User login
SUDs rates highest in head, neck, and gastric cancer survivors
.
The association between cancer and substance use is well known, but data on the prevalence of different substance use disorders (SUDs) in different types of cancer are limited, Katie F. Jones, PhD, of the VA Boston Healthcare System, and colleagues, wrote in their paper.
“Substance use and use disorders are on the rise in general and among older adults, who represent the majority of people diagnosed with cancer, and SUDs have significant potential to complicate cancer care and negatively impact cancer outcomes,” corresponding author Devon K. Check, PhD, of Duke University, Durham, N.C., said in an interview. “We thought it was important to understand whether SUDs are more common with certain types of cancer. We can use that information to guide resources toward populations where interventions to integrate SUD treatment and cancer treatment are most needed,” he said. “In addition, because different SUDs (opioid use disorder, alcohol use disorder) might complicate cancer treatment in different ways and necessitate different types of interventions, we thought it was important to understand the distribution of specific disorders,” he explained.
In the cross-sectional study published in JAMA Oncology, the researchers reviewed data from 6,101 adult cancer survivors who participated in the National Survey of Drug Use and Health (NSDUH) between 2015 and 2020.
The study population included survivors of solid tumor cancers. SUD was defined as meeting at least one of four criteria for substance abuse or at least 3 of 6 criteria for dependence based on the Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition) criteria.
Overall, 3.83% of the participants met criteria for SUD. Survivors of head and neck cancers and survivors of gastric and esophageal cancers had the highest rates of SUDs (approximately 9%), followed by cervical cancer and melanoma survivors (approximately 6%).
Alcohol use disorder was the most common SUD both overall (2.8%) and among survivors of head and neck cancers, cervical cancers, and melanoma.
Cannabis use disorder was the most prevalent SUD among esophageal and gastric cancer survivors (approximately 9%).
The prevalence of SUDs overall and within the past year (active) was approximately 4%, but the prevalence of active SUDs was significantly higher for those with head and neck cancers and cervical cancer (18.73% and 15.70%, respectively). However, the distribution of specific SUDs was different in the newly diagnosed patients. Sedative use disorder took the top spot as the most common SUD for head and neck cancer survivors (9.81%), while alcohol use disorder was the most common SUD among cervical cancer survivors (10.49%).
Limitations and Implications
The findings were limited by several factors, including the nature of the study population and the data source, said Dr. Check.
“The average prevalence of SUD (or the prevalence across cancer types) was lower than we might have expected,” but the results make sense given the mainly older and female study population, he said. SUDs are less common among older adults compared with younger adults and among women compared with men, and the study’s data source (NSDUH) has been shown in other research to underestimate the prevalence of opioid use disorder, he added.
“Otherwise, the study findings were generally consistent with what we would expect,” Dr. Check said in an interview. “For example, alcohol use disorder is the most common SUD in the general U.S. population, and that was true for our study population of cancer survivors as well. In addition, SUD prevalence was higher in cancers such as cervical cancer and head and neck cancers that are causally linked to alcohol and/or tobacco use,” he said.
Integrated care is needed
“Among people diagnosed with certain types of cancers, including cervical and head and neck cancers, the estimated prevalence of SUD is similar to those [with] medical comorbidities such as diabetes and cardiopulmonary conditions,” said Dr. Check. “Within the field, there is an increasing emphasis on ensuring that people diagnosed with cancer have access to integrated care for their comorbid medical conditions. Similar efforts for people who concurrently manage cancer and SUD are largely absent but critically needed; these efforts should prioritize cancer populations where SUD prevalence is high,” he said.
Looking ahead, “We need to understand more about the specific challenges that arise at the intersection of cancer and SUD so we can design interventions and programs to better support both patients who concurrently manage cancer and SUD and the clinicians who care for them,” Dr. Check added.
Recognize risk factors
“It is very important to study overall substance use disorders in patients with cancer, because understanding the risks of developing these issues after treatment helps us develop approaches to best support these patients following their cancer therapies,” Henry S. Park, MD, a radiation oncologist at Yale University, New Haven, Connecticut, said in an interview.
The current study findings “are generally consistent with my experience and intuition, but it is still helpful to see the actual data,” said Dr. Park, who was not involved in the study. “This may be partially because of the baseline elevated risk of preexisting SUDs for certain patients from the higher-prevalence disease sites. However, it may also be related to the intense side effects that survivors of some types of cancers, such as head and neck cancer, gastroesophageal cancer, and cervical cancer, may experience soon after treatment, and even chronically long after treatment,” he said.
Individualize risk assessment
“Ultimately, clinicians should be aware that not all patients with cancer are the same, and that the majority do not necessarily develop SUDs,” Dr. Park said in an interview. “We should be careful to treat symptoms appropriately, and not withhold therapies purely because of an elevated risk of developing SUDs. However, there are some patients who are at higher risk of SUDs who will need extra support and care from physicians, advanced practice providers, nutritionists, social workers, psychologists, dietitians, and survivorship clinics, both in the short-term and long-term,” he emphasized.
As for additional research, “more work needs to be done on which particular patients within each disease subset are most likely to develop SUDs,” said Dr. Park. “Most importantly, once we identify our high-risk group as reliably as possible, we will have to study interventions that rely on supporting and partnering with patients to decrease the risk of developing SUDs as much as possible, while adequately treating residual symptoms and quality-of-life effects following cancer treatment,” he said.
The study received no outside funding. Dr. Check disclosed grants from Duke University during the study period and grants from the National Institutes of Health and AstraZeneca unrelated to the current study. Dr. Park had no financial conflicts to disclose.
.
The association between cancer and substance use is well known, but data on the prevalence of different substance use disorders (SUDs) in different types of cancer are limited, Katie F. Jones, PhD, of the VA Boston Healthcare System, and colleagues, wrote in their paper.
“Substance use and use disorders are on the rise in general and among older adults, who represent the majority of people diagnosed with cancer, and SUDs have significant potential to complicate cancer care and negatively impact cancer outcomes,” corresponding author Devon K. Check, PhD, of Duke University, Durham, N.C., said in an interview. “We thought it was important to understand whether SUDs are more common with certain types of cancer. We can use that information to guide resources toward populations where interventions to integrate SUD treatment and cancer treatment are most needed,” he said. “In addition, because different SUDs (opioid use disorder, alcohol use disorder) might complicate cancer treatment in different ways and necessitate different types of interventions, we thought it was important to understand the distribution of specific disorders,” he explained.
In the cross-sectional study published in JAMA Oncology, the researchers reviewed data from 6,101 adult cancer survivors who participated in the National Survey of Drug Use and Health (NSDUH) between 2015 and 2020.
The study population included survivors of solid tumor cancers. SUD was defined as meeting at least one of four criteria for substance abuse or at least 3 of 6 criteria for dependence based on the Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition) criteria.
Overall, 3.83% of the participants met criteria for SUD. Survivors of head and neck cancers and survivors of gastric and esophageal cancers had the highest rates of SUDs (approximately 9%), followed by cervical cancer and melanoma survivors (approximately 6%).
Alcohol use disorder was the most common SUD both overall (2.8%) and among survivors of head and neck cancers, cervical cancers, and melanoma.
Cannabis use disorder was the most prevalent SUD among esophageal and gastric cancer survivors (approximately 9%).
The prevalence of SUDs overall and within the past year (active) was approximately 4%, but the prevalence of active SUDs was significantly higher for those with head and neck cancers and cervical cancer (18.73% and 15.70%, respectively). However, the distribution of specific SUDs was different in the newly diagnosed patients. Sedative use disorder took the top spot as the most common SUD for head and neck cancer survivors (9.81%), while alcohol use disorder was the most common SUD among cervical cancer survivors (10.49%).
Limitations and Implications
The findings were limited by several factors, including the nature of the study population and the data source, said Dr. Check.
“The average prevalence of SUD (or the prevalence across cancer types) was lower than we might have expected,” but the results make sense given the mainly older and female study population, he said. SUDs are less common among older adults compared with younger adults and among women compared with men, and the study’s data source (NSDUH) has been shown in other research to underestimate the prevalence of opioid use disorder, he added.
“Otherwise, the study findings were generally consistent with what we would expect,” Dr. Check said in an interview. “For example, alcohol use disorder is the most common SUD in the general U.S. population, and that was true for our study population of cancer survivors as well. In addition, SUD prevalence was higher in cancers such as cervical cancer and head and neck cancers that are causally linked to alcohol and/or tobacco use,” he said.
Integrated care is needed
“Among people diagnosed with certain types of cancers, including cervical and head and neck cancers, the estimated prevalence of SUD is similar to those [with] medical comorbidities such as diabetes and cardiopulmonary conditions,” said Dr. Check. “Within the field, there is an increasing emphasis on ensuring that people diagnosed with cancer have access to integrated care for their comorbid medical conditions. Similar efforts for people who concurrently manage cancer and SUD are largely absent but critically needed; these efforts should prioritize cancer populations where SUD prevalence is high,” he said.
Looking ahead, “We need to understand more about the specific challenges that arise at the intersection of cancer and SUD so we can design interventions and programs to better support both patients who concurrently manage cancer and SUD and the clinicians who care for them,” Dr. Check added.
Recognize risk factors
“It is very important to study overall substance use disorders in patients with cancer, because understanding the risks of developing these issues after treatment helps us develop approaches to best support these patients following their cancer therapies,” Henry S. Park, MD, a radiation oncologist at Yale University, New Haven, Connecticut, said in an interview.
The current study findings “are generally consistent with my experience and intuition, but it is still helpful to see the actual data,” said Dr. Park, who was not involved in the study. “This may be partially because of the baseline elevated risk of preexisting SUDs for certain patients from the higher-prevalence disease sites. However, it may also be related to the intense side effects that survivors of some types of cancers, such as head and neck cancer, gastroesophageal cancer, and cervical cancer, may experience soon after treatment, and even chronically long after treatment,” he said.
Individualize risk assessment
“Ultimately, clinicians should be aware that not all patients with cancer are the same, and that the majority do not necessarily develop SUDs,” Dr. Park said in an interview. “We should be careful to treat symptoms appropriately, and not withhold therapies purely because of an elevated risk of developing SUDs. However, there are some patients who are at higher risk of SUDs who will need extra support and care from physicians, advanced practice providers, nutritionists, social workers, psychologists, dietitians, and survivorship clinics, both in the short-term and long-term,” he emphasized.
As for additional research, “more work needs to be done on which particular patients within each disease subset are most likely to develop SUDs,” said Dr. Park. “Most importantly, once we identify our high-risk group as reliably as possible, we will have to study interventions that rely on supporting and partnering with patients to decrease the risk of developing SUDs as much as possible, while adequately treating residual symptoms and quality-of-life effects following cancer treatment,” he said.
The study received no outside funding. Dr. Check disclosed grants from Duke University during the study period and grants from the National Institutes of Health and AstraZeneca unrelated to the current study. Dr. Park had no financial conflicts to disclose.
.
The association between cancer and substance use is well known, but data on the prevalence of different substance use disorders (SUDs) in different types of cancer are limited, Katie F. Jones, PhD, of the VA Boston Healthcare System, and colleagues, wrote in their paper.
“Substance use and use disorders are on the rise in general and among older adults, who represent the majority of people diagnosed with cancer, and SUDs have significant potential to complicate cancer care and negatively impact cancer outcomes,” corresponding author Devon K. Check, PhD, of Duke University, Durham, N.C., said in an interview. “We thought it was important to understand whether SUDs are more common with certain types of cancer. We can use that information to guide resources toward populations where interventions to integrate SUD treatment and cancer treatment are most needed,” he said. “In addition, because different SUDs (opioid use disorder, alcohol use disorder) might complicate cancer treatment in different ways and necessitate different types of interventions, we thought it was important to understand the distribution of specific disorders,” he explained.
In the cross-sectional study published in JAMA Oncology, the researchers reviewed data from 6,101 adult cancer survivors who participated in the National Survey of Drug Use and Health (NSDUH) between 2015 and 2020.
The study population included survivors of solid tumor cancers. SUD was defined as meeting at least one of four criteria for substance abuse or at least 3 of 6 criteria for dependence based on the Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition) criteria.
Overall, 3.83% of the participants met criteria for SUD. Survivors of head and neck cancers and survivors of gastric and esophageal cancers had the highest rates of SUDs (approximately 9%), followed by cervical cancer and melanoma survivors (approximately 6%).
Alcohol use disorder was the most common SUD both overall (2.8%) and among survivors of head and neck cancers, cervical cancers, and melanoma.
Cannabis use disorder was the most prevalent SUD among esophageal and gastric cancer survivors (approximately 9%).
The prevalence of SUDs overall and within the past year (active) was approximately 4%, but the prevalence of active SUDs was significantly higher for those with head and neck cancers and cervical cancer (18.73% and 15.70%, respectively). However, the distribution of specific SUDs was different in the newly diagnosed patients. Sedative use disorder took the top spot as the most common SUD for head and neck cancer survivors (9.81%), while alcohol use disorder was the most common SUD among cervical cancer survivors (10.49%).
Limitations and Implications
The findings were limited by several factors, including the nature of the study population and the data source, said Dr. Check.
“The average prevalence of SUD (or the prevalence across cancer types) was lower than we might have expected,” but the results make sense given the mainly older and female study population, he said. SUDs are less common among older adults compared with younger adults and among women compared with men, and the study’s data source (NSDUH) has been shown in other research to underestimate the prevalence of opioid use disorder, he added.
“Otherwise, the study findings were generally consistent with what we would expect,” Dr. Check said in an interview. “For example, alcohol use disorder is the most common SUD in the general U.S. population, and that was true for our study population of cancer survivors as well. In addition, SUD prevalence was higher in cancers such as cervical cancer and head and neck cancers that are causally linked to alcohol and/or tobacco use,” he said.
Integrated care is needed
“Among people diagnosed with certain types of cancers, including cervical and head and neck cancers, the estimated prevalence of SUD is similar to those [with] medical comorbidities such as diabetes and cardiopulmonary conditions,” said Dr. Check. “Within the field, there is an increasing emphasis on ensuring that people diagnosed with cancer have access to integrated care for their comorbid medical conditions. Similar efforts for people who concurrently manage cancer and SUD are largely absent but critically needed; these efforts should prioritize cancer populations where SUD prevalence is high,” he said.
Looking ahead, “We need to understand more about the specific challenges that arise at the intersection of cancer and SUD so we can design interventions and programs to better support both patients who concurrently manage cancer and SUD and the clinicians who care for them,” Dr. Check added.
Recognize risk factors
“It is very important to study overall substance use disorders in patients with cancer, because understanding the risks of developing these issues after treatment helps us develop approaches to best support these patients following their cancer therapies,” Henry S. Park, MD, a radiation oncologist at Yale University, New Haven, Connecticut, said in an interview.
The current study findings “are generally consistent with my experience and intuition, but it is still helpful to see the actual data,” said Dr. Park, who was not involved in the study. “This may be partially because of the baseline elevated risk of preexisting SUDs for certain patients from the higher-prevalence disease sites. However, it may also be related to the intense side effects that survivors of some types of cancers, such as head and neck cancer, gastroesophageal cancer, and cervical cancer, may experience soon after treatment, and even chronically long after treatment,” he said.
Individualize risk assessment
“Ultimately, clinicians should be aware that not all patients with cancer are the same, and that the majority do not necessarily develop SUDs,” Dr. Park said in an interview. “We should be careful to treat symptoms appropriately, and not withhold therapies purely because of an elevated risk of developing SUDs. However, there are some patients who are at higher risk of SUDs who will need extra support and care from physicians, advanced practice providers, nutritionists, social workers, psychologists, dietitians, and survivorship clinics, both in the short-term and long-term,” he emphasized.
As for additional research, “more work needs to be done on which particular patients within each disease subset are most likely to develop SUDs,” said Dr. Park. “Most importantly, once we identify our high-risk group as reliably as possible, we will have to study interventions that rely on supporting and partnering with patients to decrease the risk of developing SUDs as much as possible, while adequately treating residual symptoms and quality-of-life effects following cancer treatment,” he said.
The study received no outside funding. Dr. Check disclosed grants from Duke University during the study period and grants from the National Institutes of Health and AstraZeneca unrelated to the current study. Dr. Park had no financial conflicts to disclose.
FROM JAMA ONCOLOGY
Researchers Take Aim at Genetic Influence on Asthma and Allergy
The impact of maternal factors on allergy and asthma is the subject of new research in the wake of a grant from the National Institute of Allergy and Infectious Diseases to a team at Indiana University School of Medicine, according to a university press release.
Researchers led by Joan Cook-Mills, PhD, will examine the mechanisms behind the development of asthma, food allergies, and allergic diseases in children whose mothers had allergies.
“Research from the Cook-Mills lab revealed mothers with allergies have elevated levels of a specific lipid within the eicosanoid class of lipids, suggesting this lipid may have a potential influence on their offspring also developing allergies,” according to the press release.
A 5-year grant for $3.9 million was awarded to extend work by the Cook-Mills lab, and the research will focus on four areas, according to the university:
The potential impact of higher levels of lipid from mothers’ lungs may affect infants’ risk for allergy and whether this lipid is transmitted to infants during pregnancy or breastfeeding.
The potential impact of elevated levels of a specific eicosanoid in mothers with allergies promotes the creation of more dendritic cells by fetal bone marrow and how this might affect allergy risk for infants.
, potentially leading to altered lung bacteria, which can affect immune cell responses to allergies and asthma.
The potential impact of elevated eicosanoids on whether the altered lung microbiome “actively changes the production of this eicosanoid in the lungs of allergic mothers,” according to the press release.
“Allergies and asthma cause a significant burden of disease in our pediatric population, which is further complicated by limited therapies and interventions to combat these diseases, let alone prevent their development,” Anne C. Coates, MD, a pediatric pulmonologist at Maine Medical Center, Portland, said in an interview.
“The work by Cook-Mills and her colleagues will expand our understanding of the role maternal health may have on allergies and asthma and opportunities to mitigate it,” she said. The key implications of the research are the potential to facilitate the development of future clinical studies and trials that could yield novel targeted treatments for significant allergies, Dr. Coates told this news organization.
The research by Cook-Mills and her team had “the potential for the development of transformative approaches to allergy prevention and management, which could improve the health and quality of life for scores of individuals worldwide,” she said.
Dr. Coates had no financial conflicts to disclose but served on the Editorial Advisory Board of Chest Physician.
A version of this article appeared on Medscape.com.
The impact of maternal factors on allergy and asthma is the subject of new research in the wake of a grant from the National Institute of Allergy and Infectious Diseases to a team at Indiana University School of Medicine, according to a university press release.
Researchers led by Joan Cook-Mills, PhD, will examine the mechanisms behind the development of asthma, food allergies, and allergic diseases in children whose mothers had allergies.
“Research from the Cook-Mills lab revealed mothers with allergies have elevated levels of a specific lipid within the eicosanoid class of lipids, suggesting this lipid may have a potential influence on their offspring also developing allergies,” according to the press release.
A 5-year grant for $3.9 million was awarded to extend work by the Cook-Mills lab, and the research will focus on four areas, according to the university:
The potential impact of higher levels of lipid from mothers’ lungs may affect infants’ risk for allergy and whether this lipid is transmitted to infants during pregnancy or breastfeeding.
The potential impact of elevated levels of a specific eicosanoid in mothers with allergies promotes the creation of more dendritic cells by fetal bone marrow and how this might affect allergy risk for infants.
, potentially leading to altered lung bacteria, which can affect immune cell responses to allergies and asthma.
The potential impact of elevated eicosanoids on whether the altered lung microbiome “actively changes the production of this eicosanoid in the lungs of allergic mothers,” according to the press release.
“Allergies and asthma cause a significant burden of disease in our pediatric population, which is further complicated by limited therapies and interventions to combat these diseases, let alone prevent their development,” Anne C. Coates, MD, a pediatric pulmonologist at Maine Medical Center, Portland, said in an interview.
“The work by Cook-Mills and her colleagues will expand our understanding of the role maternal health may have on allergies and asthma and opportunities to mitigate it,” she said. The key implications of the research are the potential to facilitate the development of future clinical studies and trials that could yield novel targeted treatments for significant allergies, Dr. Coates told this news organization.
The research by Cook-Mills and her team had “the potential for the development of transformative approaches to allergy prevention and management, which could improve the health and quality of life for scores of individuals worldwide,” she said.
Dr. Coates had no financial conflicts to disclose but served on the Editorial Advisory Board of Chest Physician.
A version of this article appeared on Medscape.com.
The impact of maternal factors on allergy and asthma is the subject of new research in the wake of a grant from the National Institute of Allergy and Infectious Diseases to a team at Indiana University School of Medicine, according to a university press release.
Researchers led by Joan Cook-Mills, PhD, will examine the mechanisms behind the development of asthma, food allergies, and allergic diseases in children whose mothers had allergies.
“Research from the Cook-Mills lab revealed mothers with allergies have elevated levels of a specific lipid within the eicosanoid class of lipids, suggesting this lipid may have a potential influence on their offspring also developing allergies,” according to the press release.
A 5-year grant for $3.9 million was awarded to extend work by the Cook-Mills lab, and the research will focus on four areas, according to the university:
The potential impact of higher levels of lipid from mothers’ lungs may affect infants’ risk for allergy and whether this lipid is transmitted to infants during pregnancy or breastfeeding.
The potential impact of elevated levels of a specific eicosanoid in mothers with allergies promotes the creation of more dendritic cells by fetal bone marrow and how this might affect allergy risk for infants.
, potentially leading to altered lung bacteria, which can affect immune cell responses to allergies and asthma.
The potential impact of elevated eicosanoids on whether the altered lung microbiome “actively changes the production of this eicosanoid in the lungs of allergic mothers,” according to the press release.
“Allergies and asthma cause a significant burden of disease in our pediatric population, which is further complicated by limited therapies and interventions to combat these diseases, let alone prevent their development,” Anne C. Coates, MD, a pediatric pulmonologist at Maine Medical Center, Portland, said in an interview.
“The work by Cook-Mills and her colleagues will expand our understanding of the role maternal health may have on allergies and asthma and opportunities to mitigate it,” she said. The key implications of the research are the potential to facilitate the development of future clinical studies and trials that could yield novel targeted treatments for significant allergies, Dr. Coates told this news organization.
The research by Cook-Mills and her team had “the potential for the development of transformative approaches to allergy prevention and management, which could improve the health and quality of life for scores of individuals worldwide,” she said.
Dr. Coates had no financial conflicts to disclose but served on the Editorial Advisory Board of Chest Physician.
A version of this article appeared on Medscape.com.
Severely Irregular Sleep Patterns and OSA Prompt Increased Odds of Hypertension
TOPLINE:
Severe sleep irregularity often occurs with obstructive sleep apnea (OSA), and this combination approximately doubled the odds of hypertension in middle-aged individuals.
METHODOLOGY:
- OSA has demonstrated an association with hypertension, but data on the impact of sleep irregularity on this relationship are lacking.
- The researchers used the recently developed sleep regularity index (SRI) to determine sleep patterns using a scale of 0-100 (with higher numbers indicating greater regularity) to assess relationships between OSA, sleep patterns, and hypertension in 602 adults with a mean age of 57 years.
- The study’s goal was an assessment of the associations between sleep regularity, OSA, and hypertension in a community sample of adults with normal circadian patterns.
TAKEAWAY:
- The odds of OSA were significantly greater for individuals with mildly irregular or severely irregular sleep than for regular sleepers (odds ratios, 1.97 and 2.06, respectively).
- Individuals with OSA and severely irregular sleep had the highest odds of hypertension compared with individuals with no OSA and regular sleep (OR, 2.34).
- However, participants with OSA and regular sleep or mildly irregular sleep had no significant increase in hypertension risk.
IN PRACTICE:
“Irregular sleep may be an important marker of OSA-related sleep disruption and may be an important modifiable health target,” the researchers wrote.
SOURCE:
The study was led by Kelly Sansom, a PhD candidate at the Centre for Sleep Science at the University of Western Australia, Albany. The study was published online in the journal Sleep.
LIMITATIONS:
The cross-sectional design prevented conclusions of causality, and the SRI is a nonspecific measure that may capture a range of phenotypes with one score; other limitations included the small sample sizes of sleep regularity groups and the use of actigraphy to collect sleep times.
DISCLOSURES:
The study was supported by an Australian Government Research Training Program Scholarship and the Raine Study PhD Top-up Scholarship; the Raine Study Scholarship is supported by the NHMRC, the Centre for Sleep Science, School of Anatomy, Physiology & Human Biology of the University of Western Australia, and the Lions Eye Institute. The researchers had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.
TOPLINE:
Severe sleep irregularity often occurs with obstructive sleep apnea (OSA), and this combination approximately doubled the odds of hypertension in middle-aged individuals.
METHODOLOGY:
- OSA has demonstrated an association with hypertension, but data on the impact of sleep irregularity on this relationship are lacking.
- The researchers used the recently developed sleep regularity index (SRI) to determine sleep patterns using a scale of 0-100 (with higher numbers indicating greater regularity) to assess relationships between OSA, sleep patterns, and hypertension in 602 adults with a mean age of 57 years.
- The study’s goal was an assessment of the associations between sleep regularity, OSA, and hypertension in a community sample of adults with normal circadian patterns.
TAKEAWAY:
- The odds of OSA were significantly greater for individuals with mildly irregular or severely irregular sleep than for regular sleepers (odds ratios, 1.97 and 2.06, respectively).
- Individuals with OSA and severely irregular sleep had the highest odds of hypertension compared with individuals with no OSA and regular sleep (OR, 2.34).
- However, participants with OSA and regular sleep or mildly irregular sleep had no significant increase in hypertension risk.
IN PRACTICE:
“Irregular sleep may be an important marker of OSA-related sleep disruption and may be an important modifiable health target,” the researchers wrote.
SOURCE:
The study was led by Kelly Sansom, a PhD candidate at the Centre for Sleep Science at the University of Western Australia, Albany. The study was published online in the journal Sleep.
LIMITATIONS:
The cross-sectional design prevented conclusions of causality, and the SRI is a nonspecific measure that may capture a range of phenotypes with one score; other limitations included the small sample sizes of sleep regularity groups and the use of actigraphy to collect sleep times.
DISCLOSURES:
The study was supported by an Australian Government Research Training Program Scholarship and the Raine Study PhD Top-up Scholarship; the Raine Study Scholarship is supported by the NHMRC, the Centre for Sleep Science, School of Anatomy, Physiology & Human Biology of the University of Western Australia, and the Lions Eye Institute. The researchers had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.
TOPLINE:
Severe sleep irregularity often occurs with obstructive sleep apnea (OSA), and this combination approximately doubled the odds of hypertension in middle-aged individuals.
METHODOLOGY:
- OSA has demonstrated an association with hypertension, but data on the impact of sleep irregularity on this relationship are lacking.
- The researchers used the recently developed sleep regularity index (SRI) to determine sleep patterns using a scale of 0-100 (with higher numbers indicating greater regularity) to assess relationships between OSA, sleep patterns, and hypertension in 602 adults with a mean age of 57 years.
- The study’s goal was an assessment of the associations between sleep regularity, OSA, and hypertension in a community sample of adults with normal circadian patterns.
TAKEAWAY:
- The odds of OSA were significantly greater for individuals with mildly irregular or severely irregular sleep than for regular sleepers (odds ratios, 1.97 and 2.06, respectively).
- Individuals with OSA and severely irregular sleep had the highest odds of hypertension compared with individuals with no OSA and regular sleep (OR, 2.34).
- However, participants with OSA and regular sleep or mildly irregular sleep had no significant increase in hypertension risk.
IN PRACTICE:
“Irregular sleep may be an important marker of OSA-related sleep disruption and may be an important modifiable health target,” the researchers wrote.
SOURCE:
The study was led by Kelly Sansom, a PhD candidate at the Centre for Sleep Science at the University of Western Australia, Albany. The study was published online in the journal Sleep.
LIMITATIONS:
The cross-sectional design prevented conclusions of causality, and the SRI is a nonspecific measure that may capture a range of phenotypes with one score; other limitations included the small sample sizes of sleep regularity groups and the use of actigraphy to collect sleep times.
DISCLOSURES:
The study was supported by an Australian Government Research Training Program Scholarship and the Raine Study PhD Top-up Scholarship; the Raine Study Scholarship is supported by the NHMRC, the Centre for Sleep Science, School of Anatomy, Physiology & Human Biology of the University of Western Australia, and the Lions Eye Institute. The researchers had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.
Circadian Blood Pressure Shifts Earlier in Children With Moderate to Severe OSA
TOPLINE:
The time arrived at peak blood pressure (BP) velocity (TAPV) was significantly earlier in children with moderate to severe (MS) obstructive sleep apnea (OSA) than in controls.
METHODOLOGY:
- The researchers compared 24-hour circadian BP in children with OSA and controls to examine the impact of OSA on circadian BP.
- The study population included 219 children aged 5-14 years: 52 with mild OSA, 50 with MS OSA, and 117 controls.
- Participants underwent 24-hour BP monitoring and actigraphy; models included the times of BP peaks and TAPV.
TAKEAWAY:
- Children with MS OSA had a TAPV for diastolic BP in the morning, an average of 51 minutes earlier than controls (P < .001).
- Evening TAPV was significantly earlier in the children with MS OSA than in controls for both systolic BP (SBP) and diastolic BP (DBP) (95 min, P < .001 and 28 min, P = .028, respectively).
- Midday SBP and DBP velocity nadirs were significantly earlier in the children with MS OSA than in controls (57 min, P < .001 and 38 min, P < .01, respectively).
- Overall, children with MS OSA reached most BP values significantly earlier than controls, and both SBP and DBP were significantly elevated in the MS OSA group compared with the control group.
IN PRACTICE:
“The findings provide an essential puzzle piece in our understanding of the cardiovascular effects of OSA in children,” wrote the authors of an accompanying editorial.
SOURCE:
The lead author of the study was Md Tareq Ferdous Khan, MD, of the University of Cincinnati, Cincinnati, Ohio; the authors of the accompanying editorial were Kate Ching-Ching Chan, MD, and Albert Martin Li, MD, of the Chinese University of Hong Kong, China. The study was published online in the journal Sleep on December 13, 2023, along with the accompanying editorial.
LIMITATIONS:
More research is needed to investigate the potential mechanisms of action, optimize methodology, and investigate circadian biology via actigraphy and biomarkers, the authors of an accompanying editorial wrote.
DISCLOSURES:
The study received no outside funding. The researchers and editorialists had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.
TOPLINE:
The time arrived at peak blood pressure (BP) velocity (TAPV) was significantly earlier in children with moderate to severe (MS) obstructive sleep apnea (OSA) than in controls.
METHODOLOGY:
- The researchers compared 24-hour circadian BP in children with OSA and controls to examine the impact of OSA on circadian BP.
- The study population included 219 children aged 5-14 years: 52 with mild OSA, 50 with MS OSA, and 117 controls.
- Participants underwent 24-hour BP monitoring and actigraphy; models included the times of BP peaks and TAPV.
TAKEAWAY:
- Children with MS OSA had a TAPV for diastolic BP in the morning, an average of 51 minutes earlier than controls (P < .001).
- Evening TAPV was significantly earlier in the children with MS OSA than in controls for both systolic BP (SBP) and diastolic BP (DBP) (95 min, P < .001 and 28 min, P = .028, respectively).
- Midday SBP and DBP velocity nadirs were significantly earlier in the children with MS OSA than in controls (57 min, P < .001 and 38 min, P < .01, respectively).
- Overall, children with MS OSA reached most BP values significantly earlier than controls, and both SBP and DBP were significantly elevated in the MS OSA group compared with the control group.
IN PRACTICE:
“The findings provide an essential puzzle piece in our understanding of the cardiovascular effects of OSA in children,” wrote the authors of an accompanying editorial.
SOURCE:
The lead author of the study was Md Tareq Ferdous Khan, MD, of the University of Cincinnati, Cincinnati, Ohio; the authors of the accompanying editorial were Kate Ching-Ching Chan, MD, and Albert Martin Li, MD, of the Chinese University of Hong Kong, China. The study was published online in the journal Sleep on December 13, 2023, along with the accompanying editorial.
LIMITATIONS:
More research is needed to investigate the potential mechanisms of action, optimize methodology, and investigate circadian biology via actigraphy and biomarkers, the authors of an accompanying editorial wrote.
DISCLOSURES:
The study received no outside funding. The researchers and editorialists had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.
TOPLINE:
The time arrived at peak blood pressure (BP) velocity (TAPV) was significantly earlier in children with moderate to severe (MS) obstructive sleep apnea (OSA) than in controls.
METHODOLOGY:
- The researchers compared 24-hour circadian BP in children with OSA and controls to examine the impact of OSA on circadian BP.
- The study population included 219 children aged 5-14 years: 52 with mild OSA, 50 with MS OSA, and 117 controls.
- Participants underwent 24-hour BP monitoring and actigraphy; models included the times of BP peaks and TAPV.
TAKEAWAY:
- Children with MS OSA had a TAPV for diastolic BP in the morning, an average of 51 minutes earlier than controls (P < .001).
- Evening TAPV was significantly earlier in the children with MS OSA than in controls for both systolic BP (SBP) and diastolic BP (DBP) (95 min, P < .001 and 28 min, P = .028, respectively).
- Midday SBP and DBP velocity nadirs were significantly earlier in the children with MS OSA than in controls (57 min, P < .001 and 38 min, P < .01, respectively).
- Overall, children with MS OSA reached most BP values significantly earlier than controls, and both SBP and DBP were significantly elevated in the MS OSA group compared with the control group.
IN PRACTICE:
“The findings provide an essential puzzle piece in our understanding of the cardiovascular effects of OSA in children,” wrote the authors of an accompanying editorial.
SOURCE:
The lead author of the study was Md Tareq Ferdous Khan, MD, of the University of Cincinnati, Cincinnati, Ohio; the authors of the accompanying editorial were Kate Ching-Ching Chan, MD, and Albert Martin Li, MD, of the Chinese University of Hong Kong, China. The study was published online in the journal Sleep on December 13, 2023, along with the accompanying editorial.
LIMITATIONS:
More research is needed to investigate the potential mechanisms of action, optimize methodology, and investigate circadian biology via actigraphy and biomarkers, the authors of an accompanying editorial wrote.
DISCLOSURES:
The study received no outside funding. The researchers and editorialists had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.
Short Course of Amoxicillin Shows Effectiveness for Febrile UTIs
Use of oral amoxicillin-clavulanic acid for 5 days was noninferior to a 10-day course of treatment among children with noncomplicated febrile urinary tract infections (UTIs), according to new research.
Well-appearing children with febrile UTIs are generally treated with a 10-day course of oral antibiotics, but the effectiveness of a 5-day course has not been evaluated, wrote Giovanni Montini, MD, of the University of Milan, Milan, Italy, and colleagues.
Robert W. Frenck Jr, MD, a director of the Center for Vaccine Research at Cincinnati Children’s Hospital Medical Center, Ohio, said he was not surprised that the shorter course was sufficient to treat these cases. The antibiotic concentration in the urine often significantly exceeds the levels in the blood, he said.
Dr. Frenck, who was not involved in the study, said that he saw no real barriers to the use of a shorter course of therapy in clinical practice.
“I think both parents and the medical team would be happy to be able to use a shorter course of therapy,” he said.
In the study published in Pediatrics , researchers randomized 142 children aged 3 months to 5 years with uncomplicated febrile UTIs to 50 mg/kg/d of amoxicillin-clavulanate for either the short or standard period. The study took place at eight pediatric emergency departments in Italy between May 2020 and September 2022. All patients received prescriptions for 5 days of antibiotics, and those randomized to the standard course received a second prescription after randomization.
The primary endpoint was recurrence of the UTI within 30 days of completion of therapy. Secondary endpoints included clinical recovery at the end of treatment, adverse events related to the therapy, and signs of antibiotic resistance.
The UTI recurrence rate within 30 days of treatment completion was 2.8% in the short-course group and 14.3% in the standard group. A post hoc analysis excluding patients with vesicoureteral reflux and non–Escherichia coli UTIs further confirmed the noninferiority of short-course treatment.
“It is a bit surprising that the short-course group had fewer relapses within 30 days of discontinuing antibiotics,” Dr. Frenck said. “However, the differences may be due to small sample sizes and do not appear to be statistically significant differences in recurrence rates.”
Resolution of symptoms was similar between the short-course and standard groups (97.2% and 92.9%, respectively), and indications of antibiotic resistance were similar between the groups. No adverse events were reported in the standard group, and one case of diarrhea occurred in the short-course group.
The findings were limited by the study’s unblinded randomization, so parents were aware of the trial and were potentially sensitized to look for signs of infection. Researchers also relied on parent reports of adverse drug effects rather than through a standardized questionnaire, the researchers noted.
Dr. Frenck said a potential benefit to shortening treatment is that adherence usually increases.
“But you only want to decrease the length of a course of medicine if you can do so without compromising the effectiveness of the treatment,” Dr. Frenck said.
Dr. Frenck also noted a recent study, which demonstrated that 5 days of antibiotics had equivalent efficacy as 10 days for uncomplicated pneumonia.
“The current paper further demonstrates that shorter courses of antibiotics may be possible for other mild forms of infections.”
Looking ahead, researchers could evaluate the use of short-course antibiotics for other common infections such as otitis media, he noted.
The study was supported by the Ministry of Health, Rome, Italy, in collaboration with the Institute for Maternal and Child Health IRCCS Burlo Garofolo, Trieste, Italy. The researchers report no financial conflicts. Dr. Frenck disclosed conducting clinical trials for Pfizer, Moderna, AstraZeneca, Merck, and GSK; none of those trials were for antibiotics or urinary tract infections.
A version of this article appeared on Medscape.com.
Use of oral amoxicillin-clavulanic acid for 5 days was noninferior to a 10-day course of treatment among children with noncomplicated febrile urinary tract infections (UTIs), according to new research.
Well-appearing children with febrile UTIs are generally treated with a 10-day course of oral antibiotics, but the effectiveness of a 5-day course has not been evaluated, wrote Giovanni Montini, MD, of the University of Milan, Milan, Italy, and colleagues.
Robert W. Frenck Jr, MD, a director of the Center for Vaccine Research at Cincinnati Children’s Hospital Medical Center, Ohio, said he was not surprised that the shorter course was sufficient to treat these cases. The antibiotic concentration in the urine often significantly exceeds the levels in the blood, he said.
Dr. Frenck, who was not involved in the study, said that he saw no real barriers to the use of a shorter course of therapy in clinical practice.
“I think both parents and the medical team would be happy to be able to use a shorter course of therapy,” he said.
In the study published in Pediatrics , researchers randomized 142 children aged 3 months to 5 years with uncomplicated febrile UTIs to 50 mg/kg/d of amoxicillin-clavulanate for either the short or standard period. The study took place at eight pediatric emergency departments in Italy between May 2020 and September 2022. All patients received prescriptions for 5 days of antibiotics, and those randomized to the standard course received a second prescription after randomization.
The primary endpoint was recurrence of the UTI within 30 days of completion of therapy. Secondary endpoints included clinical recovery at the end of treatment, adverse events related to the therapy, and signs of antibiotic resistance.
The UTI recurrence rate within 30 days of treatment completion was 2.8% in the short-course group and 14.3% in the standard group. A post hoc analysis excluding patients with vesicoureteral reflux and non–Escherichia coli UTIs further confirmed the noninferiority of short-course treatment.
“It is a bit surprising that the short-course group had fewer relapses within 30 days of discontinuing antibiotics,” Dr. Frenck said. “However, the differences may be due to small sample sizes and do not appear to be statistically significant differences in recurrence rates.”
Resolution of symptoms was similar between the short-course and standard groups (97.2% and 92.9%, respectively), and indications of antibiotic resistance were similar between the groups. No adverse events were reported in the standard group, and one case of diarrhea occurred in the short-course group.
The findings were limited by the study’s unblinded randomization, so parents were aware of the trial and were potentially sensitized to look for signs of infection. Researchers also relied on parent reports of adverse drug effects rather than through a standardized questionnaire, the researchers noted.
Dr. Frenck said a potential benefit to shortening treatment is that adherence usually increases.
“But you only want to decrease the length of a course of medicine if you can do so without compromising the effectiveness of the treatment,” Dr. Frenck said.
Dr. Frenck also noted a recent study, which demonstrated that 5 days of antibiotics had equivalent efficacy as 10 days for uncomplicated pneumonia.
“The current paper further demonstrates that shorter courses of antibiotics may be possible for other mild forms of infections.”
Looking ahead, researchers could evaluate the use of short-course antibiotics for other common infections such as otitis media, he noted.
The study was supported by the Ministry of Health, Rome, Italy, in collaboration with the Institute for Maternal and Child Health IRCCS Burlo Garofolo, Trieste, Italy. The researchers report no financial conflicts. Dr. Frenck disclosed conducting clinical trials for Pfizer, Moderna, AstraZeneca, Merck, and GSK; none of those trials were for antibiotics or urinary tract infections.
A version of this article appeared on Medscape.com.
Use of oral amoxicillin-clavulanic acid for 5 days was noninferior to a 10-day course of treatment among children with noncomplicated febrile urinary tract infections (UTIs), according to new research.
Well-appearing children with febrile UTIs are generally treated with a 10-day course of oral antibiotics, but the effectiveness of a 5-day course has not been evaluated, wrote Giovanni Montini, MD, of the University of Milan, Milan, Italy, and colleagues.
Robert W. Frenck Jr, MD, a director of the Center for Vaccine Research at Cincinnati Children’s Hospital Medical Center, Ohio, said he was not surprised that the shorter course was sufficient to treat these cases. The antibiotic concentration in the urine often significantly exceeds the levels in the blood, he said.
Dr. Frenck, who was not involved in the study, said that he saw no real barriers to the use of a shorter course of therapy in clinical practice.
“I think both parents and the medical team would be happy to be able to use a shorter course of therapy,” he said.
In the study published in Pediatrics , researchers randomized 142 children aged 3 months to 5 years with uncomplicated febrile UTIs to 50 mg/kg/d of amoxicillin-clavulanate for either the short or standard period. The study took place at eight pediatric emergency departments in Italy between May 2020 and September 2022. All patients received prescriptions for 5 days of antibiotics, and those randomized to the standard course received a second prescription after randomization.
The primary endpoint was recurrence of the UTI within 30 days of completion of therapy. Secondary endpoints included clinical recovery at the end of treatment, adverse events related to the therapy, and signs of antibiotic resistance.
The UTI recurrence rate within 30 days of treatment completion was 2.8% in the short-course group and 14.3% in the standard group. A post hoc analysis excluding patients with vesicoureteral reflux and non–Escherichia coli UTIs further confirmed the noninferiority of short-course treatment.
“It is a bit surprising that the short-course group had fewer relapses within 30 days of discontinuing antibiotics,” Dr. Frenck said. “However, the differences may be due to small sample sizes and do not appear to be statistically significant differences in recurrence rates.”
Resolution of symptoms was similar between the short-course and standard groups (97.2% and 92.9%, respectively), and indications of antibiotic resistance were similar between the groups. No adverse events were reported in the standard group, and one case of diarrhea occurred in the short-course group.
The findings were limited by the study’s unblinded randomization, so parents were aware of the trial and were potentially sensitized to look for signs of infection. Researchers also relied on parent reports of adverse drug effects rather than through a standardized questionnaire, the researchers noted.
Dr. Frenck said a potential benefit to shortening treatment is that adherence usually increases.
“But you only want to decrease the length of a course of medicine if you can do so without compromising the effectiveness of the treatment,” Dr. Frenck said.
Dr. Frenck also noted a recent study, which demonstrated that 5 days of antibiotics had equivalent efficacy as 10 days for uncomplicated pneumonia.
“The current paper further demonstrates that shorter courses of antibiotics may be possible for other mild forms of infections.”
Looking ahead, researchers could evaluate the use of short-course antibiotics for other common infections such as otitis media, he noted.
The study was supported by the Ministry of Health, Rome, Italy, in collaboration with the Institute for Maternal and Child Health IRCCS Burlo Garofolo, Trieste, Italy. The researchers report no financial conflicts. Dr. Frenck disclosed conducting clinical trials for Pfizer, Moderna, AstraZeneca, Merck, and GSK; none of those trials were for antibiotics or urinary tract infections.
A version of this article appeared on Medscape.com.
FROM PEDIATRICS
Hospital Adverse Events Rise After Private Equity Acquisition
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.
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.
Olympus provides recall correction for bronchoscopes to reduce fire risk
A series of Olympus bronchofiberscopes and bronchovideoscopes have been recalled by the manufacturer because of a risk for burns and fire, according to a statement from the US Food and Drug Administration (FDA).
However, “this recall is a correction, not a product removal,” according to the FDA.
“While health care providers may choose to continue using the Olympus bronchofiberscopes and bronchovideoscopes, to maximize patient safety and mitigate any potential risk to patient health, the FDA and Olympus advise users not to perform high-frequency cauterization while supplying oxygen, and carefully follow the warnings provided in the Olympus operators manual and highlighted in its October 12, 2023, letter to customers,” an FDA spokesperson said.
The recall affects Olympus bronchofiberscopes and bronchovideoscopes distributed between January 1, 2001, and September 11, 2023. According to the FDA statement, use of these devices may cause serious adverse events to patients and to clinicians. Patients treated with these devices could experience critical burns in the airways or lungs, airway bleeding, breathing difficulty, apnea, loss of consciousness, or death. Healthcare workers using the devices also may be affected in the event of combustion.
On October 12, 2023, Olympus sent an Urgent Medical Device Corrective Action letter. This letter outlined the risks associated with the devices as follows:
“There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the electrosurgical accessory is too close to the distal end of the endoscope.”
To mitigate this risk, Olympus reminds clinicians to heed the warnings found in the device operations manuals, notably these three:
- Do not perform high-frequency cauterization while supplying oxygen.
- Confirm that the electrode section of the electrosurgical device used with the endoscope is at a safe distance from the distal end of the endoscope.
- Only use the Olympus bronchoscopes with compatible high-frequency therapy equipment as described in the operations manual.
The letter also asks facilities that have purchased any of the affected bronchoscopes to ensure that all personnel are “completely knowledgeable and thoroughly aware” of the warnings stated in the operations manual, and it states that users may continue to use the devices according to the current instructions and with attention to the warnings.
Olympus Explains
“Olympus Corporation initiated this Field Corrective Action (FCA) to address complaints of endobronchial combustion occurring when high-frequency-compatible bronchoscopes are used during therapeutic procedures in combination with high-frequency therapy equipment,” a spokeswoman for Olympus said in an interview.
“This corrective action was taken following a thorough assessment of adverse event complaints involving serious patient injury; Olympus takes these complaints very seriously. Patient safety is our top priority,” the spokeswoman said. “The customer notification is intended to remind users of existing warnings not to use oxygen while performing high-frequency cauterization and appropriate distance while using high-frequency therapy equipment.”
The products are not being removed, and no labeling changes are being made at this time, she said.
The bottom line for clinicians: “Users can continue to use Olympus bronchoscopes according to the instructions provided in the operation manual and the customer letter,” the Olympus spokeswoman told this news organization. “This is not a removal action. There are no changes to the existing operation manual regarding compatibility of bronchoscopes with high-frequency therapy equipment,” she said.
“In terms of actions going forward, in addition to the communication provided through this Field Corrective Action, which is intended to remind users of recommendations on oxygen use and clarify the appropriate distance while using high-frequency therapy equipment, the root cause and potential contributing factors are currently under investigation through a formal CAPA (Corrective Action Preventative Action) process. Olympus will take any appropriate enhancement action based on investigation results,” according to the Olympus spokeswoman.
In 2016, this news organization reported that Olympus made medical headlines by recalling its TJF-Q180V duodenoscope in the wake of Congressional investigations after the product was linked to spreading bacterial infections because of design flaws.
United States customers can contact Olympus by phone at 1-800-848-9024 (option 1) with questions about the recall, and healthcare professionals and consumers may report adverse reactions or quality problems associated with the devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program via an online form, regular mail, or fax.
A version of this article first appeared on Medscape.com.
A series of Olympus bronchofiberscopes and bronchovideoscopes have been recalled by the manufacturer because of a risk for burns and fire, according to a statement from the US Food and Drug Administration (FDA).
However, “this recall is a correction, not a product removal,” according to the FDA.
“While health care providers may choose to continue using the Olympus bronchofiberscopes and bronchovideoscopes, to maximize patient safety and mitigate any potential risk to patient health, the FDA and Olympus advise users not to perform high-frequency cauterization while supplying oxygen, and carefully follow the warnings provided in the Olympus operators manual and highlighted in its October 12, 2023, letter to customers,” an FDA spokesperson said.
The recall affects Olympus bronchofiberscopes and bronchovideoscopes distributed between January 1, 2001, and September 11, 2023. According to the FDA statement, use of these devices may cause serious adverse events to patients and to clinicians. Patients treated with these devices could experience critical burns in the airways or lungs, airway bleeding, breathing difficulty, apnea, loss of consciousness, or death. Healthcare workers using the devices also may be affected in the event of combustion.
On October 12, 2023, Olympus sent an Urgent Medical Device Corrective Action letter. This letter outlined the risks associated with the devices as follows:
“There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the electrosurgical accessory is too close to the distal end of the endoscope.”
To mitigate this risk, Olympus reminds clinicians to heed the warnings found in the device operations manuals, notably these three:
- Do not perform high-frequency cauterization while supplying oxygen.
- Confirm that the electrode section of the electrosurgical device used with the endoscope is at a safe distance from the distal end of the endoscope.
- Only use the Olympus bronchoscopes with compatible high-frequency therapy equipment as described in the operations manual.
The letter also asks facilities that have purchased any of the affected bronchoscopes to ensure that all personnel are “completely knowledgeable and thoroughly aware” of the warnings stated in the operations manual, and it states that users may continue to use the devices according to the current instructions and with attention to the warnings.
Olympus Explains
“Olympus Corporation initiated this Field Corrective Action (FCA) to address complaints of endobronchial combustion occurring when high-frequency-compatible bronchoscopes are used during therapeutic procedures in combination with high-frequency therapy equipment,” a spokeswoman for Olympus said in an interview.
“This corrective action was taken following a thorough assessment of adverse event complaints involving serious patient injury; Olympus takes these complaints very seriously. Patient safety is our top priority,” the spokeswoman said. “The customer notification is intended to remind users of existing warnings not to use oxygen while performing high-frequency cauterization and appropriate distance while using high-frequency therapy equipment.”
The products are not being removed, and no labeling changes are being made at this time, she said.
The bottom line for clinicians: “Users can continue to use Olympus bronchoscopes according to the instructions provided in the operation manual and the customer letter,” the Olympus spokeswoman told this news organization. “This is not a removal action. There are no changes to the existing operation manual regarding compatibility of bronchoscopes with high-frequency therapy equipment,” she said.
“In terms of actions going forward, in addition to the communication provided through this Field Corrective Action, which is intended to remind users of recommendations on oxygen use and clarify the appropriate distance while using high-frequency therapy equipment, the root cause and potential contributing factors are currently under investigation through a formal CAPA (Corrective Action Preventative Action) process. Olympus will take any appropriate enhancement action based on investigation results,” according to the Olympus spokeswoman.
In 2016, this news organization reported that Olympus made medical headlines by recalling its TJF-Q180V duodenoscope in the wake of Congressional investigations after the product was linked to spreading bacterial infections because of design flaws.
United States customers can contact Olympus by phone at 1-800-848-9024 (option 1) with questions about the recall, and healthcare professionals and consumers may report adverse reactions or quality problems associated with the devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program via an online form, regular mail, or fax.
A version of this article first appeared on Medscape.com.
A series of Olympus bronchofiberscopes and bronchovideoscopes have been recalled by the manufacturer because of a risk for burns and fire, according to a statement from the US Food and Drug Administration (FDA).
However, “this recall is a correction, not a product removal,” according to the FDA.
“While health care providers may choose to continue using the Olympus bronchofiberscopes and bronchovideoscopes, to maximize patient safety and mitigate any potential risk to patient health, the FDA and Olympus advise users not to perform high-frequency cauterization while supplying oxygen, and carefully follow the warnings provided in the Olympus operators manual and highlighted in its October 12, 2023, letter to customers,” an FDA spokesperson said.
The recall affects Olympus bronchofiberscopes and bronchovideoscopes distributed between January 1, 2001, and September 11, 2023. According to the FDA statement, use of these devices may cause serious adverse events to patients and to clinicians. Patients treated with these devices could experience critical burns in the airways or lungs, airway bleeding, breathing difficulty, apnea, loss of consciousness, or death. Healthcare workers using the devices also may be affected in the event of combustion.
On October 12, 2023, Olympus sent an Urgent Medical Device Corrective Action letter. This letter outlined the risks associated with the devices as follows:
“There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the electrosurgical accessory is too close to the distal end of the endoscope.”
To mitigate this risk, Olympus reminds clinicians to heed the warnings found in the device operations manuals, notably these three:
- Do not perform high-frequency cauterization while supplying oxygen.
- Confirm that the electrode section of the electrosurgical device used with the endoscope is at a safe distance from the distal end of the endoscope.
- Only use the Olympus bronchoscopes with compatible high-frequency therapy equipment as described in the operations manual.
The letter also asks facilities that have purchased any of the affected bronchoscopes to ensure that all personnel are “completely knowledgeable and thoroughly aware” of the warnings stated in the operations manual, and it states that users may continue to use the devices according to the current instructions and with attention to the warnings.
Olympus Explains
“Olympus Corporation initiated this Field Corrective Action (FCA) to address complaints of endobronchial combustion occurring when high-frequency-compatible bronchoscopes are used during therapeutic procedures in combination with high-frequency therapy equipment,” a spokeswoman for Olympus said in an interview.
“This corrective action was taken following a thorough assessment of adverse event complaints involving serious patient injury; Olympus takes these complaints very seriously. Patient safety is our top priority,” the spokeswoman said. “The customer notification is intended to remind users of existing warnings not to use oxygen while performing high-frequency cauterization and appropriate distance while using high-frequency therapy equipment.”
The products are not being removed, and no labeling changes are being made at this time, she said.
The bottom line for clinicians: “Users can continue to use Olympus bronchoscopes according to the instructions provided in the operation manual and the customer letter,” the Olympus spokeswoman told this news organization. “This is not a removal action. There are no changes to the existing operation manual regarding compatibility of bronchoscopes with high-frequency therapy equipment,” she said.
“In terms of actions going forward, in addition to the communication provided through this Field Corrective Action, which is intended to remind users of recommendations on oxygen use and clarify the appropriate distance while using high-frequency therapy equipment, the root cause and potential contributing factors are currently under investigation through a formal CAPA (Corrective Action Preventative Action) process. Olympus will take any appropriate enhancement action based on investigation results,” according to the Olympus spokeswoman.
In 2016, this news organization reported that Olympus made medical headlines by recalling its TJF-Q180V duodenoscope in the wake of Congressional investigations after the product was linked to spreading bacterial infections because of design flaws.
United States customers can contact Olympus by phone at 1-800-848-9024 (option 1) with questions about the recall, and healthcare professionals and consumers may report adverse reactions or quality problems associated with the devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program via an online form, regular mail, or fax.
A version of this article first appeared on Medscape.com.
Systemic Bias in AI Models May Undermine Diagnostic Accuracy
Systematically biased artificial intelligence (AI) models did not improve clinicians’ accuracy in diagnosing hospitalized patients, based on data from more than 450 clinicians.
“Artificial Intelligence (AI) could support clinicians in their diagnostic decisions of hospitalized patients but could also be biased and cause potential harm,” said Sarah Jabbour, MSE, a PhD candidate in computer science and engineering at the University of Michigan, Ann Arbor, in an interview.
“Regulatory guidance has suggested that the use of AI explanations could mitigate these harms, but the effectiveness of using AI explanations has not been established,” she said.
To examine whether AI explanations can be effective in mitigating the potential harms of systemic bias in AI models, Ms. Jabbour and colleagues conducted a randomized clinical vignette survey study. The survey was administered between April 2022 and January 2023 across 13 states, and the study population included hospitalist physicians, nurse practitioners, and physician assistants. The results were published in JAMA.
Participants were randomized to AI predictions with AI explanations (226 clinicians) or without AI explanations (231 clinicians).
The primary outcome was diagnostic accuracy for pneumonia, heart failure, and chronic obstructive pulmonary disease, defined as the number of correct diagnoses over the total number of assessments, the researchers wrote.
The clinicians viewed nine clinical vignettes of patients hospitalized with acute respiratory failure, including their presenting symptoms, physical examination, laboratory results, and chest radiographs. Clinicians viewed two vignettes with no AI model input to establish baseline diagnostic accuracy. They made three assessments in each vignette, one for each diagnosis. The order of the vignettes was two without AI predictions (to establish baseline diagnostic accuracy), six with AI predictions, and one with a clinical consultation by a hypothetical colleague. The vignettes included standard and systematically biased AI models.
The baseline diagnostic accuracy was 73% for the diagnoses of pneumonia, heart failure, and chronic obstructive pulmonary disease. Clinicians’ accuracy increased by 2.9% when they viewed a standard diagnostic AI model without explanations and by 4.4% when they viewed models with AI explanations.
However, clinicians’ accuracy decreased by 11.3% after viewing systematically biased AI model predictions without explanations compared with baseline, and biased AI model predictions with explanations decreased accuracy by 9.1%.
The decrease in accuracy with systematically biased AI predictions without explanations was mainly attributable to a decrease in the participants’ diagnostic specificity, the researchers noted, but the addition of explanations did little to improve it, the researchers said.
Potentially Useful but Still Imperfect
The findings were limited by several factors including the use of a web-based survey, which differs from surveys in a clinical setting, the researchers wrote. Other limitations included the younger than average study population, and the focus on the clinicians making treatment decisions, vs other clinicians who might have a better understanding of the AI explanations.
“In our study, explanations were presented in a way that were considered to be obvious, where the AI model was completely focused on areas of the chest X-rays unrelated to the clinical condition,” Ms. Jabbour told this news organization. “We hypothesized that if presented with such explanations, the participants in our study would notice that the model was behaving incorrectly and not rely on its predictions. This was surprisingly not the case, and the explanations when presented alongside biased AI predictions had seemingly no effect in mitigating clinicians’ overreliance on biased AI,” she said.
“AI is being developed at an extraordinary rate, and our study shows that it has the potential to improve clinical decision-making. At the same time, it could harm clinical decision-making when biased,” Ms. Jabbour said. “We must be thoughtful about how to carefully integrate AI into clinical workflows, with the goal of improving clinical care while not introducing systematic errors or harming patients,” she added.
Looking ahead, “There are several potential research areas that could be explored,” said Ms. Jabbour. “Researchers should focus on careful validation of AI models to identify biased model behavior prior to deployment. AI researchers should also continue including and communicating with clinicians during the development of AI tools to better understand clinicians’ needs and how they interact with AI,” she said. “This is not an exhaustive list of research directions, and it will take much discussion between experts across disciplines such as AI, human computer interaction, and medicine to ultimately deploy AI safely into clinical care.”
Don’t Overestimate AI
“With the increasing use of artificial intelligence and machine learning in other spheres, there has been an increase in interest in exploring how they can be utilized to improve clinical outcomes,” said Suman Pal, MD, assistant professor in the division of hospital medicine at the University of New Mexico, Albuquerque, in an interview. “However, concerns remain regarding the possible harms and ways to mitigate them,” said Dr. Pal, who was not involved in the current study.
In the current study, “It was interesting to note that explanations did not significantly mitigate the decrease in clinician accuracy from systematically biased AI model predictions,” Dr. Pal said.
“For the clinician, the findings of this study caution against overreliance on AI in clinical decision-making, especially because of the risk of exacerbating existing health disparities due to systemic inequities in existing literature,” Dr. Pal told this news organization.
“Additional research is needed to explore how clinicians can be better trained in identifying both the utility and the limitations of AI and into methods of validation and continuous quality checks with integration of AI into clinical workflows,” he noted.
The study was funded by the National Heart, Lung, and Blood Institute. The researchers had no financial conflicts to disclose. Dr. Pal had no financial conflicts to disclose.
A version of this article first appeared on Medscape.com.
Systematically biased artificial intelligence (AI) models did not improve clinicians’ accuracy in diagnosing hospitalized patients, based on data from more than 450 clinicians.
“Artificial Intelligence (AI) could support clinicians in their diagnostic decisions of hospitalized patients but could also be biased and cause potential harm,” said Sarah Jabbour, MSE, a PhD candidate in computer science and engineering at the University of Michigan, Ann Arbor, in an interview.
“Regulatory guidance has suggested that the use of AI explanations could mitigate these harms, but the effectiveness of using AI explanations has not been established,” she said.
To examine whether AI explanations can be effective in mitigating the potential harms of systemic bias in AI models, Ms. Jabbour and colleagues conducted a randomized clinical vignette survey study. The survey was administered between April 2022 and January 2023 across 13 states, and the study population included hospitalist physicians, nurse practitioners, and physician assistants. The results were published in JAMA.
Participants were randomized to AI predictions with AI explanations (226 clinicians) or without AI explanations (231 clinicians).
The primary outcome was diagnostic accuracy for pneumonia, heart failure, and chronic obstructive pulmonary disease, defined as the number of correct diagnoses over the total number of assessments, the researchers wrote.
The clinicians viewed nine clinical vignettes of patients hospitalized with acute respiratory failure, including their presenting symptoms, physical examination, laboratory results, and chest radiographs. Clinicians viewed two vignettes with no AI model input to establish baseline diagnostic accuracy. They made three assessments in each vignette, one for each diagnosis. The order of the vignettes was two without AI predictions (to establish baseline diagnostic accuracy), six with AI predictions, and one with a clinical consultation by a hypothetical colleague. The vignettes included standard and systematically biased AI models.
The baseline diagnostic accuracy was 73% for the diagnoses of pneumonia, heart failure, and chronic obstructive pulmonary disease. Clinicians’ accuracy increased by 2.9% when they viewed a standard diagnostic AI model without explanations and by 4.4% when they viewed models with AI explanations.
However, clinicians’ accuracy decreased by 11.3% after viewing systematically biased AI model predictions without explanations compared with baseline, and biased AI model predictions with explanations decreased accuracy by 9.1%.
The decrease in accuracy with systematically biased AI predictions without explanations was mainly attributable to a decrease in the participants’ diagnostic specificity, the researchers noted, but the addition of explanations did little to improve it, the researchers said.
Potentially Useful but Still Imperfect
The findings were limited by several factors including the use of a web-based survey, which differs from surveys in a clinical setting, the researchers wrote. Other limitations included the younger than average study population, and the focus on the clinicians making treatment decisions, vs other clinicians who might have a better understanding of the AI explanations.
“In our study, explanations were presented in a way that were considered to be obvious, where the AI model was completely focused on areas of the chest X-rays unrelated to the clinical condition,” Ms. Jabbour told this news organization. “We hypothesized that if presented with such explanations, the participants in our study would notice that the model was behaving incorrectly and not rely on its predictions. This was surprisingly not the case, and the explanations when presented alongside biased AI predictions had seemingly no effect in mitigating clinicians’ overreliance on biased AI,” she said.
“AI is being developed at an extraordinary rate, and our study shows that it has the potential to improve clinical decision-making. At the same time, it could harm clinical decision-making when biased,” Ms. Jabbour said. “We must be thoughtful about how to carefully integrate AI into clinical workflows, with the goal of improving clinical care while not introducing systematic errors or harming patients,” she added.
Looking ahead, “There are several potential research areas that could be explored,” said Ms. Jabbour. “Researchers should focus on careful validation of AI models to identify biased model behavior prior to deployment. AI researchers should also continue including and communicating with clinicians during the development of AI tools to better understand clinicians’ needs and how they interact with AI,” she said. “This is not an exhaustive list of research directions, and it will take much discussion between experts across disciplines such as AI, human computer interaction, and medicine to ultimately deploy AI safely into clinical care.”
Don’t Overestimate AI
“With the increasing use of artificial intelligence and machine learning in other spheres, there has been an increase in interest in exploring how they can be utilized to improve clinical outcomes,” said Suman Pal, MD, assistant professor in the division of hospital medicine at the University of New Mexico, Albuquerque, in an interview. “However, concerns remain regarding the possible harms and ways to mitigate them,” said Dr. Pal, who was not involved in the current study.
In the current study, “It was interesting to note that explanations did not significantly mitigate the decrease in clinician accuracy from systematically biased AI model predictions,” Dr. Pal said.
“For the clinician, the findings of this study caution against overreliance on AI in clinical decision-making, especially because of the risk of exacerbating existing health disparities due to systemic inequities in existing literature,” Dr. Pal told this news organization.
“Additional research is needed to explore how clinicians can be better trained in identifying both the utility and the limitations of AI and into methods of validation and continuous quality checks with integration of AI into clinical workflows,” he noted.
The study was funded by the National Heart, Lung, and Blood Institute. The researchers had no financial conflicts to disclose. Dr. Pal had no financial conflicts to disclose.
A version of this article first appeared on Medscape.com.
Systematically biased artificial intelligence (AI) models did not improve clinicians’ accuracy in diagnosing hospitalized patients, based on data from more than 450 clinicians.
“Artificial Intelligence (AI) could support clinicians in their diagnostic decisions of hospitalized patients but could also be biased and cause potential harm,” said Sarah Jabbour, MSE, a PhD candidate in computer science and engineering at the University of Michigan, Ann Arbor, in an interview.
“Regulatory guidance has suggested that the use of AI explanations could mitigate these harms, but the effectiveness of using AI explanations has not been established,” she said.
To examine whether AI explanations can be effective in mitigating the potential harms of systemic bias in AI models, Ms. Jabbour and colleagues conducted a randomized clinical vignette survey study. The survey was administered between April 2022 and January 2023 across 13 states, and the study population included hospitalist physicians, nurse practitioners, and physician assistants. The results were published in JAMA.
Participants were randomized to AI predictions with AI explanations (226 clinicians) or without AI explanations (231 clinicians).
The primary outcome was diagnostic accuracy for pneumonia, heart failure, and chronic obstructive pulmonary disease, defined as the number of correct diagnoses over the total number of assessments, the researchers wrote.
The clinicians viewed nine clinical vignettes of patients hospitalized with acute respiratory failure, including their presenting symptoms, physical examination, laboratory results, and chest radiographs. Clinicians viewed two vignettes with no AI model input to establish baseline diagnostic accuracy. They made three assessments in each vignette, one for each diagnosis. The order of the vignettes was two without AI predictions (to establish baseline diagnostic accuracy), six with AI predictions, and one with a clinical consultation by a hypothetical colleague. The vignettes included standard and systematically biased AI models.
The baseline diagnostic accuracy was 73% for the diagnoses of pneumonia, heart failure, and chronic obstructive pulmonary disease. Clinicians’ accuracy increased by 2.9% when they viewed a standard diagnostic AI model without explanations and by 4.4% when they viewed models with AI explanations.
However, clinicians’ accuracy decreased by 11.3% after viewing systematically biased AI model predictions without explanations compared with baseline, and biased AI model predictions with explanations decreased accuracy by 9.1%.
The decrease in accuracy with systematically biased AI predictions without explanations was mainly attributable to a decrease in the participants’ diagnostic specificity, the researchers noted, but the addition of explanations did little to improve it, the researchers said.
Potentially Useful but Still Imperfect
The findings were limited by several factors including the use of a web-based survey, which differs from surveys in a clinical setting, the researchers wrote. Other limitations included the younger than average study population, and the focus on the clinicians making treatment decisions, vs other clinicians who might have a better understanding of the AI explanations.
“In our study, explanations were presented in a way that were considered to be obvious, where the AI model was completely focused on areas of the chest X-rays unrelated to the clinical condition,” Ms. Jabbour told this news organization. “We hypothesized that if presented with such explanations, the participants in our study would notice that the model was behaving incorrectly and not rely on its predictions. This was surprisingly not the case, and the explanations when presented alongside biased AI predictions had seemingly no effect in mitigating clinicians’ overreliance on biased AI,” she said.
“AI is being developed at an extraordinary rate, and our study shows that it has the potential to improve clinical decision-making. At the same time, it could harm clinical decision-making when biased,” Ms. Jabbour said. “We must be thoughtful about how to carefully integrate AI into clinical workflows, with the goal of improving clinical care while not introducing systematic errors or harming patients,” she added.
Looking ahead, “There are several potential research areas that could be explored,” said Ms. Jabbour. “Researchers should focus on careful validation of AI models to identify biased model behavior prior to deployment. AI researchers should also continue including and communicating with clinicians during the development of AI tools to better understand clinicians’ needs and how they interact with AI,” she said. “This is not an exhaustive list of research directions, and it will take much discussion between experts across disciplines such as AI, human computer interaction, and medicine to ultimately deploy AI safely into clinical care.”
Don’t Overestimate AI
“With the increasing use of artificial intelligence and machine learning in other spheres, there has been an increase in interest in exploring how they can be utilized to improve clinical outcomes,” said Suman Pal, MD, assistant professor in the division of hospital medicine at the University of New Mexico, Albuquerque, in an interview. “However, concerns remain regarding the possible harms and ways to mitigate them,” said Dr. Pal, who was not involved in the current study.
In the current study, “It was interesting to note that explanations did not significantly mitigate the decrease in clinician accuracy from systematically biased AI model predictions,” Dr. Pal said.
“For the clinician, the findings of this study caution against overreliance on AI in clinical decision-making, especially because of the risk of exacerbating existing health disparities due to systemic inequities in existing literature,” Dr. Pal told this news organization.
“Additional research is needed to explore how clinicians can be better trained in identifying both the utility and the limitations of AI and into methods of validation and continuous quality checks with integration of AI into clinical workflows,” he noted.
The study was funded by the National Heart, Lung, and Blood Institute. The researchers had no financial conflicts to disclose. Dr. Pal had no financial conflicts to disclose.
A version of this article first appeared on Medscape.com.
FROM JAMA
Thiazide Diuretics May Promote Hyponatremia
Adults who used thiazide diuretics for hypertension were more likely than were those who used nonthiazide agents to develop hyponatremia within 2 years of starting treatment, a new study of more than 180,000 people has found.
Although thiazide diuretics generally are well-tolerated in the routine treatment of uncomplicated hypertension, severe adverse effects are possible, and their frequency has not been examined, according to Niklas Worm Andersson, MD, of Statens Serum Institut, in Copenhagen, Denmark, and his colleagues.
“Thiazide diuretics are commonly used drugs for the treatment of uncomplicated hypertension, and hyponatremia is a known potential side effect to thiazide treatment, but the frequency of this adverse event is inconsistently reported across drug labels,” Dr. Andersson told this news organization.
Product labels for thiazide diuretics list hyponatremia as a potential adverse event that can occur rarely (defined as a range from less than 1 in 10,000 to less than 1 in 100 individuals), but the extent of the burden is unclear given the wide range of symptoms of the condition, the researchers write.
In a study published in Annals of Internal Medicine, Dr. Andersson and his colleagues reviewed data from population-based registries in Denmark of adults aged 40 years or older with uncomplicated hypertension, no recent prescriptions for antihypertensives, and no previous history of hyponatremia. They emulated two target trials. One trial compared the incidence of hyponatremia in new users of bendroflumethiazide (BFZ) vs a calcium-channel blocker (CCB). The other emulation compared the incidence of hyponatremia in new users of hydrochlorothiazide (HCTZ) plus a renin-angiotensin system (RAS) inhibitor vs a RAS inhibitor without HCTZ.
The primary outcome was hyponatremia, defined as blood sodium < 130 mmol/L, within 2 years of starting treatment.
The 2-year incidence of hyponatremia for the two thiazide diuretics was 3.83% for BFZ and 3.51% for HCTZ-RAS inhibitor. The risk difference in the incidence of hyponatremia was 1.35% for BFZ vs CCB and 1.38% for HCTZ-RAS inhibitor vs RAS inhibitor, the researchers reported.
The study population included 37,786 new users of BFZ who were compared with 44,963 new users of CCBs as well as 11,943 new users of HCTZ-RAS inhibitors who were compared with 85,784 new users of RAS inhibitors only.
Overall, older age and a greater number of comorbidities increased the cumulative hyponatremia in new users of thiazide-based hypertensives. The risk differences among individuals aged 80 years or older were 4.80% in the BFZ vs CCB study and 5.52% in the HCTZ-RAS inhibitor vs RAS inhibitor study. Among participants with three or more comorbidities, the risk differences in the two studies were 5.24% and 2.91%, respectively, Dr. Andersson’s group found.
The findings were limited by several factors, mainly the potential for confounding on the basis of the assumption that filled prescriptions equaled drug use, the researchers noted. Other limitations included the focus on new users and a Danish population only, which might limit generalizability, and a lack of data on blood pressure measures.
However, the results suggest a greater risk for hyponatremia with thiazide diuretics than what the drug labels indicate, especially early in treatment, the researchers concluded.
Data Reinforce Need for Vigilance in the Clinic
“Our findings highlight the continued need for clinical awareness and monitoring of this adverse drug reaction; particularly during the first months of treatment, in persons who are older or who have comorbidities,” Dr. Andersson told this news organization. “Further mapping of potential subpopulations at risk in terms of specific comorbidities is important to improve the prevention of this adverse event.”
“The thiazide diuretics have been recommended as first-line therapy for hypertension, and it was important to evaluate the potential development of hyponatremia, especially in the older patients given the potentially serious health effects caused by hyponatremia,” said Noel Deep, MD, a general internist in private practice in Antigo, Wisconsin. Dr. Deep, who was not involved in the study, also serves as chief medical officer and a staff physician at Aspirus Langlade Hospital in Antigo.
The current study findings were not surprising, Dr. Deep added. “I have seen this occur in my patients, especially in the older female patients,” he said. “The results reinforce my practice of monitoring the electrolytes and renal function in 1-2 weeks after starting a thiazide diuretic, and then at regular intervals.”
In practice, clinicians should be aware of the potential development of hyponatremia and monitor and address the electrolyte abnormalities, Dr. Deep said. “While thiazide and thiazide-like diuretics are an important component of our treatment options for patients with hypertension and other conditions, we should also ensure that we are cognizant of and address the potential side effects or electrolyte imbalances caused by the medications.”
The study was funded by the Independent Research Fund Denmark, Helsefonden, Dagmar Marshalls Fond, Gangstedfonden, A.P. Møller and Chastine Mc-Kinney Møller Foundation, Brødrene Hartmanns Fond, and Snedkermester Sophus Jacobsen og hustru Astrid Jacobsens Fond.
The researchers had no financial conflicts to disclose. Dr. Deep had no financial conflicts to disclose.
A version of this article first appeared on Medscape.com.
Adults who used thiazide diuretics for hypertension were more likely than were those who used nonthiazide agents to develop hyponatremia within 2 years of starting treatment, a new study of more than 180,000 people has found.
Although thiazide diuretics generally are well-tolerated in the routine treatment of uncomplicated hypertension, severe adverse effects are possible, and their frequency has not been examined, according to Niklas Worm Andersson, MD, of Statens Serum Institut, in Copenhagen, Denmark, and his colleagues.
“Thiazide diuretics are commonly used drugs for the treatment of uncomplicated hypertension, and hyponatremia is a known potential side effect to thiazide treatment, but the frequency of this adverse event is inconsistently reported across drug labels,” Dr. Andersson told this news organization.
Product labels for thiazide diuretics list hyponatremia as a potential adverse event that can occur rarely (defined as a range from less than 1 in 10,000 to less than 1 in 100 individuals), but the extent of the burden is unclear given the wide range of symptoms of the condition, the researchers write.
In a study published in Annals of Internal Medicine, Dr. Andersson and his colleagues reviewed data from population-based registries in Denmark of adults aged 40 years or older with uncomplicated hypertension, no recent prescriptions for antihypertensives, and no previous history of hyponatremia. They emulated two target trials. One trial compared the incidence of hyponatremia in new users of bendroflumethiazide (BFZ) vs a calcium-channel blocker (CCB). The other emulation compared the incidence of hyponatremia in new users of hydrochlorothiazide (HCTZ) plus a renin-angiotensin system (RAS) inhibitor vs a RAS inhibitor without HCTZ.
The primary outcome was hyponatremia, defined as blood sodium < 130 mmol/L, within 2 years of starting treatment.
The 2-year incidence of hyponatremia for the two thiazide diuretics was 3.83% for BFZ and 3.51% for HCTZ-RAS inhibitor. The risk difference in the incidence of hyponatremia was 1.35% for BFZ vs CCB and 1.38% for HCTZ-RAS inhibitor vs RAS inhibitor, the researchers reported.
The study population included 37,786 new users of BFZ who were compared with 44,963 new users of CCBs as well as 11,943 new users of HCTZ-RAS inhibitors who were compared with 85,784 new users of RAS inhibitors only.
Overall, older age and a greater number of comorbidities increased the cumulative hyponatremia in new users of thiazide-based hypertensives. The risk differences among individuals aged 80 years or older were 4.80% in the BFZ vs CCB study and 5.52% in the HCTZ-RAS inhibitor vs RAS inhibitor study. Among participants with three or more comorbidities, the risk differences in the two studies were 5.24% and 2.91%, respectively, Dr. Andersson’s group found.
The findings were limited by several factors, mainly the potential for confounding on the basis of the assumption that filled prescriptions equaled drug use, the researchers noted. Other limitations included the focus on new users and a Danish population only, which might limit generalizability, and a lack of data on blood pressure measures.
However, the results suggest a greater risk for hyponatremia with thiazide diuretics than what the drug labels indicate, especially early in treatment, the researchers concluded.
Data Reinforce Need for Vigilance in the Clinic
“Our findings highlight the continued need for clinical awareness and monitoring of this adverse drug reaction; particularly during the first months of treatment, in persons who are older or who have comorbidities,” Dr. Andersson told this news organization. “Further mapping of potential subpopulations at risk in terms of specific comorbidities is important to improve the prevention of this adverse event.”
“The thiazide diuretics have been recommended as first-line therapy for hypertension, and it was important to evaluate the potential development of hyponatremia, especially in the older patients given the potentially serious health effects caused by hyponatremia,” said Noel Deep, MD, a general internist in private practice in Antigo, Wisconsin. Dr. Deep, who was not involved in the study, also serves as chief medical officer and a staff physician at Aspirus Langlade Hospital in Antigo.
The current study findings were not surprising, Dr. Deep added. “I have seen this occur in my patients, especially in the older female patients,” he said. “The results reinforce my practice of monitoring the electrolytes and renal function in 1-2 weeks after starting a thiazide diuretic, and then at regular intervals.”
In practice, clinicians should be aware of the potential development of hyponatremia and monitor and address the electrolyte abnormalities, Dr. Deep said. “While thiazide and thiazide-like diuretics are an important component of our treatment options for patients with hypertension and other conditions, we should also ensure that we are cognizant of and address the potential side effects or electrolyte imbalances caused by the medications.”
The study was funded by the Independent Research Fund Denmark, Helsefonden, Dagmar Marshalls Fond, Gangstedfonden, A.P. Møller and Chastine Mc-Kinney Møller Foundation, Brødrene Hartmanns Fond, and Snedkermester Sophus Jacobsen og hustru Astrid Jacobsens Fond.
The researchers had no financial conflicts to disclose. Dr. Deep had no financial conflicts to disclose.
A version of this article first appeared on Medscape.com.
Adults who used thiazide diuretics for hypertension were more likely than were those who used nonthiazide agents to develop hyponatremia within 2 years of starting treatment, a new study of more than 180,000 people has found.
Although thiazide diuretics generally are well-tolerated in the routine treatment of uncomplicated hypertension, severe adverse effects are possible, and their frequency has not been examined, according to Niklas Worm Andersson, MD, of Statens Serum Institut, in Copenhagen, Denmark, and his colleagues.
“Thiazide diuretics are commonly used drugs for the treatment of uncomplicated hypertension, and hyponatremia is a known potential side effect to thiazide treatment, but the frequency of this adverse event is inconsistently reported across drug labels,” Dr. Andersson told this news organization.
Product labels for thiazide diuretics list hyponatremia as a potential adverse event that can occur rarely (defined as a range from less than 1 in 10,000 to less than 1 in 100 individuals), but the extent of the burden is unclear given the wide range of symptoms of the condition, the researchers write.
In a study published in Annals of Internal Medicine, Dr. Andersson and his colleagues reviewed data from population-based registries in Denmark of adults aged 40 years or older with uncomplicated hypertension, no recent prescriptions for antihypertensives, and no previous history of hyponatremia. They emulated two target trials. One trial compared the incidence of hyponatremia in new users of bendroflumethiazide (BFZ) vs a calcium-channel blocker (CCB). The other emulation compared the incidence of hyponatremia in new users of hydrochlorothiazide (HCTZ) plus a renin-angiotensin system (RAS) inhibitor vs a RAS inhibitor without HCTZ.
The primary outcome was hyponatremia, defined as blood sodium < 130 mmol/L, within 2 years of starting treatment.
The 2-year incidence of hyponatremia for the two thiazide diuretics was 3.83% for BFZ and 3.51% for HCTZ-RAS inhibitor. The risk difference in the incidence of hyponatremia was 1.35% for BFZ vs CCB and 1.38% for HCTZ-RAS inhibitor vs RAS inhibitor, the researchers reported.
The study population included 37,786 new users of BFZ who were compared with 44,963 new users of CCBs as well as 11,943 new users of HCTZ-RAS inhibitors who were compared with 85,784 new users of RAS inhibitors only.
Overall, older age and a greater number of comorbidities increased the cumulative hyponatremia in new users of thiazide-based hypertensives. The risk differences among individuals aged 80 years or older were 4.80% in the BFZ vs CCB study and 5.52% in the HCTZ-RAS inhibitor vs RAS inhibitor study. Among participants with three or more comorbidities, the risk differences in the two studies were 5.24% and 2.91%, respectively, Dr. Andersson’s group found.
The findings were limited by several factors, mainly the potential for confounding on the basis of the assumption that filled prescriptions equaled drug use, the researchers noted. Other limitations included the focus on new users and a Danish population only, which might limit generalizability, and a lack of data on blood pressure measures.
However, the results suggest a greater risk for hyponatremia with thiazide diuretics than what the drug labels indicate, especially early in treatment, the researchers concluded.
Data Reinforce Need for Vigilance in the Clinic
“Our findings highlight the continued need for clinical awareness and monitoring of this adverse drug reaction; particularly during the first months of treatment, in persons who are older or who have comorbidities,” Dr. Andersson told this news organization. “Further mapping of potential subpopulations at risk in terms of specific comorbidities is important to improve the prevention of this adverse event.”
“The thiazide diuretics have been recommended as first-line therapy for hypertension, and it was important to evaluate the potential development of hyponatremia, especially in the older patients given the potentially serious health effects caused by hyponatremia,” said Noel Deep, MD, a general internist in private practice in Antigo, Wisconsin. Dr. Deep, who was not involved in the study, also serves as chief medical officer and a staff physician at Aspirus Langlade Hospital in Antigo.
The current study findings were not surprising, Dr. Deep added. “I have seen this occur in my patients, especially in the older female patients,” he said. “The results reinforce my practice of monitoring the electrolytes and renal function in 1-2 weeks after starting a thiazide diuretic, and then at regular intervals.”
In practice, clinicians should be aware of the potential development of hyponatremia and monitor and address the electrolyte abnormalities, Dr. Deep said. “While thiazide and thiazide-like diuretics are an important component of our treatment options for patients with hypertension and other conditions, we should also ensure that we are cognizant of and address the potential side effects or electrolyte imbalances caused by the medications.”
The study was funded by the Independent Research Fund Denmark, Helsefonden, Dagmar Marshalls Fond, Gangstedfonden, A.P. Møller and Chastine Mc-Kinney Møller Foundation, Brødrene Hartmanns Fond, and Snedkermester Sophus Jacobsen og hustru Astrid Jacobsens Fond.
The researchers had no financial conflicts to disclose. Dr. Deep had no financial conflicts to disclose.
A version of this article first appeared on Medscape.com.
FROM ANNALS OF INTERNAL MEDICINE
Blood Eosinophil-Directed Prednisolone Proves Noninferior to Standard Care for COPD Exacerbations
TOPLINE:
Both blood eosinophil-directed treatment (BET) and standard care treatment (ST) similarly reduced treatment failure following acute exacerbations in chronic obstructive pulmonary disease (COPD).
METHODOLOGY:
- The researchers randomized 152 adults with a mean age of 70 years to BET or a placebo (if eosinophil counts were less than 2%) or to standard care treatment regardless of baseline eosinophil counts; the final population available for analysis included 47 patients in the blood eosinophil group and 46 in the primary care group, with 73 and 71 exacerbations, respectively.
- Participants were assessed at baseline and at day 14, day 30, and day 90 after exacerbation; the primary outcome was the rate of treatment failure at 30 days post exacerbation, defined as any need for retreatment with antibiotics or steroids, hospitalization, or death; secondary outcomes included health-related quality of life, forced expiratory volume in 1 second, and visual analogue score respiratory symptoms.
- Participants were recruited from 14 general practices between November 6, 2017, and April 30, 2020; the study was terminated on April 30, 2023, because of the COVID-19 pandemic.
TAKEAWAY:
- BET was noninferior to ST in a noninferiority analysis.
- At 30 days post exacerbation, 14 treatment failures had occurred in the BET group and 23 in the ST group; the relative risk was 0.60 (P = .070).
- The frequency of adverse events was similar between the groups; the most common adverse events were glycosuria and hospital admission for COPD exacerbation (2% in the BET group and 1% in the ST group for both event types), and no deaths occurred during the study period.
- Subgroup analysis showed the greatest benefit in both groups was to patients with higher eosinophil counts who received prednisolone.
IN PRACTICE:
“There was improvement of lung function, quality of life, and symptoms in exacerbations with low eosinophil count independent of whether placebo or prednisolone was prescribed,” the authors wrote in their discussion.
SOURCE:
The lead author on the study was Sanjay Ramakrishnan, MBBS, University of Oxford, United Kingdom. The study was published online in Lancet Respiratory Medicine .
LIMITATIONS:
A key limitation was an error in the randomization code that prevented the trial’s completion as a superiority study; other limitations included the relatively low number of exacerbations associated with low eosinophil counts and reduction in the recommended length of treatment with prednisolone during the study period.
DISCLOSURES:
The study was supported by the National Institute for Health and Care Research. Dr. Ramakrishnan disclosed personal salary support from the National Institute for Health and Care Research, an unrestricted research grant from AstraZeneca to his institution, and speaker fees and conference travel support from AstraZeneca, all unrelated to the current study.
A version of this article first appeared on Medscape.com.
TOPLINE:
Both blood eosinophil-directed treatment (BET) and standard care treatment (ST) similarly reduced treatment failure following acute exacerbations in chronic obstructive pulmonary disease (COPD).
METHODOLOGY:
- The researchers randomized 152 adults with a mean age of 70 years to BET or a placebo (if eosinophil counts were less than 2%) or to standard care treatment regardless of baseline eosinophil counts; the final population available for analysis included 47 patients in the blood eosinophil group and 46 in the primary care group, with 73 and 71 exacerbations, respectively.
- Participants were assessed at baseline and at day 14, day 30, and day 90 after exacerbation; the primary outcome was the rate of treatment failure at 30 days post exacerbation, defined as any need for retreatment with antibiotics or steroids, hospitalization, or death; secondary outcomes included health-related quality of life, forced expiratory volume in 1 second, and visual analogue score respiratory symptoms.
- Participants were recruited from 14 general practices between November 6, 2017, and April 30, 2020; the study was terminated on April 30, 2023, because of the COVID-19 pandemic.
TAKEAWAY:
- BET was noninferior to ST in a noninferiority analysis.
- At 30 days post exacerbation, 14 treatment failures had occurred in the BET group and 23 in the ST group; the relative risk was 0.60 (P = .070).
- The frequency of adverse events was similar between the groups; the most common adverse events were glycosuria and hospital admission for COPD exacerbation (2% in the BET group and 1% in the ST group for both event types), and no deaths occurred during the study period.
- Subgroup analysis showed the greatest benefit in both groups was to patients with higher eosinophil counts who received prednisolone.
IN PRACTICE:
“There was improvement of lung function, quality of life, and symptoms in exacerbations with low eosinophil count independent of whether placebo or prednisolone was prescribed,” the authors wrote in their discussion.
SOURCE:
The lead author on the study was Sanjay Ramakrishnan, MBBS, University of Oxford, United Kingdom. The study was published online in Lancet Respiratory Medicine .
LIMITATIONS:
A key limitation was an error in the randomization code that prevented the trial’s completion as a superiority study; other limitations included the relatively low number of exacerbations associated with low eosinophil counts and reduction in the recommended length of treatment with prednisolone during the study period.
DISCLOSURES:
The study was supported by the National Institute for Health and Care Research. Dr. Ramakrishnan disclosed personal salary support from the National Institute for Health and Care Research, an unrestricted research grant from AstraZeneca to his institution, and speaker fees and conference travel support from AstraZeneca, all unrelated to the current study.
A version of this article first appeared on Medscape.com.
TOPLINE:
Both blood eosinophil-directed treatment (BET) and standard care treatment (ST) similarly reduced treatment failure following acute exacerbations in chronic obstructive pulmonary disease (COPD).
METHODOLOGY:
- The researchers randomized 152 adults with a mean age of 70 years to BET or a placebo (if eosinophil counts were less than 2%) or to standard care treatment regardless of baseline eosinophil counts; the final population available for analysis included 47 patients in the blood eosinophil group and 46 in the primary care group, with 73 and 71 exacerbations, respectively.
- Participants were assessed at baseline and at day 14, day 30, and day 90 after exacerbation; the primary outcome was the rate of treatment failure at 30 days post exacerbation, defined as any need for retreatment with antibiotics or steroids, hospitalization, or death; secondary outcomes included health-related quality of life, forced expiratory volume in 1 second, and visual analogue score respiratory symptoms.
- Participants were recruited from 14 general practices between November 6, 2017, and April 30, 2020; the study was terminated on April 30, 2023, because of the COVID-19 pandemic.
TAKEAWAY:
- BET was noninferior to ST in a noninferiority analysis.
- At 30 days post exacerbation, 14 treatment failures had occurred in the BET group and 23 in the ST group; the relative risk was 0.60 (P = .070).
- The frequency of adverse events was similar between the groups; the most common adverse events were glycosuria and hospital admission for COPD exacerbation (2% in the BET group and 1% in the ST group for both event types), and no deaths occurred during the study period.
- Subgroup analysis showed the greatest benefit in both groups was to patients with higher eosinophil counts who received prednisolone.
IN PRACTICE:
“There was improvement of lung function, quality of life, and symptoms in exacerbations with low eosinophil count independent of whether placebo or prednisolone was prescribed,” the authors wrote in their discussion.
SOURCE:
The lead author on the study was Sanjay Ramakrishnan, MBBS, University of Oxford, United Kingdom. The study was published online in Lancet Respiratory Medicine .
LIMITATIONS:
A key limitation was an error in the randomization code that prevented the trial’s completion as a superiority study; other limitations included the relatively low number of exacerbations associated with low eosinophil counts and reduction in the recommended length of treatment with prednisolone during the study period.
DISCLOSURES:
The study was supported by the National Institute for Health and Care Research. Dr. Ramakrishnan disclosed personal salary support from the National Institute for Health and Care Research, an unrestricted research grant from AstraZeneca to his institution, and speaker fees and conference travel support from AstraZeneca, all unrelated to the current study.
A version of this article first appeared on Medscape.com.