for the patient, so when the patient doesn’t listen, they may take it personally,” Dr. Hood said. “But you always have to remember, the patient is the one with disease, and it’s up to the patient to open the door.”

Still, some skeptical patients ultimately change their minds. Dr. Schumann said patients who initially declined the COVID vaccine eventually decided to get it. “It often took them more than a year. but it’s never too late.”

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

Gregory A. Hood, MD, remembers a patient of his who was perpetually dubious about COVID-19 – and then couldn’t be saved.

“I spoke to him on many occasions about the dangers of COVID, but he just didn’t believe me,” said Dr. Hood, an internist in Lexington, Ky. “He just didn’t give me enough time to help him. He waited to let me know he was ill with COVID and took days to pick up the medicine. Unfortunately, he then passed away.”
 

The rise of the skeptical patient

It can be extremely frustrating for doctors when patients question or disbelieve their physician’s medical advice and explanations. And many physicians resent the amount of time they spend trying to explain or make their case, especially during a busy day. But patients’ skepticism about the validity of some treatments seems to be increasing.

“Patients are now more likely to have their own medical explanation for their complaint than they used to, and that can be bad for their health,” Dr. Hood said.

Dr. Hood sees medical cynicism as part of Americans’ growing distrust of experts, leveraged by easy access to the internet. “When people Google, they tend to look for support of their opinions, rather than arrive at a fully educated decision.”

Only about half of patients believe their physicians “provide fair and accurate treatment information all or most of the time,” according to a 2019 survey by the Pew Research Center.

Patients’ distrust has become more obvious during the COVID-19 pandemic, said John Schumann, MD, an internist with Oak Street Health, a practice with more than 500 physicians and other providers in 20 states, treating almost exclusively Medicare patients.

“The skeptics became more entrenched during the pandemic,” said Dr. Schumann, who is based in Tulsa, Okla. “They may think the COVID vaccines were approved too quickly, or believe the pandemic itself is a hoax.”

“There’s a lot of antiscience rhetoric now,” Dr. Schumann added. “I’d say about half of my patients are comfortable with science-based decisions and the other half are not.”
 

What are patients mistrustful about?

Patients’ suspicions of certain therapies began long before the pandemic. In dermatology, for example, some patients refuse to take topical steroids, said Steven R. Feldman, MD, a dermatologist in Winston-Salem, N.C.

“Their distrust is usually based on anecdotal stories they read about,” he noted. “Patients in other specialties are dead set against vaccinations.”

In addition to refusing treatments and inoculations, some patients ask for questionable regimens mentioned in the news. “Some patients have demanded hydroxychloroquine or Noromectin, drugs that are unproven in the treatment of COVID,” Dr. Schumann said. “We refuse to prescribe them.”

Dr. Hood said patients’ reluctance to follow medical advice can often be based on cost. “I have a patient who was more willing to save $20 than to save his life. But when the progression of his test results fit my predictions, he became more willing to take treatments. I had to wait for the opportune moment to convince him.”

Many naysayer patients keep their views to themselves, and physicians may be unaware that the patients are stonewalling. A 2006 study estimated that about 10%-16% of primary care patients actively resist medical authority.

Dr. Schumann cited patients who don’t want to hear an upsetting diagnosis. “Some patients might refuse to take a biopsy to see if they have cancer because they don’t want to know,” he said. “In many cases, they simply won’t get the biopsy and won’t tell the doctor that they didn’t.”
 

Sometimes skeptics’ arguments have merit

Some patients’ concerns can be valid, such as when they refuse to go on statins, said Zain Hakeem, DO, a physician in Austin, Tex.

“In some cases, I feel that statins are not necessary,” he said. “The science on statins for primary prevention is not strong, although they should be used for exceedingly high-risk patients.”

Certain patients, especially those with chronic conditions, do a great deal of research, using legitimate sources on the Web, and their research is well supported.

However, these patients can be overconfident in their conclusions. Several studies have shown that with just a little experience, people can replace beginners’ caution with a false sense of competence.

For example, “Patients may not weigh the risks correctly,” Dr. Hakeem said. “They can be more concerned about the risk of having their colon perforated during a colonoscopy, while the risk of cancer if they don’t have a colonoscopy is much higher.”

Some highly successful people may be more likely to trust their own medical instincts. When Steve Jobs, the founder of Apple, was diagnosed with pancreatic cancer in 2003, he put off surgery for 9 months while he tried to cure his disease with a vegan diet, acupuncture, herbs, bowel cleansings, and other remedies he read about. He died in 2011. Some experts believe that delay hastened his death.

Of course, not all physicians’ diagnoses or treatments are correct. One study indicated doctors’ diagnostic error rate could be as high as 15%. And just as patients can be overconfident in their conclusions, so can doctors. Another study found that physicians’ stated confidence in their diagnosis was only slightly affected by the inaccuracy of that diagnosis or the difficulty of the case.
 

Best ways to deal with cynical patients

Patients’ skepticism can frustrate doctors, reduce the efficiency of care delivery, and interfere with recovery. What can doctors do to deal with these problems?

1. Build the patient’s trust in you. “Getting patients to adhere to your advice involves making sure they feel they have a caring doctor whom they trust,” Dr. Feldman said.

“I want to show patients that I am entirely focused on them,” he added. “For example, I may rush to the door of the exam room from my last appointment, but I open the door very slowly and deliberately, because I want the patient to see that I won’t hurry with them.”

2. Spend time with the patient. Familiarity builds trust. Dr. Schumann said doctors at Oak Street Health see their patients an average of six to eight times a year, an unusually high number. “The more patients see their physicians, the more likely they are to trust them.”

3. Keep up to date. “I make sure I’m up to date with the literature, and I try to present a truthful message,” Dr. Hood said. “For instance, my research showed that inflammation played a strong role in developing complications from COVID, so I wrote a detailed treatment protocol aimed at the inflammation and the immune response, which has been very effective.”

4. Confront patients tactfully. Patients who do research on the Web don’t want to be scolded, Dr. Feldman said. In fact, he praises them, even if he doesn’t agree with their findings. “I might say: ‘What a relief to finally find patients who’ve taken the time to educate themselves before coming here.’ ”

Dr. Feldman is careful not to dispute patients’ conclusions. “Debating the issues is not an effective approach to get patients to trust you. The last thing you want to tell a patient is: ‘Listen to me! I’m an expert.’ People just dig in.”

However, it does help to give patients feedback. “I’m a big fan of patients arguing with me,” Dr. Hakeem said. “It means you can straighten out misunderstandings and improve decision-making.”

5. Explain your reasoning. “You need to communicate clearly and show them your thinking,” Dr. Hood said. “For instance, I’ll explain why a patient has a strong risk for heart attack.”

6. Acknowledge uncertainties. “The doctor may present the science as far more certain than it is,” Dr. Hakeem said. “If you don’t acknowledge the uncertainties, you could break the patient’s trust in you.”

7. Don’t use a lot of numbers. “Data is not a good tool to convince patients,” Dr. Feldman said. “The human brain isn’t designed to work that way.”

If you want to use numbers to show clinical risk, Dr. Hakeem advisd using natural frequencies, such as 10 out of 10,000, which is less confusing to the patient than the equivalent percentage of 0.1%.

It can be helpful to refer to familiar concepts. One way to understand a risk is to compare it with risks in daily life, such as the dangers of driving or falling in the shower, Dr. Hakeem added.

Dr. Feldman often refers to another person’s experience when presenting his medical advice. “I might say to the patient: ‘You remind me of another patient I had. They were sitting in the same chair you’re sitting in. They did really well on this drug, and I think it’s probably the best choice for you, too.’ ”

8. Adopt shared decision-making. This approach involves empowering the patient to become an equal partner in medical decisions. The patient is given information through portals and is encouraged to do research. Critics, however, say that most patients don’t want this degree of empowerment and would rather depend on the doctor’s advice.

Conclusion

It’s often impossible to get through to a skeptical patient, which can be disheartening for doctors. “Physicians want to do what is best for the patient, so when the patient doesn’t listen, they may take it personally,” Dr. Hood said. “But you always have to remember, the patient is the one with disease, and it’s up to the patient to open the door.”

Still, some skeptical patients ultimately change their minds. Dr. Schumann said patients who initially declined the COVID vaccine eventually decided to get it. “It often took them more than a year. but it’s never too late.”

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

Gregory A. Hood, MD, remembers a patient of his who was perpetually dubious about COVID-19 – and then couldn’t be saved.

“I spoke to him on many occasions about the dangers of COVID, but he just didn’t believe me,” said Dr. Hood, an internist in Lexington, Ky. “He just didn’t give me enough time to help him. He waited to let me know he was ill with COVID and took days to pick up the medicine. Unfortunately, he then passed away.”
 

The rise of the skeptical patient

It can be extremely frustrating for doctors when patients question or disbelieve their physician’s medical advice and explanations. And many physicians resent the amount of time they spend trying to explain or make their case, especially during a busy day. But patients’ skepticism about the validity of some treatments seems to be increasing.

“Patients are now more likely to have their own medical explanation for their complaint than they used to, and that can be bad for their health,” Dr. Hood said.

Dr. Hood sees medical cynicism as part of Americans’ growing distrust of experts, leveraged by easy access to the internet. “When people Google, they tend to look for support of their opinions, rather than arrive at a fully educated decision.”

Only about half of patients believe their physicians “provide fair and accurate treatment information all or most of the time,” according to a 2019 survey by the Pew Research Center.

Patients’ distrust has become more obvious during the COVID-19 pandemic, said John Schumann, MD, an internist with Oak Street Health, a practice with more than 500 physicians and other providers in 20 states, treating almost exclusively Medicare patients.

“The skeptics became more entrenched during the pandemic,” said Dr. Schumann, who is based in Tulsa, Okla. “They may think the COVID vaccines were approved too quickly, or believe the pandemic itself is a hoax.”

“There’s a lot of antiscience rhetoric now,” Dr. Schumann added. “I’d say about half of my patients are comfortable with science-based decisions and the other half are not.”
 

What are patients mistrustful about?

Patients’ suspicions of certain therapies began long before the pandemic. In dermatology, for example, some patients refuse to take topical steroids, said Steven R. Feldman, MD, a dermatologist in Winston-Salem, N.C.

“Their distrust is usually based on anecdotal stories they read about,” he noted. “Patients in other specialties are dead set against vaccinations.”

In addition to refusing treatments and inoculations, some patients ask for questionable regimens mentioned in the news. “Some patients have demanded hydroxychloroquine or Noromectin, drugs that are unproven in the treatment of COVID,” Dr. Schumann said. “We refuse to prescribe them.”

Dr. Hood said patients’ reluctance to follow medical advice can often be based on cost. “I have a patient who was more willing to save $20 than to save his life. But when the progression of his test results fit my predictions, he became more willing to take treatments. I had to wait for the opportune moment to convince him.”

Many naysayer patients keep their views to themselves, and physicians may be unaware that the patients are stonewalling. A 2006 study estimated that about 10%-16% of primary care patients actively resist medical authority.

Dr. Schumann cited patients who don’t want to hear an upsetting diagnosis. “Some patients might refuse to take a biopsy to see if they have cancer because they don’t want to know,” he said. “In many cases, they simply won’t get the biopsy and won’t tell the doctor that they didn’t.”
 

Sometimes skeptics’ arguments have merit

Some patients’ concerns can be valid, such as when they refuse to go on statins, said Zain Hakeem, DO, a physician in Austin, Tex.

“In some cases, I feel that statins are not necessary,” he said. “The science on statins for primary prevention is not strong, although they should be used for exceedingly high-risk patients.”

Certain patients, especially those with chronic conditions, do a great deal of research, using legitimate sources on the Web, and their research is well supported.

However, these patients can be overconfident in their conclusions. Several studies have shown that with just a little experience, people can replace beginners’ caution with a false sense of competence.

For example, “Patients may not weigh the risks correctly,” Dr. Hakeem said. “They can be more concerned about the risk of having their colon perforated during a colonoscopy, while the risk of cancer if they don’t have a colonoscopy is much higher.”

Some highly successful people may be more likely to trust their own medical instincts. When Steve Jobs, the founder of Apple, was diagnosed with pancreatic cancer in 2003, he put off surgery for 9 months while he tried to cure his disease with a vegan diet, acupuncture, herbs, bowel cleansings, and other remedies he read about. He died in 2011. Some experts believe that delay hastened his death.

Of course, not all physicians’ diagnoses or treatments are correct. One study indicated doctors’ diagnostic error rate could be as high as 15%. And just as patients can be overconfident in their conclusions, so can doctors. Another study found that physicians’ stated confidence in their diagnosis was only slightly affected by the inaccuracy of that diagnosis or the difficulty of the case.
 

Best ways to deal with cynical patients

Patients’ skepticism can frustrate doctors, reduce the efficiency of care delivery, and interfere with recovery. What can doctors do to deal with these problems?

1. Build the patient’s trust in you. “Getting patients to adhere to your advice involves making sure they feel they have a caring doctor whom they trust,” Dr. Feldman said.

“I want to show patients that I am entirely focused on them,” he added. “For example, I may rush to the door of the exam room from my last appointment, but I open the door very slowly and deliberately, because I want the patient to see that I won’t hurry with them.”

2. Spend time with the patient. Familiarity builds trust. Dr. Schumann said doctors at Oak Street Health see their patients an average of six to eight times a year, an unusually high number. “The more patients see their physicians, the more likely they are to trust them.”

3. Keep up to date. “I make sure I’m up to date with the literature, and I try to present a truthful message,” Dr. Hood said. “For instance, my research showed that inflammation played a strong role in developing complications from COVID, so I wrote a detailed treatment protocol aimed at the inflammation and the immune response, which has been very effective.”

4. Confront patients tactfully. Patients who do research on the Web don’t want to be scolded, Dr. Feldman said. In fact, he praises them, even if he doesn’t agree with their findings. “I might say: ‘What a relief to finally find patients who’ve taken the time to educate themselves before coming here.’ ”

Dr. Feldman is careful not to dispute patients’ conclusions. “Debating the issues is not an effective approach to get patients to trust you. The last thing you want to tell a patient is: ‘Listen to me! I’m an expert.’ People just dig in.”

However, it does help to give patients feedback. “I’m a big fan of patients arguing with me,” Dr. Hakeem said. “It means you can straighten out misunderstandings and improve decision-making.”

5. Explain your reasoning. “You need to communicate clearly and show them your thinking,” Dr. Hood said. “For instance, I’ll explain why a patient has a strong risk for heart attack.”

6. Acknowledge uncertainties. “The doctor may present the science as far more certain than it is,” Dr. Hakeem said. “If you don’t acknowledge the uncertainties, you could break the patient’s trust in you.”

7. Don’t use a lot of numbers. “Data is not a good tool to convince patients,” Dr. Feldman said. “The human brain isn’t designed to work that way.”

If you want to use numbers to show clinical risk, Dr. Hakeem advisd using natural frequencies, such as 10 out of 10,000, which is less confusing to the patient than the equivalent percentage of 0.1%.

It can be helpful to refer to familiar concepts. One way to understand a risk is to compare it with risks in daily life, such as the dangers of driving or falling in the shower, Dr. Hakeem added.

Dr. Feldman often refers to another person’s experience when presenting his medical advice. “I might say to the patient: ‘You remind me of another patient I had. They were sitting in the same chair you’re sitting in. They did really well on this drug, and I think it’s probably the best choice for you, too.’ ”

8. Adopt shared decision-making. This approach involves empowering the patient to become an equal partner in medical decisions. The patient is given information through portals and is encouraged to do research. Critics, however, say that most patients don’t want this degree of empowerment and would rather depend on the doctor’s advice.

Conclusion

It’s often impossible to get through to a skeptical patient, which can be disheartening for doctors. “Physicians want to do what is best for the patient, so when the patient doesn’t listen, they may take it personally,” Dr. Hood said. “But you always have to remember, the patient is the one with disease, and it’s up to the patient to open the door.”

Still, some skeptical patients ultimately change their minds. Dr. Schumann said patients who initially declined the COVID vaccine eventually decided to get it. “It often took them more than a year. but it’s never too late.”

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

Sepsis survivors discharged to post-acute care facilities are at high risk for mortality and hospital readmission, according to Nicholas Colucciello, MD, and few interventions have been shown to reduce these adverse outcomes.

Dr. Colucciello and colleagues compared the effects of a Sepsis Transition And Recovery (STAR) program versus Usual Care (UC) alone on 30-day mortality and hospital readmission among sepsis survivors discharged to post-acute care.

In a study presented at the annual meeting of the American College of Chest Physicians (CHEST), Dr. Colucciello, a primary care physician in Toledo, Ohio, presented data suggesting that the STAR intervention program appears beneficial for patients discharged to post-acute care facilities and may lead to decreased 30-day mortality and readmission rates.
 

Study of IMPACTS

The study was a secondary analysis of patients from the IMPACTS (Improving Morbidity During Post-Acute Care Transitions for Sepsis) randomized clinical trial, focusing only on those patients who were discharged to a post-acute care facility. IMPACTS evaluated the effectiveness of STAR, a post-sepsis transition program using nurse navigators to deliver best-practice post-sepsis care during and after hospitalization, Dr. Colucciello said. The interventions included comorbidity monitoring, medication review, evaluation for new impairments/symptoms, and goals of care assessment.

“Over one-third of sepsis survivors are discharged to post-acute care as they are not stable enough to go home,” said Dr. Colucciello, and among these patients there is a high risk for mortality and hospital readmission.

Dr. Colucciello and his colleagues randomly assigned patients hospitalized with sepsis and deemed high risk for post-discharge readmission or mortality to either STAR or usual care. The primary outcome was a composite of 30-day readmission and mortality, which was assessed from the electronic health record and social security death master file.

Of the 175 (21%) IMPACTS patients discharged to post-acute care facilities, 143 (82%) were sent to skilled nursing facilities, and 12 (7%) were sent to long-term acute care hospitals. The remaining 20 patients (11%) were sent to inpatient rehabilitation. A total of 88 of these patients received the STAR intervention and 87 received usual care.
 

Suggestive results

The study showed that the composite primary endpoint occurred in 26 (30.6%) patients in the usual care group versus 18 (20.7%) patients in the STAR group, for a risk difference of –9.9% (95% CI, –22.9 to 3.1), according to Dr. Colucciello. As individual factors, 30-day all-cause mortality was 8.2% in the UC group, compared with 5.8% in the STAR group, for a risk difference of –2.5% (95% CI, –10.1 to 5.0) and the 30-day all-cause readmission was 27.1% in the UC group, compared with 17.2% in the STAR program, for a risk difference of –9.8% (95% CI, –22.2 to 2.5). On average, patients receiving UC experienced 26.5 hospital-free days, compared with 27.4 hospital-free days in the STAR group, he added.

The biggest limitation of the study was the fact that it was underpowered to detect statistically significant differences, despite the suggestive results, said Dr. Colucciello. However, he added: “This secondary analysis of the IMPACTS randomized trial found that the STAR intervention may decrease 30-day mortality and readmission rates among sepsis patients discharged to a post-acute care facility,” he concluded.

Dr. Colucciello and colleagues report no relevant financial relationships.

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

Sepsis survivors discharged to post-acute care facilities are at high risk for mortality and hospital readmission, according to Nicholas Colucciello, MD, and few interventions have been shown to reduce these adverse outcomes.

Dr. Colucciello and colleagues compared the effects of a Sepsis Transition And Recovery (STAR) program versus Usual Care (UC) alone on 30-day mortality and hospital readmission among sepsis survivors discharged to post-acute care.

In a study presented at the annual meeting of the American College of Chest Physicians (CHEST), Dr. Colucciello, a primary care physician in Toledo, Ohio, presented data suggesting that the STAR intervention program appears beneficial for patients discharged to post-acute care facilities and may lead to decreased 30-day mortality and readmission rates.
 

Study of IMPACTS

The study was a secondary analysis of patients from the IMPACTS (Improving Morbidity During Post-Acute Care Transitions for Sepsis) randomized clinical trial, focusing only on those patients who were discharged to a post-acute care facility. IMPACTS evaluated the effectiveness of STAR, a post-sepsis transition program using nurse navigators to deliver best-practice post-sepsis care during and after hospitalization, Dr. Colucciello said. The interventions included comorbidity monitoring, medication review, evaluation for new impairments/symptoms, and goals of care assessment.

“Over one-third of sepsis survivors are discharged to post-acute care as they are not stable enough to go home,” said Dr. Colucciello, and among these patients there is a high risk for mortality and hospital readmission.

Dr. Colucciello and his colleagues randomly assigned patients hospitalized with sepsis and deemed high risk for post-discharge readmission or mortality to either STAR or usual care. The primary outcome was a composite of 30-day readmission and mortality, which was assessed from the electronic health record and social security death master file.

Of the 175 (21%) IMPACTS patients discharged to post-acute care facilities, 143 (82%) were sent to skilled nursing facilities, and 12 (7%) were sent to long-term acute care hospitals. The remaining 20 patients (11%) were sent to inpatient rehabilitation. A total of 88 of these patients received the STAR intervention and 87 received usual care.
 

Suggestive results

The study showed that the composite primary endpoint occurred in 26 (30.6%) patients in the usual care group versus 18 (20.7%) patients in the STAR group, for a risk difference of –9.9% (95% CI, –22.9 to 3.1), according to Dr. Colucciello. As individual factors, 30-day all-cause mortality was 8.2% in the UC group, compared with 5.8% in the STAR group, for a risk difference of –2.5% (95% CI, –10.1 to 5.0) and the 30-day all-cause readmission was 27.1% in the UC group, compared with 17.2% in the STAR program, for a risk difference of –9.8% (95% CI, –22.2 to 2.5). On average, patients receiving UC experienced 26.5 hospital-free days, compared with 27.4 hospital-free days in the STAR group, he added.

The biggest limitation of the study was the fact that it was underpowered to detect statistically significant differences, despite the suggestive results, said Dr. Colucciello. However, he added: “This secondary analysis of the IMPACTS randomized trial found that the STAR intervention may decrease 30-day mortality and readmission rates among sepsis patients discharged to a post-acute care facility,” he concluded.

Dr. Colucciello and colleagues report no relevant financial relationships.

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

Sepsis survivors discharged to post-acute care facilities are at high risk for mortality and hospital readmission, according to Nicholas Colucciello, MD, and few interventions have been shown to reduce these adverse outcomes.

Dr. Colucciello and colleagues compared the effects of a Sepsis Transition And Recovery (STAR) program versus Usual Care (UC) alone on 30-day mortality and hospital readmission among sepsis survivors discharged to post-acute care.

In a study presented at the annual meeting of the American College of Chest Physicians (CHEST), Dr. Colucciello, a primary care physician in Toledo, Ohio, presented data suggesting that the STAR intervention program appears beneficial for patients discharged to post-acute care facilities and may lead to decreased 30-day mortality and readmission rates.
 

Study of IMPACTS

The study was a secondary analysis of patients from the IMPACTS (Improving Morbidity During Post-Acute Care Transitions for Sepsis) randomized clinical trial, focusing only on those patients who were discharged to a post-acute care facility. IMPACTS evaluated the effectiveness of STAR, a post-sepsis transition program using nurse navigators to deliver best-practice post-sepsis care during and after hospitalization, Dr. Colucciello said. The interventions included comorbidity monitoring, medication review, evaluation for new impairments/symptoms, and goals of care assessment.

“Over one-third of sepsis survivors are discharged to post-acute care as they are not stable enough to go home,” said Dr. Colucciello, and among these patients there is a high risk for mortality and hospital readmission.

Dr. Colucciello and his colleagues randomly assigned patients hospitalized with sepsis and deemed high risk for post-discharge readmission or mortality to either STAR or usual care. The primary outcome was a composite of 30-day readmission and mortality, which was assessed from the electronic health record and social security death master file.

Of the 175 (21%) IMPACTS patients discharged to post-acute care facilities, 143 (82%) were sent to skilled nursing facilities, and 12 (7%) were sent to long-term acute care hospitals. The remaining 20 patients (11%) were sent to inpatient rehabilitation. A total of 88 of these patients received the STAR intervention and 87 received usual care.
 

Suggestive results

The study showed that the composite primary endpoint occurred in 26 (30.6%) patients in the usual care group versus 18 (20.7%) patients in the STAR group, for a risk difference of –9.9% (95% CI, –22.9 to 3.1), according to Dr. Colucciello. As individual factors, 30-day all-cause mortality was 8.2% in the UC group, compared with 5.8% in the STAR group, for a risk difference of –2.5% (95% CI, –10.1 to 5.0) and the 30-day all-cause readmission was 27.1% in the UC group, compared with 17.2% in the STAR program, for a risk difference of –9.8% (95% CI, –22.2 to 2.5). On average, patients receiving UC experienced 26.5 hospital-free days, compared with 27.4 hospital-free days in the STAR group, he added.

The biggest limitation of the study was the fact that it was underpowered to detect statistically significant differences, despite the suggestive results, said Dr. Colucciello. However, he added: “This secondary analysis of the IMPACTS randomized trial found that the STAR intervention may decrease 30-day mortality and readmission rates among sepsis patients discharged to a post-acute care facility,” he concluded.

Dr. Colucciello and colleagues report no relevant financial relationships.

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

Use of a sepsis predictor made little difference in time to antibiotic administration for septic patients in the emergency department, based on data from more than 200 patients.

“One of the big problems with sepsis is the lack of current tools for early and accurate diagnoses,” said Daniel Burgin, MD, an internal medicine resident at Louisiana State University, Baton Rouge, in a presentation at the annual meeting of the American College of Chest Physicians.

The EPIC Sepsis Model (ESM) was designed to help facilitate earlier detection of sepsis and speed time to the start of antibiotics, but its effectiveness has not been well studied, Dr. Burgin said.

In Dr. Burgin’s facility, the ESM is mainly driven by systemic inflammatory response syndrome (SIRS) and blood pressure and is calculated every 15 minutes; the system triggers a best-practice advisory if needed, with an alert that sepsis may be suspected.

To assess the impact of ESM on time to antibiotics, Dr. Burgin and colleagues reviewed data from 226 adult patients who presented to a single emergency department between February 2019 and June 2019. All patients presented with at least two criteria for SIRS. An ESM threshold of 6 was designed to trigger a set of orders to guide providers on a treatment plan that included antibiotics.

The researchers compared times to the ordering and the administration of antibiotics for patients with ESM scores of 6 or higher vs. less than 6 within 6 hours of triage in the ED. A total of 109 patients (48.2%) received antibiotics in the ED. Of these, 71 (74.5%) had ESM less than 6 and 38 (40.6%) had ESM of 6 or higher. The times from triage to antibiotics ordered and administered was significantly less in patients with ESM of 6 or higher (90.5 minutes vs. 131.5 minutes; 136 minutes vs. 186 minutes, respectively; P = .011 for both).

A total of 188 patients were evaluated for infection, and 86 met Sepsis-2 criteria based on physician chart review. These patients were significantly more likely than those not meeting the Sepsis-2 criteria to receive antibiotics in the ED (76.7% vs. 22.8%; P <.001).

Another 21 patients met criteria for Sepsis-3 based on a physician panel. Although all 21 received antibiotics, 5 did not receive them within 6 hours of triage in the ED, Dr. Burgin said. The median times to ordering and administration of antibiotics for Sepsis-3 patients with an ESM of 6 or higher were –5 and 38.5 (interquartile range), respectively.

“We hope that the ESM would prompt providers to start the order [for antibiotics],” Dr. Burgin said in his presentation. However, the researchers found no consistent patterns, and in many cases the ESM alerts occurred after the orders had been initiated, he noted.

The study findings were limited by the use of data from a single center; the implementation of the EPIC tool is hospital specific, said Dr. Burgin. However, the results suggest that “the ESM trigger is not improving the time to ordering of antibiotics for septic patients, and we question the utility of this tool in its current state,” he said.

“While this research proved useful in assessing the impact of ESM on time to antibiotics, more research is needed to understand how to operationalize predictive analytics,” Dr. Burgin said of the study findings. “The goal is to find the balance between early identification of sepsis and timely antimicrobial therapy and the potential harm of overalerting treatment teams.”

The study was supported in part by Cytovale, a sepsis diagnostics company. Several coauthors disclosed financial relationships with Cytovale. Dr. Burgin reports no relevant financial relationships.

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

Use of a sepsis predictor made little difference in time to antibiotic administration for septic patients in the emergency department, based on data from more than 200 patients.

“One of the big problems with sepsis is the lack of current tools for early and accurate diagnoses,” said Daniel Burgin, MD, an internal medicine resident at Louisiana State University, Baton Rouge, in a presentation at the annual meeting of the American College of Chest Physicians.

The EPIC Sepsis Model (ESM) was designed to help facilitate earlier detection of sepsis and speed time to the start of antibiotics, but its effectiveness has not been well studied, Dr. Burgin said.

In Dr. Burgin’s facility, the ESM is mainly driven by systemic inflammatory response syndrome (SIRS) and blood pressure and is calculated every 15 minutes; the system triggers a best-practice advisory if needed, with an alert that sepsis may be suspected.

To assess the impact of ESM on time to antibiotics, Dr. Burgin and colleagues reviewed data from 226 adult patients who presented to a single emergency department between February 2019 and June 2019. All patients presented with at least two criteria for SIRS. An ESM threshold of 6 was designed to trigger a set of orders to guide providers on a treatment plan that included antibiotics.

The researchers compared times to the ordering and the administration of antibiotics for patients with ESM scores of 6 or higher vs. less than 6 within 6 hours of triage in the ED. A total of 109 patients (48.2%) received antibiotics in the ED. Of these, 71 (74.5%) had ESM less than 6 and 38 (40.6%) had ESM of 6 or higher. The times from triage to antibiotics ordered and administered was significantly less in patients with ESM of 6 or higher (90.5 minutes vs. 131.5 minutes; 136 minutes vs. 186 minutes, respectively; P = .011 for both).

A total of 188 patients were evaluated for infection, and 86 met Sepsis-2 criteria based on physician chart review. These patients were significantly more likely than those not meeting the Sepsis-2 criteria to receive antibiotics in the ED (76.7% vs. 22.8%; P <.001).

Another 21 patients met criteria for Sepsis-3 based on a physician panel. Although all 21 received antibiotics, 5 did not receive them within 6 hours of triage in the ED, Dr. Burgin said. The median times to ordering and administration of antibiotics for Sepsis-3 patients with an ESM of 6 or higher were –5 and 38.5 (interquartile range), respectively.

“We hope that the ESM would prompt providers to start the order [for antibiotics],” Dr. Burgin said in his presentation. However, the researchers found no consistent patterns, and in many cases the ESM alerts occurred after the orders had been initiated, he noted.

The study findings were limited by the use of data from a single center; the implementation of the EPIC tool is hospital specific, said Dr. Burgin. However, the results suggest that “the ESM trigger is not improving the time to ordering of antibiotics for septic patients, and we question the utility of this tool in its current state,” he said.

“While this research proved useful in assessing the impact of ESM on time to antibiotics, more research is needed to understand how to operationalize predictive analytics,” Dr. Burgin said of the study findings. “The goal is to find the balance between early identification of sepsis and timely antimicrobial therapy and the potential harm of overalerting treatment teams.”

The study was supported in part by Cytovale, a sepsis diagnostics company. Several coauthors disclosed financial relationships with Cytovale. Dr. Burgin reports no relevant financial relationships.

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

Use of a sepsis predictor made little difference in time to antibiotic administration for septic patients in the emergency department, based on data from more than 200 patients.

“One of the big problems with sepsis is the lack of current tools for early and accurate diagnoses,” said Daniel Burgin, MD, an internal medicine resident at Louisiana State University, Baton Rouge, in a presentation at the annual meeting of the American College of Chest Physicians.

The EPIC Sepsis Model (ESM) was designed to help facilitate earlier detection of sepsis and speed time to the start of antibiotics, but its effectiveness has not been well studied, Dr. Burgin said.

In Dr. Burgin’s facility, the ESM is mainly driven by systemic inflammatory response syndrome (SIRS) and blood pressure and is calculated every 15 minutes; the system triggers a best-practice advisory if needed, with an alert that sepsis may be suspected.

To assess the impact of ESM on time to antibiotics, Dr. Burgin and colleagues reviewed data from 226 adult patients who presented to a single emergency department between February 2019 and June 2019. All patients presented with at least two criteria for SIRS. An ESM threshold of 6 was designed to trigger a set of orders to guide providers on a treatment plan that included antibiotics.

The researchers compared times to the ordering and the administration of antibiotics for patients with ESM scores of 6 or higher vs. less than 6 within 6 hours of triage in the ED. A total of 109 patients (48.2%) received antibiotics in the ED. Of these, 71 (74.5%) had ESM less than 6 and 38 (40.6%) had ESM of 6 or higher. The times from triage to antibiotics ordered and administered was significantly less in patients with ESM of 6 or higher (90.5 minutes vs. 131.5 minutes; 136 minutes vs. 186 minutes, respectively; P = .011 for both).

A total of 188 patients were evaluated for infection, and 86 met Sepsis-2 criteria based on physician chart review. These patients were significantly more likely than those not meeting the Sepsis-2 criteria to receive antibiotics in the ED (76.7% vs. 22.8%; P <.001).

Another 21 patients met criteria for Sepsis-3 based on a physician panel. Although all 21 received antibiotics, 5 did not receive them within 6 hours of triage in the ED, Dr. Burgin said. The median times to ordering and administration of antibiotics for Sepsis-3 patients with an ESM of 6 or higher were –5 and 38.5 (interquartile range), respectively.

“We hope that the ESM would prompt providers to start the order [for antibiotics],” Dr. Burgin said in his presentation. However, the researchers found no consistent patterns, and in many cases the ESM alerts occurred after the orders had been initiated, he noted.

The study findings were limited by the use of data from a single center; the implementation of the EPIC tool is hospital specific, said Dr. Burgin. However, the results suggest that “the ESM trigger is not improving the time to ordering of antibiotics for septic patients, and we question the utility of this tool in its current state,” he said.

“While this research proved useful in assessing the impact of ESM on time to antibiotics, more research is needed to understand how to operationalize predictive analytics,” Dr. Burgin said of the study findings. “The goal is to find the balance between early identification of sepsis and timely antimicrobial therapy and the potential harm of overalerting treatment teams.”

The study was supported in part by Cytovale, a sepsis diagnostics company. Several coauthors disclosed financial relationships with Cytovale. Dr. Burgin reports no relevant financial relationships.

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

Nirmatrelvir/ritonavir (Paxlovid) has been a game changer for high-risk patients with early COVID-19 symptoms but has significant interactions with commonly used cardiovascular medications, a new paper cautions.

COVID-19 patients with cardiovascular disease (CVD) or risk factors such as diabetes, hypertension, and chronic kidney disease are at high risk of severe disease and account for the lion’s share of those receiving Paxlovid. Data from the initial EPIC-HR trial and recent real-world data also suggest they’re among the most likely to benefit from the oral antiviral, regardless of their COVID-19 vaccination status.

ClaudioVentrella/Thinkstock

“But at the same time, it unfortunately interacts with many very commonly prescribed cardiovascular medications and with many of them in a very clinically meaningful way, which may lead to serious adverse consequences,” senior author Sarju Ganatra, MD, said in an interview. “So, while it’s being prescribed with a good intention to help these people, we may actually end up doing more harm than good.

“We don’t want to deter people from getting their necessary COVID-19 treatment, which is excellent for the most part these days as an outpatient,” he added. “So, we felt the need to make a comprehensive list of cardiac medications and level of interactions with Paxlovid and also to help the clinicians and prescribers at the point of care to make the clinical decision of what modifications they may need to do.”

The paper, published online in the Journal of the American College of Cardiology, details drug-drug interactions with some 80 CV medications including statins, antihypertensive agents, heart failure therapies, and antiplatelet/anticoagulants.

It also includes a color-coded figure denoting whether a drug is safe to coadminister with Paxlovid, may potentially interact and require a dose adjustment or temporary discontinuation, or is contraindicated.

Among the commonly used blood thinners, for example, the paper notes that Paxlovid significantly increases drug levels of the direct oral anticoagulants (DOACs) apixaban, rivaroxaban, edoxaban, and dabigatran and, thus, increases the risk of bleeding.

“It can still be administered, if it’s necessary, but the dose of the DOAC either needs to be reduced or held depending on what they are getting it for, whether they’re getting it for pulmonary embolism or atrial fibrillation, and we adjust for all those things in the table in the paper,” said Dr. Ganatra, from Lahey Hospital and Medical Center, Burlington, Mass.

When the DOAC can’t be interrupted or dose adjusted, however, Paxlovid should not be given, the experts said. The antiviral is safe to use with enoxaparin, a low-molecular-weight heparin, but can increase or decrease levels of warfarin and should be used with close international normalized ratio monitoring.

For patients on antiplatelet agents, clinicians are advised to avoid prescribing nirmatrelvir/ritonavir to those on ticagrelor or clopidogrel unless the agents can be replaced by prasugrel.

Ritonavir – an inhibitor of cytochrome P 450 enzymes, particularly CYP3A4 – poses an increased risk of bleeding when given with ticagrelor, a CYP3A4 substrate, and decreases the active metabolite of clopidogrel, cutting its platelet inhibition by 20%. Although there’s a twofold decrease in the maximum concentration of prasugrel in patients on ritonavir, this does not affect its antiplatelet activity, the paper explains.

Among the lipid-lowering agents, experts suggested temporarily withholding atorvastatin, rosuvastatin, simvastatin, and lovastatin because of an increased risk for myopathy and liver toxicity but say that other statins, fibrates, ezetimibe, and the proprotein convertase subtilisin/kexin type 9 inhibitors evolocumab and alirocumab are safe to coadminister with Paxlovid.

While statins typically leave the body within hours, most of the antiarrhythmic drugs, except for sotalol, are not safe to give with Paxlovid, Dr. Ganatra said. It’s technically not feasible to hold these drugs because most have long half-lives, reaching about 100 days, for example, for amiodarone.

“It’s going to hang around in your system for a long time, so you don’t want to be falsely reassured that you’re holding the drug and it’s going to be fine to go back slowly,” he said. “You need to look for alternative therapies in those scenarios for COVID-19 treatment, which could be other antivirals, or a monoclonal antibody individualized to the patient’s risk.”

Although there’s limited clinical information regarding interaction-related adverse events with Paxlovid, the team used pharmacokinetics and pharmacodynamics data to provide the guidance. Serious adverse events are also well documented for ritonavir, which has been prescribed for years to treat HIV, Dr. Ganatra noted.

The Infectious Disease Society of America also published guidance on the management of potential drug interactions with Paxlovid in May and, earlier in October, the Food and Drug Administration updated its Paxlovid patient eligibility screening checklist.

Still, most prescribers are actually primary care physicians and even pharmacists, who may not be completely attuned, said Dr. Ganatra, who noted that some centers have started programs to help connect primary care physicians with their cardiology colleagues to check on CV drugs in their COVID-19 patients.

“We need to be thinking more broadly and at a system level where the hospital or health care system leverages the electronic health record systems,” he said. “Most of them are sophisticated enough to incorporate simple drug-drug interaction information, so if you try to prescribe someone Paxlovid and it’s a heart transplant patient who is on immunosuppressive therapy or a patient on a blood thinner, then it should give you a warning ... or at least give them a link to our paper or other valuable resources.

“If someone is on a blood thinner and the blood thinner level goes up by ninefold, we can only imagine what we would be dealing with,” Dr. Ganatra said. “So, these interactions should be taken very seriously and I think it’s worth the time and investment.”

The authors reported no relevant financial relationships.

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

Nirmatrelvir/ritonavir (Paxlovid) has been a game changer for high-risk patients with early COVID-19 symptoms but has significant interactions with commonly used cardiovascular medications, a new paper cautions.

COVID-19 patients with cardiovascular disease (CVD) or risk factors such as diabetes, hypertension, and chronic kidney disease are at high risk of severe disease and account for the lion’s share of those receiving Paxlovid. Data from the initial EPIC-HR trial and recent real-world data also suggest they’re among the most likely to benefit from the oral antiviral, regardless of their COVID-19 vaccination status.

ClaudioVentrella/Thinkstock

“But at the same time, it unfortunately interacts with many very commonly prescribed cardiovascular medications and with many of them in a very clinically meaningful way, which may lead to serious adverse consequences,” senior author Sarju Ganatra, MD, said in an interview. “So, while it’s being prescribed with a good intention to help these people, we may actually end up doing more harm than good.

“We don’t want to deter people from getting their necessary COVID-19 treatment, which is excellent for the most part these days as an outpatient,” he added. “So, we felt the need to make a comprehensive list of cardiac medications and level of interactions with Paxlovid and also to help the clinicians and prescribers at the point of care to make the clinical decision of what modifications they may need to do.”

The paper, published online in the Journal of the American College of Cardiology, details drug-drug interactions with some 80 CV medications including statins, antihypertensive agents, heart failure therapies, and antiplatelet/anticoagulants.

It also includes a color-coded figure denoting whether a drug is safe to coadminister with Paxlovid, may potentially interact and require a dose adjustment or temporary discontinuation, or is contraindicated.

Among the commonly used blood thinners, for example, the paper notes that Paxlovid significantly increases drug levels of the direct oral anticoagulants (DOACs) apixaban, rivaroxaban, edoxaban, and dabigatran and, thus, increases the risk of bleeding.

“It can still be administered, if it’s necessary, but the dose of the DOAC either needs to be reduced or held depending on what they are getting it for, whether they’re getting it for pulmonary embolism or atrial fibrillation, and we adjust for all those things in the table in the paper,” said Dr. Ganatra, from Lahey Hospital and Medical Center, Burlington, Mass.

When the DOAC can’t be interrupted or dose adjusted, however, Paxlovid should not be given, the experts said. The antiviral is safe to use with enoxaparin, a low-molecular-weight heparin, but can increase or decrease levels of warfarin and should be used with close international normalized ratio monitoring.

For patients on antiplatelet agents, clinicians are advised to avoid prescribing nirmatrelvir/ritonavir to those on ticagrelor or clopidogrel unless the agents can be replaced by prasugrel.

Ritonavir – an inhibitor of cytochrome P 450 enzymes, particularly CYP3A4 – poses an increased risk of bleeding when given with ticagrelor, a CYP3A4 substrate, and decreases the active metabolite of clopidogrel, cutting its platelet inhibition by 20%. Although there’s a twofold decrease in the maximum concentration of prasugrel in patients on ritonavir, this does not affect its antiplatelet activity, the paper explains.

Among the lipid-lowering agents, experts suggested temporarily withholding atorvastatin, rosuvastatin, simvastatin, and lovastatin because of an increased risk for myopathy and liver toxicity but say that other statins, fibrates, ezetimibe, and the proprotein convertase subtilisin/kexin type 9 inhibitors evolocumab and alirocumab are safe to coadminister with Paxlovid.

While statins typically leave the body within hours, most of the antiarrhythmic drugs, except for sotalol, are not safe to give with Paxlovid, Dr. Ganatra said. It’s technically not feasible to hold these drugs because most have long half-lives, reaching about 100 days, for example, for amiodarone.

“It’s going to hang around in your system for a long time, so you don’t want to be falsely reassured that you’re holding the drug and it’s going to be fine to go back slowly,” he said. “You need to look for alternative therapies in those scenarios for COVID-19 treatment, which could be other antivirals, or a monoclonal antibody individualized to the patient’s risk.”

Although there’s limited clinical information regarding interaction-related adverse events with Paxlovid, the team used pharmacokinetics and pharmacodynamics data to provide the guidance. Serious adverse events are also well documented for ritonavir, which has been prescribed for years to treat HIV, Dr. Ganatra noted.

The Infectious Disease Society of America also published guidance on the management of potential drug interactions with Paxlovid in May and, earlier in October, the Food and Drug Administration updated its Paxlovid patient eligibility screening checklist.

Still, most prescribers are actually primary care physicians and even pharmacists, who may not be completely attuned, said Dr. Ganatra, who noted that some centers have started programs to help connect primary care physicians with their cardiology colleagues to check on CV drugs in their COVID-19 patients.

“We need to be thinking more broadly and at a system level where the hospital or health care system leverages the electronic health record systems,” he said. “Most of them are sophisticated enough to incorporate simple drug-drug interaction information, so if you try to prescribe someone Paxlovid and it’s a heart transplant patient who is on immunosuppressive therapy or a patient on a blood thinner, then it should give you a warning ... or at least give them a link to our paper or other valuable resources.

“If someone is on a blood thinner and the blood thinner level goes up by ninefold, we can only imagine what we would be dealing with,” Dr. Ganatra said. “So, these interactions should be taken very seriously and I think it’s worth the time and investment.”

The authors reported no relevant financial relationships.

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

Nirmatrelvir/ritonavir (Paxlovid) has been a game changer for high-risk patients with early COVID-19 symptoms but has significant interactions with commonly used cardiovascular medications, a new paper cautions.

COVID-19 patients with cardiovascular disease (CVD) or risk factors such as diabetes, hypertension, and chronic kidney disease are at high risk of severe disease and account for the lion’s share of those receiving Paxlovid. Data from the initial EPIC-HR trial and recent real-world data also suggest they’re among the most likely to benefit from the oral antiviral, regardless of their COVID-19 vaccination status.

ClaudioVentrella/Thinkstock

“But at the same time, it unfortunately interacts with many very commonly prescribed cardiovascular medications and with many of them in a very clinically meaningful way, which may lead to serious adverse consequences,” senior author Sarju Ganatra, MD, said in an interview. “So, while it’s being prescribed with a good intention to help these people, we may actually end up doing more harm than good.

“We don’t want to deter people from getting their necessary COVID-19 treatment, which is excellent for the most part these days as an outpatient,” he added. “So, we felt the need to make a comprehensive list of cardiac medications and level of interactions with Paxlovid and also to help the clinicians and prescribers at the point of care to make the clinical decision of what modifications they may need to do.”

The paper, published online in the Journal of the American College of Cardiology, details drug-drug interactions with some 80 CV medications including statins, antihypertensive agents, heart failure therapies, and antiplatelet/anticoagulants.

It also includes a color-coded figure denoting whether a drug is safe to coadminister with Paxlovid, may potentially interact and require a dose adjustment or temporary discontinuation, or is contraindicated.

Among the commonly used blood thinners, for example, the paper notes that Paxlovid significantly increases drug levels of the direct oral anticoagulants (DOACs) apixaban, rivaroxaban, edoxaban, and dabigatran and, thus, increases the risk of bleeding.

“It can still be administered, if it’s necessary, but the dose of the DOAC either needs to be reduced or held depending on what they are getting it for, whether they’re getting it for pulmonary embolism or atrial fibrillation, and we adjust for all those things in the table in the paper,” said Dr. Ganatra, from Lahey Hospital and Medical Center, Burlington, Mass.

When the DOAC can’t be interrupted or dose adjusted, however, Paxlovid should not be given, the experts said. The antiviral is safe to use with enoxaparin, a low-molecular-weight heparin, but can increase or decrease levels of warfarin and should be used with close international normalized ratio monitoring.

For patients on antiplatelet agents, clinicians are advised to avoid prescribing nirmatrelvir/ritonavir to those on ticagrelor or clopidogrel unless the agents can be replaced by prasugrel.

Ritonavir – an inhibitor of cytochrome P 450 enzymes, particularly CYP3A4 – poses an increased risk of bleeding when given with ticagrelor, a CYP3A4 substrate, and decreases the active metabolite of clopidogrel, cutting its platelet inhibition by 20%. Although there’s a twofold decrease in the maximum concentration of prasugrel in patients on ritonavir, this does not affect its antiplatelet activity, the paper explains.

Among the lipid-lowering agents, experts suggested temporarily withholding atorvastatin, rosuvastatin, simvastatin, and lovastatin because of an increased risk for myopathy and liver toxicity but say that other statins, fibrates, ezetimibe, and the proprotein convertase subtilisin/kexin type 9 inhibitors evolocumab and alirocumab are safe to coadminister with Paxlovid.

While statins typically leave the body within hours, most of the antiarrhythmic drugs, except for sotalol, are not safe to give with Paxlovid, Dr. Ganatra said. It’s technically not feasible to hold these drugs because most have long half-lives, reaching about 100 days, for example, for amiodarone.

“It’s going to hang around in your system for a long time, so you don’t want to be falsely reassured that you’re holding the drug and it’s going to be fine to go back slowly,” he said. “You need to look for alternative therapies in those scenarios for COVID-19 treatment, which could be other antivirals, or a monoclonal antibody individualized to the patient’s risk.”

Although there’s limited clinical information regarding interaction-related adverse events with Paxlovid, the team used pharmacokinetics and pharmacodynamics data to provide the guidance. Serious adverse events are also well documented for ritonavir, which has been prescribed for years to treat HIV, Dr. Ganatra noted.

The Infectious Disease Society of America also published guidance on the management of potential drug interactions with Paxlovid in May and, earlier in October, the Food and Drug Administration updated its Paxlovid patient eligibility screening checklist.

Still, most prescribers are actually primary care physicians and even pharmacists, who may not be completely attuned, said Dr. Ganatra, who noted that some centers have started programs to help connect primary care physicians with their cardiology colleagues to check on CV drugs in their COVID-19 patients.

“We need to be thinking more broadly and at a system level where the hospital or health care system leverages the electronic health record systems,” he said. “Most of them are sophisticated enough to incorporate simple drug-drug interaction information, so if you try to prescribe someone Paxlovid and it’s a heart transplant patient who is on immunosuppressive therapy or a patient on a blood thinner, then it should give you a warning ... or at least give them a link to our paper or other valuable resources.

“If someone is on a blood thinner and the blood thinner level goes up by ninefold, we can only imagine what we would be dealing with,” Dr. Ganatra said. “So, these interactions should be taken very seriously and I think it’s worth the time and investment.”

The authors reported no relevant financial relationships.

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