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FDA Approves AI Diagnostic Tool for Early Sepsis Detection

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Thu, 04/18/2024 - 12:59

 

The US Food and Drug Administration (FDA) has approved a medical device named the Sepsis ImmunoScore, which is an artificial intelligence/machine learning software, to guide rapid diagnosis and prediction of sepsis. The authorization was granted through the FDA’s De Novo pathway.

Sepsis is a complex condition, so diagnosing it early is difficult and has been a decades-long challenge for the US healthcare system.

Using both biomarkers and clinical data with the assistance of AI, the Sepsis ImmunoScore helps assess the risk for the presence of or progression to sepsis within 24 hours of patient evaluation in the emergency department or hospital. By considering 22 diverse parameters, the AI-powered tool provides a comprehensive evaluation of the patient’s biological condition, resulting in a risk score and categorization into four distinct risk levels.

It’s important to note that this system is not an alert mechanism. These risk categories are correlated with the risk for patient deterioration, including length of hospital stay, in-hospital mortality, and the need for escalated care within 24 hours (such as intensive care unit admission, mechanical ventilation, or vasopressor use). The diagnostic software is integrated directly into hospital electronic medical records.

This is the first AI diagnostic tool for sepsis to receive marketing authorization from the FDA.

A version of this article appeared on Medscape.com.

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The US Food and Drug Administration (FDA) has approved a medical device named the Sepsis ImmunoScore, which is an artificial intelligence/machine learning software, to guide rapid diagnosis and prediction of sepsis. The authorization was granted through the FDA’s De Novo pathway.

Sepsis is a complex condition, so diagnosing it early is difficult and has been a decades-long challenge for the US healthcare system.

Using both biomarkers and clinical data with the assistance of AI, the Sepsis ImmunoScore helps assess the risk for the presence of or progression to sepsis within 24 hours of patient evaluation in the emergency department or hospital. By considering 22 diverse parameters, the AI-powered tool provides a comprehensive evaluation of the patient’s biological condition, resulting in a risk score and categorization into four distinct risk levels.

It’s important to note that this system is not an alert mechanism. These risk categories are correlated with the risk for patient deterioration, including length of hospital stay, in-hospital mortality, and the need for escalated care within 24 hours (such as intensive care unit admission, mechanical ventilation, or vasopressor use). The diagnostic software is integrated directly into hospital electronic medical records.

This is the first AI diagnostic tool for sepsis to receive marketing authorization from the FDA.

A version of this article appeared on Medscape.com.

 

The US Food and Drug Administration (FDA) has approved a medical device named the Sepsis ImmunoScore, which is an artificial intelligence/machine learning software, to guide rapid diagnosis and prediction of sepsis. The authorization was granted through the FDA’s De Novo pathway.

Sepsis is a complex condition, so diagnosing it early is difficult and has been a decades-long challenge for the US healthcare system.

Using both biomarkers and clinical data with the assistance of AI, the Sepsis ImmunoScore helps assess the risk for the presence of or progression to sepsis within 24 hours of patient evaluation in the emergency department or hospital. By considering 22 diverse parameters, the AI-powered tool provides a comprehensive evaluation of the patient’s biological condition, resulting in a risk score and categorization into four distinct risk levels.

It’s important to note that this system is not an alert mechanism. These risk categories are correlated with the risk for patient deterioration, including length of hospital stay, in-hospital mortality, and the need for escalated care within 24 hours (such as intensive care unit admission, mechanical ventilation, or vasopressor use). The diagnostic software is integrated directly into hospital electronic medical records.

This is the first AI diagnostic tool for sepsis to receive marketing authorization from the FDA.

A version of this article appeared on Medscape.com.

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All rights reserved. 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The authorization was granted through the FDA’s <span class="Hyperlink"><a href="https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/de-novo-classification-request">De Novo pathway</a></span>.</p> <p>Sepsis is a complex condition, so diagnosing it early is difficult and has been a decades-long challenge for the US healthcare system.<br/><br/>Using both biomarkers and clinical data with the assistance of AI, the Sepsis ImmunoScore helps assess the risk for the presence of or progression to sepsis within 24 hours of patient evaluation in the emergency department or hospital. By considering 22 diverse parameters, the AI-powered tool provides a comprehensive evaluation of the patient’s biological condition, resulting in a risk score and categorization into four distinct risk levels.<br/><br/>It’s important to note that this system is not an alert mechanism. These risk categories are correlated with the risk for patient deterioration, including length of hospital stay, in-hospital mortality, and the need for escalated care within 24 hours (such as intensive care unit admission, <span class="Hyperlink"><a href="https://emedicine.medscape.com/article/304068-overview">mechanical ventilation</a></span>, or vasopressor use). The diagnostic software is integrated directly into hospital electronic medical records.<br/><br/>This is the first AI diagnostic tool for sepsis to receive marketing authorization from the FDA.<span class="end"/></p> <p> <em>A version of this article appeared on <span class="Hyperlink"><a href="https://www.medscape.com/viewarticle/fda-approves-ai-diagnostic-tool-early-sepsis-detection-2024a100074d?src=">Medscape.com</a></span>.</em> </p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>
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The ED Sailed Smoothly in the Early COVID-19 Days

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Changed
Thu, 04/04/2024 - 09:26

 

TOPLINE: 

There were few cases of SARS-CoV-2 infections among emergency department (ED) healthcare personnel and no substantial changes in the delivery of emergency medical care during the initial phase of the COVID-19 pandemic.

METHODOLOGY:

  • This multicenter prospective cohort study of US ED healthcare personnel called Project COVERED was conducted from May to December 2020 to evaluate the following outcomes:
  • The possibility of infected ED personnel reporting to work
  • The burden of COVID-19 symptoms on an ED personnel’s work status
  • The association between SARS-CoV-2 infection levels and ED staffing
  • Project COVERED enrolled 1673 ED healthcare personnel with 29,825 person weeks of observational data from 25 geographically diverse EDs.
  • The presence of any SARS-CoV-2 infection was determined using reverse transcription polymerase chain reaction or IgG antibody testing at baseline, week 2, week 4, and every four subsequent weeks through week 20.
  • Investigators also collected weekly data on ED staffing and the incidence of SARS-CoV-2 infections in healthcare facilities.

TAKEAWAY:

  • Despite the absence of widespread natural immunity or COVID-19 vaccine availability during the time of this study, only 4.5% of ED healthcare personnel tested positive for SARS-CoV-2 infections, with more than half (57.3%) not experiencing any symptoms.
  • Most personnel (83%) who experienced symptoms associated with COVID-19 reported working at least one shift in the ED and nearly all of them continued to work until they received laboratory confirmation of their infection.
  • The working time lost as a result of COVID-19 and related concerns was minimal, as 89 healthcare personnel reported 90 person weeks of missed work (0.3% of all weeks).
  • During this study, physician-staffing levels ranged from 98.7% to 102.0% of normal staffing, with similar values noted for nursing and nonclinical staffs. Reduced staffing was rare, even during COVID-19 surges.

IN PRACTICE:

“Our findings suggest that the cumulative interaction between infected healthcare personnel and others resulted in a negligible risk of transmission on the scale of public health emergencies,” the authors wrote.

SOURCE:

This study was led by Kurt D. Weber, MD, Department of Emergency Medicine, Orlando Health, Orlando, Florida, and published online in Annals of Emergency Medicine.

LIMITATIONS:

Data regarding the Delta variant surges that occurred toward the end of December and the ED status after the advent of the COVID-19 vaccine were not recorded. There may also have been a selection bias risk in this study because the volunteer participants may have exhibited behaviors like social distancing and use of protective equipment, which may have decreased their risk for infections.

DISCLOSURES:

This study was funded by a cooperative agreement from the Centers for Disease Control and Prevention and the Institute for Clinical and Translational Science at the University of Iowa through a grant from the National Center for Advancing Translational Sciences at the National Institutes of Health. The authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

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TOPLINE: 

There were few cases of SARS-CoV-2 infections among emergency department (ED) healthcare personnel and no substantial changes in the delivery of emergency medical care during the initial phase of the COVID-19 pandemic.

METHODOLOGY:

  • This multicenter prospective cohort study of US ED healthcare personnel called Project COVERED was conducted from May to December 2020 to evaluate the following outcomes:
  • The possibility of infected ED personnel reporting to work
  • The burden of COVID-19 symptoms on an ED personnel’s work status
  • The association between SARS-CoV-2 infection levels and ED staffing
  • Project COVERED enrolled 1673 ED healthcare personnel with 29,825 person weeks of observational data from 25 geographically diverse EDs.
  • The presence of any SARS-CoV-2 infection was determined using reverse transcription polymerase chain reaction or IgG antibody testing at baseline, week 2, week 4, and every four subsequent weeks through week 20.
  • Investigators also collected weekly data on ED staffing and the incidence of SARS-CoV-2 infections in healthcare facilities.

TAKEAWAY:

  • Despite the absence of widespread natural immunity or COVID-19 vaccine availability during the time of this study, only 4.5% of ED healthcare personnel tested positive for SARS-CoV-2 infections, with more than half (57.3%) not experiencing any symptoms.
  • Most personnel (83%) who experienced symptoms associated with COVID-19 reported working at least one shift in the ED and nearly all of them continued to work until they received laboratory confirmation of their infection.
  • The working time lost as a result of COVID-19 and related concerns was minimal, as 89 healthcare personnel reported 90 person weeks of missed work (0.3% of all weeks).
  • During this study, physician-staffing levels ranged from 98.7% to 102.0% of normal staffing, with similar values noted for nursing and nonclinical staffs. Reduced staffing was rare, even during COVID-19 surges.

IN PRACTICE:

“Our findings suggest that the cumulative interaction between infected healthcare personnel and others resulted in a negligible risk of transmission on the scale of public health emergencies,” the authors wrote.

SOURCE:

This study was led by Kurt D. Weber, MD, Department of Emergency Medicine, Orlando Health, Orlando, Florida, and published online in Annals of Emergency Medicine.

LIMITATIONS:

Data regarding the Delta variant surges that occurred toward the end of December and the ED status after the advent of the COVID-19 vaccine were not recorded. There may also have been a selection bias risk in this study because the volunteer participants may have exhibited behaviors like social distancing and use of protective equipment, which may have decreased their risk for infections.

DISCLOSURES:

This study was funded by a cooperative agreement from the Centers for Disease Control and Prevention and the Institute for Clinical and Translational Science at the University of Iowa through a grant from the National Center for Advancing Translational Sciences at the National Institutes of Health. The authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

 

TOPLINE: 

There were few cases of SARS-CoV-2 infections among emergency department (ED) healthcare personnel and no substantial changes in the delivery of emergency medical care during the initial phase of the COVID-19 pandemic.

METHODOLOGY:

  • This multicenter prospective cohort study of US ED healthcare personnel called Project COVERED was conducted from May to December 2020 to evaluate the following outcomes:
  • The possibility of infected ED personnel reporting to work
  • The burden of COVID-19 symptoms on an ED personnel’s work status
  • The association between SARS-CoV-2 infection levels and ED staffing
  • Project COVERED enrolled 1673 ED healthcare personnel with 29,825 person weeks of observational data from 25 geographically diverse EDs.
  • The presence of any SARS-CoV-2 infection was determined using reverse transcription polymerase chain reaction or IgG antibody testing at baseline, week 2, week 4, and every four subsequent weeks through week 20.
  • Investigators also collected weekly data on ED staffing and the incidence of SARS-CoV-2 infections in healthcare facilities.

TAKEAWAY:

  • Despite the absence of widespread natural immunity or COVID-19 vaccine availability during the time of this study, only 4.5% of ED healthcare personnel tested positive for SARS-CoV-2 infections, with more than half (57.3%) not experiencing any symptoms.
  • Most personnel (83%) who experienced symptoms associated with COVID-19 reported working at least one shift in the ED and nearly all of them continued to work until they received laboratory confirmation of their infection.
  • The working time lost as a result of COVID-19 and related concerns was minimal, as 89 healthcare personnel reported 90 person weeks of missed work (0.3% of all weeks).
  • During this study, physician-staffing levels ranged from 98.7% to 102.0% of normal staffing, with similar values noted for nursing and nonclinical staffs. Reduced staffing was rare, even during COVID-19 surges.

IN PRACTICE:

“Our findings suggest that the cumulative interaction between infected healthcare personnel and others resulted in a negligible risk of transmission on the scale of public health emergencies,” the authors wrote.

SOURCE:

This study was led by Kurt D. Weber, MD, Department of Emergency Medicine, Orlando Health, Orlando, Florida, and published online in Annals of Emergency Medicine.

LIMITATIONS:

Data regarding the Delta variant surges that occurred toward the end of December and the ED status after the advent of the COVID-19 vaccine were not recorded. There may also have been a selection bias risk in this study because the volunteer participants may have exhibited behaviors like social distancing and use of protective equipment, which may have decreased their risk for infections.

DISCLOSURES:

This study was funded by a cooperative agreement from the Centers for Disease Control and Prevention and the Institute for Clinical and Translational Science at the University of Iowa through a grant from the National Center for Advancing Translational Sciences at the National Institutes of Health. The authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

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Reduced staffing was rare, even during COVID-19 surges.</li> </ul> <h2>IN PRACTICE:</h2> <p>“Our findings suggest that the cumulative interaction between infected healthcare personnel and others resulted in a negligible risk of transmission on the scale of public health emergencies,” the authors wrote.</p> <h2>SOURCE:</h2> <p>This study was led by Kurt D. Weber, MD, Department of Emergency Medicine, Orlando Health, Orlando, Florida, and published <a href="https://www.annemergmed.com/article/S0196-0644(24)00035-0/abstract">online</a> in <em>Annals of Emergency Medicine</em>.</p> <h2>LIMITATIONS:</h2> <p>Data regarding the Delta variant surges that occurred toward the end of December and the ED status after the advent of the COVID-19 vaccine were not recorded. There may also have been a selection bias risk in this study because the volunteer participants may have exhibited behaviors like social distancing and use of protective equipment, which may have decreased their risk for infections.</p> <h2>DISCLOSURES:</h2> <p>This study was funded by a cooperative agreement from the Centers for Disease Control and Prevention and the Institute for Clinical and Translational Science at the University of Iowa through a grant from the National Center for Advancing Translational Sciences at the National Institutes of Health. The authors declared no conflicts of interest.<span class="end"/></p> <p> <em>A version of this article appeared on <span class="Hyperlink"><a href="https://www.medscape.com/viewarticle/ed-sailed-smoothly-early-covid-19-days-2024a1000623">Medscape.com</a></span>.</em> </p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>
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How the New MRSA Antibiotic Cracked AI’s ‘Black Box’

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“New antibiotics discovered using AI!”

That’s how headlines read in December 2023, when MIT researchers announced a new class of antibiotics that could wipe out the drug-resistant superbug methicillin-resistant Staphylococcus aureus (MRSA) in mice.

Powered by deep learning, the study was a significant breakthrough. Few new antibiotics have come out since the 1960s, and this one in particular could be crucial in fighting tough-to-treat MRSA, which kills more than 10,000 people annually in the United States.

But as remarkable as the antibiotic discovery was, it may not be the most impactful part of this study.

The researchers used a method known as explainable artificial intelligence (AI), which unveils the AI’s reasoning process, sometimes known as the black box because it’s hidden from the user. Their work in this emerging field could be pivotal in advancing new drug design.

“Of course, we view the antibiotic-discovery angle to be very important,” said Felix Wong, PhD, a colead author of the study and postdoctoral fellow at the Broad Institute of MIT and Harvard, Cambridge, Massachusetts. “But I think equally important, or maybe even more important, is really our method of opening up the black box.”

The black box is generally thought of as impenetrable in complex machine learning models, and that poses a challenge in the drug discovery realm.

“A major bottleneck in AI-ML-driven drug discovery is that nobody knows what the heck is going on,” said Dr. Wong. Models have such powerful architectures that their decision-making is mysterious.

Researchers input data, such as patient features, and the model says what drugs might be effective. But researchers have no idea how the model arrived at its predictions — until now.

What the Researchers Did

Dr. Wong and his colleagues first mined 39,000 compounds for antibiotic activity against MRSA. They fed information about the compounds’ chemical structures and antibiotic activity into their machine learning model. With this, they “trained” the model to predict whether a compound is antibacterial.

Next, they used additional deep learning to narrow the field, ruling out compounds toxic to humans. Then, deploying their various models at once, they screened 12 million commercially available compounds. Five classes emerged as likely MRSA fighters. Further testing of 280 compounds from the five classes produced the final results: Two compounds from the same class. Both reduced MRSA infection in mouse models.

How did the computer flag these compounds? The researchers sought to answer that question by figuring out which chemical structures the model had been looking for.

A chemical structure can be “pruned” — that is, scientists can remove certain atoms and bonds to reveal an underlying substructure. The MIT researchers used the Monte Carlo Tree Search, a commonly used algorithm in machine learning, to select which atoms and bonds to edit out. Then they fed the pruned substructures into their model to find out which was likely responsible for the antibacterial activity.

“The main idea is we can pinpoint which substructure of a chemical structure is causative instead of just correlated with high antibiotic activity,” Dr. Wong said.

This could fuel new “design-driven” or generative AI approaches where these substructures become “starting points to design entirely unseen, unprecedented antibiotics,” Dr. Wong said. “That’s one of the key efforts that we’ve been working on since the publication of this paper.”

More broadly, their method could lead to discoveries in drug classes beyond antibiotics, such as antivirals and anticancer drugs, according to Dr. Wong.

“This is the first major study that I’ve seen seeking to incorporate explainability into deep learning models in the context of antibiotics,” said César de la Fuente, PhD, an assistant professor at the University of Pennsylvania, Philadelphia, Pennsylvania, whose lab has been engaged in AI for antibiotic discovery for the past 5 years.

“It’s kind of like going into the black box with a magnifying lens and figuring out what is actually happening in there,” Dr. de la Fuente said. “And that will open up possibilities for leveraging those different steps to make better drugs.”

 

 

How Explainable AI Could Revolutionize Medicine

In studies, explainable AI is showing its potential for informing clinical decisions as well — flagging high-risk patients and letting doctors know why that calculation was made. University of Washington researchers have used the technology to predict whether a patient will have hypoxemia during surgery, revealing which features contributed to the prediction, such as blood pressure or body mass index. Another study used explainable AI to help emergency medical services providers and emergency room clinicians optimize time — for example, by identifying trauma patients at high risk for acute traumatic coagulopathy more quickly.

A crucial benefit of explainable AI is its ability to audit machine learning models for mistakes, said Su-In Lee, PhD, a computer scientist who led the UW research.

For example, a surge of research during the pandemic suggested that AI models could predict COVID-19 infection based on chest x-rays. Dr. Lee’s research used explainable AI to show that many of the studies were not as accurate as they claimed. Her lab revealed that many models› decisions were based not on pathologies but rather on other aspects such as laterality markers in the corners of x-rays or medical devices worn by patients (like pacemakers). She applied the same model auditing technique to AI-powered dermatology devices, digging into the flawed reasoning in their melanoma predictions. 

Explainable AI is beginning to affect drug development too. A 2023 study led by Dr. Lee used it to explain how to select complementary drugs for acute myeloid leukemia patients based on the differentiation levels of cancer cells. And in two other studies aimed at identifying Alzheimer’s therapeutic targets, “explainable AI played a key role in terms of identifying the driver pathway,” she said.

Currently, the US Food and Drug Administration (FDA) approval doesn’t require an understanding of a drug’s mechanism of action. But the issue is being raised more often, including at December’s Health Regulatory Policy Conference at MIT’s Jameel Clinic. And just over a year ago, Dr. Lee predicted that the FDA approval process would come to incorporate explainable AI analysis.

“I didn’t hesitate,” Dr. Lee said, regarding her prediction. “We didn’t see this in 2023, so I won’t assert that I was right, but I can confidently say that we are progressing in that direction.”

What’s Next?

The MIT study is part of the Antibiotics-AI project, a 7-year effort to leverage AI to find new antibiotics. Phare Bio, a nonprofit started by MIT professor James Collins, PhD, and others, will do clinical testing on the antibiotic candidates.

Even with the AI’s assistance, there’s still a long way to go before clinical approval.

But knowing which elements contribute to a candidate’s effectiveness against MRSA could help the researchers formulate scientific hypotheses and design better validation, Dr. Lee noted. In other words, because they used explainable AI, they could be better positioned for clinical trial success.

A version of this article appeared on Medscape.com.

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“New antibiotics discovered using AI!”

That’s how headlines read in December 2023, when MIT researchers announced a new class of antibiotics that could wipe out the drug-resistant superbug methicillin-resistant Staphylococcus aureus (MRSA) in mice.

Powered by deep learning, the study was a significant breakthrough. Few new antibiotics have come out since the 1960s, and this one in particular could be crucial in fighting tough-to-treat MRSA, which kills more than 10,000 people annually in the United States.

But as remarkable as the antibiotic discovery was, it may not be the most impactful part of this study.

The researchers used a method known as explainable artificial intelligence (AI), which unveils the AI’s reasoning process, sometimes known as the black box because it’s hidden from the user. Their work in this emerging field could be pivotal in advancing new drug design.

“Of course, we view the antibiotic-discovery angle to be very important,” said Felix Wong, PhD, a colead author of the study and postdoctoral fellow at the Broad Institute of MIT and Harvard, Cambridge, Massachusetts. “But I think equally important, or maybe even more important, is really our method of opening up the black box.”

The black box is generally thought of as impenetrable in complex machine learning models, and that poses a challenge in the drug discovery realm.

“A major bottleneck in AI-ML-driven drug discovery is that nobody knows what the heck is going on,” said Dr. Wong. Models have such powerful architectures that their decision-making is mysterious.

Researchers input data, such as patient features, and the model says what drugs might be effective. But researchers have no idea how the model arrived at its predictions — until now.

What the Researchers Did

Dr. Wong and his colleagues first mined 39,000 compounds for antibiotic activity against MRSA. They fed information about the compounds’ chemical structures and antibiotic activity into their machine learning model. With this, they “trained” the model to predict whether a compound is antibacterial.

Next, they used additional deep learning to narrow the field, ruling out compounds toxic to humans. Then, deploying their various models at once, they screened 12 million commercially available compounds. Five classes emerged as likely MRSA fighters. Further testing of 280 compounds from the five classes produced the final results: Two compounds from the same class. Both reduced MRSA infection in mouse models.

How did the computer flag these compounds? The researchers sought to answer that question by figuring out which chemical structures the model had been looking for.

A chemical structure can be “pruned” — that is, scientists can remove certain atoms and bonds to reveal an underlying substructure. The MIT researchers used the Monte Carlo Tree Search, a commonly used algorithm in machine learning, to select which atoms and bonds to edit out. Then they fed the pruned substructures into their model to find out which was likely responsible for the antibacterial activity.

“The main idea is we can pinpoint which substructure of a chemical structure is causative instead of just correlated with high antibiotic activity,” Dr. Wong said.

This could fuel new “design-driven” or generative AI approaches where these substructures become “starting points to design entirely unseen, unprecedented antibiotics,” Dr. Wong said. “That’s one of the key efforts that we’ve been working on since the publication of this paper.”

More broadly, their method could lead to discoveries in drug classes beyond antibiotics, such as antivirals and anticancer drugs, according to Dr. Wong.

“This is the first major study that I’ve seen seeking to incorporate explainability into deep learning models in the context of antibiotics,” said César de la Fuente, PhD, an assistant professor at the University of Pennsylvania, Philadelphia, Pennsylvania, whose lab has been engaged in AI for antibiotic discovery for the past 5 years.

“It’s kind of like going into the black box with a magnifying lens and figuring out what is actually happening in there,” Dr. de la Fuente said. “And that will open up possibilities for leveraging those different steps to make better drugs.”

 

 

How Explainable AI Could Revolutionize Medicine

In studies, explainable AI is showing its potential for informing clinical decisions as well — flagging high-risk patients and letting doctors know why that calculation was made. University of Washington researchers have used the technology to predict whether a patient will have hypoxemia during surgery, revealing which features contributed to the prediction, such as blood pressure or body mass index. Another study used explainable AI to help emergency medical services providers and emergency room clinicians optimize time — for example, by identifying trauma patients at high risk for acute traumatic coagulopathy more quickly.

A crucial benefit of explainable AI is its ability to audit machine learning models for mistakes, said Su-In Lee, PhD, a computer scientist who led the UW research.

For example, a surge of research during the pandemic suggested that AI models could predict COVID-19 infection based on chest x-rays. Dr. Lee’s research used explainable AI to show that many of the studies were not as accurate as they claimed. Her lab revealed that many models› decisions were based not on pathologies but rather on other aspects such as laterality markers in the corners of x-rays or medical devices worn by patients (like pacemakers). She applied the same model auditing technique to AI-powered dermatology devices, digging into the flawed reasoning in their melanoma predictions. 

Explainable AI is beginning to affect drug development too. A 2023 study led by Dr. Lee used it to explain how to select complementary drugs for acute myeloid leukemia patients based on the differentiation levels of cancer cells. And in two other studies aimed at identifying Alzheimer’s therapeutic targets, “explainable AI played a key role in terms of identifying the driver pathway,” she said.

Currently, the US Food and Drug Administration (FDA) approval doesn’t require an understanding of a drug’s mechanism of action. But the issue is being raised more often, including at December’s Health Regulatory Policy Conference at MIT’s Jameel Clinic. And just over a year ago, Dr. Lee predicted that the FDA approval process would come to incorporate explainable AI analysis.

“I didn’t hesitate,” Dr. Lee said, regarding her prediction. “We didn’t see this in 2023, so I won’t assert that I was right, but I can confidently say that we are progressing in that direction.”

What’s Next?

The MIT study is part of the Antibiotics-AI project, a 7-year effort to leverage AI to find new antibiotics. Phare Bio, a nonprofit started by MIT professor James Collins, PhD, and others, will do clinical testing on the antibiotic candidates.

Even with the AI’s assistance, there’s still a long way to go before clinical approval.

But knowing which elements contribute to a candidate’s effectiveness against MRSA could help the researchers formulate scientific hypotheses and design better validation, Dr. Lee noted. In other words, because they used explainable AI, they could be better positioned for clinical trial success.

A version of this article appeared on Medscape.com.

“New antibiotics discovered using AI!”

That’s how headlines read in December 2023, when MIT researchers announced a new class of antibiotics that could wipe out the drug-resistant superbug methicillin-resistant Staphylococcus aureus (MRSA) in mice.

Powered by deep learning, the study was a significant breakthrough. Few new antibiotics have come out since the 1960s, and this one in particular could be crucial in fighting tough-to-treat MRSA, which kills more than 10,000 people annually in the United States.

But as remarkable as the antibiotic discovery was, it may not be the most impactful part of this study.

The researchers used a method known as explainable artificial intelligence (AI), which unveils the AI’s reasoning process, sometimes known as the black box because it’s hidden from the user. Their work in this emerging field could be pivotal in advancing new drug design.

“Of course, we view the antibiotic-discovery angle to be very important,” said Felix Wong, PhD, a colead author of the study and postdoctoral fellow at the Broad Institute of MIT and Harvard, Cambridge, Massachusetts. “But I think equally important, or maybe even more important, is really our method of opening up the black box.”

The black box is generally thought of as impenetrable in complex machine learning models, and that poses a challenge in the drug discovery realm.

“A major bottleneck in AI-ML-driven drug discovery is that nobody knows what the heck is going on,” said Dr. Wong. Models have such powerful architectures that their decision-making is mysterious.

Researchers input data, such as patient features, and the model says what drugs might be effective. But researchers have no idea how the model arrived at its predictions — until now.

What the Researchers Did

Dr. Wong and his colleagues first mined 39,000 compounds for antibiotic activity against MRSA. They fed information about the compounds’ chemical structures and antibiotic activity into their machine learning model. With this, they “trained” the model to predict whether a compound is antibacterial.

Next, they used additional deep learning to narrow the field, ruling out compounds toxic to humans. Then, deploying their various models at once, they screened 12 million commercially available compounds. Five classes emerged as likely MRSA fighters. Further testing of 280 compounds from the five classes produced the final results: Two compounds from the same class. Both reduced MRSA infection in mouse models.

How did the computer flag these compounds? The researchers sought to answer that question by figuring out which chemical structures the model had been looking for.

A chemical structure can be “pruned” — that is, scientists can remove certain atoms and bonds to reveal an underlying substructure. The MIT researchers used the Monte Carlo Tree Search, a commonly used algorithm in machine learning, to select which atoms and bonds to edit out. Then they fed the pruned substructures into their model to find out which was likely responsible for the antibacterial activity.

“The main idea is we can pinpoint which substructure of a chemical structure is causative instead of just correlated with high antibiotic activity,” Dr. Wong said.

This could fuel new “design-driven” or generative AI approaches where these substructures become “starting points to design entirely unseen, unprecedented antibiotics,” Dr. Wong said. “That’s one of the key efforts that we’ve been working on since the publication of this paper.”

More broadly, their method could lead to discoveries in drug classes beyond antibiotics, such as antivirals and anticancer drugs, according to Dr. Wong.

“This is the first major study that I’ve seen seeking to incorporate explainability into deep learning models in the context of antibiotics,” said César de la Fuente, PhD, an assistant professor at the University of Pennsylvania, Philadelphia, Pennsylvania, whose lab has been engaged in AI for antibiotic discovery for the past 5 years.

“It’s kind of like going into the black box with a magnifying lens and figuring out what is actually happening in there,” Dr. de la Fuente said. “And that will open up possibilities for leveraging those different steps to make better drugs.”

 

 

How Explainable AI Could Revolutionize Medicine

In studies, explainable AI is showing its potential for informing clinical decisions as well — flagging high-risk patients and letting doctors know why that calculation was made. University of Washington researchers have used the technology to predict whether a patient will have hypoxemia during surgery, revealing which features contributed to the prediction, such as blood pressure or body mass index. Another study used explainable AI to help emergency medical services providers and emergency room clinicians optimize time — for example, by identifying trauma patients at high risk for acute traumatic coagulopathy more quickly.

A crucial benefit of explainable AI is its ability to audit machine learning models for mistakes, said Su-In Lee, PhD, a computer scientist who led the UW research.

For example, a surge of research during the pandemic suggested that AI models could predict COVID-19 infection based on chest x-rays. Dr. Lee’s research used explainable AI to show that many of the studies were not as accurate as they claimed. Her lab revealed that many models› decisions were based not on pathologies but rather on other aspects such as laterality markers in the corners of x-rays or medical devices worn by patients (like pacemakers). She applied the same model auditing technique to AI-powered dermatology devices, digging into the flawed reasoning in their melanoma predictions. 

Explainable AI is beginning to affect drug development too. A 2023 study led by Dr. Lee used it to explain how to select complementary drugs for acute myeloid leukemia patients based on the differentiation levels of cancer cells. And in two other studies aimed at identifying Alzheimer’s therapeutic targets, “explainable AI played a key role in terms of identifying the driver pathway,” she said.

Currently, the US Food and Drug Administration (FDA) approval doesn’t require an understanding of a drug’s mechanism of action. But the issue is being raised more often, including at December’s Health Regulatory Policy Conference at MIT’s Jameel Clinic. And just over a year ago, Dr. Lee predicted that the FDA approval process would come to incorporate explainable AI analysis.

“I didn’t hesitate,” Dr. Lee said, regarding her prediction. “We didn’t see this in 2023, so I won’t assert that I was right, but I can confidently say that we are progressing in that direction.”

What’s Next?

The MIT study is part of the Antibiotics-AI project, a 7-year effort to leverage AI to find new antibiotics. Phare Bio, a nonprofit started by MIT professor James Collins, PhD, and others, will do clinical testing on the antibiotic candidates.

Even with the AI’s assistance, there’s still a long way to go before clinical approval.

But knowing which elements contribute to a candidate’s effectiveness against MRSA could help the researchers formulate scientific hypotheses and design better validation, Dr. Lee noted. In other words, because they used explainable AI, they could be better positioned for clinical trial success.

A version of this article appeared on Medscape.com.

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<root generator="drupal.xsl" gversion="1.7"> <header> <fileName>166930</fileName> <TBEID>0C04E894.SIG</TBEID> <TBUniqueIdentifier>MD_0C04E894</TBUniqueIdentifier> <newsOrJournal>News</newsOrJournal> <publisherName>Frontline Medical Communications</publisherName> <storyname/> <articleType>2</articleType> <TBLocation>QC Done-All Pubs</TBLocation> <QCDate>20240213T151318</QCDate> <firstPublished>20240213T152025</firstPublished> <LastPublished>20240213T152025</LastPublished> <pubStatus qcode="stat:"/> <embargoDate/> <killDate/> <CMSDate>20240213T152025</CMSDate> <articleSource/> <facebookInfo/> <meetingNumber/> <byline>Sarah Amandolare</byline> <bylineText>SARAH AMANDOLARE</bylineText> <bylineFull>SARAH AMANDOLARE</bylineFull> <bylineTitleText/> <USOrGlobal/> <wireDocType/> <newsDocType>News</newsDocType> <journalDocType/> <linkLabel/> <pageRange/> <citation/> <quizID/> <indexIssueDate/> <itemClass qcode="ninat:text"/> <provider qcode="provider:imng"> <name>IMNG Medical Media</name> <rightsInfo> <copyrightHolder> <name>Frontline Medical News</name> </copyrightHolder> <copyrightNotice>Copyright (c) 2015 Frontline Medical News, a Frontline Medical Communications Inc. company. All rights reserved. This material may not be published, broadcast, copied, or otherwise reproduced or distributed without the prior written permission of Frontline Medical Communications Inc.</copyrightNotice> </rightsInfo> </provider> <abstract/> <metaDescription>The researchers used a method known as explainable artificial intelligence (AI), which unveils the AI’s reasoning process, sometimes known as the black box beca</metaDescription> <articlePDF/> <teaserImage/> <teaser>MIT scientists use ‘explainable AI’ to discover new antibiotics, and possibly lead the way for other developments.</teaser> <title>How the New MRSA Antibiotic Cracked AI’s ‘Black Box’</title> <deck/> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>1</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear/> <pubPubdateMonth/> <pubPubdateDay/> <pubVolume/> <pubNumber/> <wireChannels/> <primaryCMSID/> <CMSIDs/> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>fp</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>im</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>idprac</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> </publications_g> <publications> <term>15</term> <term>21</term> <term canonical="true">20</term> </publications> <sections> <term canonical="true">39313</term> </sections> <topics> <term>27442</term> <term canonical="true">319</term> </topics> <links/> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>How the New MRSA Antibiotic Cracked AI’s ‘Black Box’</title> <deck/> </itemMeta> <itemContent> <p>“New antibiotics discovered using AI!”</p> <p>That’s how headlines read in December 2023, when MIT researchers <a href="https://www.nature.com/articles/s41586-023-06887-8">announced</a> a new class of antibiotics that could wipe out the drug-resistant superbug methicillin-resistant <em>Staphylococcus aureus</em> (MRSA) in mice.<br/><br/>Powered by deep learning, the study was a significant breakthrough. Few new antibiotics have come out since the 1960s, and this one in particular could be crucial in fighting tough-to-treat MRSA, which kills more than <a href="https://www.cdc.gov/mmwr/volumes/68/wr/mm6809e1.htm">10,000 people</a> annually in the United States.<br/><br/>But as remarkable as the antibiotic discovery was, it may not be the most impactful part of this study.<br/><br/><span class="tag metaDescription">The researchers used a method known as explainable artificial intelligence (AI), which unveils the AI’s reasoning process, sometimes known as the black box because it’s hidden from the user. Their work in this emerging field could be pivotal in advancing new drug design.</span><br/><br/>“Of course, we view the antibiotic-discovery angle to be very important,” said <span class="Hyperlink"><a href="https://www.mit.edu/~wongf/">Felix Wong, PhD</a></span>, a colead author of the study and postdoctoral fellow at the Broad Institute of MIT and Harvard, Cambridge, Massachusetts. “But I think equally important, or maybe even more important, is really our method of opening up the black box.”<br/><br/>The black box is generally thought of as impenetrable in complex machine learning models, and that poses a challenge in the drug discovery realm.<br/><br/>“A major bottleneck in AI-ML-driven drug discovery is that nobody knows what the heck is going on,” said Dr. Wong. Models have such powerful architectures that their decision-making is mysterious.<br/><br/>Researchers input data, such as patient features, and the model says what drugs might be effective. But researchers have no idea how the model arrived at its predictions — until now.</p> <h2>What the Researchers Did</h2> <p>Dr. Wong and his colleagues first mined 39,000 compounds for antibiotic activity against MRSA. They fed information about the compounds’ chemical structures and antibiotic activity into their machine learning model. With this, they “trained” the model to predict whether a compound is antibacterial.</p> <p>Next, they used additional deep learning to narrow the field, ruling out compounds toxic to humans. Then, deploying their various models at once, they screened 12 million commercially available compounds. Five classes emerged as likely MRSA fighters. Further testing of 280 compounds from the five classes produced the final results: Two compounds from the same class. Both reduced MRSA infection in mouse models.<br/><br/>How did the computer flag these compounds? The researchers sought to answer that question by figuring out which chemical structures the model had been looking for.<br/><br/>A chemical structure can be “pruned” — that is, scientists can remove certain atoms and bonds to reveal an underlying substructure. The MIT researchers used the Monte Carlo Tree Search, a commonly used algorithm in machine learning, to select which atoms and bonds to edit out. Then they fed the pruned substructures into their model to find out which was likely responsible for the antibacterial activity.<br/><br/>“The main idea is we can pinpoint which substructure of a chemical structure is causative instead of just correlated with high antibiotic activity,” Dr. Wong said.<br/><br/>This could fuel new “design-driven” or generative AI approaches where these substructures become “starting points to design entirely unseen, unprecedented antibiotics,” Dr. Wong said. “That’s one of the key efforts that we’ve been working on since the publication of this paper.”<br/><br/>More broadly, their method could lead to discoveries in drug classes beyond antibiotics, such as antivirals and anticancer drugs, according to Dr. Wong.<br/><br/>“This is the first major study that I’ve seen seeking to incorporate explainability into deep learning models in the context of antibiotics,” said <a href="https://delafuentelab.seas.upenn.edu/">César de la Fuente</a>, PhD, an assistant professor at the University of Pennsylvania, Philadelphia, Pennsylvania, whose lab has been engaged in AI for antibiotic discovery for the past 5 years.<br/><br/>“It’s kind of like going into the black box with a magnifying lens and figuring out what is actually happening in there,” Dr. de la Fuente said. “And that will open up possibilities for leveraging those different steps to make better drugs.”</p> <h2>How Explainable AI Could Revolutionize Medicine</h2> <p>In studies, explainable AI is showing its potential for informing clinical decisions as well — flagging high-risk patients and letting doctors know why that calculation was made. University of Washington researchers have used the technology to predict whether a patient will <a href="https://www.nature.com/articles/s41551-018-0304-0">have hypoxemia</a> during surgery, revealing which features contributed to the prediction, such as blood pressure or body mass index. Another <a href="https://www.nature.com/articles/s41551-022-00872-8.epdf?sharing_token=AbecY23Lw9m6UtX02tjMWdRgN0jAjWel9jnR3ZoTv0Ot6IX5edej-UY9W2MjXAysD9FAAl40c14kJUNO34dE5yS4HDpJI-kfl9kW3-c-Xr_rC1zpMvMte4aGtpoCNucExyt7DBFAqu2S0AyfPUulA8gn-j8iD9BlxDp_RUhykYM%3D">study</a> used explainable AI to help emergency medical services providers and emergency room clinicians optimize time — for example, by identifying trauma patients at high risk for acute traumatic coagulopathy more quickly.</p> <p>A crucial benefit of explainable AI is its ability to audit machine learning models for mistakes, said <a href="https://aims.cs.washington.edu/su-in-lee">Su-In Lee</a>, PhD, a computer scientist who led the UW research.<br/><br/>For example, a surge of research during the pandemic suggested that AI models could predict COVID-19 infection based on chest x-rays. Dr. Lee’s <a href="https://www.nature.com/articles/s42256-021-00338-7">research</a> used explainable AI to show that many of the studies were not as accurate as they claimed. Her lab revealed that many models› decisions were based not on pathologies but rather on <a href="https://www.nature.com/articles/d41586-022-00858-1">other aspects</a> such as laterality markers in the corners of x-rays or medical devices worn by patients (like <a href="https://emedicine.medscape.com/article/162245-overview">pacemakers</a>). She applied the same model auditing technique to <a href="https://www.nature.com/articles/s41551-023-01160-9">AI-powered dermatology devices</a>, digging into the flawed reasoning in their <a href="https://emedicine.medscape.com/article/1295718-overview">melanoma</a> predictions. <br/><br/>Explainable AI is beginning to affect drug development too. A <a href="https://www.nature.com/articles/s41551-023-01034-0">2023 study</a> led by Dr. Lee used it to explain how to select <a href="https://www.medrxiv.org/content/10.1101/2023.06.07.23291119v1">complementary drugs</a> for <a href="https://emedicine.medscape.com/article/197802-overview">acute myeloid leukemia</a> patients based on the differentiation levels of cancer cells. And in <a href="https://genomebiology.biomedcentral.com/articles/10.1186/s13059-023-02901-4">two other </a><a href="https://www.nature.com/articles/s41467-021-25680-7">studies</a> aimed at identifying Alzheimer’s therapeutic targets, “explainable AI played a key role in terms of identifying the driver pathway,” she said.<br/><br/>Currently, the US Food and Drug Administration (FDA) approval doesn’t require an understanding of a drug’s mechanism of action. But the issue is being raised more often, including at December’s <a href="https://news.mit.edu/2024/what-to-do-about-ai-in-health-0123">Health Regulatory Policy Conference</a> at MIT’s Jameel Clinic. And just over a year ago, Dr. Lee <a href="https://www.geekwire.com/2022/digital-health-leaders-share-predictions-on-what-to-expect-in-2023/">predicted</a> that the FDA approval process would come to incorporate explainable AI analysis.<br/><br/>“I didn’t hesitate,” Dr. Lee said, regarding her prediction. “We didn’t see this in 2023, so I won’t assert that I was right, but I can confidently say that we are progressing in that direction.”</p> <h2>What’s Next?</h2> <p>The MIT study is part of the Antibiotics-AI project, a 7-year effort to leverage AI to find new antibiotics. Phare Bio, a nonprofit started by MIT professor James Collins, PhD, and others, will do clinical testing on the antibiotic candidates.</p> <p>Even with the AI’s assistance, there’s still a long way to go before clinical approval.<br/><br/>But knowing which elements contribute to a candidate’s effectiveness against MRSA could help the researchers formulate scientific hypotheses and design better validation, Dr. Lee noted. In other words, because they used explainable AI, they could be better positioned for clinical trial success.<span class="end"/></p> <p> <em>A version of this article appeared on <span class="Hyperlink"><a href="https://www.medscape.com/viewarticle/how-new-mrsa-antibiotic-cracked-open-ais-black-box-2024a1000326">Medscape.com</a></span>.</em> </p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>
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Healthcare Workers Face Increased Risks During the Pandemic

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Thu, 02/08/2024 - 13:38

Healthcare workers have been at an increased risk for SARS-CoV-2 infection and mental distress such as anxiety and depression during the pandemic, according to new research.

In an analysis of administrative health records for about 3000 healthcare workers in Alberta, Canada, the workers were as much as twice as likely to become infected with SARS-CoV-2 compared with the overall population. The risk for infection was higher among healthcare workers in the first two waves of the pandemic and again during the fifth wave.

“Previous publications, including ours, suggested that the main problem was in the early weeks and months of the pandemic, but this paper shows that it continued until the later stages,” senior author Nicola Cherry, MD, an occupational epidemiologist at the University of Alberta in Edmonton, Canada, told this news organization.

The findings were published in the Canadian Journal of Public Health.
 

Wave Upon Wave

In the current study, the investigators sought to compare the risk for SARS-CoV-2 infection and mental distress among healthcare workers and among community referents (CRs). They examined the following waves of the COVID-19 pandemic:

  • Wave 1: From March to June 2020 (4 months).
  • Wave 2: From July 2020 to February 2021 (8 months).
  • Wave 3: From March to June 2021 (4 months).
  • Wave 4: From July to October 2021 (4 months).
  • Wave 5 (Omicron): From November 2021 to March 2022 (5 months).

Healthcare workers in Alberta were asked at recruitment for consent to match their individual records to the Alberta Administrative Health Database. As the pandemic progressed, participants were also asked for consent to be linked to COVID-19 immunization records maintained by the provinces, as well as for the results of all polymerase chain reaction (PCR) testing for the SARS-CoV-2 virus.

The investigators matched 2959 healthcare workers to 14,546 CRs according to their age, sex, geographic location in Alberta, and number of physician claims from April 1, 2019, to March 31, 2020.

Incident SARS-CoV-2 infection was examined using PCR testing and the first date of a physician consultation at which the code for SARS-CoV-2 infection had been recorded. Mental health disorders were identified from physician records. They included anxiety disorders, stress and adjustment reactions, and depressive disorders.

Most (79.5%) of the healthcare workers were registered nurses, followed by physicians (16.1%), healthcare aides (2.4%), and licensed practical nurses (2.0%). Most participants (87.5%) were female. The median age at recruitment was 44 years.

Healthcare workers were at a greater risk for COVID-19 overall, with the first SARS-CoV-2 infection defined from either PCR tests (odds ratio [OR], 1.96) or from physician records (OR, 1.33). They were also at an increased risk for anxiety (adjusted OR, 1.25; P < .001), stress/adjustment reaction (adjusted OR, 1.52; P < .001), and depressive condition (adjusted OR, 1.39; P < .001). Moreover, the excess risks for stress/adjustment reactions and depressive conditions increased with successive waves during the pandemic, peaking in the fourth wave and continuing in the fifth wave.

“Although the increase was less in the middle of the phases of the pandemic, it came back with a vengeance during the last phase, which was the Omicron phase,” said Dr. Cherry.

“Employers of healthcare workers can’t assume that everything is now under control, that they know what they’re doing, and that there is no risk. We are now having some increases in COVID. It’s going to go on. The pandemic is not over in that sense, and infection control continues to be major,” she added.

The finding that mental health worsened among healthcare workers was not surprising, Dr. Cherry said. Even before the pandemic, studies had shown that healthcare workers were at a greater risk for depression than the population overall.

“There is a lot of need for care in mental health support of healthcare workers, whether during a pandemic or not,” said Dr. Cherry.
 

 

 

Nurses Are Suffering

Commenting on the research for this news organization, Farinaz Havaei, PhD, RN, assistant professor of nursing at the University of British Columbia in Vancouver, Canada, said, “This is a very important and timely study that draws on objective clinical and administrative data, as opposed to healthcare workers’ subjective reports.” Dr. Havaei did not participate in the research.

Overall, the findings are consistent with previous research that drew upon healthcare workers’ reports. They speak to the chronic and cumulative impact of COVID-19 and its associated stressors on the mental health and well-being of healthcare workers, said Dr. Havaei.

“The likelihood of stress/adjustment reaction and depression showed a relatively steady increase with increasing COVID-19 waves. This increase can likely be explained by healthcare workers’ depleting emotional reserves for coping with chronic workplace stressors such as concerns about exposure to COVID-19, inadequate staffing, and work overload,” she said. Witnessing the suffering and trauma of patients and their families likely added to this risk.

Dr. Havaei also pointed out that most of the study participants were nurses. The findings are consistent with prepandemic research that showed that the suboptimal conditions that nurses increasingly faced resulted in high levels of exhaustion and burnout.

“While I agree with the authors’ call for more mental health support for healthcare workers, I think prevention efforts that address the root cause of the problem should be prioritized,” she said.
 

From Heroes to Zeros

The same phenomena have been observed in the United States, said John Q. Young, MD, MPP, PhD, professor and chair of psychiatry at the Donald and Barbara Zucker School of Medicine at Hofstra/Northwell in Hempstead, New York. In various studies, Dr. Young and his colleagues have reported a strong association between exposure to the stressors of the pandemic and subsequent development of depression, anxiety, and posttraumatic stress disorder (PTSD) among healthcare workers.

“The findings from Alberta are remarkably consistent. In the beginning of the pandemic, there was a lot of acknowledgment of the work healthcare workers were doing. The fire department clapping as you leave work at night, being called heroes, even though a lot of healthcare workers feel uncomfortable with the hero language because they don’t feel like heroes. Yes, they’re afraid, but they are going to do what they need to do and help,” he said.

But as the pandemic continued, public sentiment changed, Dr. Young said. “They’ve gone from heroes to zeros. Now we are seeing the accumulated, chronic effects over months and years, and these are significant. Our healthcare workforce is vulnerable now. The reserves are low. There are serious shortages in nursing, with more retirements and more people leaving the field,” he said.

As part of a campaign to help healthcare workers cope, psychiatrists at Northwell Health have started a program called Stress First Aid at their Center for Traumatic Stress Response Resilience, where they train nurses, physicians, and other healthcare staff to use basic tools to recognize and respond to stress and distress in themselves and in their colleagues, said Dr. Young.

“For those healthcare workers who find that they are struggling and need more support, there is resilience coaching, which is one-on-one support. For those who need more clinical attention, there is a clinical program where our healthcare workers can meet with a psychologist, psychiatrist, or a therapist, to work through depression, PTSD, and anxiety. We didn’t have this before the pandemic, but it is now a big focus for our workforce,” he said. “We are trying to build resilience. The trauma is real.”

The study was supported by the College of Physicians and Surgeons of Alberta, the Canadian Institutes of Health Research, and the Canadian Immunology Task Force. Dr. Cherry and Dr. Havaei reported no relevant financial relationships. Dr. Young reported that he is senior vice president of behavioral health at Northwell.

A version of this article appeared on Medscape.com.

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Healthcare workers have been at an increased risk for SARS-CoV-2 infection and mental distress such as anxiety and depression during the pandemic, according to new research.

In an analysis of administrative health records for about 3000 healthcare workers in Alberta, Canada, the workers were as much as twice as likely to become infected with SARS-CoV-2 compared with the overall population. The risk for infection was higher among healthcare workers in the first two waves of the pandemic and again during the fifth wave.

“Previous publications, including ours, suggested that the main problem was in the early weeks and months of the pandemic, but this paper shows that it continued until the later stages,” senior author Nicola Cherry, MD, an occupational epidemiologist at the University of Alberta in Edmonton, Canada, told this news organization.

The findings were published in the Canadian Journal of Public Health.
 

Wave Upon Wave

In the current study, the investigators sought to compare the risk for SARS-CoV-2 infection and mental distress among healthcare workers and among community referents (CRs). They examined the following waves of the COVID-19 pandemic:

  • Wave 1: From March to June 2020 (4 months).
  • Wave 2: From July 2020 to February 2021 (8 months).
  • Wave 3: From March to June 2021 (4 months).
  • Wave 4: From July to October 2021 (4 months).
  • Wave 5 (Omicron): From November 2021 to March 2022 (5 months).

Healthcare workers in Alberta were asked at recruitment for consent to match their individual records to the Alberta Administrative Health Database. As the pandemic progressed, participants were also asked for consent to be linked to COVID-19 immunization records maintained by the provinces, as well as for the results of all polymerase chain reaction (PCR) testing for the SARS-CoV-2 virus.

The investigators matched 2959 healthcare workers to 14,546 CRs according to their age, sex, geographic location in Alberta, and number of physician claims from April 1, 2019, to March 31, 2020.

Incident SARS-CoV-2 infection was examined using PCR testing and the first date of a physician consultation at which the code for SARS-CoV-2 infection had been recorded. Mental health disorders were identified from physician records. They included anxiety disorders, stress and adjustment reactions, and depressive disorders.

Most (79.5%) of the healthcare workers were registered nurses, followed by physicians (16.1%), healthcare aides (2.4%), and licensed practical nurses (2.0%). Most participants (87.5%) were female. The median age at recruitment was 44 years.

Healthcare workers were at a greater risk for COVID-19 overall, with the first SARS-CoV-2 infection defined from either PCR tests (odds ratio [OR], 1.96) or from physician records (OR, 1.33). They were also at an increased risk for anxiety (adjusted OR, 1.25; P < .001), stress/adjustment reaction (adjusted OR, 1.52; P < .001), and depressive condition (adjusted OR, 1.39; P < .001). Moreover, the excess risks for stress/adjustment reactions and depressive conditions increased with successive waves during the pandemic, peaking in the fourth wave and continuing in the fifth wave.

“Although the increase was less in the middle of the phases of the pandemic, it came back with a vengeance during the last phase, which was the Omicron phase,” said Dr. Cherry.

“Employers of healthcare workers can’t assume that everything is now under control, that they know what they’re doing, and that there is no risk. We are now having some increases in COVID. It’s going to go on. The pandemic is not over in that sense, and infection control continues to be major,” she added.

The finding that mental health worsened among healthcare workers was not surprising, Dr. Cherry said. Even before the pandemic, studies had shown that healthcare workers were at a greater risk for depression than the population overall.

“There is a lot of need for care in mental health support of healthcare workers, whether during a pandemic or not,” said Dr. Cherry.
 

 

 

Nurses Are Suffering

Commenting on the research for this news organization, Farinaz Havaei, PhD, RN, assistant professor of nursing at the University of British Columbia in Vancouver, Canada, said, “This is a very important and timely study that draws on objective clinical and administrative data, as opposed to healthcare workers’ subjective reports.” Dr. Havaei did not participate in the research.

Overall, the findings are consistent with previous research that drew upon healthcare workers’ reports. They speak to the chronic and cumulative impact of COVID-19 and its associated stressors on the mental health and well-being of healthcare workers, said Dr. Havaei.

“The likelihood of stress/adjustment reaction and depression showed a relatively steady increase with increasing COVID-19 waves. This increase can likely be explained by healthcare workers’ depleting emotional reserves for coping with chronic workplace stressors such as concerns about exposure to COVID-19, inadequate staffing, and work overload,” she said. Witnessing the suffering and trauma of patients and their families likely added to this risk.

Dr. Havaei also pointed out that most of the study participants were nurses. The findings are consistent with prepandemic research that showed that the suboptimal conditions that nurses increasingly faced resulted in high levels of exhaustion and burnout.

“While I agree with the authors’ call for more mental health support for healthcare workers, I think prevention efforts that address the root cause of the problem should be prioritized,” she said.
 

From Heroes to Zeros

The same phenomena have been observed in the United States, said John Q. Young, MD, MPP, PhD, professor and chair of psychiatry at the Donald and Barbara Zucker School of Medicine at Hofstra/Northwell in Hempstead, New York. In various studies, Dr. Young and his colleagues have reported a strong association between exposure to the stressors of the pandemic and subsequent development of depression, anxiety, and posttraumatic stress disorder (PTSD) among healthcare workers.

“The findings from Alberta are remarkably consistent. In the beginning of the pandemic, there was a lot of acknowledgment of the work healthcare workers were doing. The fire department clapping as you leave work at night, being called heroes, even though a lot of healthcare workers feel uncomfortable with the hero language because they don’t feel like heroes. Yes, they’re afraid, but they are going to do what they need to do and help,” he said.

But as the pandemic continued, public sentiment changed, Dr. Young said. “They’ve gone from heroes to zeros. Now we are seeing the accumulated, chronic effects over months and years, and these are significant. Our healthcare workforce is vulnerable now. The reserves are low. There are serious shortages in nursing, with more retirements and more people leaving the field,” he said.

As part of a campaign to help healthcare workers cope, psychiatrists at Northwell Health have started a program called Stress First Aid at their Center for Traumatic Stress Response Resilience, where they train nurses, physicians, and other healthcare staff to use basic tools to recognize and respond to stress and distress in themselves and in their colleagues, said Dr. Young.

“For those healthcare workers who find that they are struggling and need more support, there is resilience coaching, which is one-on-one support. For those who need more clinical attention, there is a clinical program where our healthcare workers can meet with a psychologist, psychiatrist, or a therapist, to work through depression, PTSD, and anxiety. We didn’t have this before the pandemic, but it is now a big focus for our workforce,” he said. “We are trying to build resilience. The trauma is real.”

The study was supported by the College of Physicians and Surgeons of Alberta, the Canadian Institutes of Health Research, and the Canadian Immunology Task Force. Dr. Cherry and Dr. Havaei reported no relevant financial relationships. Dr. Young reported that he is senior vice president of behavioral health at Northwell.

A version of this article appeared on Medscape.com.

Healthcare workers have been at an increased risk for SARS-CoV-2 infection and mental distress such as anxiety and depression during the pandemic, according to new research.

In an analysis of administrative health records for about 3000 healthcare workers in Alberta, Canada, the workers were as much as twice as likely to become infected with SARS-CoV-2 compared with the overall population. The risk for infection was higher among healthcare workers in the first two waves of the pandemic and again during the fifth wave.

“Previous publications, including ours, suggested that the main problem was in the early weeks and months of the pandemic, but this paper shows that it continued until the later stages,” senior author Nicola Cherry, MD, an occupational epidemiologist at the University of Alberta in Edmonton, Canada, told this news organization.

The findings were published in the Canadian Journal of Public Health.
 

Wave Upon Wave

In the current study, the investigators sought to compare the risk for SARS-CoV-2 infection and mental distress among healthcare workers and among community referents (CRs). They examined the following waves of the COVID-19 pandemic:

  • Wave 1: From March to June 2020 (4 months).
  • Wave 2: From July 2020 to February 2021 (8 months).
  • Wave 3: From March to June 2021 (4 months).
  • Wave 4: From July to October 2021 (4 months).
  • Wave 5 (Omicron): From November 2021 to March 2022 (5 months).

Healthcare workers in Alberta were asked at recruitment for consent to match their individual records to the Alberta Administrative Health Database. As the pandemic progressed, participants were also asked for consent to be linked to COVID-19 immunization records maintained by the provinces, as well as for the results of all polymerase chain reaction (PCR) testing for the SARS-CoV-2 virus.

The investigators matched 2959 healthcare workers to 14,546 CRs according to their age, sex, geographic location in Alberta, and number of physician claims from April 1, 2019, to March 31, 2020.

Incident SARS-CoV-2 infection was examined using PCR testing and the first date of a physician consultation at which the code for SARS-CoV-2 infection had been recorded. Mental health disorders were identified from physician records. They included anxiety disorders, stress and adjustment reactions, and depressive disorders.

Most (79.5%) of the healthcare workers were registered nurses, followed by physicians (16.1%), healthcare aides (2.4%), and licensed practical nurses (2.0%). Most participants (87.5%) were female. The median age at recruitment was 44 years.

Healthcare workers were at a greater risk for COVID-19 overall, with the first SARS-CoV-2 infection defined from either PCR tests (odds ratio [OR], 1.96) or from physician records (OR, 1.33). They were also at an increased risk for anxiety (adjusted OR, 1.25; P < .001), stress/adjustment reaction (adjusted OR, 1.52; P < .001), and depressive condition (adjusted OR, 1.39; P < .001). Moreover, the excess risks for stress/adjustment reactions and depressive conditions increased with successive waves during the pandemic, peaking in the fourth wave and continuing in the fifth wave.

“Although the increase was less in the middle of the phases of the pandemic, it came back with a vengeance during the last phase, which was the Omicron phase,” said Dr. Cherry.

“Employers of healthcare workers can’t assume that everything is now under control, that they know what they’re doing, and that there is no risk. We are now having some increases in COVID. It’s going to go on. The pandemic is not over in that sense, and infection control continues to be major,” she added.

The finding that mental health worsened among healthcare workers was not surprising, Dr. Cherry said. Even before the pandemic, studies had shown that healthcare workers were at a greater risk for depression than the population overall.

“There is a lot of need for care in mental health support of healthcare workers, whether during a pandemic or not,” said Dr. Cherry.
 

 

 

Nurses Are Suffering

Commenting on the research for this news organization, Farinaz Havaei, PhD, RN, assistant professor of nursing at the University of British Columbia in Vancouver, Canada, said, “This is a very important and timely study that draws on objective clinical and administrative data, as opposed to healthcare workers’ subjective reports.” Dr. Havaei did not participate in the research.

Overall, the findings are consistent with previous research that drew upon healthcare workers’ reports. They speak to the chronic and cumulative impact of COVID-19 and its associated stressors on the mental health and well-being of healthcare workers, said Dr. Havaei.

“The likelihood of stress/adjustment reaction and depression showed a relatively steady increase with increasing COVID-19 waves. This increase can likely be explained by healthcare workers’ depleting emotional reserves for coping with chronic workplace stressors such as concerns about exposure to COVID-19, inadequate staffing, and work overload,” she said. Witnessing the suffering and trauma of patients and their families likely added to this risk.

Dr. Havaei also pointed out that most of the study participants were nurses. The findings are consistent with prepandemic research that showed that the suboptimal conditions that nurses increasingly faced resulted in high levels of exhaustion and burnout.

“While I agree with the authors’ call for more mental health support for healthcare workers, I think prevention efforts that address the root cause of the problem should be prioritized,” she said.
 

From Heroes to Zeros

The same phenomena have been observed in the United States, said John Q. Young, MD, MPP, PhD, professor and chair of psychiatry at the Donald and Barbara Zucker School of Medicine at Hofstra/Northwell in Hempstead, New York. In various studies, Dr. Young and his colleagues have reported a strong association between exposure to the stressors of the pandemic and subsequent development of depression, anxiety, and posttraumatic stress disorder (PTSD) among healthcare workers.

“The findings from Alberta are remarkably consistent. In the beginning of the pandemic, there was a lot of acknowledgment of the work healthcare workers were doing. The fire department clapping as you leave work at night, being called heroes, even though a lot of healthcare workers feel uncomfortable with the hero language because they don’t feel like heroes. Yes, they’re afraid, but they are going to do what they need to do and help,” he said.

But as the pandemic continued, public sentiment changed, Dr. Young said. “They’ve gone from heroes to zeros. Now we are seeing the accumulated, chronic effects over months and years, and these are significant. Our healthcare workforce is vulnerable now. The reserves are low. There are serious shortages in nursing, with more retirements and more people leaving the field,” he said.

As part of a campaign to help healthcare workers cope, psychiatrists at Northwell Health have started a program called Stress First Aid at their Center for Traumatic Stress Response Resilience, where they train nurses, physicians, and other healthcare staff to use basic tools to recognize and respond to stress and distress in themselves and in their colleagues, said Dr. Young.

“For those healthcare workers who find that they are struggling and need more support, there is resilience coaching, which is one-on-one support. For those who need more clinical attention, there is a clinical program where our healthcare workers can meet with a psychologist, psychiatrist, or a therapist, to work through depression, PTSD, and anxiety. We didn’t have this before the pandemic, but it is now a big focus for our workforce,” he said. “We are trying to build resilience. The trauma is real.”

The study was supported by the College of Physicians and Surgeons of Alberta, the Canadian Institutes of Health Research, and the Canadian Immunology Task Force. Dr. Cherry and Dr. Havaei reported no relevant financial relationships. Dr. Young reported that he is senior vice president of behavioral health at Northwell.

A version of this article appeared on Medscape.com.

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They examined the following waves of the COVID-19 pandemic:</p> <ul class="body"> <li>Wave 1: From March to June 2020 (4 months).</li> <li>Wave 2: From July 2020 to February 2021 (8 months).</li> <li>Wave 3: From March to June 2021 (4 months).</li> <li>Wave 4: From July to October 2021 (4 months).</li> <li>Wave 5 (Omicron): From November 2021 to March 2022 (5 months).</li> </ul> <p>Healthcare workers in Alberta were asked at recruitment for consent to match their individual records to the Alberta Administrative Health Database. As the pandemic progressed, participants were also asked for consent to be linked to COVID-19 immunization records maintained by the provinces, as well as for the results of all polymerase chain reaction (PCR) testing for the SARS-CoV-2 virus.<br/><br/>The investigators matched 2959 healthcare workers to 14,546 CRs according to their age, sex, geographic location in Alberta, and number of physician claims from April 1, 2019, to March 31, 2020.<br/><br/>Incident SARS-CoV-2 infection was examined using PCR testing and the first date of a physician consultation at which the code for SARS-CoV-2 infection had been recorded. Mental health disorders were identified from physician records. They included <span class="Hyperlink"><a href="https://emedicine.medscape.com/article/286227-overview">anxiety disorders</a></span>, stress and adjustment reactions, and depressive disorders.<br/><br/>Most (79.5%) of the healthcare workers were registered nurses, followed by physicians (16.1%), healthcare aides (2.4%), and licensed practical nurses (2.0%). Most participants (87.5%) were female. The median age at recruitment was 44 years.<br/><br/>Healthcare workers were at a greater risk for COVID-19 overall, with the first SARS-CoV-2 infection defined from either PCR tests (odds ratio [OR], 1.96) or from physician records (OR, 1.33). They were also at an increased risk for anxiety (adjusted OR, 1.25; <em>P</em> &lt; .001), stress/adjustment reaction (adjusted OR, 1.52; <em>P</em> &lt; .001), and depressive condition (adjusted OR, 1.39; <em>P</em> &lt; .001). Moreover, the excess risks for stress/adjustment reactions and depressive conditions increased with successive waves during the pandemic, peaking in the fourth wave and continuing in the fifth wave.<br/><br/>“Although the increase was less in the middle of the phases of the pandemic, it came back with a vengeance during the last phase, which was the Omicron phase,” said Dr. Cherry.<br/><br/>“Employers of healthcare workers can’t assume that everything is now under control, that they know what they’re doing, and that there is no risk. We are now having some increases in COVID. It’s going to go on. The pandemic is not over in that sense, and infection control continues to be major,” she added.<br/><br/>The finding that mental health worsened among healthcare workers was not surprising, Dr. Cherry said. Even before the pandemic, studies had shown that healthcare workers were at a greater risk for depression than the population overall.<br/><br/>“There is a lot of need for care in mental health support of healthcare workers, whether during a pandemic or not,” said Dr. Cherry.<br/><br/></p> <h2>Nurses Are Suffering</h2> <p>Commenting on the research for this news organization, Farinaz Havaei, PhD, RN, assistant professor of nursing at the University of British Columbia in Vancouver, Canada, said, “This is a very important and timely study that draws on objective clinical and administrative data, as opposed to healthcare workers’ subjective reports.” Dr. Havaei did not participate in the research.<br/><br/>Overall, the findings are consistent with previous research that drew upon healthcare workers’ reports. They speak to the chronic and cumulative impact of COVID-19 and its associated stressors on the mental health and well-being of healthcare workers, said Dr. Havaei.<br/><br/>“The likelihood of stress/adjustment reaction and depression showed a relatively steady increase with increasing COVID-19 waves. This increase can likely be explained by healthcare workers’ depleting emotional reserves for coping with chronic workplace stressors such as concerns about exposure to COVID-19, inadequate staffing, and work overload,” she said. Witnessing the suffering and trauma of patients and their families likely added to this risk.<br/><br/>Dr. Havaei also pointed out that most of the study participants were nurses. The findings are consistent with prepandemic research that showed that the suboptimal conditions that nurses increasingly faced resulted in high levels of exhaustion and burnout.<br/><br/>“While I agree with the authors’ call for more mental health support for healthcare workers, I think prevention efforts that address the root cause of the problem should be prioritized,” she said.<br/><br/></p> <h2>From Heroes to Zeros</h2> <p>The same phenomena have been observed in the United States, said John Q. Young, MD, MPP, PhD, professor and chair of psychiatry at the Donald and Barbara Zucker School of Medicine at Hofstra/Northwell in Hempstead, New York. In various studies, Dr. Young and his colleagues have reported a strong association between exposure to the stressors of the pandemic and subsequent development of depression, anxiety, and <span class="Hyperlink"><a href="https://emedicine.medscape.com/article/288154-overview">posttraumatic stress disorder</a></span> (PTSD) among healthcare workers.<br/><br/>“The findings from Alberta are remarkably consistent. In the beginning of the pandemic, there was a lot of acknowledgment of the work healthcare workers were doing. The fire department clapping as you leave work at night, being called heroes, even though a lot of healthcare workers feel uncomfortable with the hero language because they don’t feel like heroes. Yes, they’re afraid, but they are going to do what they need to do and help,” he said.<br/><br/>But as the pandemic continued, public sentiment changed, Dr. Young said. “They’ve gone from heroes to zeros. Now we are seeing the accumulated, chronic effects over months and years, and these are significant. Our healthcare workforce is vulnerable now. The reserves are low. There are serious shortages in nursing, with more retirements and more people leaving the field,” he said.<br/><br/>As part of a campaign to help healthcare workers cope, psychiatrists at Northwell Health have started a program called Stress First Aid at their Center for Traumatic Stress Response Resilience, where they train nurses, physicians, and other healthcare staff to use basic tools to recognize and respond to stress and distress in themselves and in their colleagues, said Dr. Young.<br/><br/>“For those healthcare workers who find that they are struggling and need more support, there is resilience coaching, which is one-on-one support. For those who need more clinical attention, there is a clinical program where our healthcare workers can meet with a psychologist, psychiatrist, or a therapist, to work through depression, PTSD, and anxiety. We didn’t have this before the pandemic, but it is now a big focus for our workforce,” he said. “We are trying to build resilience. The trauma is real.”<br/><br/>The study was supported by the College of Physicians and Surgeons of Alberta, the Canadian Institutes of Health Research, and the Canadian Immunology Task Force. Dr. Cherry and Dr. Havaei reported no relevant financial relationships. Dr. Young reported that he is senior vice president of behavioral health at Northwell.<span class="end"/></p> <p> <em>A version of this article appeared on <span class="Hyperlink"><a href="https://www.medscape.com/viewarticle/healthcare-workers-face-increased-risks-during-pandemic-2024a100027i?src=">Medscape.com</a></span>.</em> </p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>
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Hospital Adverse Events Rise After Private Equity Acquisition

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Hospital-acquired adverse events or conditions including falls and infections increased by approximately 25% after hospitals’ acquisition by private equity compared with control hospitals, on the basis of a study of Medicare claims for more than 4,500,000 hospitalizations.

“Prior research on private equity in health care showed that acquisition is associated with higher charges, prices, and spending; however, the implications for quality of care and patient outcomes remained less understood,” corresponding author Zirui Song, MD, of Harvard Medical School, Boston, said in an interview. “This was particularly true for measures of clinical quality that were less susceptible to changes in patient mix or coding behavior, such as hospital-acquired adverse events.”

In the study, published in JAMA, the researchers compared data from 100% Medicare Part A claims for 662,095 hospitalizations at 51 hospitals acquired by private equities and 4,160,720 hospitalizations at 259 control hospitals. The hospitalizations occurred between 2009 and 2019. The researchers also used a difference-in-differences design to evaluate hospitalizations from 3 years before to 3 years after acquisition, controlling for patient and hospital attributes.

Hospital-acquired adverse events as defined by the US Centers for Medicare & Medicaid Services included falls, infections, stage III or IV pressure ulcers, foreign objects retained after surgery, air embolism, and blood incompatibility.

Overall, Medicare patients in private equity hospitals experienced a 25.4% increase in hospital-acquired conditions compared with those in control hospitals through a period of up to 3 years after acquisition, with a difference of 4.6 additional hospital-acquired conditions per 10,000 hospitalizations (P = .004). Central line-associated bloodstream infections accounted for 37.7% of the increase (P = .04), despite a 16.2% decrease in placement of central lines, and falls accounted for 27.3% (P = .02).

Notably, the incidence of surgical site infections increased from 10.8 per 10,000 hospitalizations before acquisition to 21.6 per 10,000 hospitalizations after acquisition, despite a reduction of 8.1% in surgical volume. By contrast, surgical site infections decreased at control hospitals over the study period.

In-hospital mortality decreased slightly at private equity hospitals compared with the control hospitals, but there was no differential change in mortality by 30 days after hospital discharge. The slight difference might be caused by the trend in slightly younger Medicare beneficiaries treated at private equity hospitals; these patients were less likely to be eligible for both Medicaid and Medicare and were more likely to be transferred to other hospitals, the researchers noted.

The findings were limited by several factors including the lack of generalizability to all private equity-acquired hospitals and to non-Medicare patients, the researchers noted. Other limitations include the use of the International Classification of Diseases, Ninth Revision (ICD-9) and Tenth Revision (ICD-10) codes that might have failed to capture all hospital-acquired conditions and the inability to account for all confounding factors.

However, the results suggest that private equity acquisition was associated with increased hospital-acquired adverse events and highlight concerns about the impact of private equity ownership on healthcare delivery, the researchers concluded.

In a related story published in July 2023, this news organization described a report showing an association between private equity ownership of medical practices and increased consumer prices for multiple medical specialties.

“Medicare patients admitted to private equity-owned hospitals experienced, on average, an 25% increase in hospital-acquired adverse events after the hospital was bought compared to similar patients at hospitals not acquired by private equity firms. We were surprised by the extent of this change relative to the comparison (non-private equity) hospitals, including the sizable increase in central line-associated bloodstream infections and the doubling of surgical site infections at private equity hospitals — both of which went down at the comparison hospitals during the same period,” Dr. Song said in an interview.

“A key implication is that patients, providers, and policymakers might be more attuned to the potential clinical impact of private equity ownership in the delivery system. Given that a plausible explanation for these findings is reductions in clinician staffing, clinical organizations and policymakers might also be more aware of cost-cutting strategies after acquisition,” Dr. Song said. “Prior research has shown that hospitals, nursing homes, and physician practices experience staffing cuts after private equity acquisition, which is a common way to reduce operating costs and boost the profitability of acquired entities,” he noted.

“More research is needed to understand the impact of private equity acquisitions across health care settings and the potential effects of policy levers that aim to protect patients and societal resources,” said Dr. Song, who coauthored an article outlining a policy framework for addressing private equity in healthcare, published in JAMA in April 2023. “Potential regulatory remedies include minimum staffing ratios, antitrust enforcement, mitigating the financial risk of such acquisitions, increasing the transparency of these acquisitions, and protecting patients and society from the higher prices of care attributed to this model of provider ownership,” he said.
 

 

 

Patients Pay the Price of Private Equity Acquisition

“The exponential growth in private equity ownership in hospital and physician practices in the past few decades has left a majority of health care providers disillusioned with cost-cutting practices resulting in staffing reductions and ratios that sacrifice patient care as part of their approach to running clinical operations ‘lean,’ ” Robert Glatter, MD, an emergency medicine physician at Lenox Hill Hospital, New York, NY, said in an interview.

“While private equity companies argue that such practices are essential to meet their bottom line and increase operating margins, it doesn’t translate into ideal care for patients; lean practices in staffing which focus on profits at the expense of patient safety and quality of care.

“When you look at patient outcomes, it is the patients who ultimately pay the price — not the shareholders,” Dr. Glatter said. “This translates to higher risks of hospital-acquired complications including falls and blood-borne infections, including surgical site infections, as noted by the authors of the current study when private equity took over operations in hospitals.

Dr. Glatter said he was not surprised by the findings. “In my world, patient care and safety come first. Period,” he said. “Would you want your family’s health and well-being sacrificed in the name of company profits? I think it’s a rhetorical question, but one that every health care provider who works in a hospital or practice run by private equity must consider.”

Despite a decline in utilization at private equity hospitals as noted in the current study, hospital-acquired infections and adverse outcomes still increased, illustrating a decline in quality of care, said Dr. Glatter. “While these disparities were not evident when looking at 30-day outcomes, they demonstrate how operational changes impact patient outcomes in the near term. Having younger and healthier patients, and fewer Medicare and Medicaid patients combined with more hospital transfers to non–private equity run hospitals, resulted in lower in-hospital mortality in the near term, which was not apparent at 30 days post discharge,” he said.

“The explosion of hospital mergers and consolidation in the past several decades has led to skyrocketing health care costs at the expense of patient satisfaction, but also health care providers’ autonomy to manage and maintain quality care for their patients,” Dr. Glatter said.

“It’s important to understand that private equity’s interests are primarily aligned with their shareholder’s interests, as opposed to patients’ outcomes and interests,” Dr. Glatter told this news organization. “Within 5-7 years, the goal is to increase operating margins and profits and then sell a practice or hospital, which is ultimately part of a ‘health care portfolio,’ ” he said.

Additional research is needed to examine whether other hospital-acquired conditions including pressure sores, catheter-associated UTIs, methicillin-resistant Staphylococcus aureus infections, Clostridium difficile infections, and nosocomial pneumonia have increased in hospitals following private equity acquisition, given the overall national decline in these events, he said.

“At the same time, it is vital to also look at management and readmission rates for patients with strokes, heart attacks, and congestive heart failure in hospitals that are run by private equity,” Dr. Glatter noted. “These are important benchmarks of care monitored by CMS that reflect the quality of care that payers ultimately factor into reimbursement.”

Examining the metrics associated with these diagnoses will help in understanding whether private equity-managed facilities are leading to adverse outcomes and mortality, increased length of stay, hospital readmissions, and increased nosocomial infections, apart from other aspects of patient experience, Dr. Glatter added.

The study was supported by the National Heart, Lung, and Blood Institute, the National Institute on Aging, and Arnold Ventures. The researchers had no financial conflicts to disclose. Dr. Glatter had no financial conflicts to disclose and serves on the Medscape Emergency Medicine Editorial Board.
 

A version of this article appeared on Medscape.com.

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Hospital-acquired adverse events or conditions including falls and infections increased by approximately 25% after hospitals’ acquisition by private equity compared with control hospitals, on the basis of a study of Medicare claims for more than 4,500,000 hospitalizations.

“Prior research on private equity in health care showed that acquisition is associated with higher charges, prices, and spending; however, the implications for quality of care and patient outcomes remained less understood,” corresponding author Zirui Song, MD, of Harvard Medical School, Boston, said in an interview. “This was particularly true for measures of clinical quality that were less susceptible to changes in patient mix or coding behavior, such as hospital-acquired adverse events.”

In the study, published in JAMA, the researchers compared data from 100% Medicare Part A claims for 662,095 hospitalizations at 51 hospitals acquired by private equities and 4,160,720 hospitalizations at 259 control hospitals. The hospitalizations occurred between 2009 and 2019. The researchers also used a difference-in-differences design to evaluate hospitalizations from 3 years before to 3 years after acquisition, controlling for patient and hospital attributes.

Hospital-acquired adverse events as defined by the US Centers for Medicare & Medicaid Services included falls, infections, stage III or IV pressure ulcers, foreign objects retained after surgery, air embolism, and blood incompatibility.

Overall, Medicare patients in private equity hospitals experienced a 25.4% increase in hospital-acquired conditions compared with those in control hospitals through a period of up to 3 years after acquisition, with a difference of 4.6 additional hospital-acquired conditions per 10,000 hospitalizations (P = .004). Central line-associated bloodstream infections accounted for 37.7% of the increase (P = .04), despite a 16.2% decrease in placement of central lines, and falls accounted for 27.3% (P = .02).

Notably, the incidence of surgical site infections increased from 10.8 per 10,000 hospitalizations before acquisition to 21.6 per 10,000 hospitalizations after acquisition, despite a reduction of 8.1% in surgical volume. By contrast, surgical site infections decreased at control hospitals over the study period.

In-hospital mortality decreased slightly at private equity hospitals compared with the control hospitals, but there was no differential change in mortality by 30 days after hospital discharge. The slight difference might be caused by the trend in slightly younger Medicare beneficiaries treated at private equity hospitals; these patients were less likely to be eligible for both Medicaid and Medicare and were more likely to be transferred to other hospitals, the researchers noted.

The findings were limited by several factors including the lack of generalizability to all private equity-acquired hospitals and to non-Medicare patients, the researchers noted. Other limitations include the use of the International Classification of Diseases, Ninth Revision (ICD-9) and Tenth Revision (ICD-10) codes that might have failed to capture all hospital-acquired conditions and the inability to account for all confounding factors.

However, the results suggest that private equity acquisition was associated with increased hospital-acquired adverse events and highlight concerns about the impact of private equity ownership on healthcare delivery, the researchers concluded.

In a related story published in July 2023, this news organization described a report showing an association between private equity ownership of medical practices and increased consumer prices for multiple medical specialties.

“Medicare patients admitted to private equity-owned hospitals experienced, on average, an 25% increase in hospital-acquired adverse events after the hospital was bought compared to similar patients at hospitals not acquired by private equity firms. We were surprised by the extent of this change relative to the comparison (non-private equity) hospitals, including the sizable increase in central line-associated bloodstream infections and the doubling of surgical site infections at private equity hospitals — both of which went down at the comparison hospitals during the same period,” Dr. Song said in an interview.

“A key implication is that patients, providers, and policymakers might be more attuned to the potential clinical impact of private equity ownership in the delivery system. Given that a plausible explanation for these findings is reductions in clinician staffing, clinical organizations and policymakers might also be more aware of cost-cutting strategies after acquisition,” Dr. Song said. “Prior research has shown that hospitals, nursing homes, and physician practices experience staffing cuts after private equity acquisition, which is a common way to reduce operating costs and boost the profitability of acquired entities,” he noted.

“More research is needed to understand the impact of private equity acquisitions across health care settings and the potential effects of policy levers that aim to protect patients and societal resources,” said Dr. Song, who coauthored an article outlining a policy framework for addressing private equity in healthcare, published in JAMA in April 2023. “Potential regulatory remedies include minimum staffing ratios, antitrust enforcement, mitigating the financial risk of such acquisitions, increasing the transparency of these acquisitions, and protecting patients and society from the higher prices of care attributed to this model of provider ownership,” he said.
 

 

 

Patients Pay the Price of Private Equity Acquisition

“The exponential growth in private equity ownership in hospital and physician practices in the past few decades has left a majority of health care providers disillusioned with cost-cutting practices resulting in staffing reductions and ratios that sacrifice patient care as part of their approach to running clinical operations ‘lean,’ ” Robert Glatter, MD, an emergency medicine physician at Lenox Hill Hospital, New York, NY, said in an interview.

“While private equity companies argue that such practices are essential to meet their bottom line and increase operating margins, it doesn’t translate into ideal care for patients; lean practices in staffing which focus on profits at the expense of patient safety and quality of care.

“When you look at patient outcomes, it is the patients who ultimately pay the price — not the shareholders,” Dr. Glatter said. “This translates to higher risks of hospital-acquired complications including falls and blood-borne infections, including surgical site infections, as noted by the authors of the current study when private equity took over operations in hospitals.

Dr. Glatter said he was not surprised by the findings. “In my world, patient care and safety come first. Period,” he said. “Would you want your family’s health and well-being sacrificed in the name of company profits? I think it’s a rhetorical question, but one that every health care provider who works in a hospital or practice run by private equity must consider.”

Despite a decline in utilization at private equity hospitals as noted in the current study, hospital-acquired infections and adverse outcomes still increased, illustrating a decline in quality of care, said Dr. Glatter. “While these disparities were not evident when looking at 30-day outcomes, they demonstrate how operational changes impact patient outcomes in the near term. Having younger and healthier patients, and fewer Medicare and Medicaid patients combined with more hospital transfers to non–private equity run hospitals, resulted in lower in-hospital mortality in the near term, which was not apparent at 30 days post discharge,” he said.

“The explosion of hospital mergers and consolidation in the past several decades has led to skyrocketing health care costs at the expense of patient satisfaction, but also health care providers’ autonomy to manage and maintain quality care for their patients,” Dr. Glatter said.

“It’s important to understand that private equity’s interests are primarily aligned with their shareholder’s interests, as opposed to patients’ outcomes and interests,” Dr. Glatter told this news organization. “Within 5-7 years, the goal is to increase operating margins and profits and then sell a practice or hospital, which is ultimately part of a ‘health care portfolio,’ ” he said.

Additional research is needed to examine whether other hospital-acquired conditions including pressure sores, catheter-associated UTIs, methicillin-resistant Staphylococcus aureus infections, Clostridium difficile infections, and nosocomial pneumonia have increased in hospitals following private equity acquisition, given the overall national decline in these events, he said.

“At the same time, it is vital to also look at management and readmission rates for patients with strokes, heart attacks, and congestive heart failure in hospitals that are run by private equity,” Dr. Glatter noted. “These are important benchmarks of care monitored by CMS that reflect the quality of care that payers ultimately factor into reimbursement.”

Examining the metrics associated with these diagnoses will help in understanding whether private equity-managed facilities are leading to adverse outcomes and mortality, increased length of stay, hospital readmissions, and increased nosocomial infections, apart from other aspects of patient experience, Dr. Glatter added.

The study was supported by the National Heart, Lung, and Blood Institute, the National Institute on Aging, and Arnold Ventures. The researchers had no financial conflicts to disclose. Dr. Glatter had no financial conflicts to disclose and serves on the Medscape Emergency Medicine Editorial Board.
 

A version of this article appeared on Medscape.com.

Hospital-acquired adverse events or conditions including falls and infections increased by approximately 25% after hospitals’ acquisition by private equity compared with control hospitals, on the basis of a study of Medicare claims for more than 4,500,000 hospitalizations.

“Prior research on private equity in health care showed that acquisition is associated with higher charges, prices, and spending; however, the implications for quality of care and patient outcomes remained less understood,” corresponding author Zirui Song, MD, of Harvard Medical School, Boston, said in an interview. “This was particularly true for measures of clinical quality that were less susceptible to changes in patient mix or coding behavior, such as hospital-acquired adverse events.”

In the study, published in JAMA, the researchers compared data from 100% Medicare Part A claims for 662,095 hospitalizations at 51 hospitals acquired by private equities and 4,160,720 hospitalizations at 259 control hospitals. The hospitalizations occurred between 2009 and 2019. The researchers also used a difference-in-differences design to evaluate hospitalizations from 3 years before to 3 years after acquisition, controlling for patient and hospital attributes.

Hospital-acquired adverse events as defined by the US Centers for Medicare & Medicaid Services included falls, infections, stage III or IV pressure ulcers, foreign objects retained after surgery, air embolism, and blood incompatibility.

Overall, Medicare patients in private equity hospitals experienced a 25.4% increase in hospital-acquired conditions compared with those in control hospitals through a period of up to 3 years after acquisition, with a difference of 4.6 additional hospital-acquired conditions per 10,000 hospitalizations (P = .004). Central line-associated bloodstream infections accounted for 37.7% of the increase (P = .04), despite a 16.2% decrease in placement of central lines, and falls accounted for 27.3% (P = .02).

Notably, the incidence of surgical site infections increased from 10.8 per 10,000 hospitalizations before acquisition to 21.6 per 10,000 hospitalizations after acquisition, despite a reduction of 8.1% in surgical volume. By contrast, surgical site infections decreased at control hospitals over the study period.

In-hospital mortality decreased slightly at private equity hospitals compared with the control hospitals, but there was no differential change in mortality by 30 days after hospital discharge. The slight difference might be caused by the trend in slightly younger Medicare beneficiaries treated at private equity hospitals; these patients were less likely to be eligible for both Medicaid and Medicare and were more likely to be transferred to other hospitals, the researchers noted.

The findings were limited by several factors including the lack of generalizability to all private equity-acquired hospitals and to non-Medicare patients, the researchers noted. Other limitations include the use of the International Classification of Diseases, Ninth Revision (ICD-9) and Tenth Revision (ICD-10) codes that might have failed to capture all hospital-acquired conditions and the inability to account for all confounding factors.

However, the results suggest that private equity acquisition was associated with increased hospital-acquired adverse events and highlight concerns about the impact of private equity ownership on healthcare delivery, the researchers concluded.

In a related story published in July 2023, this news organization described a report showing an association between private equity ownership of medical practices and increased consumer prices for multiple medical specialties.

“Medicare patients admitted to private equity-owned hospitals experienced, on average, an 25% increase in hospital-acquired adverse events after the hospital was bought compared to similar patients at hospitals not acquired by private equity firms. We were surprised by the extent of this change relative to the comparison (non-private equity) hospitals, including the sizable increase in central line-associated bloodstream infections and the doubling of surgical site infections at private equity hospitals — both of which went down at the comparison hospitals during the same period,” Dr. Song said in an interview.

“A key implication is that patients, providers, and policymakers might be more attuned to the potential clinical impact of private equity ownership in the delivery system. Given that a plausible explanation for these findings is reductions in clinician staffing, clinical organizations and policymakers might also be more aware of cost-cutting strategies after acquisition,” Dr. Song said. “Prior research has shown that hospitals, nursing homes, and physician practices experience staffing cuts after private equity acquisition, which is a common way to reduce operating costs and boost the profitability of acquired entities,” he noted.

“More research is needed to understand the impact of private equity acquisitions across health care settings and the potential effects of policy levers that aim to protect patients and societal resources,” said Dr. Song, who coauthored an article outlining a policy framework for addressing private equity in healthcare, published in JAMA in April 2023. “Potential regulatory remedies include minimum staffing ratios, antitrust enforcement, mitigating the financial risk of such acquisitions, increasing the transparency of these acquisitions, and protecting patients and society from the higher prices of care attributed to this model of provider ownership,” he said.
 

 

 

Patients Pay the Price of Private Equity Acquisition

“The exponential growth in private equity ownership in hospital and physician practices in the past few decades has left a majority of health care providers disillusioned with cost-cutting practices resulting in staffing reductions and ratios that sacrifice patient care as part of their approach to running clinical operations ‘lean,’ ” Robert Glatter, MD, an emergency medicine physician at Lenox Hill Hospital, New York, NY, said in an interview.

“While private equity companies argue that such practices are essential to meet their bottom line and increase operating margins, it doesn’t translate into ideal care for patients; lean practices in staffing which focus on profits at the expense of patient safety and quality of care.

“When you look at patient outcomes, it is the patients who ultimately pay the price — not the shareholders,” Dr. Glatter said. “This translates to higher risks of hospital-acquired complications including falls and blood-borne infections, including surgical site infections, as noted by the authors of the current study when private equity took over operations in hospitals.

Dr. Glatter said he was not surprised by the findings. “In my world, patient care and safety come first. Period,” he said. “Would you want your family’s health and well-being sacrificed in the name of company profits? I think it’s a rhetorical question, but one that every health care provider who works in a hospital or practice run by private equity must consider.”

Despite a decline in utilization at private equity hospitals as noted in the current study, hospital-acquired infections and adverse outcomes still increased, illustrating a decline in quality of care, said Dr. Glatter. “While these disparities were not evident when looking at 30-day outcomes, they demonstrate how operational changes impact patient outcomes in the near term. Having younger and healthier patients, and fewer Medicare and Medicaid patients combined with more hospital transfers to non–private equity run hospitals, resulted in lower in-hospital mortality in the near term, which was not apparent at 30 days post discharge,” he said.

“The explosion of hospital mergers and consolidation in the past several decades has led to skyrocketing health care costs at the expense of patient satisfaction, but also health care providers’ autonomy to manage and maintain quality care for their patients,” Dr. Glatter said.

“It’s important to understand that private equity’s interests are primarily aligned with their shareholder’s interests, as opposed to patients’ outcomes and interests,” Dr. Glatter told this news organization. “Within 5-7 years, the goal is to increase operating margins and profits and then sell a practice or hospital, which is ultimately part of a ‘health care portfolio,’ ” he said.

Additional research is needed to examine whether other hospital-acquired conditions including pressure sores, catheter-associated UTIs, methicillin-resistant Staphylococcus aureus infections, Clostridium difficile infections, and nosocomial pneumonia have increased in hospitals following private equity acquisition, given the overall national decline in these events, he said.

“At the same time, it is vital to also look at management and readmission rates for patients with strokes, heart attacks, and congestive heart failure in hospitals that are run by private equity,” Dr. Glatter noted. “These are important benchmarks of care monitored by CMS that reflect the quality of care that payers ultimately factor into reimbursement.”

Examining the metrics associated with these diagnoses will help in understanding whether private equity-managed facilities are leading to adverse outcomes and mortality, increased length of stay, hospital readmissions, and increased nosocomial infections, apart from other aspects of patient experience, Dr. Glatter added.

The study was supported by the National Heart, Lung, and Blood Institute, the National Institute on Aging, and Arnold Ventures. The researchers had no financial conflicts to disclose. Dr. Glatter had no financial conflicts to disclose and serves on the Medscape Emergency Medicine Editorial Board.
 

A version of this article appeared on Medscape.com.

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All rights reserved. This material may not be published, broadcast, copied, or otherwise reproduced or distributed without the prior written permission of Frontline Medical Communications Inc.</copyrightNotice> </rightsInfo> </provider> <abstract/> <metaDescription>Hospital-acquired adverse events or conditions including falls and infections increased by approximately 25% after hospitals’ acquisition by private equity comp</metaDescription> <articlePDF/> <teaserImage/> <teaser>Notably, the incidence of surgical site infections increased from 10.8 per 10,000 hospitalizations before acquisition to 21.6 per 10,000 hospitalizations after acquisition, despite a reduction of 8.1% in surgical volume.</teaser> <title>Hospital Adverse Events Rise After Private Equity Acquisition</title> <deck/> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>1</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear/> <pubPubdateMonth/> <pubPubdateDay/> <pubVolume/> <pubNumber/> <wireChannels/> <primaryCMSID/> <CMSIDs/> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>fp</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>im</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>idprac</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>mdsurg</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> <journalTitle/> <journalFullTitle/> <copyrightStatement>2018 Frontline Medical Communications Inc.,</copyrightStatement> </publicationData> <publicationData> <publicationCode>mdemed</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> <journalTitle/> <journalFullTitle/> <copyrightStatement/> </publicationData> </publications_g> <publications> <term>15</term> <term>21</term> <term>20</term> <term>52226</term> <term canonical="true">58877</term> </publications> <sections> <term>27980</term> <term canonical="true">39313</term> </sections> <topics> <term canonical="true">38029</term> <term>234</term> <term>319</term> <term>315</term> </topics> <links/> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>Hospital Adverse Events Rise After Private Equity Acquisition</title> <deck/> </itemMeta> <itemContent> <p>Hospital-acquired adverse events or conditions including falls and infections increased by approximately 25% after hospitals’ acquisition by private equity compared with control hospitals, on the basis of a study of Medicare claims for more than 4,500,000 hospitalizations.</p> <p>“Prior research on private equity in health care showed that acquisition is associated with higher charges, prices, and spending; however, the implications for quality of care and patient outcomes remained less understood,” corresponding author Zirui Song, MD, of Harvard Medical School, Boston, said in an interview. “This was particularly true for measures of clinical quality that were less susceptible to changes in patient mix or coding behavior, such as hospital-acquired adverse events.”<br/><br/>In <span class="Hyperlink"><a href="https://jamanetwork.com/journals/jama/article-abstract/2813379">the study</a></span>, published in <em>JAMA</em>, the researchers compared data from 100% Medicare Part A claims for 662,095 hospitalizations at 51 hospitals acquired by private equities and 4,160,720 hospitalizations at 259 control hospitals. The hospitalizations occurred between 2009 and 2019. The researchers also used a difference-in-differences design to evaluate hospitalizations from 3 years before to 3 years after acquisition, controlling for patient and hospital attributes.<br/><br/>Hospital-acquired adverse events as defined by the US Centers for Medicare &amp; Medicaid Services included falls, infections, stage III or IV pressure ulcers, foreign objects retained after surgery, air embolism, and blood incompatibility.<br/><br/>Overall, Medicare patients in private equity hospitals experienced a 25.4% increase in hospital-acquired conditions compared with those in control hospitals through a period of up to 3 years after acquisition, with a difference of 4.6 additional hospital-acquired conditions per 10,000 hospitalizations (<em>P</em> = .004). Central line-associated <span class="Hyperlink">bloodstream infections</span> accounted for 37.7% of the increase (<em>P</em> = .04), despite a 16.2% decrease in placement of central lines, and falls accounted for 27.3% (<em>P</em> = .02).<br/><br/>Notably, the incidence of surgical site infections increased from 10.8 per 10,000 hospitalizations before acquisition to 21.6 per 10,000 hospitalizations after acquisition, despite a reduction of 8.1% in surgical volume. By contrast, surgical site infections decreased at control hospitals over the study period.<br/><br/>In-hospital mortality decreased slightly at private equity hospitals compared with the control hospitals, but there was no differential change in mortality by 30 days after hospital discharge. The slight difference might be caused by the trend in slightly younger Medicare beneficiaries treated at private equity hospitals; these patients were less likely to be eligible for both Medicaid and Medicare and were more likely to be transferred to other hospitals, the researchers noted.<br/><br/>The findings were limited by several factors including the lack of generalizability to all private equity-acquired hospitals and to non-Medicare patients, the researchers noted. Other limitations include the use of the International Classification of Diseases, Ninth Revision (ICD-9) and Tenth Revision (ICD-10) codes that might have failed to capture all hospital-acquired conditions and the inability to account for all confounding factors.<br/><br/>However, the results suggest that private equity acquisition was associated with increased hospital-acquired adverse events and highlight concerns about the impact of private equity ownership on healthcare delivery, the researchers concluded.<br/><br/>In a <span class="Hyperlink"><a href="https://www.medscape.com/viewarticle/994610?&amp;icd=login_success_email_match_fpf">related story</a></span> published in July 2023, this news organization described a report showing an association between private equity ownership of medical practices and increased consumer prices for multiple medical specialties.<br/><br/>“Medicare patients admitted to private equity-owned hospitals experienced, on average, an 25% increase in hospital-acquired adverse events after the hospital was bought compared to similar patients at hospitals not acquired by private equity firms. We were surprised by the extent of this change relative to the comparison (non-private equity) hospitals, including the sizable increase in central line-associated bloodstream infections and the doubling of surgical site infections at private equity hospitals — both of which went down at the comparison hospitals during the same period,” Dr. Song said in an interview.<br/><br/>“A key implication is that patients, providers, and policymakers might be more attuned to the potential clinical impact of private equity ownership in the delivery system. Given that a plausible explanation for these findings is reductions in clinician staffing, clinical organizations and policymakers might also be more aware of cost-cutting strategies after acquisition,” Dr. Song said. “Prior research has shown that hospitals, nursing homes, and physician practices experience staffing cuts after private equity acquisition, which is a common way to reduce operating costs and boost the profitability of acquired entities,” he noted.<br/><br/>“More research is needed to understand the impact of private equity acquisitions across health care settings and the potential effects of policy levers that aim to protect patients and societal resources,” said Dr. Song, who coauthored an article outlining a policy framework for addressing private equity in healthcare, <span class="Hyperlink"><a href="https://jamanetwork.com/journals/jama/article-abstract/2804025">published in</a> </span><em>JAMA</em><span class="Hyperlink"> in April 2023</span>. “Potential regulatory remedies include minimum staffing ratios, antitrust enforcement, mitigating the financial risk of such acquisitions, increasing the transparency of these acquisitions, and protecting patients and society from the higher prices of care attributed to this model of provider ownership,” he said.<br/><br/></p> <h2>Patients Pay the Price of Private Equity Acquisition</h2> <p>“The exponential growth in private equity ownership in hospital and physician practices in the past few decades has left a majority of health care providers disillusioned with cost-cutting practices resulting in staffing reductions and ratios that sacrifice patient care as part of their approach to running clinical operations ‘lean,’ ” Robert Glatter, MD, an emergency medicine physician at Lenox Hill Hospital, New York, NY, said in an interview.<br/><br/>“While private equity companies argue that such practices are essential to meet their bottom line and increase operating margins, it doesn’t translate into ideal care for patients; lean practices in staffing which focus on profits at the expense of patient safety and quality of care.<br/><br/>“When you look at patient outcomes, it is the patients who ultimately pay the price — not the shareholders,” Dr. Glatter said. “This translates to higher risks of hospital-acquired complications including falls and blood-borne infections, including surgical site infections, as noted by the authors of the current study when private equity took over operations in hospitals.<br/><br/>Dr. Glatter said he was not surprised by the findings. “In my world, patient care and safety come first. Period,” he said. “Would you want your family’s health and well-being sacrificed in the name of company profits? I think it’s a rhetorical question, but one that every health care provider who works in a hospital or practice run by private equity must consider.”<br/><br/>Despite a decline in utilization at private equity hospitals as noted in the current study, hospital-acquired infections and adverse outcomes still increased, illustrating a decline in quality of care, said Dr. Glatter. “While these disparities were not evident when looking at 30-day outcomes, they demonstrate how operational changes impact patient outcomes in the near term. Having younger and healthier patients, and fewer Medicare and Medicaid patients combined with more hospital transfers to non–private equity run hospitals, resulted in lower in-hospital mortality in the near term, which was not apparent at 30 days post discharge,” he said.<br/><br/>“The explosion of hospital mergers and consolidation in the past several decades has led to skyrocketing health care costs at the expense of patient satisfaction, but also health care providers’ autonomy to manage and maintain quality care for their patients,” Dr. Glatter said.<br/><br/>“It’s important to understand that private equity’s interests are primarily aligned with their shareholder’s interests, as opposed to patients’ outcomes and interests,” Dr. Glatter told this news organization. “Within 5-7 years, the goal is to increase operating margins and profits and then sell a practice or hospital, which is ultimately part of a ‘health care portfolio,’ ” he said.<br/><br/>Additional research is needed to examine whether other hospital-acquired conditions including pressure sores, catheter-associated UTIs, methicillin-resistant <em>Staphylococcus aureus</em> infections, <em>Clostridium difficile</em> infections, and <span class="Hyperlink">nosocomial pneumonia</span> have increased in hospitals following private equity acquisition, given the overall national decline in these events, he said.<br/><br/>“At the same time, it is vital to also look at management and readmission rates for patients with strokes, heart attacks, and <span class="Hyperlink">congestive heart failure</span> in hospitals that are run by private equity,” Dr. Glatter noted. “These are important benchmarks of care monitored by CMS that reflect the quality of care that payers ultimately factor into reimbursement.”<br/><br/>Examining the metrics associated with these diagnoses will help in understanding whether private equity-managed facilities are leading to adverse outcomes and mortality, increased length of stay, hospital readmissions, and increased nosocomial infections, apart from other aspects of patient experience, Dr. Glatter added.<br/><br/>The study was supported by the National Heart, Lung, and Blood Institute, the National Institute on Aging, and Arnold Ventures. The researchers had no financial conflicts to disclose. Dr. Glatter had no financial conflicts to disclose and serves on the Medscape Emergency Medicine Editorial Board.<br/><br/></p> <p> <em>A version of this article appeared on <span class="Hyperlink"><a href="https://www.medscape.com/viewarticle/hospital-adverse-events-rise-after-private-equity-2023a1000wya">Medscape.com</a></span>.</em> </p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>
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How to optimize in-hospital antimicrobial prescribing?

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Fri, 09/01/2023 - 17:24

Variability in antimicrobial prescribing among hospital-based physicians is not associated with patient characteristics or clinical outcomes, data suggest. The lowest level of such prescribing within each hospital could be considered a target for antimicrobial stewardship, according to the researchers.

In a multicenter study of 124 physicians responsible for more than 124,000 hospitalized patients, the difference in mean prescribing between the highest and lowest quartiles of prescription volume was 15.8 days of treatment per 100 patient-days.

Baseline patient characteristics were similar across the quartiles, and there were no differences in patient outcomes, including in-hospital deaths, hospital length of stay, intensive care unit transfer, and hospital readmission.

Although the investigators expected variation in prescribing, “what surprised us most was the limited association with any differences in clinical outcomes, particularly when it came to the amount of antimicrobials used,” study author Mark T. McIntyre, PharmD, pharmacotherapy specialist at the Sinai Health System in Toronto, told this news organization.

“Importantly, this is not a study that defines quality of care,” he said. “We looked at natural variation in practice and association with outcomes. So, I don’t want clinicians to think, ‘Well, I’m high, therefore I’m bad,’ or, ‘I’m low, therefore I’m good.’

“This is an early explanatory analysis that asks whether this is an opportunity to optimize prescribing in ways we hadn’t thought of before,” he said. “Now that we don’t have an association with higher or lower prescribing and outcomes, we can look at what else is driving that antimicrobial prescribing and what we can do about it. Comfort level, risk tolerance, and social, cultural, and contextual factors all likely play a role.”

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

Antimicrobial reductions possible

The investigators conducted a retrospective cohort study using the General Medicine Inpatient Initiative database to assess physician-level volume and spectrum of antimicrobial prescribing in adult general medical wards. Four academic hospitals in Toronto were evaluated for the period 2010 to 2019.

The investigators stratified physicians into quartiles by hospital site on the basis of volume of antimicrobial prescribing (specifically, days of therapy per 100 patient-days and antimicrobial-free days) and antibacterial spectrum (modified spectrum score, which assigns a value to each antibacterial agent on the basis of its breadth of coverage).

They also examined potential differences between physician quartiles in patient characteristics, such as age, sex, the Laboratory-Based Acute Physiology Score, discharge diagnosis, and the Charlson Comorbidity Index.

Multilevel modeling allowed the investigators to evaluate the association between clinical outcomes and antimicrobial volume and spectrum.

The primary measure was days of therapy per 100 patient-days.

As noted, the cohort included 124 physicians who were responsible for 124,158 hospital admissions. The median physician-level volume of antimicrobial prescribing was 56.1 days of therapy per 100 patient-days. Patient characteristics were balanced across the quartiles of physician prescribing.

The difference in mean prescribing between physician quartile 4 and quartile 1 was 15.8 days of therapy per 100 patient-days, meaning the median physician in quartile 4 prescribed antimicrobials at a volume that was 30% higher than that of the median physician in quartile 1.

No significant differences were noted for any clinical outcome with regard to quartile of days of therapy, antimicrobial-free days, or modified spectrum score after adjustment for patient-level characteristics.

In addition, no significant differences in the case mix between quartile 4 and quartile 1 were found when the cohort was restricted to patients admitted and discharged by the same most responsible person, nor were differences found in an analysis that was restricted to those without a discharge diagnosis code of palliative care.

In-hospital mortality was higher among patients cared for by prescribers with higher modified spectrum scores (odds ratio, 1.13). “We still can’t fully explain this finding,” Dr. McIntyre acknowledged. “We only saw that in our primary analysis. When we did several sensitivity analyses, that finding didn’t appear.”

The authors concluded, “Ultimately, without discernible benefit in outcomes of patients of physicians who prescribe more frequently, less antimicrobial exposure may be possible, leading to lower risk of antimicrobial resistance.”
 

 

 

Decision-making support

Commenting on the study, Lawrence I. Kaplan, MD, section chief of general internal medicine and associate dean for interprofessional education at the Lewis Katz School of Medicine at Temple University in Philadelphia, said, “Trying to get to the lowest quartile would be a goal, and given that physician characteristics are involved, I think there needs to be much better training in clinical management decision-making: how you come about making a decision based on a diagnosis for a particular patient, in or out of the hospital.” Dr. Kaplan was not involved in the research.

“Clinical decision-making tools that can be plugged into the electronic health record can help,” he suggested. “The tools basically ask if a patient meets certain criteria and then might give a prompt that says, for example, ‘These symptoms are not consistent with bacterial sinusitis. The patient should be treated with decongestants, nasal steroids, et cetera, because antibiotics aren’t appropriate.’

“It’s a bit like checkbox medicine, which a lot of physicians bridle at,” he said. “But if it’s really based on evidence, I think that’s an appropriate use of evidence-based medicine.”

Dr. Kaplan said that more research is needed into the best way to get a physician or any provider to step back and say, “Is this the right decision?” or, “I’m doing this but I’m really on shaky ground. What am I missing?’” He noted that the Society for Medical Decision Making publishes research and resources in this area.

“I love the fact that the paper was authored by an interdisciplinary group,” Dr. Kaplan added. “A pharmacist embedded in the team can, for example, help with treatment decision-making and point out potential drug interactions that prescribers might not be aware of.

“We need to stop practicing medicine siloed, which is what we do a lot of ways, both in the hospital and out of the hospital, because it’s the path of least resistance,” Dr. Kaplan added. “But when we can say, ‘Hey, I have a question about this,’ be it to a computer or a colleague, I would argue that we come up with better care.”

No funding was provided for the study. Dr. McIntyre and Dr. Kaplan have disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

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Variability in antimicrobial prescribing among hospital-based physicians is not associated with patient characteristics or clinical outcomes, data suggest. The lowest level of such prescribing within each hospital could be considered a target for antimicrobial stewardship, according to the researchers.

In a multicenter study of 124 physicians responsible for more than 124,000 hospitalized patients, the difference in mean prescribing between the highest and lowest quartiles of prescription volume was 15.8 days of treatment per 100 patient-days.

Baseline patient characteristics were similar across the quartiles, and there were no differences in patient outcomes, including in-hospital deaths, hospital length of stay, intensive care unit transfer, and hospital readmission.

Although the investigators expected variation in prescribing, “what surprised us most was the limited association with any differences in clinical outcomes, particularly when it came to the amount of antimicrobials used,” study author Mark T. McIntyre, PharmD, pharmacotherapy specialist at the Sinai Health System in Toronto, told this news organization.

“Importantly, this is not a study that defines quality of care,” he said. “We looked at natural variation in practice and association with outcomes. So, I don’t want clinicians to think, ‘Well, I’m high, therefore I’m bad,’ or, ‘I’m low, therefore I’m good.’

“This is an early explanatory analysis that asks whether this is an opportunity to optimize prescribing in ways we hadn’t thought of before,” he said. “Now that we don’t have an association with higher or lower prescribing and outcomes, we can look at what else is driving that antimicrobial prescribing and what we can do about it. Comfort level, risk tolerance, and social, cultural, and contextual factors all likely play a role.”

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

Antimicrobial reductions possible

The investigators conducted a retrospective cohort study using the General Medicine Inpatient Initiative database to assess physician-level volume and spectrum of antimicrobial prescribing in adult general medical wards. Four academic hospitals in Toronto were evaluated for the period 2010 to 2019.

The investigators stratified physicians into quartiles by hospital site on the basis of volume of antimicrobial prescribing (specifically, days of therapy per 100 patient-days and antimicrobial-free days) and antibacterial spectrum (modified spectrum score, which assigns a value to each antibacterial agent on the basis of its breadth of coverage).

They also examined potential differences between physician quartiles in patient characteristics, such as age, sex, the Laboratory-Based Acute Physiology Score, discharge diagnosis, and the Charlson Comorbidity Index.

Multilevel modeling allowed the investigators to evaluate the association between clinical outcomes and antimicrobial volume and spectrum.

The primary measure was days of therapy per 100 patient-days.

As noted, the cohort included 124 physicians who were responsible for 124,158 hospital admissions. The median physician-level volume of antimicrobial prescribing was 56.1 days of therapy per 100 patient-days. Patient characteristics were balanced across the quartiles of physician prescribing.

The difference in mean prescribing between physician quartile 4 and quartile 1 was 15.8 days of therapy per 100 patient-days, meaning the median physician in quartile 4 prescribed antimicrobials at a volume that was 30% higher than that of the median physician in quartile 1.

No significant differences were noted for any clinical outcome with regard to quartile of days of therapy, antimicrobial-free days, or modified spectrum score after adjustment for patient-level characteristics.

In addition, no significant differences in the case mix between quartile 4 and quartile 1 were found when the cohort was restricted to patients admitted and discharged by the same most responsible person, nor were differences found in an analysis that was restricted to those without a discharge diagnosis code of palliative care.

In-hospital mortality was higher among patients cared for by prescribers with higher modified spectrum scores (odds ratio, 1.13). “We still can’t fully explain this finding,” Dr. McIntyre acknowledged. “We only saw that in our primary analysis. When we did several sensitivity analyses, that finding didn’t appear.”

The authors concluded, “Ultimately, without discernible benefit in outcomes of patients of physicians who prescribe more frequently, less antimicrobial exposure may be possible, leading to lower risk of antimicrobial resistance.”
 

 

 

Decision-making support

Commenting on the study, Lawrence I. Kaplan, MD, section chief of general internal medicine and associate dean for interprofessional education at the Lewis Katz School of Medicine at Temple University in Philadelphia, said, “Trying to get to the lowest quartile would be a goal, and given that physician characteristics are involved, I think there needs to be much better training in clinical management decision-making: how you come about making a decision based on a diagnosis for a particular patient, in or out of the hospital.” Dr. Kaplan was not involved in the research.

“Clinical decision-making tools that can be plugged into the electronic health record can help,” he suggested. “The tools basically ask if a patient meets certain criteria and then might give a prompt that says, for example, ‘These symptoms are not consistent with bacterial sinusitis. The patient should be treated with decongestants, nasal steroids, et cetera, because antibiotics aren’t appropriate.’

“It’s a bit like checkbox medicine, which a lot of physicians bridle at,” he said. “But if it’s really based on evidence, I think that’s an appropriate use of evidence-based medicine.”

Dr. Kaplan said that more research is needed into the best way to get a physician or any provider to step back and say, “Is this the right decision?” or, “I’m doing this but I’m really on shaky ground. What am I missing?’” He noted that the Society for Medical Decision Making publishes research and resources in this area.

“I love the fact that the paper was authored by an interdisciplinary group,” Dr. Kaplan added. “A pharmacist embedded in the team can, for example, help with treatment decision-making and point out potential drug interactions that prescribers might not be aware of.

“We need to stop practicing medicine siloed, which is what we do a lot of ways, both in the hospital and out of the hospital, because it’s the path of least resistance,” Dr. Kaplan added. “But when we can say, ‘Hey, I have a question about this,’ be it to a computer or a colleague, I would argue that we come up with better care.”

No funding was provided for the study. Dr. McIntyre and Dr. Kaplan have disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

Variability in antimicrobial prescribing among hospital-based physicians is not associated with patient characteristics or clinical outcomes, data suggest. The lowest level of such prescribing within each hospital could be considered a target for antimicrobial stewardship, according to the researchers.

In a multicenter study of 124 physicians responsible for more than 124,000 hospitalized patients, the difference in mean prescribing between the highest and lowest quartiles of prescription volume was 15.8 days of treatment per 100 patient-days.

Baseline patient characteristics were similar across the quartiles, and there were no differences in patient outcomes, including in-hospital deaths, hospital length of stay, intensive care unit transfer, and hospital readmission.

Although the investigators expected variation in prescribing, “what surprised us most was the limited association with any differences in clinical outcomes, particularly when it came to the amount of antimicrobials used,” study author Mark T. McIntyre, PharmD, pharmacotherapy specialist at the Sinai Health System in Toronto, told this news organization.

“Importantly, this is not a study that defines quality of care,” he said. “We looked at natural variation in practice and association with outcomes. So, I don’t want clinicians to think, ‘Well, I’m high, therefore I’m bad,’ or, ‘I’m low, therefore I’m good.’

“This is an early explanatory analysis that asks whether this is an opportunity to optimize prescribing in ways we hadn’t thought of before,” he said. “Now that we don’t have an association with higher or lower prescribing and outcomes, we can look at what else is driving that antimicrobial prescribing and what we can do about it. Comfort level, risk tolerance, and social, cultural, and contextual factors all likely play a role.”

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

Antimicrobial reductions possible

The investigators conducted a retrospective cohort study using the General Medicine Inpatient Initiative database to assess physician-level volume and spectrum of antimicrobial prescribing in adult general medical wards. Four academic hospitals in Toronto were evaluated for the period 2010 to 2019.

The investigators stratified physicians into quartiles by hospital site on the basis of volume of antimicrobial prescribing (specifically, days of therapy per 100 patient-days and antimicrobial-free days) and antibacterial spectrum (modified spectrum score, which assigns a value to each antibacterial agent on the basis of its breadth of coverage).

They also examined potential differences between physician quartiles in patient characteristics, such as age, sex, the Laboratory-Based Acute Physiology Score, discharge diagnosis, and the Charlson Comorbidity Index.

Multilevel modeling allowed the investigators to evaluate the association between clinical outcomes and antimicrobial volume and spectrum.

The primary measure was days of therapy per 100 patient-days.

As noted, the cohort included 124 physicians who were responsible for 124,158 hospital admissions. The median physician-level volume of antimicrobial prescribing was 56.1 days of therapy per 100 patient-days. Patient characteristics were balanced across the quartiles of physician prescribing.

The difference in mean prescribing between physician quartile 4 and quartile 1 was 15.8 days of therapy per 100 patient-days, meaning the median physician in quartile 4 prescribed antimicrobials at a volume that was 30% higher than that of the median physician in quartile 1.

No significant differences were noted for any clinical outcome with regard to quartile of days of therapy, antimicrobial-free days, or modified spectrum score after adjustment for patient-level characteristics.

In addition, no significant differences in the case mix between quartile 4 and quartile 1 were found when the cohort was restricted to patients admitted and discharged by the same most responsible person, nor were differences found in an analysis that was restricted to those without a discharge diagnosis code of palliative care.

In-hospital mortality was higher among patients cared for by prescribers with higher modified spectrum scores (odds ratio, 1.13). “We still can’t fully explain this finding,” Dr. McIntyre acknowledged. “We only saw that in our primary analysis. When we did several sensitivity analyses, that finding didn’t appear.”

The authors concluded, “Ultimately, without discernible benefit in outcomes of patients of physicians who prescribe more frequently, less antimicrobial exposure may be possible, leading to lower risk of antimicrobial resistance.”
 

 

 

Decision-making support

Commenting on the study, Lawrence I. Kaplan, MD, section chief of general internal medicine and associate dean for interprofessional education at the Lewis Katz School of Medicine at Temple University in Philadelphia, said, “Trying to get to the lowest quartile would be a goal, and given that physician characteristics are involved, I think there needs to be much better training in clinical management decision-making: how you come about making a decision based on a diagnosis for a particular patient, in or out of the hospital.” Dr. Kaplan was not involved in the research.

“Clinical decision-making tools that can be plugged into the electronic health record can help,” he suggested. “The tools basically ask if a patient meets certain criteria and then might give a prompt that says, for example, ‘These symptoms are not consistent with bacterial sinusitis. The patient should be treated with decongestants, nasal steroids, et cetera, because antibiotics aren’t appropriate.’

“It’s a bit like checkbox medicine, which a lot of physicians bridle at,” he said. “But if it’s really based on evidence, I think that’s an appropriate use of evidence-based medicine.”

Dr. Kaplan said that more research is needed into the best way to get a physician or any provider to step back and say, “Is this the right decision?” or, “I’m doing this but I’m really on shaky ground. What am I missing?’” He noted that the Society for Medical Decision Making publishes research and resources in this area.

“I love the fact that the paper was authored by an interdisciplinary group,” Dr. Kaplan added. “A pharmacist embedded in the team can, for example, help with treatment decision-making and point out potential drug interactions that prescribers might not be aware of.

“We need to stop practicing medicine siloed, which is what we do a lot of ways, both in the hospital and out of the hospital, because it’s the path of least resistance,” Dr. Kaplan added. “But when we can say, ‘Hey, I have a question about this,’ be it to a computer or a colleague, I would argue that we come up with better care.”

No funding was provided for the study. Dr. McIntyre and Dr. Kaplan have disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

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<root generator="drupal.xsl" gversion="1.7"> <header> <fileName>164928</fileName> <TBEID>0C04BF72.SIG</TBEID> <TBUniqueIdentifier>MD_0C04BF72</TBUniqueIdentifier> <newsOrJournal>News</newsOrJournal> <publisherName>Frontline Medical Communications</publisherName> <storyname/> <articleType>2</articleType> <TBLocation>QC Done-All Pubs</TBLocation> <QCDate>20230831T112106</QCDate> <firstPublished>20230831T113053</firstPublished> <LastPublished>20230831T113053</LastPublished> <pubStatus qcode="stat:"/> <embargoDate/> <killDate/> <CMSDate>20230831T113053</CMSDate> <articleSource/> <facebookInfo/> <meetingNumber/> <byline>Marilynn Larkin</byline> <bylineText>MARILYNN LARKIN</bylineText> <bylineFull>MARILYNN LARKIN</bylineFull> <bylineTitleText/> <USOrGlobal/> <wireDocType/> <newsDocType/> <journalDocType/> <linkLabel/> <pageRange/> <citation/> <quizID/> <indexIssueDate/> <itemClass qcode="ninat:text"/> <provider qcode="provider:imng"> <name>IMNG Medical Media</name> <rightsInfo> <copyrightHolder> <name>Frontline Medical News</name> </copyrightHolder> <copyrightNotice>Copyright (c) 2015 Frontline Medical News, a Frontline Medical Communications Inc. company. All rights reserved. This material may not be published, broadcast, copied, or otherwise reproduced or distributed without the prior written permission of Frontline Medical Communications Inc.</copyrightNotice> </rightsInfo> </provider> <abstract/> <metaDescription>Variability in antimicrobial prescribing among hospital-based physicians is not associated with patient characteristics or clinical outcomes, data suggest. The </metaDescription> <articlePDF/> <teaserImage/> <title>How to optimize in-hospital antimicrobial prescribing?</title> <deck/> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>1</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear/> <pubPubdateMonth/> <pubPubdateDay/> <pubVolume/> <pubNumber/> <wireChannels/> <primaryCMSID/> <CMSIDs/> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>fp</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>idprac</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>im</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>pn</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> </publications_g> <publications> <term>15</term> <term canonical="true">20</term> <term>21</term> <term>25</term> </publications> <sections> <term>27970</term> <term canonical="true">39313</term> </sections> <topics> <term>234</term> <term canonical="true">315</term> <term>319</term> </topics> <links/> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>How to optimize in-hospital antimicrobial prescribing?</title> <deck/> </itemMeta> <itemContent> <p>Variability in antimicrobial prescribing among hospital-based physicians is not associated with patient characteristics or clinical outcomes, data suggest. The lowest level of such prescribing within each hospital could be considered a target for antimicrobial stewardship, according to the researchers.</p> <p>In a multicenter study of 124 physicians responsible for more than 124,000 hospitalized patients, the difference in mean prescribing between the highest and lowest quartiles of prescription volume was 15.8 days of treatment per 100 patient-days.<br/><br/>Baseline patient characteristics were similar across the quartiles, and there were no differences in patient outcomes, including in-hospital deaths, hospital length of stay, intensive care unit transfer, and hospital readmission.<br/><br/>Although the investigators expected variation in prescribing, “what surprised us most was the limited association with any differences in clinical outcomes, particularly when it came to the amount of antimicrobials used,” study author Mark T. McIntyre, PharmD, pharmacotherapy specialist at the Sinai Health System in Toronto, told this news organization.<br/><br/>“Importantly, this is not a study that defines quality of care,” he said. “We looked at natural variation in practice and association with outcomes. So, I don’t want clinicians to think, ‘Well, I’m high, therefore I’m bad,’ or, ‘I’m low, therefore I’m good.’<br/><br/>“This is an early explanatory analysis that asks whether this is an opportunity to optimize prescribing in ways we hadn’t thought of before,” he said. “Now that we don’t have an association with higher or lower prescribing and outcomes, we can look at what else is driving that antimicrobial prescribing and what we can do about it. Comfort level, risk tolerance, and social, cultural, and contextual factors all likely play a role.”<br/><br/>The study <span class="Hyperlink"><a href="https://www.cmaj.ca/content/195/32/E1065.long">was published</a></span> online in the Canadian Medical Association Journal.<br/><br/></p> <h2>Antimicrobial reductions possible</h2> <p>The investigators conducted a retrospective cohort study using the General Medicine Inpatient Initiative database to assess physician-level volume and spectrum of antimicrobial prescribing in adult general medical wards. Four academic hospitals in Toronto were evaluated for the period 2010 to 2019.</p> <p>The investigators stratified physicians into quartiles by hospital site on the basis of volume of antimicrobial prescribing (specifically, days of therapy per 100 patient-days and antimicrobial-free days) and antibacterial spectrum (modified spectrum score, which assigns a value to each antibacterial agent on the basis of its breadth of coverage).<br/><br/>They also examined potential differences between physician quartiles in patient characteristics, such as age, sex, the Laboratory-Based Acute Physiology Score, discharge diagnosis, and the Charlson Comorbidity Index.<br/><br/>Multilevel modeling allowed the investigators to evaluate the association between clinical outcomes and antimicrobial volume and spectrum.<br/><br/>The primary measure was days of therapy per 100 patient-days.<br/><br/>As noted, the cohort included 124 physicians who were responsible for 124,158 hospital admissions. The median physician-level volume of antimicrobial prescribing was 56.1 days of therapy per 100 patient-days. Patient characteristics were balanced across the quartiles of physician prescribing.<br/><br/>The difference in mean prescribing between physician quartile 4 and quartile 1 was 15.8 days of therapy per 100 patient-days, meaning the median physician in quartile 4 prescribed antimicrobials at a volume that was 30% higher than that of the median physician in quartile 1.<br/><br/>No significant differences were noted for any clinical outcome with regard to quartile of days of therapy, antimicrobial-free days, or modified spectrum score after adjustment for patient-level characteristics.<br/><br/>In addition, no significant differences in the case mix between quartile 4 and quartile 1 were found when the cohort was restricted to patients admitted and discharged by the same most responsible person, nor were differences found in an analysis that was restricted to those without a discharge diagnosis code of palliative care.<br/><br/>In-hospital mortality was higher among patients cared for by prescribers with higher modified spectrum scores (odds ratio, 1.13). “We still can’t fully explain this finding,” Dr. McIntyre acknowledged. “We only saw that in our primary analysis. When we did several sensitivity analyses, that finding didn’t appear.”<br/><br/>The authors concluded, “Ultimately, without discernible benefit in outcomes of patients of physicians who prescribe more frequently, less antimicrobial exposure may be possible, leading to lower risk of antimicrobial resistance.”<br/><br/></p> <h2>Decision-making support</h2> <p>Commenting on the study, Lawrence I. Kaplan, MD, section chief of general internal medicine and associate dean for interprofessional education at the Lewis Katz School of Medicine at Temple University in Philadelphia, said, “Trying to get to the lowest quartile would be a goal, and given that physician characteristics are involved, I think there needs to be much better training in clinical management decision-making: how you come about making a decision based on a diagnosis for a particular patient, in or out of the hospital.” Dr. Kaplan was not involved in the research.<br/><br/>“Clinical decision-making tools that can be plugged into the electronic health record can help,” he suggested. “The tools basically ask if a patient meets certain criteria and then might give a prompt that says, for example, ‘These symptoms are not consistent with bacterial sinusitis. The patient should be treated with decongestants, nasal steroids, et cetera, because antibiotics aren’t appropriate.’<br/><br/>“It’s a bit like checkbox medicine, which a lot of physicians bridle at,” he said. “But if it’s really based on evidence, I think that’s an appropriate use of evidence-based medicine.”<br/><br/>Dr. Kaplan said that more research is needed into the best way to get a physician or any provider to step back and say, “Is this the right decision?” or, “I’m doing this but I’m really on shaky ground. What am I missing?’” He noted that the <span class="Hyperlink"><a href="https://smdm.org/">Society for Medical Decision Making</a></span> publishes research and resources in this area.<br/><br/>“I love the fact that the paper was authored by an interdisciplinary group,” Dr. Kaplan added. “A pharmacist embedded in the team can, for example, help with treatment decision-making and point out potential drug interactions that prescribers might not be aware of.<br/><br/>“We need to stop practicing medicine siloed, which is what we do a lot of ways, both in the hospital and out of the hospital, because it’s the path of least resistance,” Dr. Kaplan added. “But when we can say, ‘Hey, I have a question about this,’ be it to a computer or a colleague, I would argue that we come up with better care.”<br/><br/>No funding was provided for the study. Dr. McIntyre and Dr. Kaplan have disclosed no relevant financial relationships.</p> <p> <em>A version of this article appeared on <span class="Hyperlink"><a href="https://www.medscape.com/viewarticle/995995">Medscape.com</a></span>.</em> </p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> <p>Variability in antimicrobial prescribing among hospital-based physicians is not associated with patient characteristics or clinical outcomes, data suggest.</p> </itemContent> </newsItem> </itemSet></root>
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Low-calorie tastes sweeter with a little salt

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Fri, 06/23/2023 - 08:02

Low-calorie tastes sweeter with a little salt

Diet and sugar-free foods and drinks seem like a good idea, but it’s hard to get past that strange aftertaste, right? It’s the calling card for the noncaloric aspartame- and stevia-containing sweeteners that we consume to make us feel like we can have the best of both worlds.

That weird lingering taste can be a total turn-off for some (raises hand), but researchers have found an almost facepalm solution to the not-so-sweet problem, and it’s salt.

salt_spoon_web2.jpg

Now, the concept of sweet and salty is not a far-fetched partnership when it comes to snack consumption (try M&Ms in your popcorn). The researchers at Almendra, a manufacturer of stevia sweeteners, put that iconic flavor pair to the test by adding mineral salts that have some nutritional value to lessen the effect of a stevia compound, rebaudioside A, found in noncaloric sweeteners.

The researchers added in magnesium chloride, calcium chloride, and potassium chloride separately to lessen rebaudioside A’s intensity, but they needed so much salt that it killed the sweet taste completely. A blend of the three mineral salts, however, reduced the lingering taste by 79% and improved the real sugar-like taste. The researchers tried this blend in reduced-calorie orange juice and a citrus-flavored soft drink, improving the taste in both.

The salty and sweet match comes in for the win once again. This time helping against the fight of obesity instead of making it worse.

Pseudomonas’ Achilles’ heel is more of an Achilles’ genetic switch

Today, on the long-awaited return of “Bacteria vs. the World,” we meet one of the rock stars of infectious disease.

LOTME: Through the use of imaginary technology, we’re talking to Pseudomonas aeruginosa. Thanks for joining us on such short notice, after Neisseria gonorrhoeae canceled at the last minute.

P. aeruginosa: No problem. I think we can all guess what that little devil is up to.

163997_pseudomonas_web.jpg

LOTME: Bacterial resistance to antibiotics is a huge problem for our species. What makes you so hard to fight?

P. aeruginosa: We’ve been trying to keep that a secret, actually, but now that researchers in Switzerland and Denmark seem to have figured it out, I guess it’s okay for me to spill the beans.

LOTME: Beans? What do beans have to do with it?

P. aeruginosa: Nothing, it’s just a colloquial expression that means I’m sharing previously private information.

LOTME: Sure, we knew that. Please, continue your spilling.

P. aeruginosa: The secret is … Well, let’s just say we were a little worried when the Clash released “Should I Stay or Should I Go” back in the 1980s.

LOTME: The Clash? Now we’re really confused.

P. aeruginosa: The answer to their question, “Should I stay or should I go? is yes. Successful invasion of a human is all about division of labor. “While one fraction of the bacterial population adheres to the mucosal surface and forms a biofilm, the other subpopulation spreads to distant tissue sites,” is how the investigators described it. We can increase surface colonization by using a “job-sharing” process, they said, and even resist antibiotics because most of us remain in the protective biofilm.

LOTME: And they say you guys don’t have brains.

P. aeruginosa: But wait, there’s more. We don’t just divide the labor randomly. After the initial colonization we form two functionally distinct subpopulations. One has high levels of the bacterial signaling molecule c-di-GMP and stays put to work on the biofilm. The other group, with low levels of c-di-GMP, heads out to the surrounding tissue to continue the colonization. As project leader Urs Jenal put it, “By identifying the genetic switch, we have tracked down the Achilles heel of the pathogen.”

LOTME: Pretty clever stuff, for humans, anyway.

P. aeruginosa: We agree, but now that you know our secret, we can’t let you share it.

LOTME: Wait! The journal article’s already been published. Your secret is out. You can’t stop that by infecting me.

P. aeruginosa: True enough, but are you familiar with the fable of the scorpion and the frog? It’s our nature.

LOTME: Nooooo! N. gonorrhoeae wouldn’t have done this!
 

What a pain in the Butt

Businesses rise and businesses fall. We all know that one cursed location, that spot in town where we see businesses move in and close up in a matter of months. At the same time, though, there are also businesses that have been around as long as anyone can remember, pillars of the community.

Corydon, IN., likely has a few such long-lived shops, but it is officially down one 70-year-old family business as of late April, with the unfortunate passing of beloved local pharmacy Butt Drugs. Prescription pick-up in rear.

Butt_Drugs_web.jpg

The business dates back to 1952, when it was founded as William H. Butt Drugs. We’re sure William Butt was never teased about his last name. Nope. No one would ever do that. After he passed the store to his children, it underwent a stint as Butt Rexall Drugs. When the shop was passed down to its third-generation and ultimately final owner, Katie Butt Beckort, she decided to simplify the name. Get right down to the bottom of things, as it were.

Butt Drugs was a popular spot, featuring an old-school soda fountain and themed souvenirs. According to Ms. Butt Beckort, people would come from miles away to buy “I love Butt Drugs” T-shirts, magnets, and so on. Yes, they knew perfectly well what they were sitting on.

So, if was such a hit, why did it close? Butt Drugs may have a hilarious name and merchandise to match, but the pharmacy portion of the pharmacy had been losing money for years. You know, the actual point of the business. As with so many things, we can blame it on the insurance companies. More than half the drugs that passed through Butt Drugs’ doors were sold at a loss, because the insurance companies refused to reimburse the store more than the wholesale price of the drug. Not even a good butt drug could clear up that financial diarrhea.

And so, we’ve lost Butt Drugs forever. Spicy food enthusiasts, coffee drinkers, and all patrons of Taco Bell, take a moment to reflect and mourn on what you’ve lost. No more Butt Drugs to relieve your suffering. A true kick in the butt indeed.

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Low-calorie tastes sweeter with a little salt

Diet and sugar-free foods and drinks seem like a good idea, but it’s hard to get past that strange aftertaste, right? It’s the calling card for the noncaloric aspartame- and stevia-containing sweeteners that we consume to make us feel like we can have the best of both worlds.

That weird lingering taste can be a total turn-off for some (raises hand), but researchers have found an almost facepalm solution to the not-so-sweet problem, and it’s salt.

salt_spoon_web2.jpg

Now, the concept of sweet and salty is not a far-fetched partnership when it comes to snack consumption (try M&Ms in your popcorn). The researchers at Almendra, a manufacturer of stevia sweeteners, put that iconic flavor pair to the test by adding mineral salts that have some nutritional value to lessen the effect of a stevia compound, rebaudioside A, found in noncaloric sweeteners.

The researchers added in magnesium chloride, calcium chloride, and potassium chloride separately to lessen rebaudioside A’s intensity, but they needed so much salt that it killed the sweet taste completely. A blend of the three mineral salts, however, reduced the lingering taste by 79% and improved the real sugar-like taste. The researchers tried this blend in reduced-calorie orange juice and a citrus-flavored soft drink, improving the taste in both.

The salty and sweet match comes in for the win once again. This time helping against the fight of obesity instead of making it worse.

Pseudomonas’ Achilles’ heel is more of an Achilles’ genetic switch

Today, on the long-awaited return of “Bacteria vs. the World,” we meet one of the rock stars of infectious disease.

LOTME: Through the use of imaginary technology, we’re talking to Pseudomonas aeruginosa. Thanks for joining us on such short notice, after Neisseria gonorrhoeae canceled at the last minute.

P. aeruginosa: No problem. I think we can all guess what that little devil is up to.

163997_pseudomonas_web.jpg

LOTME: Bacterial resistance to antibiotics is a huge problem for our species. What makes you so hard to fight?

P. aeruginosa: We’ve been trying to keep that a secret, actually, but now that researchers in Switzerland and Denmark seem to have figured it out, I guess it’s okay for me to spill the beans.

LOTME: Beans? What do beans have to do with it?

P. aeruginosa: Nothing, it’s just a colloquial expression that means I’m sharing previously private information.

LOTME: Sure, we knew that. Please, continue your spilling.

P. aeruginosa: The secret is … Well, let’s just say we were a little worried when the Clash released “Should I Stay or Should I Go” back in the 1980s.

LOTME: The Clash? Now we’re really confused.

P. aeruginosa: The answer to their question, “Should I stay or should I go? is yes. Successful invasion of a human is all about division of labor. “While one fraction of the bacterial population adheres to the mucosal surface and forms a biofilm, the other subpopulation spreads to distant tissue sites,” is how the investigators described it. We can increase surface colonization by using a “job-sharing” process, they said, and even resist antibiotics because most of us remain in the protective biofilm.

LOTME: And they say you guys don’t have brains.

P. aeruginosa: But wait, there’s more. We don’t just divide the labor randomly. After the initial colonization we form two functionally distinct subpopulations. One has high levels of the bacterial signaling molecule c-di-GMP and stays put to work on the biofilm. The other group, with low levels of c-di-GMP, heads out to the surrounding tissue to continue the colonization. As project leader Urs Jenal put it, “By identifying the genetic switch, we have tracked down the Achilles heel of the pathogen.”

LOTME: Pretty clever stuff, for humans, anyway.

P. aeruginosa: We agree, but now that you know our secret, we can’t let you share it.

LOTME: Wait! The journal article’s already been published. Your secret is out. You can’t stop that by infecting me.

P. aeruginosa: True enough, but are you familiar with the fable of the scorpion and the frog? It’s our nature.

LOTME: Nooooo! N. gonorrhoeae wouldn’t have done this!
 

What a pain in the Butt

Businesses rise and businesses fall. We all know that one cursed location, that spot in town where we see businesses move in and close up in a matter of months. At the same time, though, there are also businesses that have been around as long as anyone can remember, pillars of the community.

Corydon, IN., likely has a few such long-lived shops, but it is officially down one 70-year-old family business as of late April, with the unfortunate passing of beloved local pharmacy Butt Drugs. Prescription pick-up in rear.

Butt_Drugs_web.jpg

The business dates back to 1952, when it was founded as William H. Butt Drugs. We’re sure William Butt was never teased about his last name. Nope. No one would ever do that. After he passed the store to his children, it underwent a stint as Butt Rexall Drugs. When the shop was passed down to its third-generation and ultimately final owner, Katie Butt Beckort, she decided to simplify the name. Get right down to the bottom of things, as it were.

Butt Drugs was a popular spot, featuring an old-school soda fountain and themed souvenirs. According to Ms. Butt Beckort, people would come from miles away to buy “I love Butt Drugs” T-shirts, magnets, and so on. Yes, they knew perfectly well what they were sitting on.

So, if was such a hit, why did it close? Butt Drugs may have a hilarious name and merchandise to match, but the pharmacy portion of the pharmacy had been losing money for years. You know, the actual point of the business. As with so many things, we can blame it on the insurance companies. More than half the drugs that passed through Butt Drugs’ doors were sold at a loss, because the insurance companies refused to reimburse the store more than the wholesale price of the drug. Not even a good butt drug could clear up that financial diarrhea.

And so, we’ve lost Butt Drugs forever. Spicy food enthusiasts, coffee drinkers, and all patrons of Taco Bell, take a moment to reflect and mourn on what you’ve lost. No more Butt Drugs to relieve your suffering. A true kick in the butt indeed.

Low-calorie tastes sweeter with a little salt

Diet and sugar-free foods and drinks seem like a good idea, but it’s hard to get past that strange aftertaste, right? It’s the calling card for the noncaloric aspartame- and stevia-containing sweeteners that we consume to make us feel like we can have the best of both worlds.

That weird lingering taste can be a total turn-off for some (raises hand), but researchers have found an almost facepalm solution to the not-so-sweet problem, and it’s salt.

salt_spoon_web2.jpg

Now, the concept of sweet and salty is not a far-fetched partnership when it comes to snack consumption (try M&Ms in your popcorn). The researchers at Almendra, a manufacturer of stevia sweeteners, put that iconic flavor pair to the test by adding mineral salts that have some nutritional value to lessen the effect of a stevia compound, rebaudioside A, found in noncaloric sweeteners.

The researchers added in magnesium chloride, calcium chloride, and potassium chloride separately to lessen rebaudioside A’s intensity, but they needed so much salt that it killed the sweet taste completely. A blend of the three mineral salts, however, reduced the lingering taste by 79% and improved the real sugar-like taste. The researchers tried this blend in reduced-calorie orange juice and a citrus-flavored soft drink, improving the taste in both.

The salty and sweet match comes in for the win once again. This time helping against the fight of obesity instead of making it worse.

Pseudomonas’ Achilles’ heel is more of an Achilles’ genetic switch

Today, on the long-awaited return of “Bacteria vs. the World,” we meet one of the rock stars of infectious disease.

LOTME: Through the use of imaginary technology, we’re talking to Pseudomonas aeruginosa. Thanks for joining us on such short notice, after Neisseria gonorrhoeae canceled at the last minute.

P. aeruginosa: No problem. I think we can all guess what that little devil is up to.

163997_pseudomonas_web.jpg

LOTME: Bacterial resistance to antibiotics is a huge problem for our species. What makes you so hard to fight?

P. aeruginosa: We’ve been trying to keep that a secret, actually, but now that researchers in Switzerland and Denmark seem to have figured it out, I guess it’s okay for me to spill the beans.

LOTME: Beans? What do beans have to do with it?

P. aeruginosa: Nothing, it’s just a colloquial expression that means I’m sharing previously private information.

LOTME: Sure, we knew that. Please, continue your spilling.

P. aeruginosa: The secret is … Well, let’s just say we were a little worried when the Clash released “Should I Stay or Should I Go” back in the 1980s.

LOTME: The Clash? Now we’re really confused.

P. aeruginosa: The answer to their question, “Should I stay or should I go? is yes. Successful invasion of a human is all about division of labor. “While one fraction of the bacterial population adheres to the mucosal surface and forms a biofilm, the other subpopulation spreads to distant tissue sites,” is how the investigators described it. We can increase surface colonization by using a “job-sharing” process, they said, and even resist antibiotics because most of us remain in the protective biofilm.

LOTME: And they say you guys don’t have brains.

P. aeruginosa: But wait, there’s more. We don’t just divide the labor randomly. After the initial colonization we form two functionally distinct subpopulations. One has high levels of the bacterial signaling molecule c-di-GMP and stays put to work on the biofilm. The other group, with low levels of c-di-GMP, heads out to the surrounding tissue to continue the colonization. As project leader Urs Jenal put it, “By identifying the genetic switch, we have tracked down the Achilles heel of the pathogen.”

LOTME: Pretty clever stuff, for humans, anyway.

P. aeruginosa: We agree, but now that you know our secret, we can’t let you share it.

LOTME: Wait! The journal article’s already been published. Your secret is out. You can’t stop that by infecting me.

P. aeruginosa: True enough, but are you familiar with the fable of the scorpion and the frog? It’s our nature.

LOTME: Nooooo! N. gonorrhoeae wouldn’t have done this!
 

What a pain in the Butt

Businesses rise and businesses fall. We all know that one cursed location, that spot in town where we see businesses move in and close up in a matter of months. At the same time, though, there are also businesses that have been around as long as anyone can remember, pillars of the community.

Corydon, IN., likely has a few such long-lived shops, but it is officially down one 70-year-old family business as of late April, with the unfortunate passing of beloved local pharmacy Butt Drugs. Prescription pick-up in rear.

Butt_Drugs_web.jpg

The business dates back to 1952, when it was founded as William H. Butt Drugs. We’re sure William Butt was never teased about his last name. Nope. No one would ever do that. After he passed the store to his children, it underwent a stint as Butt Rexall Drugs. When the shop was passed down to its third-generation and ultimately final owner, Katie Butt Beckort, she decided to simplify the name. Get right down to the bottom of things, as it were.

Butt Drugs was a popular spot, featuring an old-school soda fountain and themed souvenirs. According to Ms. Butt Beckort, people would come from miles away to buy “I love Butt Drugs” T-shirts, magnets, and so on. Yes, they knew perfectly well what they were sitting on.

So, if was such a hit, why did it close? Butt Drugs may have a hilarious name and merchandise to match, but the pharmacy portion of the pharmacy had been losing money for years. You know, the actual point of the business. As with so many things, we can blame it on the insurance companies. More than half the drugs that passed through Butt Drugs’ doors were sold at a loss, because the insurance companies refused to reimburse the store more than the wholesale price of the drug. Not even a good butt drug could clear up that financial diarrhea.

And so, we’ve lost Butt Drugs forever. Spicy food enthusiasts, coffee drinkers, and all patrons of Taco Bell, take a moment to reflect and mourn on what you’ve lost. No more Butt Drugs to relieve your suffering. A true kick in the butt indeed.

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All rights reserved. This material may not be published, broadcast, copied, or otherwise reproduced or distributed without the prior written permission of Frontline Medical Communications Inc.</copyrightNotice> </rightsInfo> </provider> <abstract/> <metaDescription>Today, on the long-awaited return of “Bacteria vs. the World,” we meet one of the rock stars of infectious disease.</metaDescription> <articlePDF/> <teaserImage>295947</teaserImage> <teaser>Plus: Indiana loses its biggest Butt, and sugarless sweeteners lose the aftertaste.</teaser> <title>News from the biofilm: Genetic switch could shut down bacterial infections</title> <deck/> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>1</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear/> <pubPubdateMonth/> <pubPubdateDay/> <pubVolume/> <pubNumber/> <wireChannels/> <primaryCMSID/> <CMSIDs/> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>im</publicationCode> 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canonical="true">51510</term> <term>27442</term> <term>234</term> <term>38029</term> <term>319</term> </topics> <links> <link> <itemClass qcode="ninat:picture"/> <altRep contenttype="image/jpeg">images/24011f21.jpg</altRep> <description role="drol:caption"/> <description role="drol:credit">Benoit-Joseph Laventie, Biozentrum, University of Basel</description> </link> <link> <itemClass qcode="ninat:picture"/> <altRep contenttype="image/jpeg">images/24011f20.jpg</altRep> <description role="drol:caption"/> <description role="drol:credit">Bildflut/Wikimedia Commons</description> </link> <link> <itemClass qcode="ninat:picture"/> <altRep contenttype="image/jpeg">images/24011f1f.jpg</altRep> <description role="drol:caption"/> <description role="drol:credit">Jason Tuinstra/Unsplash</description> </link> </links> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>News from the biofilm: Genetic switch could shut down bacterial infections</title> <deck/> </itemMeta> <itemContent> <h2>Pseudomonas’ Achilles’ heel is more of an Achilles’ genetic switch</h2> <p>Today, on the long-awaited return of “Bacteria vs. the World,” we meet <span class="Hyperlink"><a href="https://www.youtube.com/watch?v=2ID-1mzRAew&amp;t=2s">one of the rock stars</a></span> of infectious disease.</p> <p><strong>LOTME:</strong> Through the use of imaginary technology, we’re talking to <em>Pseudomonas aeruginosa</em>. Thanks for joining us on such short notice, after <em>Neisseria gonorrhoeae</em> canceled at the last minute.<br/><br/><strong>P. aeruginosa:</strong> No problem. I think we can all guess what that little devil is up to. <br/><br/><strong>[[{"fid":"295947","view_mode":"medstat_image_flush_right","fields":{"format":"medstat_image_flush_right","field_file_image_alt_text[und][0][value]":"Pseudomonas aeruginosa colonizes lung mucosa (blue) by forming two subpopulations – sessile (red) and motile (green)","field_file_image_credit[und][0][value]":"Benoit-Joseph Laventie, Biozentrum, University of Basel","field_file_image_caption[und][0][value]":""},"type":"media","attributes":{"class":"media-element file-medstat_image_flush_right"}}]]LOTME:</strong> Bacterial resistance to antibiotics is a huge problem for our species. What makes you so hard to fight?<br/><br/><strong>P. aeruginosa:</strong> We’ve been trying to keep that a secret, actually, but now that researchers in Switzerland and Denmark <span class="Hyperlink"><a href="https://www.nature.com/articles/s41564-023-01403-0">seem to have figured it out</a></span>, I guess it’s okay for me to spill the beans.<br/><br/><strong>LOTME:</strong> Beans? What do beans have to do with it?<br/><br/><strong>P. aeruginosa:</strong> Nothing, it’s just a colloquial expression that means I’m sharing previously private information.<br/><br/><strong>LOTME:</strong> Sure, we knew that. Please, continue your spilling.<br/><br/><strong>P. aeruginosa:</strong> The secret is … Well, let’s just say we were a little worried when the Clash released “<span class="Hyperlink"><a href="https://www.youtube.com/watch?v=xMaE6toi4mk">Should I Stay or Should I Go</a></span>” back in the 1980s.<br/><br/><strong>LOTME:</strong> The Clash? Now we’re really confused.<br/><br/><strong>P. aeruginosa:</strong> The answer to their question, “Should I stay or should I go? is yes. Successful invasion of a human is all about division of labor. “While one fraction of the bacterial population adheres to the mucosal surface and forms a biofilm, the other subpopulation spreads to distant tissue sites,” is how <span class="Hyperlink"><a href="https://www.unibas.ch/en/News-Events/News/Uni-Research/Should-I-stay-or-should-I-go--Hospital-germ-s-dual-strategy.html">the investigators described it</a></span>. We can increase surface colonization by using a “job-sharing” process, they said, and even resist antibiotics because most of us remain in the protective biofilm.<br/><br/><strong>LOTME:</strong> And they say you guys don’t have brains.<br/><br/><strong>P. aeruginosa:</strong> But wait, there’s more. We don’t just divide the labor randomly. After the initial colonization we form two functionally distinct subpopulations. One has high levels of the bacterial signaling molecule c-di-GMP and stays put to work on the biofilm. The other group, with low levels of c-di-GMP, heads out to the surrounding tissue to continue the colonization. As project leader Urs Jenal put it, “By identifying the genetic switch, we have tracked down the Achilles heel of the pathogen.” <br/><br/><strong>LOTME:</strong> Pretty clever stuff, for humans, anyway.<br/><br/><strong>P. aeruginosa:</strong> We agree, but now that you know our secret, we can’t let you share it.<br/><br/><strong>LOTME:</strong> Wait! The journal article’s already been published. Your secret is out. You can’t stop that by infecting me.<br/><br/><strong>P. aeruginosa:</strong> True enough, but are you familiar with the <span class="Hyperlink"><a href="http://allaboutfrogs.org/stories/scorpion.html">fable of the scorpion and the frog</a></span>? It’s our nature.<br/><br/><strong>LOTME:</strong> Nooooo! <em>N. gonorrhoeae</em> wouldn’t have done this!<br/><br/></p> <h2>What a pain in the Butt</h2> <p>Businesses rise and businesses fall. We all know that one cursed location, that spot in town where we see businesses move in and close up in a matter of months. At the same time, though, there are also businesses that have been around as long as anyone can remember, pillars of the community.</p> <p>Corydon, Ky., likely has a few such long-lived shops, but it is officially down one 70-year-old family business as of late April, with the unfortunate <span class="Hyperlink"><a href="https://www.wdrb.com/news/business/southern-indianas-iconic-butt-drugs-announces-its-closing-its-doors-after-71-years/article_71d2b3d4-dfa5-11ed-8ff9-f3a02d9a59f9.html?utm_source=fark&amp;utm_medium=website&amp;utm_content=link&amp;ICID=ref_fark">passing of beloved local pharmacy Butt Drugs</a></span>. Prescription pick-up in rear.<br/><br/>[[{"fid":"295946","view_mode":"medstat_image_flush_right","fields":{"format":"medstat_image_flush_right","field_file_image_alt_text[und][0][value]":"Store front of Butt Drugs in Corydon, Indiana","field_file_image_credit[und][0][value]":"Bildflut/Wikimedia Commons","field_file_image_caption[und][0][value]":""},"type":"media","attributes":{"class":"media-element file-medstat_image_flush_right"}}]]The business dates back to 1952, when it was founded as William H. Butt Drugs. We’re sure William Butt was never teased about his last name. Nope. No one would ever do that. After he passed the store to his children, it underwent a stint as Butt Rexall Drugs. When the shop was passed down to its third-generation and ultimately final owner, Katie Butt Beckort, she decided to simplify the name. Get right down to the bottom of things, as it were.<br/><br/>Butt Drugs was a popular spot, featuring an old-school soda fountain and themed souvenirs. According to Ms. Butt Beckort, people would come from miles away to buy “I love Butt Drugs” T-shirts, magnets, and so on. Yes, they knew perfectly well what they were sitting on.<br/><br/>So, if was such a hit, why did it close? Butt Drugs may have a hilarious name and merchandise to match, but the pharmacy portion of the pharmacy had been losing money for years. You know, the actual point of the business. As with so many things, we can blame it on the insurance companies. More than half the drugs that passed through Butt Drugs’ doors were sold at a loss, because the insurance companies refused to reimburse the store more than the wholesale price of the drug. Not even a good butt drug could clear up that financial diarrhea.<br/><br/>And so, we’ve lost Butt Drugs forever. Spicy food enthusiasts, coffee drinkers, and all patrons of Taco Bell, take a moment to reflect and mourn on what you’ve lost. No more Butt Drugs to relieve your suffering. A true kick in the butt indeed.<br/><br/></p> <h2>Low-calorie tastes sweeter with a little salt </h2> <p>Diet and sugar-free foods and drinks seem like a good idea, but it’s hard to get past that strange aftertaste, right? It’s the calling card for the noncaloric <span class="Hyperlink"><a href="https://www.fda.gov/food/food-additives-petitions/aspartame-and-other-sweeteners-food#:~:text=Aspartame%20%5BL%2Daspartyl%2DL,consumed%20in%20any%20healthful%20diet.">aspartame</a></span>- and stevia-containing sweeteners that we consume to make us feel like we can have the best of both worlds. </p> <p>That weird lingering taste can be a total turn-off for some (raises hand), but researchers have found an almost facepalm solution to the not-so-sweet problem, and it’s salt. <br/><br/>[[{"fid":"295948","view_mode":"medstat_image_flush_right","fields":{"format":"medstat_image_flush_right","field_file_image_alt_text[und][0][value]":"wooden spoon holding salt","field_file_image_credit[und][0][value]":"Jason Tuinstra/Unsplash","field_file_image_caption[und][0][value]":""},"type":"media","attributes":{"class":"media-element file-medstat_image_flush_right"}}]]Now, the concept of sweet and salty is <span class="Hyperlink"><a href="https://www.eater.com/ad/17313326/sweet-salty-flavor-combination-science">not a far-fetched partnership</a></span> when it comes to snack consumption (try M&amp;Ms in your popcorn). The researchers at Almendra, a manufacturer of stevia sweeteners, put that iconic flavor pair to the test by adding mineral salts that have some nutritional value to lessen the effect of a stevia compound, rebaudioside A, found in noncaloric sweeteners. <br/><br/>The researchers added in magnesium chloride, calcium chloride, and potassium chloride separately to lessen rebaudioside A’s intensity, but they needed so much salt that it killed the sweet taste completely. A blend of the three mineral salts, however, reduced the lingering taste by 79% and improved the real sugar-like taste. The researchers tried this blend in reduced-calorie orange juice and a citrus-flavored soft drink, improving the taste in both. <br/><br/>The salty and sweet match comes in for the win once again. This time helping against the fight of obesity instead of making it worse.<span class="end"/></p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>
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Cases of potentially deadly fungus jump 200%: CDC

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Thu, 03/23/2023 - 10:57

Cases of a potentially deadly and increasingly treatment-resistant fungus called Candida auris have skyrocketed 200% since 2019, prompting the Centers for Disease Control and Prevention to issue a warning to health care facilities about the rising threat.

C. auris is a yeast that spreads easily from touching it on a surface like a countertop. It can also spread from person to person. It isn’t a threat to healthy people, but people in hospitals and nursing homes are at a heightened risk because they might have weakened immune systems or be using invasive medical devices that can introduce the fungus inside their bodies. When C. auris progresses to causing an infection that reaches the brain, blood, or lungs, more than one in three people die.

The worrying increase was detailed in the journal Annals of Internal Medicine. In 2021, cases reached a count of 3,270 with an active infection, and 7,413 cases showed the fungus was present but hadn’t caused an infection. Infection counts were up 95% over the previous year, and the fungus showed up on screenings three times as often. The number of cases resistant to medication also tripled.

The CDC called the figures “alarming,” noting that the fungus was only detected in the United States in 2016. 

“The timing of this increase and findings from public health investigations suggest C. auris spread may have worsened due to strain on health care and public health systems during the COVID-19 pandemic,” the CDC explained in a news release.

Another potential reason for the jump could be that screening for C. auris has simply increased and it’s being found more often because it’s being looked for more often. But researchers believe that, even with the increase in testing, the reported counts are underestimated. That’s because even though screening has increased, health care providers still aren’t looking for the presence of the fungus as often as the CDC would like.

“The rapid rise and geographic spread of cases is concerning and emphasizes the need for continued surveillance, expanded lab capacity, quicker diagnostic tests, and adherence to proven infection prevention and control,” said study author Meghan Lyman, MD, a CDC epidemiologist in Atlanta, in a statement.

Cases of C. auris continued to rise in 2022, the CDC said. A map on the agency’s website of reported cases from 2022 shows it was found in more than half of U.S. states, with the highest counts occurring in California, Florida, Illinois, Nevada, New York, and Texas. The fungus is a problem worldwide and is listed among the most threatening treatment-resistant fungi by the World Health Organization.

The study authors concluded that screening capacity for the fungus needs to be expanded nationwide so that when C. auris is detected, measures can be taken to prevent its spread.

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

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Cases of a potentially deadly and increasingly treatment-resistant fungus called Candida auris have skyrocketed 200% since 2019, prompting the Centers for Disease Control and Prevention to issue a warning to health care facilities about the rising threat.

C. auris is a yeast that spreads easily from touching it on a surface like a countertop. It can also spread from person to person. It isn’t a threat to healthy people, but people in hospitals and nursing homes are at a heightened risk because they might have weakened immune systems or be using invasive medical devices that can introduce the fungus inside their bodies. When C. auris progresses to causing an infection that reaches the brain, blood, or lungs, more than one in three people die.

The worrying increase was detailed in the journal Annals of Internal Medicine. In 2021, cases reached a count of 3,270 with an active infection, and 7,413 cases showed the fungus was present but hadn’t caused an infection. Infection counts were up 95% over the previous year, and the fungus showed up on screenings three times as often. The number of cases resistant to medication also tripled.

The CDC called the figures “alarming,” noting that the fungus was only detected in the United States in 2016. 

“The timing of this increase and findings from public health investigations suggest C. auris spread may have worsened due to strain on health care and public health systems during the COVID-19 pandemic,” the CDC explained in a news release.

Another potential reason for the jump could be that screening for C. auris has simply increased and it’s being found more often because it’s being looked for more often. But researchers believe that, even with the increase in testing, the reported counts are underestimated. That’s because even though screening has increased, health care providers still aren’t looking for the presence of the fungus as often as the CDC would like.

“The rapid rise and geographic spread of cases is concerning and emphasizes the need for continued surveillance, expanded lab capacity, quicker diagnostic tests, and adherence to proven infection prevention and control,” said study author Meghan Lyman, MD, a CDC epidemiologist in Atlanta, in a statement.

Cases of C. auris continued to rise in 2022, the CDC said. A map on the agency’s website of reported cases from 2022 shows it was found in more than half of U.S. states, with the highest counts occurring in California, Florida, Illinois, Nevada, New York, and Texas. The fungus is a problem worldwide and is listed among the most threatening treatment-resistant fungi by the World Health Organization.

The study authors concluded that screening capacity for the fungus needs to be expanded nationwide so that when C. auris is detected, measures can be taken to prevent its spread.

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

Cases of a potentially deadly and increasingly treatment-resistant fungus called Candida auris have skyrocketed 200% since 2019, prompting the Centers for Disease Control and Prevention to issue a warning to health care facilities about the rising threat.

C. auris is a yeast that spreads easily from touching it on a surface like a countertop. It can also spread from person to person. It isn’t a threat to healthy people, but people in hospitals and nursing homes are at a heightened risk because they might have weakened immune systems or be using invasive medical devices that can introduce the fungus inside their bodies. When C. auris progresses to causing an infection that reaches the brain, blood, or lungs, more than one in three people die.

The worrying increase was detailed in the journal Annals of Internal Medicine. In 2021, cases reached a count of 3,270 with an active infection, and 7,413 cases showed the fungus was present but hadn’t caused an infection. Infection counts were up 95% over the previous year, and the fungus showed up on screenings three times as often. The number of cases resistant to medication also tripled.

The CDC called the figures “alarming,” noting that the fungus was only detected in the United States in 2016. 

“The timing of this increase and findings from public health investigations suggest C. auris spread may have worsened due to strain on health care and public health systems during the COVID-19 pandemic,” the CDC explained in a news release.

Another potential reason for the jump could be that screening for C. auris has simply increased and it’s being found more often because it’s being looked for more often. But researchers believe that, even with the increase in testing, the reported counts are underestimated. That’s because even though screening has increased, health care providers still aren’t looking for the presence of the fungus as often as the CDC would like.

“The rapid rise and geographic spread of cases is concerning and emphasizes the need for continued surveillance, expanded lab capacity, quicker diagnostic tests, and adherence to proven infection prevention and control,” said study author Meghan Lyman, MD, a CDC epidemiologist in Atlanta, in a statement.

Cases of C. auris continued to rise in 2022, the CDC said. A map on the agency’s website of reported cases from 2022 shows it was found in more than half of U.S. states, with the highest counts occurring in California, Florida, Illinois, Nevada, New York, and Texas. The fungus is a problem worldwide and is listed among the most threatening treatment-resistant fungi by the World Health Organization.

The study authors concluded that screening capacity for the fungus needs to be expanded nationwide so that when C. auris is detected, measures can be taken to prevent its spread.

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

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All rights reserved. This material may not be published, broadcast, copied, or otherwise reproduced or distributed without the prior written permission of Frontline Medical Communications Inc.</copyrightNotice> </rightsInfo> </provider> <abstract/> <metaDescription>Cases of a potentially deadly and increasingly treatment-resistant fungus called Candida auris have skyrocketed 200% since 2019,</metaDescription> <articlePDF/> <teaserImage/> <teaser>People in hospitals and nursing homes are at a heightened risk because they might have weakened immune systems or be using invasive medical devices that can introduce the fungus inside their bodies. </teaser> <title>Cases of potentially deadly fungus jump 200%: CDC</title> <deck/> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>1</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear/> <pubPubdateMonth/> <pubPubdateDay/> <pubVolume/> <pubNumber/> <wireChannels/> <primaryCMSID/> <CMSIDs/> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>idprac</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>skin</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>fp</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>pn</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>chph</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>im</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> </publications_g> <publications> <term canonical="true">20</term> <term>13</term> <term>15</term> <term>25</term> <term>6</term> <term>21</term> </publications> <sections> <term canonical="true">27979</term> <term>39313</term> <term>27980</term> <term>37225</term> </sections> <topics> <term>27442</term> <term>319</term> <term canonical="true">315</term> <term>234</term> <term>203</term> </topics> <links/> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>Cases of potentially deadly fungus jump 200%: CDC</title> <deck/> </itemMeta> <itemContent> <p><span class="tag metaDescription">Cases of a potentially deadly and increasingly treatment-resistant fungus called <em>Candida auris</em> have skyrocketed 200% since 2019,</span> prompting the Centers for Disease Control and Prevention to issue a warning to health care facilities about the rising threat.</p> <p><em>C. auris</em> is a yeast that spreads easily from touching it on a surface like a countertop. It can also spread from person to person. It isn’t a threat to healthy people, but people in hospitals and nursing homes are at a heightened risk because they might have weakened immune systems or be using invasive medical devices that can introduce the fungus inside their bodies. When <em>C. auris</em> progresses to causing an infection that reaches the brain, blood, or lungs, more than one in three people die.<br/><br/>The worrying increase was detailed in the journal <span class="Hyperlink"><a href="https://www.acpjournals.org/doi/10.7326/M22-3469">Annals of Internal Medicine</a></span>. In 2021, cases reached a count of 3,270 with an active infection, and 7,413 cases showed the fungus was present but hadn’t caused an infection. Infection counts were up 95% over the previous year, and the fungus showed up on screenings three times as often. The number of cases resistant to medication also tripled.<br/><br/>The CDC called the figures “alarming,” noting that the fungus was only detected in the United States in 2016. <br/><br/>“The timing of this increase and findings from public health investigations suggest <em>C. auris</em> spread may have worsened due to strain on health care and public health systems during the COVID-19 pandemic,” the CDC explained in a <span class="Hyperlink"><a href="https://www.cdc.gov/media/releases/2023/p0320-cauris.html">news release</a></span>.<br/><br/>Another potential reason for the jump could be that screening for <em>C. auris</em> has simply increased and it’s being found more often because it’s being looked for more often. But researchers believe that, even with the increase in testing, the reported counts are underestimated. That’s because even though screening has increased, health care providers still aren’t looking for the presence of the fungus as often as the CDC would like.<br/><br/>“The rapid rise and geographic spread of cases is concerning and emphasizes the need for continued surveillance, expanded lab capacity, quicker diagnostic tests, and adherence to proven infection prevention and control,” said study author Meghan Lyman, MD, a CDC epidemiologist in Atlanta, in a statement.<br/><br/>Cases of <em>C. auris</em> continued to rise in 2022, the CDC said. A <span class="Hyperlink"><a href="https://www.cdc.gov/fungal/candida-auris/tracking-c-auris.html">map</a></span> on the agency’s website of reported cases from 2022 shows it was found in more than half of U.S. states, with the highest counts occurring in California, Florida, Illinois, Nevada, New York, and Texas. The fungus is a problem worldwide and is listed among the most threatening treatment-resistant fungi by the <span class="Hyperlink"><a href="https://www.who.int/news/item/25-10-2022-who-releases-first-ever-list-of-health-threatening-fungi">World Health Organization</a></span>.<br/><br/>The study authors concluded that screening capacity for the fungus needs to be expanded nationwide so that when <em>C. auris</em> is detected, measures can be taken to prevent its spread.<span class="end"/></p> <p> <em>A version of this article originally appeared on <span class="Hyperlink"><a href="https://www.webmd.com/a-to-z-guides/news/20230321/cases-potentially-deadly-fungus-jump-200-percent-cdc">WebMD.com</a></span>.</em> </p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>
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Droplet dispersal in sterile processing units far exceeds guideline limit

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Fri, 10/28/2022 - 08:42

In the era of Ebola, COVID-19, and even Legionnaires, technicians and other staff working behind the scenes to ensure provider and patient safety continue to face a long-recognized but under addressed challenge: splashes and airborne droplets.

Granted, National Institute for Occupational Safety and Health (NIOSH) standards, industry standards, and professional guidelines are all in place to prevent unintentional exposure to pathogens. However, findings from a newly published study in the American Journal of Infection Control suggest they fall short.

In the study, researchers found that simulated manual cleaning of medical devices generated a drenching splash throughout the process with droplet dispersal exceeding 7 feet (2.1 meters).

“The guidelines say that droplets stop at 3 or 4 feet, and they don’t,” Cori L. Ofstead, MSPH, lead author and president/CEO of Ofstead & Associates, Bloomington, Minn., told this news organization. “That’s the problem with having standards and guidelines that are not based on relevant evidence, [which] in this case, is a single study that was done in an intensive care area where they had an infection outbreak.”

Ms. Ofstead was referring to a report in the journal Infection Control and Hospital Epidemiology, detailing a Canadian investigation involving a multidrug-resistant Pseudomonas aeruginosa outbreak in an ICU. The report implicated the faucets over the hand hygiene sinks, with fluorescent dye showing droplet dispersal roughly 3 feet away from the sinks.

“Somehow it [the 3-feet rule] got implemented in guidelines in sterile processing decontamination areas, which are not the same as hand hygiene,’’ Ms. Ofstead explained.

With a goal of providing more current evidence on droplet generation and dispersal, as well as personal protection equipment (PPE) exposure/effectiveness, she and her colleagues simulated manual cleaning of a decommissioned colonoscope and transvaginal ultrasound probe, using for the study location a new academic sterile processing unit.

To detect droplet generation and dispersal as well as splash following common technician activities (for example, colonoscope brushing, scrubbing, rinsing and transport to an automated endoscope reprocessor [AER] for sterilization), the researchers affixed blue moisture-detection paper to environmental surfaces, on carts positioned 4 feet (1.2 meters) from the sink (to simulate observers), and along a 15-foot pathway between the sink and AER.

They observed droplets everywhere.

Technician activities such as running the faucet and rinsing the probe under running water generated substantial splashing overall. Instrument rinsing in particular produced small and large droplets and confluent puddles of water around the sink and in the broad area surrounding the workspace. Droplets were also dispersed on the floor 7.25 feet (2.2 meters) away and along the entire 15-foot path from the sink to the AER.

At the sink, the technician risked drenching exposure from head to toe during most activities, and even observers positioned 3-4 feet away were found to have droplets on their gowns. In addition, saturated shoe covers reportedly tracked moisture away from the sink to the unit door – a distance of 13 feet (4 meters) – and 2 feet (0.6 meters) farther out into the PPE foyer for donning and doffing.

Although PPE gowns effectively repelled moisture during cleaning of a single device, Ms. Ofstead emphasized that technicians typically handle up to 10 instruments during a normal, 2-hour shift, further increasing exposure risk with each subsequent cleaning.

However, perhaps one of the most surprising findings was that despite an optimal unit design, including physical separation of clean and dirty activities and pressurized air flow to protect workers, droplets were still broadly dispersed.

Current efforts, however well-intentioned, might not be offering the degree of protection (and consideration) that sterile processing technicians need.

“The study was conducted in a new sterile processing area that had an extra excellent kind of distancing and three separate rooms, something that I think most of our hospitals are working toward,” Stella Hines, MD, associate professor at the University of Maryland School of Medicine, Baltimore, explained. Dr. Hines was not directly involved in the study.

“But it also really kind of highlighted what’s happening to workers potentially,” she added. “For example, we want to know if that spray or splatter has a live microbe it in that could cause a problem or ... in a highly wet environment, if that water has some kind of chemical in it that could pose an occupational hazard to the worker based on skin or mucous membrane exposure.”

Ms. Ofstead agreed. “We need to be thinking about the exposure of critically important workers and the environment in an era where we are worried about aerosol-generating procedures and superbugs,” she explained.

Dr. Hines and Ms. Ofstead also noted that the majority of staff involved in front-line patient care have never actually ventured into the sterile processing units nor do they recognize the risks that technicians working in these units face on a daily, or even hourly, basis.

“The people who run these operations are very well trained and knowledgeable. I think that it would be helpful for them to know that they’re appreciated and for the people upstairs on the front lines using the equipment to see what goes on downstairs and all of the painstaking steps that need to be in place for the equipment to come out of sterile processing and be ready to go,” said Dr. Hines.

In the meantime, hospital leaders need to address the challenges and danger posed by migrating infectious droplets, especially for workers involved in processes that stir them up in the first place – workers who by the end of their shifts are unavoidably drenched with infectious blood and tissue secretions.

“I think that it’s going to take a much bigger kind of worldview from hospital leadership,” Dr. Hines said.

The study was supported in part by a grant from Healthmark Industries. Ms. Ofstead reports research grants or consulting fees through her organization with 3M Company, Ambu, Boston Scientific, Cleanis, Fortive/Advanced Sterilization Products, Healthmark Industries, Pentax, and Steris/Cantel/Medviators. Dr. Hines reports no relevant financial relationships.

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

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In the era of Ebola, COVID-19, and even Legionnaires, technicians and other staff working behind the scenes to ensure provider and patient safety continue to face a long-recognized but under addressed challenge: splashes and airborne droplets.

Granted, National Institute for Occupational Safety and Health (NIOSH) standards, industry standards, and professional guidelines are all in place to prevent unintentional exposure to pathogens. However, findings from a newly published study in the American Journal of Infection Control suggest they fall short.

In the study, researchers found that simulated manual cleaning of medical devices generated a drenching splash throughout the process with droplet dispersal exceeding 7 feet (2.1 meters).

“The guidelines say that droplets stop at 3 or 4 feet, and they don’t,” Cori L. Ofstead, MSPH, lead author and president/CEO of Ofstead & Associates, Bloomington, Minn., told this news organization. “That’s the problem with having standards and guidelines that are not based on relevant evidence, [which] in this case, is a single study that was done in an intensive care area where they had an infection outbreak.”

Ms. Ofstead was referring to a report in the journal Infection Control and Hospital Epidemiology, detailing a Canadian investigation involving a multidrug-resistant Pseudomonas aeruginosa outbreak in an ICU. The report implicated the faucets over the hand hygiene sinks, with fluorescent dye showing droplet dispersal roughly 3 feet away from the sinks.

“Somehow it [the 3-feet rule] got implemented in guidelines in sterile processing decontamination areas, which are not the same as hand hygiene,’’ Ms. Ofstead explained.

With a goal of providing more current evidence on droplet generation and dispersal, as well as personal protection equipment (PPE) exposure/effectiveness, she and her colleagues simulated manual cleaning of a decommissioned colonoscope and transvaginal ultrasound probe, using for the study location a new academic sterile processing unit.

To detect droplet generation and dispersal as well as splash following common technician activities (for example, colonoscope brushing, scrubbing, rinsing and transport to an automated endoscope reprocessor [AER] for sterilization), the researchers affixed blue moisture-detection paper to environmental surfaces, on carts positioned 4 feet (1.2 meters) from the sink (to simulate observers), and along a 15-foot pathway between the sink and AER.

They observed droplets everywhere.

Technician activities such as running the faucet and rinsing the probe under running water generated substantial splashing overall. Instrument rinsing in particular produced small and large droplets and confluent puddles of water around the sink and in the broad area surrounding the workspace. Droplets were also dispersed on the floor 7.25 feet (2.2 meters) away and along the entire 15-foot path from the sink to the AER.

At the sink, the technician risked drenching exposure from head to toe during most activities, and even observers positioned 3-4 feet away were found to have droplets on their gowns. In addition, saturated shoe covers reportedly tracked moisture away from the sink to the unit door – a distance of 13 feet (4 meters) – and 2 feet (0.6 meters) farther out into the PPE foyer for donning and doffing.

Although PPE gowns effectively repelled moisture during cleaning of a single device, Ms. Ofstead emphasized that technicians typically handle up to 10 instruments during a normal, 2-hour shift, further increasing exposure risk with each subsequent cleaning.

However, perhaps one of the most surprising findings was that despite an optimal unit design, including physical separation of clean and dirty activities and pressurized air flow to protect workers, droplets were still broadly dispersed.

Current efforts, however well-intentioned, might not be offering the degree of protection (and consideration) that sterile processing technicians need.

“The study was conducted in a new sterile processing area that had an extra excellent kind of distancing and three separate rooms, something that I think most of our hospitals are working toward,” Stella Hines, MD, associate professor at the University of Maryland School of Medicine, Baltimore, explained. Dr. Hines was not directly involved in the study.

“But it also really kind of highlighted what’s happening to workers potentially,” she added. “For example, we want to know if that spray or splatter has a live microbe it in that could cause a problem or ... in a highly wet environment, if that water has some kind of chemical in it that could pose an occupational hazard to the worker based on skin or mucous membrane exposure.”

Ms. Ofstead agreed. “We need to be thinking about the exposure of critically important workers and the environment in an era where we are worried about aerosol-generating procedures and superbugs,” she explained.

Dr. Hines and Ms. Ofstead also noted that the majority of staff involved in front-line patient care have never actually ventured into the sterile processing units nor do they recognize the risks that technicians working in these units face on a daily, or even hourly, basis.

“The people who run these operations are very well trained and knowledgeable. I think that it would be helpful for them to know that they’re appreciated and for the people upstairs on the front lines using the equipment to see what goes on downstairs and all of the painstaking steps that need to be in place for the equipment to come out of sterile processing and be ready to go,” said Dr. Hines.

In the meantime, hospital leaders need to address the challenges and danger posed by migrating infectious droplets, especially for workers involved in processes that stir them up in the first place – workers who by the end of their shifts are unavoidably drenched with infectious blood and tissue secretions.

“I think that it’s going to take a much bigger kind of worldview from hospital leadership,” Dr. Hines said.

The study was supported in part by a grant from Healthmark Industries. Ms. Ofstead reports research grants or consulting fees through her organization with 3M Company, Ambu, Boston Scientific, Cleanis, Fortive/Advanced Sterilization Products, Healthmark Industries, Pentax, and Steris/Cantel/Medviators. Dr. Hines reports no relevant financial relationships.

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

In the era of Ebola, COVID-19, and even Legionnaires, technicians and other staff working behind the scenes to ensure provider and patient safety continue to face a long-recognized but under addressed challenge: splashes and airborne droplets.

Granted, National Institute for Occupational Safety and Health (NIOSH) standards, industry standards, and professional guidelines are all in place to prevent unintentional exposure to pathogens. However, findings from a newly published study in the American Journal of Infection Control suggest they fall short.

In the study, researchers found that simulated manual cleaning of medical devices generated a drenching splash throughout the process with droplet dispersal exceeding 7 feet (2.1 meters).

“The guidelines say that droplets stop at 3 or 4 feet, and they don’t,” Cori L. Ofstead, MSPH, lead author and president/CEO of Ofstead & Associates, Bloomington, Minn., told this news organization. “That’s the problem with having standards and guidelines that are not based on relevant evidence, [which] in this case, is a single study that was done in an intensive care area where they had an infection outbreak.”

Ms. Ofstead was referring to a report in the journal Infection Control and Hospital Epidemiology, detailing a Canadian investigation involving a multidrug-resistant Pseudomonas aeruginosa outbreak in an ICU. The report implicated the faucets over the hand hygiene sinks, with fluorescent dye showing droplet dispersal roughly 3 feet away from the sinks.

“Somehow it [the 3-feet rule] got implemented in guidelines in sterile processing decontamination areas, which are not the same as hand hygiene,’’ Ms. Ofstead explained.

With a goal of providing more current evidence on droplet generation and dispersal, as well as personal protection equipment (PPE) exposure/effectiveness, she and her colleagues simulated manual cleaning of a decommissioned colonoscope and transvaginal ultrasound probe, using for the study location a new academic sterile processing unit.

To detect droplet generation and dispersal as well as splash following common technician activities (for example, colonoscope brushing, scrubbing, rinsing and transport to an automated endoscope reprocessor [AER] for sterilization), the researchers affixed blue moisture-detection paper to environmental surfaces, on carts positioned 4 feet (1.2 meters) from the sink (to simulate observers), and along a 15-foot pathway between the sink and AER.

They observed droplets everywhere.

Technician activities such as running the faucet and rinsing the probe under running water generated substantial splashing overall. Instrument rinsing in particular produced small and large droplets and confluent puddles of water around the sink and in the broad area surrounding the workspace. Droplets were also dispersed on the floor 7.25 feet (2.2 meters) away and along the entire 15-foot path from the sink to the AER.

At the sink, the technician risked drenching exposure from head to toe during most activities, and even observers positioned 3-4 feet away were found to have droplets on their gowns. In addition, saturated shoe covers reportedly tracked moisture away from the sink to the unit door – a distance of 13 feet (4 meters) – and 2 feet (0.6 meters) farther out into the PPE foyer for donning and doffing.

Although PPE gowns effectively repelled moisture during cleaning of a single device, Ms. Ofstead emphasized that technicians typically handle up to 10 instruments during a normal, 2-hour shift, further increasing exposure risk with each subsequent cleaning.

However, perhaps one of the most surprising findings was that despite an optimal unit design, including physical separation of clean and dirty activities and pressurized air flow to protect workers, droplets were still broadly dispersed.

Current efforts, however well-intentioned, might not be offering the degree of protection (and consideration) that sterile processing technicians need.

“The study was conducted in a new sterile processing area that had an extra excellent kind of distancing and three separate rooms, something that I think most of our hospitals are working toward,” Stella Hines, MD, associate professor at the University of Maryland School of Medicine, Baltimore, explained. Dr. Hines was not directly involved in the study.

“But it also really kind of highlighted what’s happening to workers potentially,” she added. “For example, we want to know if that spray or splatter has a live microbe it in that could cause a problem or ... in a highly wet environment, if that water has some kind of chemical in it that could pose an occupational hazard to the worker based on skin or mucous membrane exposure.”

Ms. Ofstead agreed. “We need to be thinking about the exposure of critically important workers and the environment in an era where we are worried about aerosol-generating procedures and superbugs,” she explained.

Dr. Hines and Ms. Ofstead also noted that the majority of staff involved in front-line patient care have never actually ventured into the sterile processing units nor do they recognize the risks that technicians working in these units face on a daily, or even hourly, basis.

“The people who run these operations are very well trained and knowledgeable. I think that it would be helpful for them to know that they’re appreciated and for the people upstairs on the front lines using the equipment to see what goes on downstairs and all of the painstaking steps that need to be in place for the equipment to come out of sterile processing and be ready to go,” said Dr. Hines.

In the meantime, hospital leaders need to address the challenges and danger posed by migrating infectious droplets, especially for workers involved in processes that stir them up in the first place – workers who by the end of their shifts are unavoidably drenched with infectious blood and tissue secretions.

“I think that it’s going to take a much bigger kind of worldview from hospital leadership,” Dr. Hines said.

The study was supported in part by a grant from Healthmark Industries. Ms. Ofstead reports research grants or consulting fees through her organization with 3M Company, Ambu, Boston Scientific, Cleanis, Fortive/Advanced Sterilization Products, Healthmark Industries, Pentax, and Steris/Cantel/Medviators. Dr. Hines reports no relevant financial relationships.

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

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All rights reserved. This material may not be published, broadcast, copied, or otherwise reproduced or distributed without the prior written permission of Frontline Medical Communications Inc.</copyrightNotice> </rightsInfo> </provider> <abstract/> <metaDescription>“The guidelines say that droplets stop at 3 or 4 feet, and they don’t,”</metaDescription> <articlePDF/> <teaserImage/> <teaser>“The guidelines say that droplets stop at 3 or 4 feet, and they don’t.”</teaser> <title>Droplet dispersal in sterile processing units far exceeds guideline limit</title> <deck/> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>1</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear/> <pubPubdateMonth/> <pubPubdateDay/> <pubVolume/> <pubNumber/> <wireChannels/> <primaryCMSID/> <CMSIDs/> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>GIHOLD</publicationCode> <pubIssueName>January 2014</pubIssueName> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> <journalTitle/> <journalFullTitle/> <copyrightStatement/> </publicationData> <publicationData> <publicationCode>chph</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>idprac</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>im</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> </publications_g> <publications> <term>6</term> <term canonical="true">20</term> <term>21</term> </publications> <sections> <term canonical="true">27970</term> <term>39313</term> </sections> <topics> <term canonical="true">319</term> <term>278</term> <term>234</term> </topics> <links/> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>Droplet dispersal in sterile processing units far exceeds guideline limit</title> <deck/> </itemMeta> <itemContent> <p>In the era of Ebola, COVID-19, and even Legionnaires, technicians and other staff working behind the scenes to ensure provider and patient safety continue to face a long-recognized but under addressed challenge: splashes and airborne droplets.</p> <p>Granted, National Institute for Occupational Safety and Health (NIOSH) standards, industry standards, and professional guidelines are all in place to prevent unintentional exposure to pathogens. However, findings from a <a href="https://www.ajicjournal.org/article/S0196-6553(22)00629-0/fulltext">newly published study</a> in the American Journal of Infection Control suggest they fall short.<br/><br/>In the study, researchers found that simulated manual cleaning of medical devices generated a drenching splash throughout the process with droplet dispersal exceeding 7 feet (2.1 meters).<br/><br/><span class="tag metaDescription">“The guidelines say that droplets stop at 3 or 4 feet, and they don’t,”</span> Cori L. Ofstead, MSPH, lead author and president/CEO of Ofstead &amp; Associates, Bloomington, Minn., told this news organization. “That’s the problem with having standards and guidelines that are not based on relevant evidence, [which] in this case, is a single study that was done in an intensive care area where they had an infection outbreak.”<br/><br/>Ms. Ofstead was referring to a <a href="https://pubmed.ncbi.nlm.nih.gov/19046054/">report</a> in the journal Infection Control and Hospital Epidemiology, detailing a Canadian investigation involving a multidrug-resistant Pseudomonas aeruginosa outbreak in an ICU. The report implicated the faucets over the hand hygiene sinks, with fluorescent dye showing droplet dispersal roughly 3 feet away from the sinks.<br/><br/>“Somehow it [the 3-feet rule] got implemented in guidelines in sterile processing decontamination areas, which are not the same as hand hygiene,’’ Ms. Ofstead explained.<br/><br/>With a goal of providing more current evidence on droplet generation and dispersal, as well as personal protection equipment (PPE) exposure/effectiveness, she and her colleagues simulated manual cleaning of a decommissioned colonoscope and transvaginal ultrasound probe, using for the study location a new academic sterile processing unit.<br/><br/>To detect droplet generation and dispersal as well as splash following common technician activities (for example, colonoscope brushing, scrubbing, rinsing and transport to an automated endoscope reprocessor [AER] for sterilization), the researchers affixed blue moisture-detection paper to environmental surfaces, on carts positioned 4 feet (1.2 meters) from the sink (to simulate observers), and along a 15-foot pathway between the sink and AER.<br/><br/>They observed droplets everywhere.<br/><br/>Technician activities such as running the faucet and rinsing the probe under running water generated substantial splashing overall. Instrument rinsing in particular produced small and large droplets and confluent puddles of water around the sink and in the broad area surrounding the workspace. Droplets were also dispersed on the floor 7.25 feet (2.2 meters) away and along the entire 15-foot path from the sink to the AER.<br/><br/>At the sink, the technician risked drenching exposure from head to toe during most activities, and even observers positioned 3-4 feet away were found to have droplets on their gowns. In addition, saturated shoe covers reportedly tracked moisture away from the sink to the unit door – a distance of 13 feet (4 meters) – and 2 feet (0.6 meters) farther out into the PPE foyer for donning and doffing.<br/><br/>Although PPE gowns effectively repelled moisture during cleaning of a single device, Ms. Ofstead emphasized that technicians typically handle up to 10 instruments during a normal, 2-hour shift, further increasing exposure risk with each subsequent cleaning.<br/><br/>However, perhaps one of the most surprising findings was that despite an optimal unit design, including physical separation of clean and dirty activities and pressurized air flow to protect workers, droplets were still broadly dispersed.<br/><br/>Current efforts, however well-intentioned, might not be offering the degree of protection (and consideration) that sterile processing technicians need.<br/><br/>“The study was conducted in a new sterile processing area that had an extra excellent kind of distancing and three separate rooms, something that I think most of our hospitals are working toward,” Stella Hines, MD, associate professor at the University of Maryland School of Medicine, Baltimore, explained. Dr. Hines was not directly involved in the study.<br/><br/>“But it also really kind of highlighted what’s happening to workers potentially,” she added. “For example, we want to know if that spray or splatter has a live microbe it in that could cause a problem or ... in a highly wet environment, if that water has some kind of chemical in it that could pose an occupational hazard to the worker based on skin or mucous membrane exposure.”<br/><br/>Ms. Ofstead agreed. “We need to be thinking about the exposure of critically important workers and the environment in an era where we are worried about aerosol-generating procedures and superbugs,” she explained.<br/><br/>Dr. Hines and Ms. Ofstead also noted that the majority of staff involved in front-line patient care have never actually ventured into the sterile processing units nor do they recognize the risks that technicians working in these units face on a daily, or even hourly, basis.<br/><br/>“The people who run these operations are very well trained and knowledgeable. I think that it would be helpful for them to know that they’re appreciated and for the people upstairs on the front lines using the equipment to see what goes on downstairs and all of the painstaking steps that need to be in place for the equipment to come out of sterile processing and be ready to go,” said Dr. Hines.<br/><br/>In the meantime, hospital leaders need to address the challenges and danger posed by migrating infectious droplets, especially for workers involved in processes that stir them up in the first place – workers who by the end of their shifts are unavoidably drenched with infectious blood and tissue secretions.<br/><br/>“I think that it’s going to take a much bigger kind of worldview from hospital leadership,” Dr. Hines said.<br/><br/>The study was supported in part by a grant from Healthmark Industries. Ms. Ofstead reports research grants or consulting fees through her organization with 3M Company, Ambu, Boston Scientific, Cleanis, Fortive/Advanced Sterilization Products, Healthmark Industries, Pentax, and Steris/Cantel/Medviators. Dr. Hines reports no relevant financial relationships.<span class="end"/> </p> <p> <em>A version of this article first appeared on <span class="Hyperlink"><a href="https://www.medscape.com/viewarticle/983035">Medscape.com</a></span>.</em> </p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>
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FROM THE AMERICAN JOURNAL OF INFECTION CONTROL

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C. diff recurrence drops with highly targeted ridinilazole

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C. diff recurrence drops with highly targeted ridinilazole

Ridinilazole, a novel, highly specific antibiotic, was safe and showed a sustained clinical response in patients with Clostridioides difficile infection (CDI), according to phase 3 trial results presented at an annual scientific meeting on infectious diseases.

According to the Centers for Disease Control and Prevention, CDI is the top cause of antibiotic-associated diarrhea and one of the most common health care–associated infections in the United States. About 200,000 people in the United States are infected with C. difficile every year in the hospital or clinical care setting.

Most infections are currently treated with vancomycin. Although vancomycin has been shown to be more than 80% effective, it has been linked with recurrence rates ranging from 20% to 30% and interferes with the protective role of the gut microbiome against infection. The current study compared ridinilazole with vancomycin.

Results of the global, double-blinded, randomized trial were presented by Pablo C. Okhuysen, MD, professor of infectious disease at the University of Texas MD Anderson Cancer Center, Houston.

Participants with CDI received a 10-day course of ridinilazole 200 mg twice a day plus placebo or vancomycin 125 mg four times a day. The primary endpoint was sustained clinical response, defined as a clinical response with no recurrent CDI through 30 days after the end of treatment. Recurrent CDI was defined as a new episode of diarrhea with confirmed positive free toxin test requiring additional therapy.

Of the 759 patients enrolled, 745 were included in the modified intention-to-treat  population (ridinilazole, n = 370; vancomycin, n = 375). Ridinilazole achieved a numerically higher rate of sustained clinical response than vancomycin (73.0% vs. 70.7%; P = .467), although the difference was not significant. Ridinilazole also resulted in a significant reduction in recurrence rate (8.1% vs. 17.3%; P < .001).

Ridinilazole’s effect was most notable in a subgroup of patients who were not receiving other antibiotics at time of enrollment – about 70% of participants. In that subgroup, the recurrence rate was 6.7% with ridinilazole versus 16.5% with vancomycin (P < .001), Dr. Okhuysen reported.

“That resulted in a relative risk reduction of 60%,” Dr. Okhuysen told this news organization.

Dr. Okhuysen pointed out that there are currently very few treatment options for CDI other than vancomycin.

“We need new agents to treat C. difficile,” he said, “particularly for those at risk of recurrence. In our study, we found that those exposed to vancomycin had very dramatic shifts in their microbiome.”

Vancomycin depletes the gut microbiome, which decreases the conversion of primary acids to secondary bile acids, the researchers noted.

“A dysbiotic microbiome is fertile ground for C. difficile to grow,” Dr. Okhuysen said. Ridinilazole does not disrupt the microbiome, he added.

Ridinilazole was well-tolerated in the study. The proportion of patients with at least one treatment-emergent adverse effect was 36.4% versus 35.5%, respectively, in the ridinilazole and vancomycin groups. And the proportion who stopped treatment because of treatment-related side effects was 0.8% versus 2.9%.

Mary Hayden, MD, pathology director in the division of infectious diseases at Rush University Medical Center, Chicago, who was not involved with the study, said the results are encouraging as “alternative agents or strategies to prevent recurrence are important to reduce CDI morbidity.”

Its double-blind, randomized, multicenter design strengthens the findings, she explained, adding that “the secondary outcomes of higher concentrations of secondary bile acids and microbiota diversity and composition lend biological plausibility.”

Ridinilazole’s narrow spectrum of activity “should result in less disruption of the colonic microbiota, which has theoretical benefit for both reducing CDI recurrence and for reducing risk of acquisition of multidrug-resistant organisms,” Dr. Hayden said.

Dr. Okhuysen shared that the team is in talks with the Food and Drug Administration and is preparing a manuscript for publication.

The study was supported by Summit Pharmaceuticals and funded by the Biomedical and Advanced Research and Development Authority. Dr. Okhuysen has reported receiving research support from and/or consulting for Summit, Merck, Deinove, Melinta, and Ferring Pharmaceuticals. Some of the coauthors have financial relationships with or received research support from Summit. Dr. Hayden has reported no relevant financial relationships.

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

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Ridinilazole, a novel, highly specific antibiotic, was safe and showed a sustained clinical response in patients with Clostridioides difficile infection (CDI), according to phase 3 trial results presented at an annual scientific meeting on infectious diseases.

According to the Centers for Disease Control and Prevention, CDI is the top cause of antibiotic-associated diarrhea and one of the most common health care–associated infections in the United States. About 200,000 people in the United States are infected with C. difficile every year in the hospital or clinical care setting.

Most infections are currently treated with vancomycin. Although vancomycin has been shown to be more than 80% effective, it has been linked with recurrence rates ranging from 20% to 30% and interferes with the protective role of the gut microbiome against infection. The current study compared ridinilazole with vancomycin.

Results of the global, double-blinded, randomized trial were presented by Pablo C. Okhuysen, MD, professor of infectious disease at the University of Texas MD Anderson Cancer Center, Houston.

Participants with CDI received a 10-day course of ridinilazole 200 mg twice a day plus placebo or vancomycin 125 mg four times a day. The primary endpoint was sustained clinical response, defined as a clinical response with no recurrent CDI through 30 days after the end of treatment. Recurrent CDI was defined as a new episode of diarrhea with confirmed positive free toxin test requiring additional therapy.

Of the 759 patients enrolled, 745 were included in the modified intention-to-treat  population (ridinilazole, n = 370; vancomycin, n = 375). Ridinilazole achieved a numerically higher rate of sustained clinical response than vancomycin (73.0% vs. 70.7%; P = .467), although the difference was not significant. Ridinilazole also resulted in a significant reduction in recurrence rate (8.1% vs. 17.3%; P < .001).

Ridinilazole’s effect was most notable in a subgroup of patients who were not receiving other antibiotics at time of enrollment – about 70% of participants. In that subgroup, the recurrence rate was 6.7% with ridinilazole versus 16.5% with vancomycin (P < .001), Dr. Okhuysen reported.

“That resulted in a relative risk reduction of 60%,” Dr. Okhuysen told this news organization.

Dr. Okhuysen pointed out that there are currently very few treatment options for CDI other than vancomycin.

“We need new agents to treat C. difficile,” he said, “particularly for those at risk of recurrence. In our study, we found that those exposed to vancomycin had very dramatic shifts in their microbiome.”

Vancomycin depletes the gut microbiome, which decreases the conversion of primary acids to secondary bile acids, the researchers noted.

“A dysbiotic microbiome is fertile ground for C. difficile to grow,” Dr. Okhuysen said. Ridinilazole does not disrupt the microbiome, he added.

Ridinilazole was well-tolerated in the study. The proportion of patients with at least one treatment-emergent adverse effect was 36.4% versus 35.5%, respectively, in the ridinilazole and vancomycin groups. And the proportion who stopped treatment because of treatment-related side effects was 0.8% versus 2.9%.

Mary Hayden, MD, pathology director in the division of infectious diseases at Rush University Medical Center, Chicago, who was not involved with the study, said the results are encouraging as “alternative agents or strategies to prevent recurrence are important to reduce CDI morbidity.”

Its double-blind, randomized, multicenter design strengthens the findings, she explained, adding that “the secondary outcomes of higher concentrations of secondary bile acids and microbiota diversity and composition lend biological plausibility.”

Ridinilazole’s narrow spectrum of activity “should result in less disruption of the colonic microbiota, which has theoretical benefit for both reducing CDI recurrence and for reducing risk of acquisition of multidrug-resistant organisms,” Dr. Hayden said.

Dr. Okhuysen shared that the team is in talks with the Food and Drug Administration and is preparing a manuscript for publication.

The study was supported by Summit Pharmaceuticals and funded by the Biomedical and Advanced Research and Development Authority. Dr. Okhuysen has reported receiving research support from and/or consulting for Summit, Merck, Deinove, Melinta, and Ferring Pharmaceuticals. Some of the coauthors have financial relationships with or received research support from Summit. Dr. Hayden has reported no relevant financial relationships.

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

Ridinilazole, a novel, highly specific antibiotic, was safe and showed a sustained clinical response in patients with Clostridioides difficile infection (CDI), according to phase 3 trial results presented at an annual scientific meeting on infectious diseases.

According to the Centers for Disease Control and Prevention, CDI is the top cause of antibiotic-associated diarrhea and one of the most common health care–associated infections in the United States. About 200,000 people in the United States are infected with C. difficile every year in the hospital or clinical care setting.

Most infections are currently treated with vancomycin. Although vancomycin has been shown to be more than 80% effective, it has been linked with recurrence rates ranging from 20% to 30% and interferes with the protective role of the gut microbiome against infection. The current study compared ridinilazole with vancomycin.

Results of the global, double-blinded, randomized trial were presented by Pablo C. Okhuysen, MD, professor of infectious disease at the University of Texas MD Anderson Cancer Center, Houston.

Participants with CDI received a 10-day course of ridinilazole 200 mg twice a day plus placebo or vancomycin 125 mg four times a day. The primary endpoint was sustained clinical response, defined as a clinical response with no recurrent CDI through 30 days after the end of treatment. Recurrent CDI was defined as a new episode of diarrhea with confirmed positive free toxin test requiring additional therapy.

Of the 759 patients enrolled, 745 were included in the modified intention-to-treat  population (ridinilazole, n = 370; vancomycin, n = 375). Ridinilazole achieved a numerically higher rate of sustained clinical response than vancomycin (73.0% vs. 70.7%; P = .467), although the difference was not significant. Ridinilazole also resulted in a significant reduction in recurrence rate (8.1% vs. 17.3%; P < .001).

Ridinilazole’s effect was most notable in a subgroup of patients who were not receiving other antibiotics at time of enrollment – about 70% of participants. In that subgroup, the recurrence rate was 6.7% with ridinilazole versus 16.5% with vancomycin (P < .001), Dr. Okhuysen reported.

“That resulted in a relative risk reduction of 60%,” Dr. Okhuysen told this news organization.

Dr. Okhuysen pointed out that there are currently very few treatment options for CDI other than vancomycin.

“We need new agents to treat C. difficile,” he said, “particularly for those at risk of recurrence. In our study, we found that those exposed to vancomycin had very dramatic shifts in their microbiome.”

Vancomycin depletes the gut microbiome, which decreases the conversion of primary acids to secondary bile acids, the researchers noted.

“A dysbiotic microbiome is fertile ground for C. difficile to grow,” Dr. Okhuysen said. Ridinilazole does not disrupt the microbiome, he added.

Ridinilazole was well-tolerated in the study. The proportion of patients with at least one treatment-emergent adverse effect was 36.4% versus 35.5%, respectively, in the ridinilazole and vancomycin groups. And the proportion who stopped treatment because of treatment-related side effects was 0.8% versus 2.9%.

Mary Hayden, MD, pathology director in the division of infectious diseases at Rush University Medical Center, Chicago, who was not involved with the study, said the results are encouraging as “alternative agents or strategies to prevent recurrence are important to reduce CDI morbidity.”

Its double-blind, randomized, multicenter design strengthens the findings, she explained, adding that “the secondary outcomes of higher concentrations of secondary bile acids and microbiota diversity and composition lend biological plausibility.”

Ridinilazole’s narrow spectrum of activity “should result in less disruption of the colonic microbiota, which has theoretical benefit for both reducing CDI recurrence and for reducing risk of acquisition of multidrug-resistant organisms,” Dr. Hayden said.

Dr. Okhuysen shared that the team is in talks with the Food and Drug Administration and is preparing a manuscript for publication.

The study was supported by Summit Pharmaceuticals and funded by the Biomedical and Advanced Research and Development Authority. Dr. Okhuysen has reported receiving research support from and/or consulting for Summit, Merck, Deinove, Melinta, and Ferring Pharmaceuticals. Some of the coauthors have financial relationships with or received research support from Summit. Dr. Hayden has reported no relevant financial relationships.

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

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Although vancomycin has been shown to be more than 80% effective, it has been linked with recurrence rates ranging from 20% to 30% and interferes with the protective role of the gut microbiome against infection. The current study compared ridinilazole with vancomycin.<br/><br/>Results of the global, double-blinded, randomized trial were presented by Pablo C. Okhuysen, MD, professor of infectious disease at the University of Texas MD Anderson Cancer Center, Houston.<br/><br/>Participants with CDI received a 10-day course of ridinilazole 200 mg twice a day plus placebo or vancomycin 125 mg four times a day. The primary endpoint was sustained clinical response, defined as a clinical response with no recurrent CDI through 30 days after the end of treatment. Recurrent CDI was defined as a new episode of diarrhea with confirmed positive free toxin test requiring additional therapy.<br/><br/>Of the 759 patients enrolled, 745 were included in the modified intention-to-treat  population (ridinilazole, n = 370; vancomycin, n = 375). Ridinilazole achieved a numerically higher rate of sustained clinical response than vancomycin (73.0% vs. 70.7%; <em>P</em> = .467), although the difference was not significant. Ridinilazole also resulted in a significant reduction in recurrence rate (8.1% vs. 17.3%; <em>P</em> &lt; .001).<br/><br/>Ridinilazole’s effect was most notable in a subgroup of patients who were not receiving other antibiotics at time of enrollment – about 70% of participants. In that subgroup, the recurrence rate was 6.7% with ridinilazole versus 16.5% with vancomycin (<em>P</em> &lt; .001), Dr. Okhuysen reported.<br/><br/>“That resulted in a relative risk reduction of 60%,” Dr. Okhuysen told this news organization.<br/><br/>Dr. Okhuysen pointed out that there are currently very few treatment options for CDI other than vancomycin.<br/><br/>“We need new agents to treat <em>C. difficile</em>,” he said, “particularly for those at risk of recurrence. In our study, we found that those exposed to vancomycin had very dramatic shifts in their microbiome.”<br/><br/>Vancomycin depletes the gut microbiome, which decreases the conversion of primary acids to secondary bile acids, the researchers noted.<br/><br/>“A dysbiotic microbiome is fertile ground for <em>C. difficile</em> to grow,” Dr. Okhuysen said. Ridinilazole does not disrupt the microbiome, he added.<br/><br/>Ridinilazole was well-tolerated in the study. The proportion of patients with at least one treatment-emergent adverse effect was 36.4% versus 35.5%, respectively, in the ridinilazole and vancomycin groups. And the proportion who stopped treatment because of treatment-related side effects was 0.8% versus 2.9%.<br/><br/>Mary Hayden, MD, pathology director in the division of infectious diseases at Rush University Medical Center, Chicago, who was not involved with the study, said the results are encouraging as “alternative agents or strategies to prevent recurrence are important to reduce CDI morbidity.”<br/><br/>Its double-blind, randomized, multicenter design strengthens the findings, she explained, adding that “the secondary outcomes of higher concentrations of secondary bile acids and microbiota diversity and composition lend biological plausibility.”<br/><br/>Ridinilazole’s narrow spectrum of activity “should result in less disruption of the colonic microbiota, which has theoretical benefit for both reducing CDI recurrence and for reducing risk of acquisition of multidrug-resistant organisms,” Dr. Hayden said.<br/><br/>Dr. Okhuysen shared that the team is in talks with the Food and Drug Administration and is preparing a manuscript for publication.<br/><br/>The study was supported by Summit Pharmaceuticals and funded by the Biomedical and Advanced Research and Development Authority. Dr. Okhuysen has reported receiving research support from and/or consulting for Summit, Merck, Deinove, Melinta, and Ferring Pharmaceuticals. Some of the coauthors have financial relationships with or received research support from Summit. Dr. Hayden has reported no relevant financial relationships.<span class="end"/></p> <p> <em>A version of this article first appeared on <span class="Hyperlink"><a href="https://www.medscape.com/viewarticle/982797">Medscape.com</a></span>.</em> </p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>
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