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Too Little Sleep Raises Health Risks for Teens With T1D
TOPLINE:
METHODOLOGY:
- Sleep is recognized as an important factor in diabetes assessment and treatment by the 2023 American Diabetes Association’s Standards of Medical Care in Diabetes, but it is unclear whether sleep may improve health outcomes across the lifespan in patients with T1D.
- This secondary analysis of the BCQR-T1D crossover trial investigated the link between sleep and cardiometabolic health in 42 adults (age, 19-60 years) and 42 adolescents (age, 12-18 years) with T1D.
- Participants had T1D duration greater than 9 months and received bromocriptine quick-release (BCQR) therapy or placebo for 4 weeks and then switched between the treatments in a separate 4-week period.
- They underwent laboratory testing and anthropometric measurements. Also, continuous glucose monitoring data were collected for a week during each treatment phase along with an accompanying insulin dosing diary.
- Participants were required to wear an actigraphy monitor on the wrist of their nondominant hand for 7 days during each treatment phase to estimate sleep duration.
TAKEAWAY:
- Most adolescents (62%) and adults (74%) with T1D reported less than 7 hours of sleep at baseline.
- Participants with insufficient sleep versus those without insufficient sleep (< 7 vs > 7 hours) had a larger waist circumference and higher mean body mass index, systolic blood pressure, and pulse pressure, as well as lower estimated insulin sensitivity and brachial artery distensibility (P < .05 for all).
- When stratified by age, only adolescents with T1D with insufficient sleep had significant differences in most health outcomes by sleep duration status, except that adults with less than 7 hours of sleep had higher pulse pressure than those with more than 7 hours of sleep.
- Compared with placebo, BCQR slightly improved sleeping parameters in adolescents by delaying their time of waking up and prolonging their time in bed.
IN PRACTICE:
“Sleep may be an important and novel target for improving health in individuals with T1D, particularly when initiated in adolescence or early in diabetes,” the authors wrote.
SOURCE:
Stacey L. Simon, PhD, and Janet K. Snell-Bergeon, PhD, University of Colorado Anschutz Medical Campus, Aurora, led this study, which was published online in Diabetes, Obesity and Metabolism.
LIMITATIONS:
The study lacked polysomnography or melatonin assessment to quantify circadian rhythms and subjective sleep quality ratings. It also had no objective measurement of the timing of the daily pills of BCQR, which, when taken in the morning, are hypothesized to reset the circadian rhythm for hypothalamic dopamine and serotonin. The recommended sleep duration of 8 hours for adolescents was not used as the cutoff value due to too few participants who qualified. Also, this study›s findings may be affected by the fact that participants were recruited throughout the year, while adolescents show different sleeping patterns during the academic year compared with school breaks.
DISCLOSURES:
This work was supported by a JDRF grant. Two authors declared receiving equipment, honoraria for lectures, and support for conference travel, which were all unrelated to this study.
A version of this article appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- Sleep is recognized as an important factor in diabetes assessment and treatment by the 2023 American Diabetes Association’s Standards of Medical Care in Diabetes, but it is unclear whether sleep may improve health outcomes across the lifespan in patients with T1D.
- This secondary analysis of the BCQR-T1D crossover trial investigated the link between sleep and cardiometabolic health in 42 adults (age, 19-60 years) and 42 adolescents (age, 12-18 years) with T1D.
- Participants had T1D duration greater than 9 months and received bromocriptine quick-release (BCQR) therapy or placebo for 4 weeks and then switched between the treatments in a separate 4-week period.
- They underwent laboratory testing and anthropometric measurements. Also, continuous glucose monitoring data were collected for a week during each treatment phase along with an accompanying insulin dosing diary.
- Participants were required to wear an actigraphy monitor on the wrist of their nondominant hand for 7 days during each treatment phase to estimate sleep duration.
TAKEAWAY:
- Most adolescents (62%) and adults (74%) with T1D reported less than 7 hours of sleep at baseline.
- Participants with insufficient sleep versus those without insufficient sleep (< 7 vs > 7 hours) had a larger waist circumference and higher mean body mass index, systolic blood pressure, and pulse pressure, as well as lower estimated insulin sensitivity and brachial artery distensibility (P < .05 for all).
- When stratified by age, only adolescents with T1D with insufficient sleep had significant differences in most health outcomes by sleep duration status, except that adults with less than 7 hours of sleep had higher pulse pressure than those with more than 7 hours of sleep.
- Compared with placebo, BCQR slightly improved sleeping parameters in adolescents by delaying their time of waking up and prolonging their time in bed.
IN PRACTICE:
“Sleep may be an important and novel target for improving health in individuals with T1D, particularly when initiated in adolescence or early in diabetes,” the authors wrote.
SOURCE:
Stacey L. Simon, PhD, and Janet K. Snell-Bergeon, PhD, University of Colorado Anschutz Medical Campus, Aurora, led this study, which was published online in Diabetes, Obesity and Metabolism.
LIMITATIONS:
The study lacked polysomnography or melatonin assessment to quantify circadian rhythms and subjective sleep quality ratings. It also had no objective measurement of the timing of the daily pills of BCQR, which, when taken in the morning, are hypothesized to reset the circadian rhythm for hypothalamic dopamine and serotonin. The recommended sleep duration of 8 hours for adolescents was not used as the cutoff value due to too few participants who qualified. Also, this study›s findings may be affected by the fact that participants were recruited throughout the year, while adolescents show different sleeping patterns during the academic year compared with school breaks.
DISCLOSURES:
This work was supported by a JDRF grant. Two authors declared receiving equipment, honoraria for lectures, and support for conference travel, which were all unrelated to this study.
A version of this article appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- Sleep is recognized as an important factor in diabetes assessment and treatment by the 2023 American Diabetes Association’s Standards of Medical Care in Diabetes, but it is unclear whether sleep may improve health outcomes across the lifespan in patients with T1D.
- This secondary analysis of the BCQR-T1D crossover trial investigated the link between sleep and cardiometabolic health in 42 adults (age, 19-60 years) and 42 adolescents (age, 12-18 years) with T1D.
- Participants had T1D duration greater than 9 months and received bromocriptine quick-release (BCQR) therapy or placebo for 4 weeks and then switched between the treatments in a separate 4-week period.
- They underwent laboratory testing and anthropometric measurements. Also, continuous glucose monitoring data were collected for a week during each treatment phase along with an accompanying insulin dosing diary.
- Participants were required to wear an actigraphy monitor on the wrist of their nondominant hand for 7 days during each treatment phase to estimate sleep duration.
TAKEAWAY:
- Most adolescents (62%) and adults (74%) with T1D reported less than 7 hours of sleep at baseline.
- Participants with insufficient sleep versus those without insufficient sleep (< 7 vs > 7 hours) had a larger waist circumference and higher mean body mass index, systolic blood pressure, and pulse pressure, as well as lower estimated insulin sensitivity and brachial artery distensibility (P < .05 for all).
- When stratified by age, only adolescents with T1D with insufficient sleep had significant differences in most health outcomes by sleep duration status, except that adults with less than 7 hours of sleep had higher pulse pressure than those with more than 7 hours of sleep.
- Compared with placebo, BCQR slightly improved sleeping parameters in adolescents by delaying their time of waking up and prolonging their time in bed.
IN PRACTICE:
“Sleep may be an important and novel target for improving health in individuals with T1D, particularly when initiated in adolescence or early in diabetes,” the authors wrote.
SOURCE:
Stacey L. Simon, PhD, and Janet K. Snell-Bergeon, PhD, University of Colorado Anschutz Medical Campus, Aurora, led this study, which was published online in Diabetes, Obesity and Metabolism.
LIMITATIONS:
The study lacked polysomnography or melatonin assessment to quantify circadian rhythms and subjective sleep quality ratings. It also had no objective measurement of the timing of the daily pills of BCQR, which, when taken in the morning, are hypothesized to reset the circadian rhythm for hypothalamic dopamine and serotonin. The recommended sleep duration of 8 hours for adolescents was not used as the cutoff value due to too few participants who qualified. Also, this study›s findings may be affected by the fact that participants were recruited throughout the year, while adolescents show different sleeping patterns during the academic year compared with school breaks.
DISCLOSURES:
This work was supported by a JDRF grant. Two authors declared receiving equipment, honoraria for lectures, and support for conference travel, which were all unrelated to this study.
A version of this article appeared on Medscape.com.
Most Targeted Cancer Drugs Lack Substantial Clinical Benefit
TOPLINE:
METHODOLOGY:
- The strength and quality of evidence supporting genome-targeted cancer drug approvals vary. A big reason is the growing number of cancer drug approvals based on surrogate endpoints, such as disease-free and progression-free survival, instead of clinical endpoints, such as overall survival or quality of life. The US Food and Drug Administration (FDA) has also approved genome-targeted cancer drugs based on phase 1 or single-arm trials.
- Given these less rigorous considerations for approval, “the validity and value of the targets and surrogate measures underlying FDA genome-targeted cancer drug approvals are uncertain,” the researchers explained.
- In the current analysis, researchers assessed the validity of the molecular targets as well as the clinical benefits of genome-targeted cancer drugs approved in the United States from 2015 to 2022 based on results from pivotal trials.
- The researchers evaluated the strength of evidence supporting molecular targetability using the European Society for Medical Oncology (ESMO) Scale for Clinical Actionability of Molecular Targets (ESCAT) and the clinical benefit using the ESMO–Magnitude of Clinical Benefit Scale (ESMO-MCBS).
- The authors defined a substantial clinical benefit as an A or B grade for curative intent and a 4 or 5 for noncurative intent. High-benefit genomic-based cancer treatments were defined as those associated with a substantial clinical benefit (ESMO-MCBS) and that qualified as ESCAT category level I-A (a clinical benefit based on prospective randomized data) or I-B (prospective nonrandomized data).
TAKEAWAY:
- The analyses focused on 50 molecular-targeted cancer drugs covering 84 indications. Of which, 45 indications (54%) were approved based on phase 1 or 2 pivotal trials, 45 (54%) were supported by single-arm pivotal trials and the remaining 39 (46%) by randomized trial, and 48 (57%) were approved based on subgroup analyses.
- Among the 84 indications, more than half (55%) of the pivotal trials supporting approval used overall response rate as a primary endpoint, 31% used progression-free survival, and 6% used disease-free survival. Only seven indications (8%) were supported by pivotal trials demonstrating an improvement in overall survival.
- Among the 84 trials, 24 (29%) met the ESMO-MCBS threshold for substantial clinical benefit.
- Overall, when combining all ratings, only 24 of the 84 indications (29%) were considered high-benefit genomic-based cancer treatments.
IN PRACTICE:
“We applied the ESMO-MCBS and ESCAT value frameworks to identify therapies and molecular targets providing high clinical value that should be widely available to patients” and “found that drug indications supported by these characteristics represent a minority of cancer drug approvals in recent years,” the authors said. Using these value frameworks could help payers, governments, and individual patients “prioritize the availability of high-value molecular-targeted therapies.”
SOURCE:
The study, with first author Ariadna Tibau, MD, PhD, Brigham and Women’s Hospital and Harvard Medical School, Boston, was published online in JAMA Oncology.
LIMITATIONS:
The study evaluated only trials that supported regulatory approval and did not include outcomes of postapproval clinical studies, which could lead to changes in ESMO-MCBS grades and ESCAT levels of evidence over time.
DISCLOSURES:
The study was funded by the Kaiser Permanente Institute for Health Policy, Arnold Ventures, and the Commonwealth Fund. The authors had no relevant disclosures.
A version of this article appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- The strength and quality of evidence supporting genome-targeted cancer drug approvals vary. A big reason is the growing number of cancer drug approvals based on surrogate endpoints, such as disease-free and progression-free survival, instead of clinical endpoints, such as overall survival or quality of life. The US Food and Drug Administration (FDA) has also approved genome-targeted cancer drugs based on phase 1 or single-arm trials.
- Given these less rigorous considerations for approval, “the validity and value of the targets and surrogate measures underlying FDA genome-targeted cancer drug approvals are uncertain,” the researchers explained.
- In the current analysis, researchers assessed the validity of the molecular targets as well as the clinical benefits of genome-targeted cancer drugs approved in the United States from 2015 to 2022 based on results from pivotal trials.
- The researchers evaluated the strength of evidence supporting molecular targetability using the European Society for Medical Oncology (ESMO) Scale for Clinical Actionability of Molecular Targets (ESCAT) and the clinical benefit using the ESMO–Magnitude of Clinical Benefit Scale (ESMO-MCBS).
- The authors defined a substantial clinical benefit as an A or B grade for curative intent and a 4 or 5 for noncurative intent. High-benefit genomic-based cancer treatments were defined as those associated with a substantial clinical benefit (ESMO-MCBS) and that qualified as ESCAT category level I-A (a clinical benefit based on prospective randomized data) or I-B (prospective nonrandomized data).
TAKEAWAY:
- The analyses focused on 50 molecular-targeted cancer drugs covering 84 indications. Of which, 45 indications (54%) were approved based on phase 1 or 2 pivotal trials, 45 (54%) were supported by single-arm pivotal trials and the remaining 39 (46%) by randomized trial, and 48 (57%) were approved based on subgroup analyses.
- Among the 84 indications, more than half (55%) of the pivotal trials supporting approval used overall response rate as a primary endpoint, 31% used progression-free survival, and 6% used disease-free survival. Only seven indications (8%) were supported by pivotal trials demonstrating an improvement in overall survival.
- Among the 84 trials, 24 (29%) met the ESMO-MCBS threshold for substantial clinical benefit.
- Overall, when combining all ratings, only 24 of the 84 indications (29%) were considered high-benefit genomic-based cancer treatments.
IN PRACTICE:
“We applied the ESMO-MCBS and ESCAT value frameworks to identify therapies and molecular targets providing high clinical value that should be widely available to patients” and “found that drug indications supported by these characteristics represent a minority of cancer drug approvals in recent years,” the authors said. Using these value frameworks could help payers, governments, and individual patients “prioritize the availability of high-value molecular-targeted therapies.”
SOURCE:
The study, with first author Ariadna Tibau, MD, PhD, Brigham and Women’s Hospital and Harvard Medical School, Boston, was published online in JAMA Oncology.
LIMITATIONS:
The study evaluated only trials that supported regulatory approval and did not include outcomes of postapproval clinical studies, which could lead to changes in ESMO-MCBS grades and ESCAT levels of evidence over time.
DISCLOSURES:
The study was funded by the Kaiser Permanente Institute for Health Policy, Arnold Ventures, and the Commonwealth Fund. The authors had no relevant disclosures.
A version of this article appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- The strength and quality of evidence supporting genome-targeted cancer drug approvals vary. A big reason is the growing number of cancer drug approvals based on surrogate endpoints, such as disease-free and progression-free survival, instead of clinical endpoints, such as overall survival or quality of life. The US Food and Drug Administration (FDA) has also approved genome-targeted cancer drugs based on phase 1 or single-arm trials.
- Given these less rigorous considerations for approval, “the validity and value of the targets and surrogate measures underlying FDA genome-targeted cancer drug approvals are uncertain,” the researchers explained.
- In the current analysis, researchers assessed the validity of the molecular targets as well as the clinical benefits of genome-targeted cancer drugs approved in the United States from 2015 to 2022 based on results from pivotal trials.
- The researchers evaluated the strength of evidence supporting molecular targetability using the European Society for Medical Oncology (ESMO) Scale for Clinical Actionability of Molecular Targets (ESCAT) and the clinical benefit using the ESMO–Magnitude of Clinical Benefit Scale (ESMO-MCBS).
- The authors defined a substantial clinical benefit as an A or B grade for curative intent and a 4 or 5 for noncurative intent. High-benefit genomic-based cancer treatments were defined as those associated with a substantial clinical benefit (ESMO-MCBS) and that qualified as ESCAT category level I-A (a clinical benefit based on prospective randomized data) or I-B (prospective nonrandomized data).
TAKEAWAY:
- The analyses focused on 50 molecular-targeted cancer drugs covering 84 indications. Of which, 45 indications (54%) were approved based on phase 1 or 2 pivotal trials, 45 (54%) were supported by single-arm pivotal trials and the remaining 39 (46%) by randomized trial, and 48 (57%) were approved based on subgroup analyses.
- Among the 84 indications, more than half (55%) of the pivotal trials supporting approval used overall response rate as a primary endpoint, 31% used progression-free survival, and 6% used disease-free survival. Only seven indications (8%) were supported by pivotal trials demonstrating an improvement in overall survival.
- Among the 84 trials, 24 (29%) met the ESMO-MCBS threshold for substantial clinical benefit.
- Overall, when combining all ratings, only 24 of the 84 indications (29%) were considered high-benefit genomic-based cancer treatments.
IN PRACTICE:
“We applied the ESMO-MCBS and ESCAT value frameworks to identify therapies and molecular targets providing high clinical value that should be widely available to patients” and “found that drug indications supported by these characteristics represent a minority of cancer drug approvals in recent years,” the authors said. Using these value frameworks could help payers, governments, and individual patients “prioritize the availability of high-value molecular-targeted therapies.”
SOURCE:
The study, with first author Ariadna Tibau, MD, PhD, Brigham and Women’s Hospital and Harvard Medical School, Boston, was published online in JAMA Oncology.
LIMITATIONS:
The study evaluated only trials that supported regulatory approval and did not include outcomes of postapproval clinical studies, which could lead to changes in ESMO-MCBS grades and ESCAT levels of evidence over time.
DISCLOSURES:
The study was funded by the Kaiser Permanente Institute for Health Policy, Arnold Ventures, and the Commonwealth Fund. The authors had no relevant disclosures.
A version of this article appeared on Medscape.com.
What Are Platanus Cough and Thunderstorm Asthma?
Because of climate change, heat waves, storms, heavy rainfalls, and floods are now occurring in areas that seldom experienced these phenomena before. “Extreme weather events are rare, but in terms of their extent, duration, and scale, they are unusual. And they are increasing due to climate change,” said Andrea Elmer, MD, an internal medicine and pulmonology specialist at the DKD Helios Clinic in Wiesbaden, Germany. She spoke at the Congress of the German Society for Pneumology and Respiratory Medicine.
Dr. Elmer referred to the 2023 status report by the Robert Koch Institute and the 2023 Synthesis Report by the Intergovernmental Panel on Climate Change, in which the likelihood of extreme weather events was acknowledged to be significantly higher than previously recognized. “Knowing about such extreme weather events is important to assess the consequences for our patients and to identify possible medical care needs,” said Dr. Elmer. She focused on the effects of platanus (plane tree) cough and thunderstorm asthma.
Platanus Cough
The symptoms worsened when the children left the building and waited in the schoolyard. Initially, a chemical attack with irritant gas was suspected because the school is located near an industrial area. There were no indications of a pollen cloud.
Eventually, doctors and firefighters found that the symptoms were caused by platanus cough, which is induced by the fine star-shaped hair found on young platanus leaves, bark, young branches, and buds. If strong winds move the leaves after prolonged dryness, these trichomes can break off when touched, creating platanus dust.
At that time, there were unusual climatic conditions. The temperature was 29 °C, it was dry, and wind gusts reached 50 km/h. The schoolyard was enclosed and densely planted with tall, old plane trees. Initial symptoms occurred in classrooms with open windows.
Twenty-five children had to be admitted to the hospital. Treatment included lorazepam and salbutamol. All students had normal oxygen levels, and the symptoms were reversed.
Cough or Allergy?
The clinical differential diagnosis for an allergy is quite simple, said Dr. Elmer. Platanus cough mainly shows symptoms of irritation, a feeling of a foreign body, and scratching in the eyes, throat, and nose. Coughing can also occur. In an allergy, there is often a runny nose and itching in the eyes and nose. Such allergic symptoms do not occur with platanus cough.
It should also be noted that the sensitization rates for a platanus allergy in Germany range between 5% and 11%. “Having so many platanus allergy sufferers in one place was relatively unlikely,” said Dr. Elmer.
She expects an increase in cases of platanus cough, especially in cities with dense construction, such as in narrow schoolyards. High concentrations of platanus dust can occur, especially when it is warm, dry, and windy. “Platanus cough does not occur every time we walk under plane trees. It strongly depends on warmth, dryness, and wind,” said Dr. Elmer.
Patients can protect themselves by avoiding skin and mucous membrane contact under appropriate climatic conditions and by wearing protective glasses and masks. Leaves and branches should not be swept but vacuumed. “Under no circumstances should plane trees be cut down. We need trees, especially in cities,” said Dr. Elmer. Moreover, the trichomes act as biofilters for air pollutants. In critical environments such as schoolyards, seasonal spraying of plane trees with a mixture of apple pectin and water can prevent the star hair from breaking off.
Thunderstorm Asthma
For patients with asthma, wildfires, storms, heavy rainfall, and thunderstorms can lead to exacerbations. Emergency room visits and hospital admissions generally increase after extreme weather events.
A study examining the consequences of the fires in California from 2004 to 2009, for example, reported that hospital visits related to asthma increased by 10.3%. Those related to respiratory problems increased by 3.3%. Infants and children up to age 5 years were most affected.
Thunderstorms are increasing because of global warming. Thunderstorm asthma arises under specific meteorological conditions. It typically occurs in patients with aeroallergies (eg, to pollen and fungal spores) in combination with thunderstorms and lightning. Large pollen grains, which normally remain in the upper airways, ascend into higher atmospheric layers and break apart due to updrafts. These very small particles are pushed back to ground level by downdrafts, enter the lower airways, and cause acute asthma.
Worldwide, cases of thunderstorm asthma are rare. About 30 events have been documented. Thunderstorm asthma was first observed in 1983 in Birmingham, England. Fungal spores were the trigger.
The most significant incident so far was a severe thunderstorm on November 21, 2016, in Melbourne, Australia. Worldwide attention was drawn to the storm because of an unusually high number of asthma cases. Within 30 hours, 3365 patients were admitted to emergency rooms. “This is also a high burden for a city with 4.6 million inhabitants,” said Dr. Elmer. Of the patients in Melbourne, 35 were admitted to the intensive care unit and 5 patients died.
Dr. Elmer calculated the corresponding number of patients for Wiesbaden and Mainz. “Assuming a population of 500,000 in this region, that would be 400 patients in emergency rooms within 30 hours, which would be a significant number.”
Such events are mainly observed in Australia, where two events per decade are expected. However, due to climate change, the risk could also increase in Europe, leading to more cases of thunderstorm asthma.
Risk Factors
The following environmental factors increase the risk:
- High pollen concentrations in the days before a thunderstorm
- Precipitation and high humidity, thunderstorms, and lightning
- Sudden temperature changes
- Increases in aeroallergen biomass and extreme weather events because of climate change
In Australia, grass pollen was often the trigger for thunderstorm asthma. In the United Kingdom, it was fungal spores. In Italy, olive pollen has a similar potential.
Patients with preexisting asthma, uncontrolled asthma, and high serum-specific immunoglobulin E levels are at risk. The risk is also increased for patients with poor compliance with inhaled steroid (ICS) therapy and for patients who have previously been hospitalized because of their asthma.
Patients with hay fever (ie, seasonal allergic rhinitis) have a significantly higher risk. As Dr. Elmer observed, 88% of patients in the emergency room in Melbourne had seasonal allergic rhinitis. “Fifty-seven percent of the patients in the emergency room did not have previously known asthma, but more than half showed symptoms indicating latent asthma. These patients had latent asthma but had not yet been diagnosed.”
Dr. Elmer emphasized how important it is not to underestimate mild asthma, which should be treated. For patients with hay fever, hyposensitization should be considered.
Reducing Risk
Many factors must come together for thunderstorm asthma to develop, according to Dr. Elmer. Because this convergence is difficult to predict, however, preparation and risk reduction are important. They consist of individual precautions and public health strategies.
The following steps can be taken at the individual level:
- Identify risk groups, including patients with allergic rhinitis and high serum-specific immunoglobulin E levels. Patients with hay fever benefit from hyposensitization.
- Avoid outdoor activities on risky days.
- Diagnose asthma, and do not underestimate mild asthma. Improve therapy compliance with ICS therapy and use maintenance and reliever therapy. This way, the patient automatically increases the steroid dose with increased symptoms and is better protected against exacerbations.
- Improve health literacy and understanding of asthma.
Thunderstorm asthma also affects healthcare professionals, Dr. Elmer warned. In Melbourne, 25% of responders themselves showed symptoms. Therefore, expect that some of these clinicians will also be unavailable.
Other steps are appropriate at the public health level. In addition to monitoring local pollen concentrations, one must identify risk groups, especially people working outdoors. “It is very difficult to predict an epidemic of thunderstorm asthma,” said Dr. Elmer. Therefore, it is important to increase awareness of the phenomenon and to develop an early warning system with emergency plans for patients and the healthcare system.
“Allergen immunotherapy is protective,” she added. “This has been well studied, and for Melbourne, it has been demonstrated. Patients with allergic rhinitis who had received immunotherapy were protected. These patients did not have to visit the emergency room. This shows that we can do something, and we should hyposensitize,” Dr. Elmer concluded.
This story was translated from the Medscape German edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Because of climate change, heat waves, storms, heavy rainfalls, and floods are now occurring in areas that seldom experienced these phenomena before. “Extreme weather events are rare, but in terms of their extent, duration, and scale, they are unusual. And they are increasing due to climate change,” said Andrea Elmer, MD, an internal medicine and pulmonology specialist at the DKD Helios Clinic in Wiesbaden, Germany. She spoke at the Congress of the German Society for Pneumology and Respiratory Medicine.
Dr. Elmer referred to the 2023 status report by the Robert Koch Institute and the 2023 Synthesis Report by the Intergovernmental Panel on Climate Change, in which the likelihood of extreme weather events was acknowledged to be significantly higher than previously recognized. “Knowing about such extreme weather events is important to assess the consequences for our patients and to identify possible medical care needs,” said Dr. Elmer. She focused on the effects of platanus (plane tree) cough and thunderstorm asthma.
Platanus Cough
The symptoms worsened when the children left the building and waited in the schoolyard. Initially, a chemical attack with irritant gas was suspected because the school is located near an industrial area. There were no indications of a pollen cloud.
Eventually, doctors and firefighters found that the symptoms were caused by platanus cough, which is induced by the fine star-shaped hair found on young platanus leaves, bark, young branches, and buds. If strong winds move the leaves after prolonged dryness, these trichomes can break off when touched, creating platanus dust.
At that time, there were unusual climatic conditions. The temperature was 29 °C, it was dry, and wind gusts reached 50 km/h. The schoolyard was enclosed and densely planted with tall, old plane trees. Initial symptoms occurred in classrooms with open windows.
Twenty-five children had to be admitted to the hospital. Treatment included lorazepam and salbutamol. All students had normal oxygen levels, and the symptoms were reversed.
Cough or Allergy?
The clinical differential diagnosis for an allergy is quite simple, said Dr. Elmer. Platanus cough mainly shows symptoms of irritation, a feeling of a foreign body, and scratching in the eyes, throat, and nose. Coughing can also occur. In an allergy, there is often a runny nose and itching in the eyes and nose. Such allergic symptoms do not occur with platanus cough.
It should also be noted that the sensitization rates for a platanus allergy in Germany range between 5% and 11%. “Having so many platanus allergy sufferers in one place was relatively unlikely,” said Dr. Elmer.
She expects an increase in cases of platanus cough, especially in cities with dense construction, such as in narrow schoolyards. High concentrations of platanus dust can occur, especially when it is warm, dry, and windy. “Platanus cough does not occur every time we walk under plane trees. It strongly depends on warmth, dryness, and wind,” said Dr. Elmer.
Patients can protect themselves by avoiding skin and mucous membrane contact under appropriate climatic conditions and by wearing protective glasses and masks. Leaves and branches should not be swept but vacuumed. “Under no circumstances should plane trees be cut down. We need trees, especially in cities,” said Dr. Elmer. Moreover, the trichomes act as biofilters for air pollutants. In critical environments such as schoolyards, seasonal spraying of plane trees with a mixture of apple pectin and water can prevent the star hair from breaking off.
Thunderstorm Asthma
For patients with asthma, wildfires, storms, heavy rainfall, and thunderstorms can lead to exacerbations. Emergency room visits and hospital admissions generally increase after extreme weather events.
A study examining the consequences of the fires in California from 2004 to 2009, for example, reported that hospital visits related to asthma increased by 10.3%. Those related to respiratory problems increased by 3.3%. Infants and children up to age 5 years were most affected.
Thunderstorms are increasing because of global warming. Thunderstorm asthma arises under specific meteorological conditions. It typically occurs in patients with aeroallergies (eg, to pollen and fungal spores) in combination with thunderstorms and lightning. Large pollen grains, which normally remain in the upper airways, ascend into higher atmospheric layers and break apart due to updrafts. These very small particles are pushed back to ground level by downdrafts, enter the lower airways, and cause acute asthma.
Worldwide, cases of thunderstorm asthma are rare. About 30 events have been documented. Thunderstorm asthma was first observed in 1983 in Birmingham, England. Fungal spores were the trigger.
The most significant incident so far was a severe thunderstorm on November 21, 2016, in Melbourne, Australia. Worldwide attention was drawn to the storm because of an unusually high number of asthma cases. Within 30 hours, 3365 patients were admitted to emergency rooms. “This is also a high burden for a city with 4.6 million inhabitants,” said Dr. Elmer. Of the patients in Melbourne, 35 were admitted to the intensive care unit and 5 patients died.
Dr. Elmer calculated the corresponding number of patients for Wiesbaden and Mainz. “Assuming a population of 500,000 in this region, that would be 400 patients in emergency rooms within 30 hours, which would be a significant number.”
Such events are mainly observed in Australia, where two events per decade are expected. However, due to climate change, the risk could also increase in Europe, leading to more cases of thunderstorm asthma.
Risk Factors
The following environmental factors increase the risk:
- High pollen concentrations in the days before a thunderstorm
- Precipitation and high humidity, thunderstorms, and lightning
- Sudden temperature changes
- Increases in aeroallergen biomass and extreme weather events because of climate change
In Australia, grass pollen was often the trigger for thunderstorm asthma. In the United Kingdom, it was fungal spores. In Italy, olive pollen has a similar potential.
Patients with preexisting asthma, uncontrolled asthma, and high serum-specific immunoglobulin E levels are at risk. The risk is also increased for patients with poor compliance with inhaled steroid (ICS) therapy and for patients who have previously been hospitalized because of their asthma.
Patients with hay fever (ie, seasonal allergic rhinitis) have a significantly higher risk. As Dr. Elmer observed, 88% of patients in the emergency room in Melbourne had seasonal allergic rhinitis. “Fifty-seven percent of the patients in the emergency room did not have previously known asthma, but more than half showed symptoms indicating latent asthma. These patients had latent asthma but had not yet been diagnosed.”
Dr. Elmer emphasized how important it is not to underestimate mild asthma, which should be treated. For patients with hay fever, hyposensitization should be considered.
Reducing Risk
Many factors must come together for thunderstorm asthma to develop, according to Dr. Elmer. Because this convergence is difficult to predict, however, preparation and risk reduction are important. They consist of individual precautions and public health strategies.
The following steps can be taken at the individual level:
- Identify risk groups, including patients with allergic rhinitis and high serum-specific immunoglobulin E levels. Patients with hay fever benefit from hyposensitization.
- Avoid outdoor activities on risky days.
- Diagnose asthma, and do not underestimate mild asthma. Improve therapy compliance with ICS therapy and use maintenance and reliever therapy. This way, the patient automatically increases the steroid dose with increased symptoms and is better protected against exacerbations.
- Improve health literacy and understanding of asthma.
Thunderstorm asthma also affects healthcare professionals, Dr. Elmer warned. In Melbourne, 25% of responders themselves showed symptoms. Therefore, expect that some of these clinicians will also be unavailable.
Other steps are appropriate at the public health level. In addition to monitoring local pollen concentrations, one must identify risk groups, especially people working outdoors. “It is very difficult to predict an epidemic of thunderstorm asthma,” said Dr. Elmer. Therefore, it is important to increase awareness of the phenomenon and to develop an early warning system with emergency plans for patients and the healthcare system.
“Allergen immunotherapy is protective,” she added. “This has been well studied, and for Melbourne, it has been demonstrated. Patients with allergic rhinitis who had received immunotherapy were protected. These patients did not have to visit the emergency room. This shows that we can do something, and we should hyposensitize,” Dr. Elmer concluded.
This story was translated from the Medscape German edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Because of climate change, heat waves, storms, heavy rainfalls, and floods are now occurring in areas that seldom experienced these phenomena before. “Extreme weather events are rare, but in terms of their extent, duration, and scale, they are unusual. And they are increasing due to climate change,” said Andrea Elmer, MD, an internal medicine and pulmonology specialist at the DKD Helios Clinic in Wiesbaden, Germany. She spoke at the Congress of the German Society for Pneumology and Respiratory Medicine.
Dr. Elmer referred to the 2023 status report by the Robert Koch Institute and the 2023 Synthesis Report by the Intergovernmental Panel on Climate Change, in which the likelihood of extreme weather events was acknowledged to be significantly higher than previously recognized. “Knowing about such extreme weather events is important to assess the consequences for our patients and to identify possible medical care needs,” said Dr. Elmer. She focused on the effects of platanus (plane tree) cough and thunderstorm asthma.
Platanus Cough
The symptoms worsened when the children left the building and waited in the schoolyard. Initially, a chemical attack with irritant gas was suspected because the school is located near an industrial area. There were no indications of a pollen cloud.
Eventually, doctors and firefighters found that the symptoms were caused by platanus cough, which is induced by the fine star-shaped hair found on young platanus leaves, bark, young branches, and buds. If strong winds move the leaves after prolonged dryness, these trichomes can break off when touched, creating platanus dust.
At that time, there were unusual climatic conditions. The temperature was 29 °C, it was dry, and wind gusts reached 50 km/h. The schoolyard was enclosed and densely planted with tall, old plane trees. Initial symptoms occurred in classrooms with open windows.
Twenty-five children had to be admitted to the hospital. Treatment included lorazepam and salbutamol. All students had normal oxygen levels, and the symptoms were reversed.
Cough or Allergy?
The clinical differential diagnosis for an allergy is quite simple, said Dr. Elmer. Platanus cough mainly shows symptoms of irritation, a feeling of a foreign body, and scratching in the eyes, throat, and nose. Coughing can also occur. In an allergy, there is often a runny nose and itching in the eyes and nose. Such allergic symptoms do not occur with platanus cough.
It should also be noted that the sensitization rates for a platanus allergy in Germany range between 5% and 11%. “Having so many platanus allergy sufferers in one place was relatively unlikely,” said Dr. Elmer.
She expects an increase in cases of platanus cough, especially in cities with dense construction, such as in narrow schoolyards. High concentrations of platanus dust can occur, especially when it is warm, dry, and windy. “Platanus cough does not occur every time we walk under plane trees. It strongly depends on warmth, dryness, and wind,” said Dr. Elmer.
Patients can protect themselves by avoiding skin and mucous membrane contact under appropriate climatic conditions and by wearing protective glasses and masks. Leaves and branches should not be swept but vacuumed. “Under no circumstances should plane trees be cut down. We need trees, especially in cities,” said Dr. Elmer. Moreover, the trichomes act as biofilters for air pollutants. In critical environments such as schoolyards, seasonal spraying of plane trees with a mixture of apple pectin and water can prevent the star hair from breaking off.
Thunderstorm Asthma
For patients with asthma, wildfires, storms, heavy rainfall, and thunderstorms can lead to exacerbations. Emergency room visits and hospital admissions generally increase after extreme weather events.
A study examining the consequences of the fires in California from 2004 to 2009, for example, reported that hospital visits related to asthma increased by 10.3%. Those related to respiratory problems increased by 3.3%. Infants and children up to age 5 years were most affected.
Thunderstorms are increasing because of global warming. Thunderstorm asthma arises under specific meteorological conditions. It typically occurs in patients with aeroallergies (eg, to pollen and fungal spores) in combination with thunderstorms and lightning. Large pollen grains, which normally remain in the upper airways, ascend into higher atmospheric layers and break apart due to updrafts. These very small particles are pushed back to ground level by downdrafts, enter the lower airways, and cause acute asthma.
Worldwide, cases of thunderstorm asthma are rare. About 30 events have been documented. Thunderstorm asthma was first observed in 1983 in Birmingham, England. Fungal spores were the trigger.
The most significant incident so far was a severe thunderstorm on November 21, 2016, in Melbourne, Australia. Worldwide attention was drawn to the storm because of an unusually high number of asthma cases. Within 30 hours, 3365 patients were admitted to emergency rooms. “This is also a high burden for a city with 4.6 million inhabitants,” said Dr. Elmer. Of the patients in Melbourne, 35 were admitted to the intensive care unit and 5 patients died.
Dr. Elmer calculated the corresponding number of patients for Wiesbaden and Mainz. “Assuming a population of 500,000 in this region, that would be 400 patients in emergency rooms within 30 hours, which would be a significant number.”
Such events are mainly observed in Australia, where two events per decade are expected. However, due to climate change, the risk could also increase in Europe, leading to more cases of thunderstorm asthma.
Risk Factors
The following environmental factors increase the risk:
- High pollen concentrations in the days before a thunderstorm
- Precipitation and high humidity, thunderstorms, and lightning
- Sudden temperature changes
- Increases in aeroallergen biomass and extreme weather events because of climate change
In Australia, grass pollen was often the trigger for thunderstorm asthma. In the United Kingdom, it was fungal spores. In Italy, olive pollen has a similar potential.
Patients with preexisting asthma, uncontrolled asthma, and high serum-specific immunoglobulin E levels are at risk. The risk is also increased for patients with poor compliance with inhaled steroid (ICS) therapy and for patients who have previously been hospitalized because of their asthma.
Patients with hay fever (ie, seasonal allergic rhinitis) have a significantly higher risk. As Dr. Elmer observed, 88% of patients in the emergency room in Melbourne had seasonal allergic rhinitis. “Fifty-seven percent of the patients in the emergency room did not have previously known asthma, but more than half showed symptoms indicating latent asthma. These patients had latent asthma but had not yet been diagnosed.”
Dr. Elmer emphasized how important it is not to underestimate mild asthma, which should be treated. For patients with hay fever, hyposensitization should be considered.
Reducing Risk
Many factors must come together for thunderstorm asthma to develop, according to Dr. Elmer. Because this convergence is difficult to predict, however, preparation and risk reduction are important. They consist of individual precautions and public health strategies.
The following steps can be taken at the individual level:
- Identify risk groups, including patients with allergic rhinitis and high serum-specific immunoglobulin E levels. Patients with hay fever benefit from hyposensitization.
- Avoid outdoor activities on risky days.
- Diagnose asthma, and do not underestimate mild asthma. Improve therapy compliance with ICS therapy and use maintenance and reliever therapy. This way, the patient automatically increases the steroid dose with increased symptoms and is better protected against exacerbations.
- Improve health literacy and understanding of asthma.
Thunderstorm asthma also affects healthcare professionals, Dr. Elmer warned. In Melbourne, 25% of responders themselves showed symptoms. Therefore, expect that some of these clinicians will also be unavailable.
Other steps are appropriate at the public health level. In addition to monitoring local pollen concentrations, one must identify risk groups, especially people working outdoors. “It is very difficult to predict an epidemic of thunderstorm asthma,” said Dr. Elmer. Therefore, it is important to increase awareness of the phenomenon and to develop an early warning system with emergency plans for patients and the healthcare system.
“Allergen immunotherapy is protective,” she added. “This has been well studied, and for Melbourne, it has been demonstrated. Patients with allergic rhinitis who had received immunotherapy were protected. These patients did not have to visit the emergency room. This shows that we can do something, and we should hyposensitize,” Dr. Elmer concluded.
This story was translated from the Medscape German edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Physicians Own Less Than Half of US Practices; Federal Agencies Want Outside Input
Physician practice ownership by corporations, including health insurers, private equity firms, and large pharmacy chains, reached 30.1% as of January for the first time surpassing ownership by hospitals and health systems (28.4%), according to a new report.
As a result, about three in five physician practices are now owned by nonphysicians.
In early 2020, corporations owned just about 17% of US medical practices, while hospitals and health systems owned about 25%, according to the report released Thursday by nonprofit Physician Advocacy Institute (PAI). But corporate ownership of medical groups surged during the pandemic.
These trends raise questions about how best to protect patients and physicians in a changing employment landscape, said Kelly Kenney, PAI’s chief executive officer, in a statement.
“Corporate entities are assuming control of physician practices and changing the face of medicine in the United States with little to no scrutiny from regulators,” Ms. Kenney said.
The research, conducted by consulting group Avalere for PAI, used the IQVIA OneKey database that contains physician and practice location information on hospital and health system ownership.
By 2022-2023, there was a 7.3% increase in the percentage of practices owned by hospitals and 5.9% increase in the percentage of physicians employed by these organizations, PAI said. In the same time frame, there was an 11% increase in the percentage of practices owned by corporations and a 3.0% increase in the percentage of physicians employed by these entities.
“Physicians have an ethical responsibility to their patients’ health,” Ms. Kenney said. “Corporate entities have a fiduciary responsibility to their shareholders and are motivated to put profits first…these interests can conflict with providing the best medical care to patients.”
Federal Scrutiny Increases
However, both federal and state regulators are paying more attention to what happens to patients and physicians when corporations acquire practices.
“Given recent trends, we are concerned that some transactions may generate profits for those firms at the expense of patients’ health, workers’ safety, quality of care, and affordable healthcare for patients and taxpayers,” said the Federal Trade Commission (FTC) and the Justice (DOJ) and Health and Human Services (HHS) departments.
This statement appears in those agencies’ joint request for information (RFI) announced in March. An RFI is a tool that federal agencies can use to gauge the level of both support and opposition they would face if they were to try to change policies. Public comments are due May 6.
Corporations and advocacy groups often submit detailed comments outlining reasons why the federal government should or should not act on an issue. But individuals also can make their case in this forum.
The FTC, DOJ, and HHS are looking broadly at consolidation in healthcare, but they also spell out potential concerns related to acquisition of physician practices.
For example, they asked clinicians and support staff to provide feedback about whether acquisitions lead to changes in:
- Take-home pay
- Staffing levels
- Workplace safety
- Compensation model (eg, from fixed salary to volume based)
- Policies regarding patient referrals
- Mix of patients
- The volume of patients
- The way providers practice medicine (eg, incentives, prescribing decisions, forced protocols, restrictions on time spent with patients, or mandatory coding practices)
- Administrative or managerial organization (eg, transition to a management services organization).
A version of this article appeared on Medscape.com.
Physician practice ownership by corporations, including health insurers, private equity firms, and large pharmacy chains, reached 30.1% as of January for the first time surpassing ownership by hospitals and health systems (28.4%), according to a new report.
As a result, about three in five physician practices are now owned by nonphysicians.
In early 2020, corporations owned just about 17% of US medical practices, while hospitals and health systems owned about 25%, according to the report released Thursday by nonprofit Physician Advocacy Institute (PAI). But corporate ownership of medical groups surged during the pandemic.
These trends raise questions about how best to protect patients and physicians in a changing employment landscape, said Kelly Kenney, PAI’s chief executive officer, in a statement.
“Corporate entities are assuming control of physician practices and changing the face of medicine in the United States with little to no scrutiny from regulators,” Ms. Kenney said.
The research, conducted by consulting group Avalere for PAI, used the IQVIA OneKey database that contains physician and practice location information on hospital and health system ownership.
By 2022-2023, there was a 7.3% increase in the percentage of practices owned by hospitals and 5.9% increase in the percentage of physicians employed by these organizations, PAI said. In the same time frame, there was an 11% increase in the percentage of practices owned by corporations and a 3.0% increase in the percentage of physicians employed by these entities.
“Physicians have an ethical responsibility to their patients’ health,” Ms. Kenney said. “Corporate entities have a fiduciary responsibility to their shareholders and are motivated to put profits first…these interests can conflict with providing the best medical care to patients.”
Federal Scrutiny Increases
However, both federal and state regulators are paying more attention to what happens to patients and physicians when corporations acquire practices.
“Given recent trends, we are concerned that some transactions may generate profits for those firms at the expense of patients’ health, workers’ safety, quality of care, and affordable healthcare for patients and taxpayers,” said the Federal Trade Commission (FTC) and the Justice (DOJ) and Health and Human Services (HHS) departments.
This statement appears in those agencies’ joint request for information (RFI) announced in March. An RFI is a tool that federal agencies can use to gauge the level of both support and opposition they would face if they were to try to change policies. Public comments are due May 6.
Corporations and advocacy groups often submit detailed comments outlining reasons why the federal government should or should not act on an issue. But individuals also can make their case in this forum.
The FTC, DOJ, and HHS are looking broadly at consolidation in healthcare, but they also spell out potential concerns related to acquisition of physician practices.
For example, they asked clinicians and support staff to provide feedback about whether acquisitions lead to changes in:
- Take-home pay
- Staffing levels
- Workplace safety
- Compensation model (eg, from fixed salary to volume based)
- Policies regarding patient referrals
- Mix of patients
- The volume of patients
- The way providers practice medicine (eg, incentives, prescribing decisions, forced protocols, restrictions on time spent with patients, or mandatory coding practices)
- Administrative or managerial organization (eg, transition to a management services organization).
A version of this article appeared on Medscape.com.
Physician practice ownership by corporations, including health insurers, private equity firms, and large pharmacy chains, reached 30.1% as of January for the first time surpassing ownership by hospitals and health systems (28.4%), according to a new report.
As a result, about three in five physician practices are now owned by nonphysicians.
In early 2020, corporations owned just about 17% of US medical practices, while hospitals and health systems owned about 25%, according to the report released Thursday by nonprofit Physician Advocacy Institute (PAI). But corporate ownership of medical groups surged during the pandemic.
These trends raise questions about how best to protect patients and physicians in a changing employment landscape, said Kelly Kenney, PAI’s chief executive officer, in a statement.
“Corporate entities are assuming control of physician practices and changing the face of medicine in the United States with little to no scrutiny from regulators,” Ms. Kenney said.
The research, conducted by consulting group Avalere for PAI, used the IQVIA OneKey database that contains physician and practice location information on hospital and health system ownership.
By 2022-2023, there was a 7.3% increase in the percentage of practices owned by hospitals and 5.9% increase in the percentage of physicians employed by these organizations, PAI said. In the same time frame, there was an 11% increase in the percentage of practices owned by corporations and a 3.0% increase in the percentage of physicians employed by these entities.
“Physicians have an ethical responsibility to their patients’ health,” Ms. Kenney said. “Corporate entities have a fiduciary responsibility to their shareholders and are motivated to put profits first…these interests can conflict with providing the best medical care to patients.”
Federal Scrutiny Increases
However, both federal and state regulators are paying more attention to what happens to patients and physicians when corporations acquire practices.
“Given recent trends, we are concerned that some transactions may generate profits for those firms at the expense of patients’ health, workers’ safety, quality of care, and affordable healthcare for patients and taxpayers,” said the Federal Trade Commission (FTC) and the Justice (DOJ) and Health and Human Services (HHS) departments.
This statement appears in those agencies’ joint request for information (RFI) announced in March. An RFI is a tool that federal agencies can use to gauge the level of both support and opposition they would face if they were to try to change policies. Public comments are due May 6.
Corporations and advocacy groups often submit detailed comments outlining reasons why the federal government should or should not act on an issue. But individuals also can make their case in this forum.
The FTC, DOJ, and HHS are looking broadly at consolidation in healthcare, but they also spell out potential concerns related to acquisition of physician practices.
For example, they asked clinicians and support staff to provide feedback about whether acquisitions lead to changes in:
- Take-home pay
- Staffing levels
- Workplace safety
- Compensation model (eg, from fixed salary to volume based)
- Policies regarding patient referrals
- Mix of patients
- The volume of patients
- The way providers practice medicine (eg, incentives, prescribing decisions, forced protocols, restrictions on time spent with patients, or mandatory coding practices)
- Administrative or managerial organization (eg, transition to a management services organization).
A version of this article appeared on Medscape.com.
‘Difficult Patient’: Stigmatizing Words and Medical Error
This transcript has been edited for clarity.
When I was doing my nephrology training, I had an attending who would write notes that were, well, kind of funny. I remember one time we were seeing a patient whose first name was “Lucky.” He dryly opened his section of the consult note as follows: “This is a 56-year-old woman with an ironic name who presents with acute renal failure.”
As an exhausted renal fellow, I appreciated the bit of color amid the ongoing series of tragedies that was the consult service. But let’s be clear — writing like this in the medical record is not a good idea. It wasn’t a good idea then, when any record might end up disclosed during a malpractice suit, and it’s really not a good idea now, when patients have ready and automated access to all the notes we write about them.
And yet, worse language than that of my attending appears in hospital notes all the time; there is research about this. Specifically, I’m talking about language that does not have high clinical utility but telegraphs the biases of the person writing the note. This is known as “stigmatizing language” and it can be overt or subtle.
For example, a physician wrote “I listed several fictitious medication names and she reported she was taking them.”
This casts suspicions about the patient’s credibility, as does the more subtle statement, “he claims nicotine patches don’t work for him.” Stigmatizing language may cast the patient in a difficult light, like this note: “she persevered on the fact that ... ‘you wouldn’t understand.’ ”
Stay with me.
We are going to start by defining a very sick patient population: those admitted to the hospital and who, within 48 hours, have either been transferred to the intensive care unit or died. Because of the severity of illness in this population we’ve just defined, figuring out whether a diagnostic or other error was made would be extremely high yield; these can mean the difference between life and death.
In a letter appearing in JAMA Internal Medicine, researchers examined a group of more than 2300 patients just like this from 29 hospitals, scouring the medical records for evidence of these types of errors.
Nearly one in four (23.2%) had at least one diagnostic error, which could include a missed physical exam finding, failure to ask a key question on history taking, inadequate testing, and so on.
Understanding why we make these errors is clearly critical to improving care for these patients. The researchers hypothesized that stigmatizing language might lead to errors like this. For example, by demonstrating that you don’t find a patient credible, you may ignore statements that would help make a better diagnosis.
Just over 5% of these patients had evidence of stigmatizing language in their medical notes. Like earlier studies, this language was more common if the patient was Black or had unstable housing.
Critically, stigmatizing language was more likely to be found among those who had diagnostic errors — a rate of 8.2% vs 4.1%. After adjustment for factors like race, the presence of stigmatizing language was associated with roughly a doubling of the risk for diagnostic errors.
Now, I’m all for eliminating stigmatizing language from our medical notes. And, given the increased transparency of all medical notes these days, I expect that we’ll see less of this over time. But of course, the fact that a physician doesn’t write something that disparages the patient does not necessarily mean that they don’t retain that bias. That said, those comments have an effect on all the other team members who care for that patient as well; it sets a tone and can entrench an individual’s bias more broadly. We should strive to eliminate our biases when it comes to caring for patients. But perhaps the second best thing is to work to keep those biases to ourselves.
Dr. Wilson is associate professor of medicine and public health and director of the Clinical and Translational Research Accelerator at Yale University, New Haven, Conn. He has disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
This transcript has been edited for clarity.
When I was doing my nephrology training, I had an attending who would write notes that were, well, kind of funny. I remember one time we were seeing a patient whose first name was “Lucky.” He dryly opened his section of the consult note as follows: “This is a 56-year-old woman with an ironic name who presents with acute renal failure.”
As an exhausted renal fellow, I appreciated the bit of color amid the ongoing series of tragedies that was the consult service. But let’s be clear — writing like this in the medical record is not a good idea. It wasn’t a good idea then, when any record might end up disclosed during a malpractice suit, and it’s really not a good idea now, when patients have ready and automated access to all the notes we write about them.
And yet, worse language than that of my attending appears in hospital notes all the time; there is research about this. Specifically, I’m talking about language that does not have high clinical utility but telegraphs the biases of the person writing the note. This is known as “stigmatizing language” and it can be overt or subtle.
For example, a physician wrote “I listed several fictitious medication names and she reported she was taking them.”
This casts suspicions about the patient’s credibility, as does the more subtle statement, “he claims nicotine patches don’t work for him.” Stigmatizing language may cast the patient in a difficult light, like this note: “she persevered on the fact that ... ‘you wouldn’t understand.’ ”
Stay with me.
We are going to start by defining a very sick patient population: those admitted to the hospital and who, within 48 hours, have either been transferred to the intensive care unit or died. Because of the severity of illness in this population we’ve just defined, figuring out whether a diagnostic or other error was made would be extremely high yield; these can mean the difference between life and death.
In a letter appearing in JAMA Internal Medicine, researchers examined a group of more than 2300 patients just like this from 29 hospitals, scouring the medical records for evidence of these types of errors.
Nearly one in four (23.2%) had at least one diagnostic error, which could include a missed physical exam finding, failure to ask a key question on history taking, inadequate testing, and so on.
Understanding why we make these errors is clearly critical to improving care for these patients. The researchers hypothesized that stigmatizing language might lead to errors like this. For example, by demonstrating that you don’t find a patient credible, you may ignore statements that would help make a better diagnosis.
Just over 5% of these patients had evidence of stigmatizing language in their medical notes. Like earlier studies, this language was more common if the patient was Black or had unstable housing.
Critically, stigmatizing language was more likely to be found among those who had diagnostic errors — a rate of 8.2% vs 4.1%. After adjustment for factors like race, the presence of stigmatizing language was associated with roughly a doubling of the risk for diagnostic errors.
Now, I’m all for eliminating stigmatizing language from our medical notes. And, given the increased transparency of all medical notes these days, I expect that we’ll see less of this over time. But of course, the fact that a physician doesn’t write something that disparages the patient does not necessarily mean that they don’t retain that bias. That said, those comments have an effect on all the other team members who care for that patient as well; it sets a tone and can entrench an individual’s bias more broadly. We should strive to eliminate our biases when it comes to caring for patients. But perhaps the second best thing is to work to keep those biases to ourselves.
Dr. Wilson is associate professor of medicine and public health and director of the Clinical and Translational Research Accelerator at Yale University, New Haven, Conn. He has disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
This transcript has been edited for clarity.
When I was doing my nephrology training, I had an attending who would write notes that were, well, kind of funny. I remember one time we were seeing a patient whose first name was “Lucky.” He dryly opened his section of the consult note as follows: “This is a 56-year-old woman with an ironic name who presents with acute renal failure.”
As an exhausted renal fellow, I appreciated the bit of color amid the ongoing series of tragedies that was the consult service. But let’s be clear — writing like this in the medical record is not a good idea. It wasn’t a good idea then, when any record might end up disclosed during a malpractice suit, and it’s really not a good idea now, when patients have ready and automated access to all the notes we write about them.
And yet, worse language than that of my attending appears in hospital notes all the time; there is research about this. Specifically, I’m talking about language that does not have high clinical utility but telegraphs the biases of the person writing the note. This is known as “stigmatizing language” and it can be overt or subtle.
For example, a physician wrote “I listed several fictitious medication names and she reported she was taking them.”
This casts suspicions about the patient’s credibility, as does the more subtle statement, “he claims nicotine patches don’t work for him.” Stigmatizing language may cast the patient in a difficult light, like this note: “she persevered on the fact that ... ‘you wouldn’t understand.’ ”
Stay with me.
We are going to start by defining a very sick patient population: those admitted to the hospital and who, within 48 hours, have either been transferred to the intensive care unit or died. Because of the severity of illness in this population we’ve just defined, figuring out whether a diagnostic or other error was made would be extremely high yield; these can mean the difference between life and death.
In a letter appearing in JAMA Internal Medicine, researchers examined a group of more than 2300 patients just like this from 29 hospitals, scouring the medical records for evidence of these types of errors.
Nearly one in four (23.2%) had at least one diagnostic error, which could include a missed physical exam finding, failure to ask a key question on history taking, inadequate testing, and so on.
Understanding why we make these errors is clearly critical to improving care for these patients. The researchers hypothesized that stigmatizing language might lead to errors like this. For example, by demonstrating that you don’t find a patient credible, you may ignore statements that would help make a better diagnosis.
Just over 5% of these patients had evidence of stigmatizing language in their medical notes. Like earlier studies, this language was more common if the patient was Black or had unstable housing.
Critically, stigmatizing language was more likely to be found among those who had diagnostic errors — a rate of 8.2% vs 4.1%. After adjustment for factors like race, the presence of stigmatizing language was associated with roughly a doubling of the risk for diagnostic errors.
Now, I’m all for eliminating stigmatizing language from our medical notes. And, given the increased transparency of all medical notes these days, I expect that we’ll see less of this over time. But of course, the fact that a physician doesn’t write something that disparages the patient does not necessarily mean that they don’t retain that bias. That said, those comments have an effect on all the other team members who care for that patient as well; it sets a tone and can entrench an individual’s bias more broadly. We should strive to eliminate our biases when it comes to caring for patients. But perhaps the second best thing is to work to keep those biases to ourselves.
Dr. Wilson is associate professor of medicine and public health and director of the Clinical and Translational Research Accelerator at Yale University, New Haven, Conn. He has disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
Working From Home: Doctors’ Options Are Not Limited to Classic Telemedicine
The appeal of working from home is undeniable. It comes with no daily commute, casual dress, and the ability to manage work-life balance more effectively.
Telemedicine is often the first thing that comes to mind when physicians think about remote medical practice. In its traditional sense, telemedicine entails live video consults, replicating the in-person experience as closely as possible, minus the hands-on component. However, this format is just one of many types of virtual care presenting opportunities to practice medicine from home.
The scope and volume of such opportunities are expanding due to technology, regulatory shifts at the state and federal levels favoring remote healthcare, and a wider move toward remote work. Virtual practice options for physicians range from full-time employment to flexible part-time positions that can be used to earn supplementary income.
Just a few of those virtual options are:
Remote Patient Monitoring
Remote patient monitoring uses technology for tracking patient health data, applicable in real-time or asynchronously, through devices ranging from specialized monitors to consumer wearables. Data are securely transmitted to healthcare providers, enabling them to guide or make treatment choices remotely. This method has proven particularly valuable in managing chronic diseases where continuous monitoring can significantly affect outcomes.
Like standard telemedicine, remote patient monitoring offers flexibility, autonomy, and the ability to work from home. It is picking up steam across the healthcare industry, especially in critical care, surgery, post-acute care, and primary care, so there are opportunities for physicians across a variety of specialties.
Online Medication Management and Text-Based Consults
Gathering necessary information for patient care decisions often doesn’t require a direct, face-to-face visit in person or by telemedicine. Clinical data can be efficiently collected through online forms, HIPAA-compliant messaging, medical record reviews, and information gathered by staff.
An approach that uses all these sources enables effective medication management for stable chronic conditions (such as hypertension), as well as straightforward but simple acute issues (such as urinary tract infections). It also is useful for quick follow-ups with patients after starting new treatments, to address questions between visits, and to give them educational material.
Some medical practices and virtual healthcare corporations have made online medication management and text-based consults the center of their business model. Part-time positions with platforms that offer this type of care let physicians fit consultations into their schedule as time permits, without committing to scheduled appointments.
eConsults
Electronic consultations, or eConsults, facilitate collaboration among healthcare professionals about complex cases without direct patient interaction.
These services operate via online platforms that support asynchronous communication and often bypass the need for a traditional referral. Typically, a primary care provider submits a query that is then assigned to a specialist. Next, the specialist reviews the information and offers recommendations for the patient’s care plan.
Major eConsult platforms such as AristaMD and RubiconMD contract with healthcare systems and medical practices. Physicians can easily join the specialist panels of these companies and complete assigned consultations from their homes or offices, paid on a per-consult basis. They should check their employment contracts to make sure such independent contract work is allowed.
Phone-Only On-Call Positions
On-call rotations for after-hour care bring with them challenges in staffing and scheduling vacations. These challenges have helped trigger as-needed or per diem on-call roles, in which a physician provides recommendations and orders over the phone without needing to visit an office or a hospital.
Examples of workplaces that employ phone-only on-call physicians include smaller jails, mental health facilities, dialysis centers, long-term care facilities, and sporting groups or events needing back-up for on-site nurses or emergency medical technicians.
While these positions can sometimes be challenging for a physician to find, they are out there. They can be a fantastic option to earn additional income through low-stress clinical work performed from home.
Supervision of Nurse Practitioners (NPs) and Physician Assistants (PAs)
In states that mandate such physician oversight, it often be conducted remotely — depending on that state’s rules, the practice type, and the scope of services being provided. This remote option introduces part-time opportunities for physicians to oversee NPs and PAs without being in the medical office. Essentially, the doctor needs to be available for phone or email consultations, complete chart reviews, and meet regularly with the provider.
Remote supervision roles are available across various types of healthcare organizations and medical practices. There also are opportunities with insurers, many of which have established NP-run, in-home member assessment programs that require remote supervision by a doctor.
Remote Medical Directorships
Medical directors are a key part of the clinician team in a wide variety of healthcare settings requiring clinical protocol oversight, regulatory compliance, and guidance for other clinicians making treatment decisions. Many directorships do not require direct patient contact and therefore are conducive to remote work, given technologies such as electronic health record and secure messaging systems.
Organizations such as emergency medical service agencies, hospice services, med spas, blood and plasma donation centers, home health agencies, and substance use disorder treatment programs increasingly rely on remote medical directorships to meet legal requirements and accreditation standards.
Although these positions are often viewed as “nonclinical,” they carry significant clinical responsibilities. Examples are developing and reviewing treatment protocols, ensuring adherence to healthcare regulations, and sometimes intervening in complex patient cases or when adverse outcomes occur.
Keeping a Role in Patient Welfare
Clearly, working from home as a physician doesn’t have to mean taking on a nonclinical job. Beyond the options already mentioned, there are numerous others — for example, working as a medical monitor for clinical trials, in utilization management for insurance companies, or in conducting independent medical exams for insurance claims. While these roles don’t involve direct patient treatment, they require similar skills and affect the quality of care.
If such remote opportunities aren’t currently available in your workplace, consider approaching your management about trying them.
Physicians who are experiencing burnout, seeking a career change, or interested in earning extra income should consider exploring more of the unconventional ways that they can practice medicine.
A version of this article appeared on Medscape.com.
The appeal of working from home is undeniable. It comes with no daily commute, casual dress, and the ability to manage work-life balance more effectively.
Telemedicine is often the first thing that comes to mind when physicians think about remote medical practice. In its traditional sense, telemedicine entails live video consults, replicating the in-person experience as closely as possible, minus the hands-on component. However, this format is just one of many types of virtual care presenting opportunities to practice medicine from home.
The scope and volume of such opportunities are expanding due to technology, regulatory shifts at the state and federal levels favoring remote healthcare, and a wider move toward remote work. Virtual practice options for physicians range from full-time employment to flexible part-time positions that can be used to earn supplementary income.
Just a few of those virtual options are:
Remote Patient Monitoring
Remote patient monitoring uses technology for tracking patient health data, applicable in real-time or asynchronously, through devices ranging from specialized monitors to consumer wearables. Data are securely transmitted to healthcare providers, enabling them to guide or make treatment choices remotely. This method has proven particularly valuable in managing chronic diseases where continuous monitoring can significantly affect outcomes.
Like standard telemedicine, remote patient monitoring offers flexibility, autonomy, and the ability to work from home. It is picking up steam across the healthcare industry, especially in critical care, surgery, post-acute care, and primary care, so there are opportunities for physicians across a variety of specialties.
Online Medication Management and Text-Based Consults
Gathering necessary information for patient care decisions often doesn’t require a direct, face-to-face visit in person or by telemedicine. Clinical data can be efficiently collected through online forms, HIPAA-compliant messaging, medical record reviews, and information gathered by staff.
An approach that uses all these sources enables effective medication management for stable chronic conditions (such as hypertension), as well as straightforward but simple acute issues (such as urinary tract infections). It also is useful for quick follow-ups with patients after starting new treatments, to address questions between visits, and to give them educational material.
Some medical practices and virtual healthcare corporations have made online medication management and text-based consults the center of their business model. Part-time positions with platforms that offer this type of care let physicians fit consultations into their schedule as time permits, without committing to scheduled appointments.
eConsults
Electronic consultations, or eConsults, facilitate collaboration among healthcare professionals about complex cases without direct patient interaction.
These services operate via online platforms that support asynchronous communication and often bypass the need for a traditional referral. Typically, a primary care provider submits a query that is then assigned to a specialist. Next, the specialist reviews the information and offers recommendations for the patient’s care plan.
Major eConsult platforms such as AristaMD and RubiconMD contract with healthcare systems and medical practices. Physicians can easily join the specialist panels of these companies and complete assigned consultations from their homes or offices, paid on a per-consult basis. They should check their employment contracts to make sure such independent contract work is allowed.
Phone-Only On-Call Positions
On-call rotations for after-hour care bring with them challenges in staffing and scheduling vacations. These challenges have helped trigger as-needed or per diem on-call roles, in which a physician provides recommendations and orders over the phone without needing to visit an office or a hospital.
Examples of workplaces that employ phone-only on-call physicians include smaller jails, mental health facilities, dialysis centers, long-term care facilities, and sporting groups or events needing back-up for on-site nurses or emergency medical technicians.
While these positions can sometimes be challenging for a physician to find, they are out there. They can be a fantastic option to earn additional income through low-stress clinical work performed from home.
Supervision of Nurse Practitioners (NPs) and Physician Assistants (PAs)
In states that mandate such physician oversight, it often be conducted remotely — depending on that state’s rules, the practice type, and the scope of services being provided. This remote option introduces part-time opportunities for physicians to oversee NPs and PAs without being in the medical office. Essentially, the doctor needs to be available for phone or email consultations, complete chart reviews, and meet regularly with the provider.
Remote supervision roles are available across various types of healthcare organizations and medical practices. There also are opportunities with insurers, many of which have established NP-run, in-home member assessment programs that require remote supervision by a doctor.
Remote Medical Directorships
Medical directors are a key part of the clinician team in a wide variety of healthcare settings requiring clinical protocol oversight, regulatory compliance, and guidance for other clinicians making treatment decisions. Many directorships do not require direct patient contact and therefore are conducive to remote work, given technologies such as electronic health record and secure messaging systems.
Organizations such as emergency medical service agencies, hospice services, med spas, blood and plasma donation centers, home health agencies, and substance use disorder treatment programs increasingly rely on remote medical directorships to meet legal requirements and accreditation standards.
Although these positions are often viewed as “nonclinical,” they carry significant clinical responsibilities. Examples are developing and reviewing treatment protocols, ensuring adherence to healthcare regulations, and sometimes intervening in complex patient cases or when adverse outcomes occur.
Keeping a Role in Patient Welfare
Clearly, working from home as a physician doesn’t have to mean taking on a nonclinical job. Beyond the options already mentioned, there are numerous others — for example, working as a medical monitor for clinical trials, in utilization management for insurance companies, or in conducting independent medical exams for insurance claims. While these roles don’t involve direct patient treatment, they require similar skills and affect the quality of care.
If such remote opportunities aren’t currently available in your workplace, consider approaching your management about trying them.
Physicians who are experiencing burnout, seeking a career change, or interested in earning extra income should consider exploring more of the unconventional ways that they can practice medicine.
A version of this article appeared on Medscape.com.
The appeal of working from home is undeniable. It comes with no daily commute, casual dress, and the ability to manage work-life balance more effectively.
Telemedicine is often the first thing that comes to mind when physicians think about remote medical practice. In its traditional sense, telemedicine entails live video consults, replicating the in-person experience as closely as possible, minus the hands-on component. However, this format is just one of many types of virtual care presenting opportunities to practice medicine from home.
The scope and volume of such opportunities are expanding due to technology, regulatory shifts at the state and federal levels favoring remote healthcare, and a wider move toward remote work. Virtual practice options for physicians range from full-time employment to flexible part-time positions that can be used to earn supplementary income.
Just a few of those virtual options are:
Remote Patient Monitoring
Remote patient monitoring uses technology for tracking patient health data, applicable in real-time or asynchronously, through devices ranging from specialized monitors to consumer wearables. Data are securely transmitted to healthcare providers, enabling them to guide or make treatment choices remotely. This method has proven particularly valuable in managing chronic diseases where continuous monitoring can significantly affect outcomes.
Like standard telemedicine, remote patient monitoring offers flexibility, autonomy, and the ability to work from home. It is picking up steam across the healthcare industry, especially in critical care, surgery, post-acute care, and primary care, so there are opportunities for physicians across a variety of specialties.
Online Medication Management and Text-Based Consults
Gathering necessary information for patient care decisions often doesn’t require a direct, face-to-face visit in person or by telemedicine. Clinical data can be efficiently collected through online forms, HIPAA-compliant messaging, medical record reviews, and information gathered by staff.
An approach that uses all these sources enables effective medication management for stable chronic conditions (such as hypertension), as well as straightforward but simple acute issues (such as urinary tract infections). It also is useful for quick follow-ups with patients after starting new treatments, to address questions between visits, and to give them educational material.
Some medical practices and virtual healthcare corporations have made online medication management and text-based consults the center of their business model. Part-time positions with platforms that offer this type of care let physicians fit consultations into their schedule as time permits, without committing to scheduled appointments.
eConsults
Electronic consultations, or eConsults, facilitate collaboration among healthcare professionals about complex cases without direct patient interaction.
These services operate via online platforms that support asynchronous communication and often bypass the need for a traditional referral. Typically, a primary care provider submits a query that is then assigned to a specialist. Next, the specialist reviews the information and offers recommendations for the patient’s care plan.
Major eConsult platforms such as AristaMD and RubiconMD contract with healthcare systems and medical practices. Physicians can easily join the specialist panels of these companies and complete assigned consultations from their homes or offices, paid on a per-consult basis. They should check their employment contracts to make sure such independent contract work is allowed.
Phone-Only On-Call Positions
On-call rotations for after-hour care bring with them challenges in staffing and scheduling vacations. These challenges have helped trigger as-needed or per diem on-call roles, in which a physician provides recommendations and orders over the phone without needing to visit an office or a hospital.
Examples of workplaces that employ phone-only on-call physicians include smaller jails, mental health facilities, dialysis centers, long-term care facilities, and sporting groups or events needing back-up for on-site nurses or emergency medical technicians.
While these positions can sometimes be challenging for a physician to find, they are out there. They can be a fantastic option to earn additional income through low-stress clinical work performed from home.
Supervision of Nurse Practitioners (NPs) and Physician Assistants (PAs)
In states that mandate such physician oversight, it often be conducted remotely — depending on that state’s rules, the practice type, and the scope of services being provided. This remote option introduces part-time opportunities for physicians to oversee NPs and PAs without being in the medical office. Essentially, the doctor needs to be available for phone or email consultations, complete chart reviews, and meet regularly with the provider.
Remote supervision roles are available across various types of healthcare organizations and medical practices. There also are opportunities with insurers, many of which have established NP-run, in-home member assessment programs that require remote supervision by a doctor.
Remote Medical Directorships
Medical directors are a key part of the clinician team in a wide variety of healthcare settings requiring clinical protocol oversight, regulatory compliance, and guidance for other clinicians making treatment decisions. Many directorships do not require direct patient contact and therefore are conducive to remote work, given technologies such as electronic health record and secure messaging systems.
Organizations such as emergency medical service agencies, hospice services, med spas, blood and plasma donation centers, home health agencies, and substance use disorder treatment programs increasingly rely on remote medical directorships to meet legal requirements and accreditation standards.
Although these positions are often viewed as “nonclinical,” they carry significant clinical responsibilities. Examples are developing and reviewing treatment protocols, ensuring adherence to healthcare regulations, and sometimes intervening in complex patient cases or when adverse outcomes occur.
Keeping a Role in Patient Welfare
Clearly, working from home as a physician doesn’t have to mean taking on a nonclinical job. Beyond the options already mentioned, there are numerous others — for example, working as a medical monitor for clinical trials, in utilization management for insurance companies, or in conducting independent medical exams for insurance claims. While these roles don’t involve direct patient treatment, they require similar skills and affect the quality of care.
If such remote opportunities aren’t currently available in your workplace, consider approaching your management about trying them.
Physicians who are experiencing burnout, seeking a career change, or interested in earning extra income should consider exploring more of the unconventional ways that they can practice medicine.
A version of this article appeared on Medscape.com.
New Trial Deepens Debate Over Late-Preterm Steroids
The early cancellation of a trial in southern India suggests that the use of antenatal steroids to prevent respiratory complications after late-preterm birth — a recommended practice in the United States — may not be effective in the developing world.
As reported in Obstetrics & Gynecology, researchers led by Hilda Yenuberi, MD, of Christian Medical College, Vellore, Tamil Nadu, India, stopped the randomized, triple-blinded, placebo-controlled CLAP (Corticosteroids in Late Pregnancy) study at 70% enrollment. An interim analysis found no benefit from prescribing betamethasone vs placebo to women at risk of late-preterm delivery between 34 and 36 and 6/7 weeks of gestation (primary outcome of respiratory distress: 4.9% vs 4.8%, respectively, relative risk [RR], 1.03; 95% CI, 0.57-1.84; number needed to treat = 786).
“These findings may suggest differing efficacy of antenatal corticosteroids in developing countries compared with developed countries ... that should be considered when late-preterm antenatal corticosteroids are administered,” the researchers wrote.
The use of steroids in patients at risk of delivery before 34 weeks is widely accepted as a way to prevent neonatal respiratory distress, a common and potentially deadly condition in premature infants whose lungs are not fully developed. However, there’s debate over steroid treatment in women who are expected to deliver later than 34 weeks but still preterm.
As the study notes, “the American College of Obstetricians and Gynecologists recommends a single course of betamethasone for pregnant individuals at risk of delivering between 34 and 36 6/7 weeks of gestation on the basis of the ALPS (Antenatal Late Preterm Steroid) trial.”
But other randomized trials have reached different conclusions, and steroids are not without risks. Studies have linked prenatal steroids to neurosensory disorders in babies, meaning they’re more likely to need hearing aids and eyeglasses, said Kellie Murphy, MD, MSc, professor of obstetrics and gynecology, University of Toronto, Toronto, Ontario, Canada, in an interview. Dr. Murphy, who was not involved in the new trial, added that there are links between steroids and greater likelihood of poorer performance in school,
For the new study, conducted from 2020 to 2022 at Christian Medical College and Hospital in Vellore, India, researchers randomly assigned 423 patients to betamethasone (410 in the interim analysis; average age, 26.8 years) and 424 to placebo (415 in the interim analysis; average age, 26.2 years).
The average age of participants was 26.8 years. All were between 34 and 36 6/7 weeks of gestation and expected to give birth within the next week. A quarter of participants delivered at term, which the authors wrote “may have influenced the primary outcome.” The total number of neonates was 883, including 58 twin pregnancies.
There was no significant difference in respiratory distress between groups, “defined as need for oxygen or continuous positive airway pressure or mechanical ventilation for at least 2 hours in the first 72 hours of life.” There also were no significant differences in maternal outcomes such as chorioamnionitis or length of hospitalization or neonatal secondary outcomes such as transient tachypnea of the newborn, respiratory distress syndrome, necrotizing enterocolitis, sepsis, hyperbilirubinemia, stillbirth, and early neonatal death.
Serious adverse events occurred in four neonates but none were linked to the intervention.
The study doesn’t discuss cost, but a 2019 report suggests that use of betamethasone to prevent neonatal respiratory distress is cost-effective.
“Our findings are contradictory to those of a systematic review, the major contributor of which was the ALPS trial,” the authors of the new study reported. “The primary outcome of the ALPS trial, the composite of neonatal treatment in the first 72 hours, was significantly less in the group who received betamethasone (11.6%), compared with the placebo group (14.4%; relative risk [RR], 0.80; 95% CI, 0.66-0.97).”
The study authors, who didn’t respond to requests for comment, noted that their trial included twin pregnancies and patients with gestational diabetes; the ALPS trial did not.
Perinatologist Cynthia Gyamfi-Bannerman, MD, MS, chair and professor of Obstetrics, Gynecology, and Reproductive Sciences at the University of California,San Diego, and principal investigator of the ALPS study, said in an interview that the inclusion of twins in the new trial is “a fundamental flaw.”
“Because antenatal corticosteroids have not been shown to be useful in twins at any gestational age, it is not surprising that including twins likely moved the findings to the null in this study,” she said. “Twins were purposefully excluded from the ALPS trial for this reason.”
According to the new study, “the primary outcome among singleton neonates occurred in 4.8% (18/374) who received betamethasone and 5.1% (20/393) who received placebo (RR, 0.94; 95% CI, 0.51-1.75)
What should clinicians take from the study findings? In an accompanying commentary, Blair J. Wylie, MD, MPH, of Columbia University Medical Center, New York, NY, and Syed Asad Ali, MBBS, MPH, of Aga Khan University, Karachi, Pakistan, wrote that, “in settings similar to the US-based ALPS trial, the practice of administering a course of late-preterm antenatal corticosteroids should be continued, as espoused by our professional organizations.”
However, the new study suggests that “research in high-resource environments may not be generalizable to low-resource settings,” they write.
Neonatologist Elizabeth Asztalos, MD, MSc, an associate scientist with Sunnybrook Health Sciences Center in Toronto, Canada, said in an interview that she doesn’t worry about pregnant mothers not getting steroids later than 34 weeks. “We have tools in our armamentarium in the NICU setting to help babies if they need it,” said Dr. Asztalos, who didn’t take part in the new trial. “We can put them on CPAP if they have wet lung. If they have an element of respiratory distress, we can give them surfactants. These bigger babies have more ability to recover from all this compared to a baby who was born at 24, 25, 26 weeks.”
For her part, the University of Toronto’s Dr. Murphy said decision-making about late-preterm steroids is complicated. “You don’t want to miss the opportunity to give to provide benefits for the patients” via steroids, she said. “But on the flip side, it’s a double-edged sword. It’s not easy. It’s not straightforward.”
In the big picture, she said, “people need to be really clear why they’re giving an intervention and what they hope to achieve.”
Christian Medical College supported the study. The authors, Dr. Murphy, Dr. Asztalos, and commentary co-author Dr. Ali have no disclosures. Dr. Gyamfi-Bannerman discloses being principal investigator of the ALPS trial. Commentary co-author Dr. Wylie serves on the ultrasound quality assurance committee of a trial discussed in the commentary.
The early cancellation of a trial in southern India suggests that the use of antenatal steroids to prevent respiratory complications after late-preterm birth — a recommended practice in the United States — may not be effective in the developing world.
As reported in Obstetrics & Gynecology, researchers led by Hilda Yenuberi, MD, of Christian Medical College, Vellore, Tamil Nadu, India, stopped the randomized, triple-blinded, placebo-controlled CLAP (Corticosteroids in Late Pregnancy) study at 70% enrollment. An interim analysis found no benefit from prescribing betamethasone vs placebo to women at risk of late-preterm delivery between 34 and 36 and 6/7 weeks of gestation (primary outcome of respiratory distress: 4.9% vs 4.8%, respectively, relative risk [RR], 1.03; 95% CI, 0.57-1.84; number needed to treat = 786).
“These findings may suggest differing efficacy of antenatal corticosteroids in developing countries compared with developed countries ... that should be considered when late-preterm antenatal corticosteroids are administered,” the researchers wrote.
The use of steroids in patients at risk of delivery before 34 weeks is widely accepted as a way to prevent neonatal respiratory distress, a common and potentially deadly condition in premature infants whose lungs are not fully developed. However, there’s debate over steroid treatment in women who are expected to deliver later than 34 weeks but still preterm.
As the study notes, “the American College of Obstetricians and Gynecologists recommends a single course of betamethasone for pregnant individuals at risk of delivering between 34 and 36 6/7 weeks of gestation on the basis of the ALPS (Antenatal Late Preterm Steroid) trial.”
But other randomized trials have reached different conclusions, and steroids are not without risks. Studies have linked prenatal steroids to neurosensory disorders in babies, meaning they’re more likely to need hearing aids and eyeglasses, said Kellie Murphy, MD, MSc, professor of obstetrics and gynecology, University of Toronto, Toronto, Ontario, Canada, in an interview. Dr. Murphy, who was not involved in the new trial, added that there are links between steroids and greater likelihood of poorer performance in school,
For the new study, conducted from 2020 to 2022 at Christian Medical College and Hospital in Vellore, India, researchers randomly assigned 423 patients to betamethasone (410 in the interim analysis; average age, 26.8 years) and 424 to placebo (415 in the interim analysis; average age, 26.2 years).
The average age of participants was 26.8 years. All were between 34 and 36 6/7 weeks of gestation and expected to give birth within the next week. A quarter of participants delivered at term, which the authors wrote “may have influenced the primary outcome.” The total number of neonates was 883, including 58 twin pregnancies.
There was no significant difference in respiratory distress between groups, “defined as need for oxygen or continuous positive airway pressure or mechanical ventilation for at least 2 hours in the first 72 hours of life.” There also were no significant differences in maternal outcomes such as chorioamnionitis or length of hospitalization or neonatal secondary outcomes such as transient tachypnea of the newborn, respiratory distress syndrome, necrotizing enterocolitis, sepsis, hyperbilirubinemia, stillbirth, and early neonatal death.
Serious adverse events occurred in four neonates but none were linked to the intervention.
The study doesn’t discuss cost, but a 2019 report suggests that use of betamethasone to prevent neonatal respiratory distress is cost-effective.
“Our findings are contradictory to those of a systematic review, the major contributor of which was the ALPS trial,” the authors of the new study reported. “The primary outcome of the ALPS trial, the composite of neonatal treatment in the first 72 hours, was significantly less in the group who received betamethasone (11.6%), compared with the placebo group (14.4%; relative risk [RR], 0.80; 95% CI, 0.66-0.97).”
The study authors, who didn’t respond to requests for comment, noted that their trial included twin pregnancies and patients with gestational diabetes; the ALPS trial did not.
Perinatologist Cynthia Gyamfi-Bannerman, MD, MS, chair and professor of Obstetrics, Gynecology, and Reproductive Sciences at the University of California,San Diego, and principal investigator of the ALPS study, said in an interview that the inclusion of twins in the new trial is “a fundamental flaw.”
“Because antenatal corticosteroids have not been shown to be useful in twins at any gestational age, it is not surprising that including twins likely moved the findings to the null in this study,” she said. “Twins were purposefully excluded from the ALPS trial for this reason.”
According to the new study, “the primary outcome among singleton neonates occurred in 4.8% (18/374) who received betamethasone and 5.1% (20/393) who received placebo (RR, 0.94; 95% CI, 0.51-1.75)
What should clinicians take from the study findings? In an accompanying commentary, Blair J. Wylie, MD, MPH, of Columbia University Medical Center, New York, NY, and Syed Asad Ali, MBBS, MPH, of Aga Khan University, Karachi, Pakistan, wrote that, “in settings similar to the US-based ALPS trial, the practice of administering a course of late-preterm antenatal corticosteroids should be continued, as espoused by our professional organizations.”
However, the new study suggests that “research in high-resource environments may not be generalizable to low-resource settings,” they write.
Neonatologist Elizabeth Asztalos, MD, MSc, an associate scientist with Sunnybrook Health Sciences Center in Toronto, Canada, said in an interview that she doesn’t worry about pregnant mothers not getting steroids later than 34 weeks. “We have tools in our armamentarium in the NICU setting to help babies if they need it,” said Dr. Asztalos, who didn’t take part in the new trial. “We can put them on CPAP if they have wet lung. If they have an element of respiratory distress, we can give them surfactants. These bigger babies have more ability to recover from all this compared to a baby who was born at 24, 25, 26 weeks.”
For her part, the University of Toronto’s Dr. Murphy said decision-making about late-preterm steroids is complicated. “You don’t want to miss the opportunity to give to provide benefits for the patients” via steroids, she said. “But on the flip side, it’s a double-edged sword. It’s not easy. It’s not straightforward.”
In the big picture, she said, “people need to be really clear why they’re giving an intervention and what they hope to achieve.”
Christian Medical College supported the study. The authors, Dr. Murphy, Dr. Asztalos, and commentary co-author Dr. Ali have no disclosures. Dr. Gyamfi-Bannerman discloses being principal investigator of the ALPS trial. Commentary co-author Dr. Wylie serves on the ultrasound quality assurance committee of a trial discussed in the commentary.
The early cancellation of a trial in southern India suggests that the use of antenatal steroids to prevent respiratory complications after late-preterm birth — a recommended practice in the United States — may not be effective in the developing world.
As reported in Obstetrics & Gynecology, researchers led by Hilda Yenuberi, MD, of Christian Medical College, Vellore, Tamil Nadu, India, stopped the randomized, triple-blinded, placebo-controlled CLAP (Corticosteroids in Late Pregnancy) study at 70% enrollment. An interim analysis found no benefit from prescribing betamethasone vs placebo to women at risk of late-preterm delivery between 34 and 36 and 6/7 weeks of gestation (primary outcome of respiratory distress: 4.9% vs 4.8%, respectively, relative risk [RR], 1.03; 95% CI, 0.57-1.84; number needed to treat = 786).
“These findings may suggest differing efficacy of antenatal corticosteroids in developing countries compared with developed countries ... that should be considered when late-preterm antenatal corticosteroids are administered,” the researchers wrote.
The use of steroids in patients at risk of delivery before 34 weeks is widely accepted as a way to prevent neonatal respiratory distress, a common and potentially deadly condition in premature infants whose lungs are not fully developed. However, there’s debate over steroid treatment in women who are expected to deliver later than 34 weeks but still preterm.
As the study notes, “the American College of Obstetricians and Gynecologists recommends a single course of betamethasone for pregnant individuals at risk of delivering between 34 and 36 6/7 weeks of gestation on the basis of the ALPS (Antenatal Late Preterm Steroid) trial.”
But other randomized trials have reached different conclusions, and steroids are not without risks. Studies have linked prenatal steroids to neurosensory disorders in babies, meaning they’re more likely to need hearing aids and eyeglasses, said Kellie Murphy, MD, MSc, professor of obstetrics and gynecology, University of Toronto, Toronto, Ontario, Canada, in an interview. Dr. Murphy, who was not involved in the new trial, added that there are links between steroids and greater likelihood of poorer performance in school,
For the new study, conducted from 2020 to 2022 at Christian Medical College and Hospital in Vellore, India, researchers randomly assigned 423 patients to betamethasone (410 in the interim analysis; average age, 26.8 years) and 424 to placebo (415 in the interim analysis; average age, 26.2 years).
The average age of participants was 26.8 years. All were between 34 and 36 6/7 weeks of gestation and expected to give birth within the next week. A quarter of participants delivered at term, which the authors wrote “may have influenced the primary outcome.” The total number of neonates was 883, including 58 twin pregnancies.
There was no significant difference in respiratory distress between groups, “defined as need for oxygen or continuous positive airway pressure or mechanical ventilation for at least 2 hours in the first 72 hours of life.” There also were no significant differences in maternal outcomes such as chorioamnionitis or length of hospitalization or neonatal secondary outcomes such as transient tachypnea of the newborn, respiratory distress syndrome, necrotizing enterocolitis, sepsis, hyperbilirubinemia, stillbirth, and early neonatal death.
Serious adverse events occurred in four neonates but none were linked to the intervention.
The study doesn’t discuss cost, but a 2019 report suggests that use of betamethasone to prevent neonatal respiratory distress is cost-effective.
“Our findings are contradictory to those of a systematic review, the major contributor of which was the ALPS trial,” the authors of the new study reported. “The primary outcome of the ALPS trial, the composite of neonatal treatment in the first 72 hours, was significantly less in the group who received betamethasone (11.6%), compared with the placebo group (14.4%; relative risk [RR], 0.80; 95% CI, 0.66-0.97).”
The study authors, who didn’t respond to requests for comment, noted that their trial included twin pregnancies and patients with gestational diabetes; the ALPS trial did not.
Perinatologist Cynthia Gyamfi-Bannerman, MD, MS, chair and professor of Obstetrics, Gynecology, and Reproductive Sciences at the University of California,San Diego, and principal investigator of the ALPS study, said in an interview that the inclusion of twins in the new trial is “a fundamental flaw.”
“Because antenatal corticosteroids have not been shown to be useful in twins at any gestational age, it is not surprising that including twins likely moved the findings to the null in this study,” she said. “Twins were purposefully excluded from the ALPS trial for this reason.”
According to the new study, “the primary outcome among singleton neonates occurred in 4.8% (18/374) who received betamethasone and 5.1% (20/393) who received placebo (RR, 0.94; 95% CI, 0.51-1.75)
What should clinicians take from the study findings? In an accompanying commentary, Blair J. Wylie, MD, MPH, of Columbia University Medical Center, New York, NY, and Syed Asad Ali, MBBS, MPH, of Aga Khan University, Karachi, Pakistan, wrote that, “in settings similar to the US-based ALPS trial, the practice of administering a course of late-preterm antenatal corticosteroids should be continued, as espoused by our professional organizations.”
However, the new study suggests that “research in high-resource environments may not be generalizable to low-resource settings,” they write.
Neonatologist Elizabeth Asztalos, MD, MSc, an associate scientist with Sunnybrook Health Sciences Center in Toronto, Canada, said in an interview that she doesn’t worry about pregnant mothers not getting steroids later than 34 weeks. “We have tools in our armamentarium in the NICU setting to help babies if they need it,” said Dr. Asztalos, who didn’t take part in the new trial. “We can put them on CPAP if they have wet lung. If they have an element of respiratory distress, we can give them surfactants. These bigger babies have more ability to recover from all this compared to a baby who was born at 24, 25, 26 weeks.”
For her part, the University of Toronto’s Dr. Murphy said decision-making about late-preterm steroids is complicated. “You don’t want to miss the opportunity to give to provide benefits for the patients” via steroids, she said. “But on the flip side, it’s a double-edged sword. It’s not easy. It’s not straightforward.”
In the big picture, she said, “people need to be really clear why they’re giving an intervention and what they hope to achieve.”
Christian Medical College supported the study. The authors, Dr. Murphy, Dr. Asztalos, and commentary co-author Dr. Ali have no disclosures. Dr. Gyamfi-Bannerman discloses being principal investigator of the ALPS trial. Commentary co-author Dr. Wylie serves on the ultrasound quality assurance committee of a trial discussed in the commentary.
FROM OBSTETRICS & GYNECOLOGY
Antibiotics of Little Benefit in Lower Respiratory Tract Infection
Antibiotics had no measurable effect on the severity or duration of coughs due to acute lower respiratory tract infection (LRTI, or acute bronchitis), a large prospective study found.
In fact, those receiving an antibiotic in the primary- and urgent-care setting had a small but significant increase in overall length of illness (17.5 vs 15.9 days; P = .05) — largely because patients with longer illness before the index visit were more likely to receive these drugs. The study adds further support for reducing the prescription of antibiotics for LRTIs.
“Importantly, the pathogen data demonstrated that the length of time until illness resolution for those with bacterial infection was the same as for those not receiving an antibiotic versus those receiving one (17.3 vs 17.4 days),” researchers led by Daniel J. Merenstein, MD, a professor and director of research programs, family medicine, at Georgetown University Medical Center in Washington, wrote in the Journal of General Internal Medicine (doi: 10.1007/s11606-024-08758-y).
Patients believed an antibiotic would shorten their illness by an average of about 4 days, from 13.4 days to 9.7 days, whereas the average duration of all coughs was more than 2 weeks regardless of pathogen type or receipt of an antibiotic.
“Patients had unrealistic expectations regarding the duration of LRTI and the effect of antibiotics, which should be the target of antibiotic stewardship efforts,” the group wrote.
LRTIs can, however, be dangerous, with 3%-5% progressing to pneumonia, “but not everyone has easy access at an initial visit to an x-ray, which may be the reason clinicians still give antibiotics without any other evidence of a bacterial infection,” Dr. Merenstein said in a news release. “Patients have come to expect antibiotics for a cough, even if it doesn’t help. Basic symptom-relieving medications plus time bring a resolution to most people’s infections.”
The authors noted that cough is the most common reason for an ambulatory care visit, accounting for 2.7 million outpatient visits and more than 4 million emergency department visits annually.
Risks
Overuse of antibiotics can result in dizziness, nausea, diarrhea, and rash, along with a roughly 4% chance of serious adverse effects including anaphylaxis; Stevens-Johnson syndrome, a serious skin and mucous membrane disorder; and Clostridioides difficile-associated diarrhea.
An estimated half of all antibiotic prescriptions for acute respiratory conditions are unnecessary. Before the COVID-19 pandemic, antibiotics were prescribed about 70% of the time for a diagnosis of uncomplicated cough and LRTI. The viral pandemic did not change this practice according to a meta-analysis of 130 studies showing that 78% of COVID-19 patients were prescribed an antibiotic.
The study
The study looked at a cohort of 718 patients, with a mean age of 38.9 years, 65.3% female, of whom 207 received an antibiotic and 511 did not. Of those with baseline data, 29% had an antibiotic prescribed at baseline, the most common (in 85%) being amoxicillin-clavulanate, azithromycin, doxycycline, and amoxicillin. Antibiotics had no effect on the duration or overall severity of cough in viral, bacterial, or mixed infections. Receipt of an antibiotic did, however, reduce the likelihood of a follow-up visit: 14.1% vs 8.2% (adjusted odds ratio, 0.47; 95% confidence interval, 0.26-0.84) — perhaps because it removed the motivation for seeking another consultation. Antibiotic recipients were more likely to receive a systemic corticosteroid (31.9% vs 4.5%, P <.001) and were also more likely to receive an albuterol inhaler (22.7% vs 7.6%, P <.001).
Jeffrey A. Linder, MD, MPH, a primary care physician and chief of internal medicine and geriatrics at Northwestern University Feinberg School of Medicine in Chicago, agrees that in the vast majority of LRTIs — usually acute bronchitis — antibiotics do not speed the healing process. “Forty years of research show that antibiotics do not make acute bronchitis go away any faster,” Dr. Linder, who was not involved in the current study, said in an interview. “There’s even growing evidence that a lot of pneumonia is viral as well, and 10 or 20 years from now we may often not be giving antibiotics for pneumonia because we’ll be able to see better if it’s caused by a virus.”
A large 2018 review by Dr. Linder and associates reported that 46% of antibiotics were prescribed without any infection-related diagnosis code and 20% without an office visit.
Dr. Linder routinely informs patients requesting an antibiotic about the risks of putting an ineffective chemical into their body. “I stress that it can cause rash and other allergic reactions, and even promote C diff infection,” he said. “And I also say it messes with the good bacteria in the microbiome, and they usually come around.”
Patients need to know, Dr. Linder added, that the normal course of healing the respiratory tract after acute bronchitis takes weeks. While a wet cough with sputum or phlegm will last a few days, it’s replaced with a dry annoying cough that persists for up to 3 weeks. “As long as they’re feeling generally better, that cough is normal,” he said. “A virus has run roughshod over their airways and they need a long time to heal and the cough is part of the healing process. Think how long it takes to heal a cut on a finger.”
In an era of escalating antimicrobial resistance fueled by antibiotic overuse, it’s become increasingly important to reserve antibiotics for necessary cases. According to a recent World Health Organization call to action, “Uncontrolled antimicrobial resistance is expected to lower life expectancy and lead to unprecedented health expenditure and economic losses.”
That said, there is important clinical work to be done to determine if there is a limited role for antibiotics in patients with cough, perhaps based on age and baseline severity. “Serious cough symptoms and how to treat them properly needs to be studied more, perhaps in a randomized clinical trial as this study was observational and there haven’t been any randomized trials looking at this issue since about 2012,” Dr. Merenstein said.
This research was funded by the Agency for Healthcare Research and Quality. The authors have no conflicts of interest to declare. Dr. Linder reported stock ownership in pharmaceutical companies but none that make antibiotics or other infectious disease drugs.
Antibiotics had no measurable effect on the severity or duration of coughs due to acute lower respiratory tract infection (LRTI, or acute bronchitis), a large prospective study found.
In fact, those receiving an antibiotic in the primary- and urgent-care setting had a small but significant increase in overall length of illness (17.5 vs 15.9 days; P = .05) — largely because patients with longer illness before the index visit were more likely to receive these drugs. The study adds further support for reducing the prescription of antibiotics for LRTIs.
“Importantly, the pathogen data demonstrated that the length of time until illness resolution for those with bacterial infection was the same as for those not receiving an antibiotic versus those receiving one (17.3 vs 17.4 days),” researchers led by Daniel J. Merenstein, MD, a professor and director of research programs, family medicine, at Georgetown University Medical Center in Washington, wrote in the Journal of General Internal Medicine (doi: 10.1007/s11606-024-08758-y).
Patients believed an antibiotic would shorten their illness by an average of about 4 days, from 13.4 days to 9.7 days, whereas the average duration of all coughs was more than 2 weeks regardless of pathogen type or receipt of an antibiotic.
“Patients had unrealistic expectations regarding the duration of LRTI and the effect of antibiotics, which should be the target of antibiotic stewardship efforts,” the group wrote.
LRTIs can, however, be dangerous, with 3%-5% progressing to pneumonia, “but not everyone has easy access at an initial visit to an x-ray, which may be the reason clinicians still give antibiotics without any other evidence of a bacterial infection,” Dr. Merenstein said in a news release. “Patients have come to expect antibiotics for a cough, even if it doesn’t help. Basic symptom-relieving medications plus time bring a resolution to most people’s infections.”
The authors noted that cough is the most common reason for an ambulatory care visit, accounting for 2.7 million outpatient visits and more than 4 million emergency department visits annually.
Risks
Overuse of antibiotics can result in dizziness, nausea, diarrhea, and rash, along with a roughly 4% chance of serious adverse effects including anaphylaxis; Stevens-Johnson syndrome, a serious skin and mucous membrane disorder; and Clostridioides difficile-associated diarrhea.
An estimated half of all antibiotic prescriptions for acute respiratory conditions are unnecessary. Before the COVID-19 pandemic, antibiotics were prescribed about 70% of the time for a diagnosis of uncomplicated cough and LRTI. The viral pandemic did not change this practice according to a meta-analysis of 130 studies showing that 78% of COVID-19 patients were prescribed an antibiotic.
The study
The study looked at a cohort of 718 patients, with a mean age of 38.9 years, 65.3% female, of whom 207 received an antibiotic and 511 did not. Of those with baseline data, 29% had an antibiotic prescribed at baseline, the most common (in 85%) being amoxicillin-clavulanate, azithromycin, doxycycline, and amoxicillin. Antibiotics had no effect on the duration or overall severity of cough in viral, bacterial, or mixed infections. Receipt of an antibiotic did, however, reduce the likelihood of a follow-up visit: 14.1% vs 8.2% (adjusted odds ratio, 0.47; 95% confidence interval, 0.26-0.84) — perhaps because it removed the motivation for seeking another consultation. Antibiotic recipients were more likely to receive a systemic corticosteroid (31.9% vs 4.5%, P <.001) and were also more likely to receive an albuterol inhaler (22.7% vs 7.6%, P <.001).
Jeffrey A. Linder, MD, MPH, a primary care physician and chief of internal medicine and geriatrics at Northwestern University Feinberg School of Medicine in Chicago, agrees that in the vast majority of LRTIs — usually acute bronchitis — antibiotics do not speed the healing process. “Forty years of research show that antibiotics do not make acute bronchitis go away any faster,” Dr. Linder, who was not involved in the current study, said in an interview. “There’s even growing evidence that a lot of pneumonia is viral as well, and 10 or 20 years from now we may often not be giving antibiotics for pneumonia because we’ll be able to see better if it’s caused by a virus.”
A large 2018 review by Dr. Linder and associates reported that 46% of antibiotics were prescribed without any infection-related diagnosis code and 20% without an office visit.
Dr. Linder routinely informs patients requesting an antibiotic about the risks of putting an ineffective chemical into their body. “I stress that it can cause rash and other allergic reactions, and even promote C diff infection,” he said. “And I also say it messes with the good bacteria in the microbiome, and they usually come around.”
Patients need to know, Dr. Linder added, that the normal course of healing the respiratory tract after acute bronchitis takes weeks. While a wet cough with sputum or phlegm will last a few days, it’s replaced with a dry annoying cough that persists for up to 3 weeks. “As long as they’re feeling generally better, that cough is normal,” he said. “A virus has run roughshod over their airways and they need a long time to heal and the cough is part of the healing process. Think how long it takes to heal a cut on a finger.”
In an era of escalating antimicrobial resistance fueled by antibiotic overuse, it’s become increasingly important to reserve antibiotics for necessary cases. According to a recent World Health Organization call to action, “Uncontrolled antimicrobial resistance is expected to lower life expectancy and lead to unprecedented health expenditure and economic losses.”
That said, there is important clinical work to be done to determine if there is a limited role for antibiotics in patients with cough, perhaps based on age and baseline severity. “Serious cough symptoms and how to treat them properly needs to be studied more, perhaps in a randomized clinical trial as this study was observational and there haven’t been any randomized trials looking at this issue since about 2012,” Dr. Merenstein said.
This research was funded by the Agency for Healthcare Research and Quality. The authors have no conflicts of interest to declare. Dr. Linder reported stock ownership in pharmaceutical companies but none that make antibiotics or other infectious disease drugs.
Antibiotics had no measurable effect on the severity or duration of coughs due to acute lower respiratory tract infection (LRTI, or acute bronchitis), a large prospective study found.
In fact, those receiving an antibiotic in the primary- and urgent-care setting had a small but significant increase in overall length of illness (17.5 vs 15.9 days; P = .05) — largely because patients with longer illness before the index visit were more likely to receive these drugs. The study adds further support for reducing the prescription of antibiotics for LRTIs.
“Importantly, the pathogen data demonstrated that the length of time until illness resolution for those with bacterial infection was the same as for those not receiving an antibiotic versus those receiving one (17.3 vs 17.4 days),” researchers led by Daniel J. Merenstein, MD, a professor and director of research programs, family medicine, at Georgetown University Medical Center in Washington, wrote in the Journal of General Internal Medicine (doi: 10.1007/s11606-024-08758-y).
Patients believed an antibiotic would shorten their illness by an average of about 4 days, from 13.4 days to 9.7 days, whereas the average duration of all coughs was more than 2 weeks regardless of pathogen type or receipt of an antibiotic.
“Patients had unrealistic expectations regarding the duration of LRTI and the effect of antibiotics, which should be the target of antibiotic stewardship efforts,” the group wrote.
LRTIs can, however, be dangerous, with 3%-5% progressing to pneumonia, “but not everyone has easy access at an initial visit to an x-ray, which may be the reason clinicians still give antibiotics without any other evidence of a bacterial infection,” Dr. Merenstein said in a news release. “Patients have come to expect antibiotics for a cough, even if it doesn’t help. Basic symptom-relieving medications plus time bring a resolution to most people’s infections.”
The authors noted that cough is the most common reason for an ambulatory care visit, accounting for 2.7 million outpatient visits and more than 4 million emergency department visits annually.
Risks
Overuse of antibiotics can result in dizziness, nausea, diarrhea, and rash, along with a roughly 4% chance of serious adverse effects including anaphylaxis; Stevens-Johnson syndrome, a serious skin and mucous membrane disorder; and Clostridioides difficile-associated diarrhea.
An estimated half of all antibiotic prescriptions for acute respiratory conditions are unnecessary. Before the COVID-19 pandemic, antibiotics were prescribed about 70% of the time for a diagnosis of uncomplicated cough and LRTI. The viral pandemic did not change this practice according to a meta-analysis of 130 studies showing that 78% of COVID-19 patients were prescribed an antibiotic.
The study
The study looked at a cohort of 718 patients, with a mean age of 38.9 years, 65.3% female, of whom 207 received an antibiotic and 511 did not. Of those with baseline data, 29% had an antibiotic prescribed at baseline, the most common (in 85%) being amoxicillin-clavulanate, azithromycin, doxycycline, and amoxicillin. Antibiotics had no effect on the duration or overall severity of cough in viral, bacterial, or mixed infections. Receipt of an antibiotic did, however, reduce the likelihood of a follow-up visit: 14.1% vs 8.2% (adjusted odds ratio, 0.47; 95% confidence interval, 0.26-0.84) — perhaps because it removed the motivation for seeking another consultation. Antibiotic recipients were more likely to receive a systemic corticosteroid (31.9% vs 4.5%, P <.001) and were also more likely to receive an albuterol inhaler (22.7% vs 7.6%, P <.001).
Jeffrey A. Linder, MD, MPH, a primary care physician and chief of internal medicine and geriatrics at Northwestern University Feinberg School of Medicine in Chicago, agrees that in the vast majority of LRTIs — usually acute bronchitis — antibiotics do not speed the healing process. “Forty years of research show that antibiotics do not make acute bronchitis go away any faster,” Dr. Linder, who was not involved in the current study, said in an interview. “There’s even growing evidence that a lot of pneumonia is viral as well, and 10 or 20 years from now we may often not be giving antibiotics for pneumonia because we’ll be able to see better if it’s caused by a virus.”
A large 2018 review by Dr. Linder and associates reported that 46% of antibiotics were prescribed without any infection-related diagnosis code and 20% without an office visit.
Dr. Linder routinely informs patients requesting an antibiotic about the risks of putting an ineffective chemical into their body. “I stress that it can cause rash and other allergic reactions, and even promote C diff infection,” he said. “And I also say it messes with the good bacteria in the microbiome, and they usually come around.”
Patients need to know, Dr. Linder added, that the normal course of healing the respiratory tract after acute bronchitis takes weeks. While a wet cough with sputum or phlegm will last a few days, it’s replaced with a dry annoying cough that persists for up to 3 weeks. “As long as they’re feeling generally better, that cough is normal,” he said. “A virus has run roughshod over their airways and they need a long time to heal and the cough is part of the healing process. Think how long it takes to heal a cut on a finger.”
In an era of escalating antimicrobial resistance fueled by antibiotic overuse, it’s become increasingly important to reserve antibiotics for necessary cases. According to a recent World Health Organization call to action, “Uncontrolled antimicrobial resistance is expected to lower life expectancy and lead to unprecedented health expenditure and economic losses.”
That said, there is important clinical work to be done to determine if there is a limited role for antibiotics in patients with cough, perhaps based on age and baseline severity. “Serious cough symptoms and how to treat them properly needs to be studied more, perhaps in a randomized clinical trial as this study was observational and there haven’t been any randomized trials looking at this issue since about 2012,” Dr. Merenstein said.
This research was funded by the Agency for Healthcare Research and Quality. The authors have no conflicts of interest to declare. Dr. Linder reported stock ownership in pharmaceutical companies but none that make antibiotics or other infectious disease drugs.
FROM JOURNAL OF GENERAL INTERNAL MEDICINE
Mandibular Device Comparable to CPAP to Reduce BP in Hypertension, OSA
Use of a mandibular advancement device (MAD) proved non-inferior to guideline-recommended continuous positive airway pressure (CPAP) to reduce blood pressure in patients with hypertension and obstructive sleep apnea (OSA), in a randomized trial.
“These findings suggest that MAD could be considered an alternative to CPAP for optimizing blood pressure control in OSA patients with hypertension and high cardiovascular risk,” the researchers conclude.
“Looking at the totality of evidence available in the literature, it is still reasonable to say that CPAP is the first-line treatment until we have more data on the MAD,” said Ronald Lee Chi-Hang, MD, professor of medicine at Yong Loo Lin School of Medicine, National University of Singapore, who presented the results.
“However, for patients who truly cannot tolerate or accept using a CPAP, we should be more open-minded in looking for an alternative therapy such as a MAD, which based on our study, numerically had a better blood pressure reduction in patients compared with a CPAP,” said Dr. Chi-Hang, who is also a senior consultant in the Department of Cardiology at Singapore’s National University Heart Centre.
The results were presented April 6 at the American College of Cardiology Scientific Sessions 2024 and published online simultaneously in the Journal of the American College of Cardiology
Oral Appliance
OSA is increasingly recognized as “an underdiagnosed and modifiable cause of hypertension,” the researchers note in their report. “Patients with OSA develop recurrent collapse of the upper airway during sleep, resulting in hypoxemia, sympathetic hyperactivity, and BP surges.”
Current guidelines recommend screening and treatment of OSA in patients with hypertension, and CPAP is considered first-line therapy, they note.
“Despite being effective, unfortunately, many patients decline to use a CPAP or find it challenging to stick to the therapy,” Dr. Chi-Hang said, particularly those without daytime sleepiness.
MADs are oral appliances that work by advancing the mandible about 5 to 10 mm during sleep, he said. They provide an alternative to OSA patients and have been shown to improve daytime sleepiness and quality of life, “and in general, is better accepted and tolerated than CPAP.”
However, early studies are small, with short follow up, included patients with and without hypertension, and didn’t specify BP reduction as the primary outcome.
The CRESCENT trial was an investigator-initiated, randomized, non-inferiority trial that aimed to compare the relative effectiveness of MAD vs CPAP in reducing 24-hour ambulatory blood pressure in patients with moderate-to-severe OSA, hypertension and high cardiovascular risk. The prespecified margin for non-inferiority was 1.5 mm Hg.
A total of 321 participants were recruited at three public hospitals for polysomnography. All were older than age 40 years, had hypertension, and were at increased cardiovascular risk. Of these, 220 with moderate-to-severe OSA, defined as an apnea–hypopnea index (AHI) of ≥ 15 events/hour, were randomly assigned to either MAD or CPAP treatment.
The primary outcome was the difference between the 24-hour mean arterial BP at baseline and 6 months. The median age was 61 years, most patients (85.5%) were male, and all were Chinese. All had essential hypertension and were on one or more antihypertensive medications. Hypertension was relatively well controlled at baseline.
At 6 months, 24-hour mean arterial BP decreased by 2.5 mm Hg in the MAD group (P = .003) compared to no change from baseline in the CPAP group (P = .374).
The between-group difference was -1.6 mm Hg (95% CI, -3.51 to 0.24, non-inferiority P < .001).
There was a larger between-group reduction in all secondary ambulatory BP parameters in the MAD versus the CPAP group, with the most pronounced effects seen in the asleep BP parameters.
Both the MAD and CPAP significantly improved daytime sleepiness, with no between-group differences (P =.384). There were no between-group differences in cardiovascular biomarkers.
During the presentation, panel discussant Julie B. Damp, MD, associate professor of medicine at Vanderbilt Health in Nashville, Tennessee, called CRESCENT “a really interesting study, and I think it has a lot of information to add [regarding] what we know about this comparison in the literature, because this is a big study and it also followed these patients for longer than we’ve seen in some of the previous studies.”
Dr. Damp asked, however, about how these results might be extrapolated to other populations, since the vast majority of participants were male.
Dr. Chi-Hang pointed out that most OSA studies include mostly male patients, but noted that particularly in Asian culture, female patients may be more conservative in seeking treatment for problems with snoring, poor quality of sleep, or extensive daytime sleepiness. “Therefore, lots of times, even in clinical practice, we see that over 80 or 90% of patients are male patients,” he said.
Dr. Damp followed up by asking about the differential effectiveness of CPAP vs MAD. “Just in thinking about these two therapies, there is some evidence that the mandibular devices are potentially less effective on some of the sleep apnea-specific measures, so how much of this do you think is an issue of a better vs a not better treatment as opposed to an issue truly of compliance and what patients are able to tolerate?”
Dr. Chi-Hang agreed that in terms of reducing the AHI, CPAP is more effective than MAD. “In fact, in our data, the residual AHI was 10 for the MAD group and 2 for the CPAP group. Clearly, CPAP is more effective,” he said. “But the problem we are facing in this area is the value of AHI as an index is being questioned.”
AHI considers only the number of events, without taking into account the duration or the depth of the apnea, he said. “AHI is simply not an ideal index to document the disease severity,” or the impact on cardiovascular outcomes.
A Tailored Approach
In an editorial accompanying the JACC publication, Michele Emdin, MD, PhD, Francesco Gentile, MD, and Alberto Giannoni, MD, PhD, all from the Health Science Interdisciplinary Center, Scuola Superiore Sant’ Anna, and Fondazione Toscana Gabriele Monasterio, in Pisa, Italy, commend the researchers for designing and conducting “such a pragmatic and informative trial, which confirms and extends previous findings.”
They also discuss the compliance vs effectiveness issue, pointing out that although CPAP appeared to be more effective in reducing apnea burden, there was higher adherence to MAD — with 57% using the device 6 or more hours per night, vs 23% for CPAP — which might have offset the greater reduction in apnea burden and resulted in the reduction in blood pressure seen in the trial.
“Addressing poor adherence to OSA treatments seems therefore necessary, particularly in the case of less symptomatic patients, who often have a lower perception of the related risks,” they write.
“Currently, a tailored approach seems reasonable, based on updated evidence, considering: a) the differential effects of CPAP or MAD on OSA, blood pressure; b) the treatment feasibility; c) the individual baseline demographic and clinical characteristics, including the presence of resistant hypertension; and d) compliance with the therapeutic tool and patient’s preferences,” the editorialists conclude.
The study was funded by the Singapore Ministry of Health. The authors and editorialists report no relevant financial relationships.
A version of this article appeared on Medscape.com.
Use of a mandibular advancement device (MAD) proved non-inferior to guideline-recommended continuous positive airway pressure (CPAP) to reduce blood pressure in patients with hypertension and obstructive sleep apnea (OSA), in a randomized trial.
“These findings suggest that MAD could be considered an alternative to CPAP for optimizing blood pressure control in OSA patients with hypertension and high cardiovascular risk,” the researchers conclude.
“Looking at the totality of evidence available in the literature, it is still reasonable to say that CPAP is the first-line treatment until we have more data on the MAD,” said Ronald Lee Chi-Hang, MD, professor of medicine at Yong Loo Lin School of Medicine, National University of Singapore, who presented the results.
“However, for patients who truly cannot tolerate or accept using a CPAP, we should be more open-minded in looking for an alternative therapy such as a MAD, which based on our study, numerically had a better blood pressure reduction in patients compared with a CPAP,” said Dr. Chi-Hang, who is also a senior consultant in the Department of Cardiology at Singapore’s National University Heart Centre.
The results were presented April 6 at the American College of Cardiology Scientific Sessions 2024 and published online simultaneously in the Journal of the American College of Cardiology
Oral Appliance
OSA is increasingly recognized as “an underdiagnosed and modifiable cause of hypertension,” the researchers note in their report. “Patients with OSA develop recurrent collapse of the upper airway during sleep, resulting in hypoxemia, sympathetic hyperactivity, and BP surges.”
Current guidelines recommend screening and treatment of OSA in patients with hypertension, and CPAP is considered first-line therapy, they note.
“Despite being effective, unfortunately, many patients decline to use a CPAP or find it challenging to stick to the therapy,” Dr. Chi-Hang said, particularly those without daytime sleepiness.
MADs are oral appliances that work by advancing the mandible about 5 to 10 mm during sleep, he said. They provide an alternative to OSA patients and have been shown to improve daytime sleepiness and quality of life, “and in general, is better accepted and tolerated than CPAP.”
However, early studies are small, with short follow up, included patients with and without hypertension, and didn’t specify BP reduction as the primary outcome.
The CRESCENT trial was an investigator-initiated, randomized, non-inferiority trial that aimed to compare the relative effectiveness of MAD vs CPAP in reducing 24-hour ambulatory blood pressure in patients with moderate-to-severe OSA, hypertension and high cardiovascular risk. The prespecified margin for non-inferiority was 1.5 mm Hg.
A total of 321 participants were recruited at three public hospitals for polysomnography. All were older than age 40 years, had hypertension, and were at increased cardiovascular risk. Of these, 220 with moderate-to-severe OSA, defined as an apnea–hypopnea index (AHI) of ≥ 15 events/hour, were randomly assigned to either MAD or CPAP treatment.
The primary outcome was the difference between the 24-hour mean arterial BP at baseline and 6 months. The median age was 61 years, most patients (85.5%) were male, and all were Chinese. All had essential hypertension and were on one or more antihypertensive medications. Hypertension was relatively well controlled at baseline.
At 6 months, 24-hour mean arterial BP decreased by 2.5 mm Hg in the MAD group (P = .003) compared to no change from baseline in the CPAP group (P = .374).
The between-group difference was -1.6 mm Hg (95% CI, -3.51 to 0.24, non-inferiority P < .001).
There was a larger between-group reduction in all secondary ambulatory BP parameters in the MAD versus the CPAP group, with the most pronounced effects seen in the asleep BP parameters.
Both the MAD and CPAP significantly improved daytime sleepiness, with no between-group differences (P =.384). There were no between-group differences in cardiovascular biomarkers.
During the presentation, panel discussant Julie B. Damp, MD, associate professor of medicine at Vanderbilt Health in Nashville, Tennessee, called CRESCENT “a really interesting study, and I think it has a lot of information to add [regarding] what we know about this comparison in the literature, because this is a big study and it also followed these patients for longer than we’ve seen in some of the previous studies.”
Dr. Damp asked, however, about how these results might be extrapolated to other populations, since the vast majority of participants were male.
Dr. Chi-Hang pointed out that most OSA studies include mostly male patients, but noted that particularly in Asian culture, female patients may be more conservative in seeking treatment for problems with snoring, poor quality of sleep, or extensive daytime sleepiness. “Therefore, lots of times, even in clinical practice, we see that over 80 or 90% of patients are male patients,” he said.
Dr. Damp followed up by asking about the differential effectiveness of CPAP vs MAD. “Just in thinking about these two therapies, there is some evidence that the mandibular devices are potentially less effective on some of the sleep apnea-specific measures, so how much of this do you think is an issue of a better vs a not better treatment as opposed to an issue truly of compliance and what patients are able to tolerate?”
Dr. Chi-Hang agreed that in terms of reducing the AHI, CPAP is more effective than MAD. “In fact, in our data, the residual AHI was 10 for the MAD group and 2 for the CPAP group. Clearly, CPAP is more effective,” he said. “But the problem we are facing in this area is the value of AHI as an index is being questioned.”
AHI considers only the number of events, without taking into account the duration or the depth of the apnea, he said. “AHI is simply not an ideal index to document the disease severity,” or the impact on cardiovascular outcomes.
A Tailored Approach
In an editorial accompanying the JACC publication, Michele Emdin, MD, PhD, Francesco Gentile, MD, and Alberto Giannoni, MD, PhD, all from the Health Science Interdisciplinary Center, Scuola Superiore Sant’ Anna, and Fondazione Toscana Gabriele Monasterio, in Pisa, Italy, commend the researchers for designing and conducting “such a pragmatic and informative trial, which confirms and extends previous findings.”
They also discuss the compliance vs effectiveness issue, pointing out that although CPAP appeared to be more effective in reducing apnea burden, there was higher adherence to MAD — with 57% using the device 6 or more hours per night, vs 23% for CPAP — which might have offset the greater reduction in apnea burden and resulted in the reduction in blood pressure seen in the trial.
“Addressing poor adherence to OSA treatments seems therefore necessary, particularly in the case of less symptomatic patients, who often have a lower perception of the related risks,” they write.
“Currently, a tailored approach seems reasonable, based on updated evidence, considering: a) the differential effects of CPAP or MAD on OSA, blood pressure; b) the treatment feasibility; c) the individual baseline demographic and clinical characteristics, including the presence of resistant hypertension; and d) compliance with the therapeutic tool and patient’s preferences,” the editorialists conclude.
The study was funded by the Singapore Ministry of Health. The authors and editorialists report no relevant financial relationships.
A version of this article appeared on Medscape.com.
Use of a mandibular advancement device (MAD) proved non-inferior to guideline-recommended continuous positive airway pressure (CPAP) to reduce blood pressure in patients with hypertension and obstructive sleep apnea (OSA), in a randomized trial.
“These findings suggest that MAD could be considered an alternative to CPAP for optimizing blood pressure control in OSA patients with hypertension and high cardiovascular risk,” the researchers conclude.
“Looking at the totality of evidence available in the literature, it is still reasonable to say that CPAP is the first-line treatment until we have more data on the MAD,” said Ronald Lee Chi-Hang, MD, professor of medicine at Yong Loo Lin School of Medicine, National University of Singapore, who presented the results.
“However, for patients who truly cannot tolerate or accept using a CPAP, we should be more open-minded in looking for an alternative therapy such as a MAD, which based on our study, numerically had a better blood pressure reduction in patients compared with a CPAP,” said Dr. Chi-Hang, who is also a senior consultant in the Department of Cardiology at Singapore’s National University Heart Centre.
The results were presented April 6 at the American College of Cardiology Scientific Sessions 2024 and published online simultaneously in the Journal of the American College of Cardiology
Oral Appliance
OSA is increasingly recognized as “an underdiagnosed and modifiable cause of hypertension,” the researchers note in their report. “Patients with OSA develop recurrent collapse of the upper airway during sleep, resulting in hypoxemia, sympathetic hyperactivity, and BP surges.”
Current guidelines recommend screening and treatment of OSA in patients with hypertension, and CPAP is considered first-line therapy, they note.
“Despite being effective, unfortunately, many patients decline to use a CPAP or find it challenging to stick to the therapy,” Dr. Chi-Hang said, particularly those without daytime sleepiness.
MADs are oral appliances that work by advancing the mandible about 5 to 10 mm during sleep, he said. They provide an alternative to OSA patients and have been shown to improve daytime sleepiness and quality of life, “and in general, is better accepted and tolerated than CPAP.”
However, early studies are small, with short follow up, included patients with and without hypertension, and didn’t specify BP reduction as the primary outcome.
The CRESCENT trial was an investigator-initiated, randomized, non-inferiority trial that aimed to compare the relative effectiveness of MAD vs CPAP in reducing 24-hour ambulatory blood pressure in patients with moderate-to-severe OSA, hypertension and high cardiovascular risk. The prespecified margin for non-inferiority was 1.5 mm Hg.
A total of 321 participants were recruited at three public hospitals for polysomnography. All were older than age 40 years, had hypertension, and were at increased cardiovascular risk. Of these, 220 with moderate-to-severe OSA, defined as an apnea–hypopnea index (AHI) of ≥ 15 events/hour, were randomly assigned to either MAD or CPAP treatment.
The primary outcome was the difference between the 24-hour mean arterial BP at baseline and 6 months. The median age was 61 years, most patients (85.5%) were male, and all were Chinese. All had essential hypertension and were on one or more antihypertensive medications. Hypertension was relatively well controlled at baseline.
At 6 months, 24-hour mean arterial BP decreased by 2.5 mm Hg in the MAD group (P = .003) compared to no change from baseline in the CPAP group (P = .374).
The between-group difference was -1.6 mm Hg (95% CI, -3.51 to 0.24, non-inferiority P < .001).
There was a larger between-group reduction in all secondary ambulatory BP parameters in the MAD versus the CPAP group, with the most pronounced effects seen in the asleep BP parameters.
Both the MAD and CPAP significantly improved daytime sleepiness, with no between-group differences (P =.384). There were no between-group differences in cardiovascular biomarkers.
During the presentation, panel discussant Julie B. Damp, MD, associate professor of medicine at Vanderbilt Health in Nashville, Tennessee, called CRESCENT “a really interesting study, and I think it has a lot of information to add [regarding] what we know about this comparison in the literature, because this is a big study and it also followed these patients for longer than we’ve seen in some of the previous studies.”
Dr. Damp asked, however, about how these results might be extrapolated to other populations, since the vast majority of participants were male.
Dr. Chi-Hang pointed out that most OSA studies include mostly male patients, but noted that particularly in Asian culture, female patients may be more conservative in seeking treatment for problems with snoring, poor quality of sleep, or extensive daytime sleepiness. “Therefore, lots of times, even in clinical practice, we see that over 80 or 90% of patients are male patients,” he said.
Dr. Damp followed up by asking about the differential effectiveness of CPAP vs MAD. “Just in thinking about these two therapies, there is some evidence that the mandibular devices are potentially less effective on some of the sleep apnea-specific measures, so how much of this do you think is an issue of a better vs a not better treatment as opposed to an issue truly of compliance and what patients are able to tolerate?”
Dr. Chi-Hang agreed that in terms of reducing the AHI, CPAP is more effective than MAD. “In fact, in our data, the residual AHI was 10 for the MAD group and 2 for the CPAP group. Clearly, CPAP is more effective,” he said. “But the problem we are facing in this area is the value of AHI as an index is being questioned.”
AHI considers only the number of events, without taking into account the duration or the depth of the apnea, he said. “AHI is simply not an ideal index to document the disease severity,” or the impact on cardiovascular outcomes.
A Tailored Approach
In an editorial accompanying the JACC publication, Michele Emdin, MD, PhD, Francesco Gentile, MD, and Alberto Giannoni, MD, PhD, all from the Health Science Interdisciplinary Center, Scuola Superiore Sant’ Anna, and Fondazione Toscana Gabriele Monasterio, in Pisa, Italy, commend the researchers for designing and conducting “such a pragmatic and informative trial, which confirms and extends previous findings.”
They also discuss the compliance vs effectiveness issue, pointing out that although CPAP appeared to be more effective in reducing apnea burden, there was higher adherence to MAD — with 57% using the device 6 or more hours per night, vs 23% for CPAP — which might have offset the greater reduction in apnea burden and resulted in the reduction in blood pressure seen in the trial.
“Addressing poor adherence to OSA treatments seems therefore necessary, particularly in the case of less symptomatic patients, who often have a lower perception of the related risks,” they write.
“Currently, a tailored approach seems reasonable, based on updated evidence, considering: a) the differential effects of CPAP or MAD on OSA, blood pressure; b) the treatment feasibility; c) the individual baseline demographic and clinical characteristics, including the presence of resistant hypertension; and d) compliance with the therapeutic tool and patient’s preferences,” the editorialists conclude.
The study was funded by the Singapore Ministry of Health. The authors and editorialists report no relevant financial relationships.
A version of this article appeared on Medscape.com.
No Routine Cancer Screening Option? New MCED Tests May Help
Analyses presented during a session at the American Association for Cancer Research annual meeting, revealed that three new MCED tests — CanScan, MERCURY, and OncoSeek — could detect a range of cancers and recognize the tissue of origin with high accuracy. One — OncoSeek — could also provide an affordable cancer screening option for individuals living in lower-income countries.
The need for these noninvasive liquid biopsy tests that can accurately identify multiple cancer types with a single blood draw, especially cancers without routine screening strategies, is pressing. “We know that the current cancer standard of care screening will identify less than 50% of all cancers, while more than 50% of all cancer deaths occur in types of cancer with no recommended screening,” said co-moderator Marie E. Wood, MD, of the University of Colorado Anschutz Medical Campus, in Aurora, Colorado.
That being said, “the clinical utility of multicancer detection tests has not been established and we’re concerned about issues of overdiagnosis and overtreatment,” she noted.
The Early Data
One new MCED test called CanScan, developed by Geneseeq Technology, uses plasma cell-free DNA fragment patterns to detect cancer signals as well as identify the tissue of origin across 13 cancer types.
Overall, the CanScan test covers cancer types that contribute to two thirds of new cancer cases and 74% of morality globally, said presenter Shanshan Yang, of Geneseeq Research Institute, in Nanjing, China.
However, only five of these cancer types have screening recommendations issued by the US Preventive Services Task Force (USPSTF), Dr. Yang added.
The interim data comes from an ongoing large-scale prospective study evaluating the MCED test in a cohort of asymptomatic individuals between ages 45 and 75 years with an average risk for cancer and no cancer-related symptoms on enrollment.
Patients at baseline had their blood collected for the CanScan test and subsequently received annual routine physical exams once a year for 3 consecutive years, with an additional 2 years of follow-up.
The analysis included 3724 participants with analyzable samples at the data cutoff in September 2023. Among the 3724 participants, 29 had confirmed cancer diagnoses. Among these cases, 14 patients had their cancer confirmed through USPSTF recommended screening and 15 were detected through outside of standard USPSTF screening, such as a thyroid ultrasound, Dr. Yang explained.
Almost 90% of the cancers (26 of 29) were detected in the stage I or II, and eight (27.5%) were not one of the test’s 13 targeted cancer types.
The CanScan test had a sensitivity of 55.2%, identifying 16 of 29 of the patients with cancer, including 10 of 21 individuals with stage I (47.6%), and two of three with stage II (66.7%).
The test had a high specificity of 97.9%, meaning out of 100 people screened, only two had false negative findings.
Among the 15 patients who had their cancer detected outside of USPSTF screening recommendations, eight (53.3%) were found using a CanScan test, including patients with liver and endometrial cancers.
Compared with a positive predictive value of (PPV) of 1.6% with screening or physical exam methods alone, the CanScan test had a PPV of 17.4%, Dr. Yang reported.
“The MCED test holds significant potential for early cancer screening in asymptomatic populations,” Dr. Yang and colleagues concluded.
Another new MCED test called MERCURY, also developed by Geneseeq Technology and presented during the session, used a similar method to detect cancer signals and predict the tissue of origin across 13 cancer types.
The researchers initially validated the test using 3076 patients with cancer and 3477 healthy controls with a target specificity of 99%. In this group, researchers reported a sensitivity of 0.865 and a specificity of 0.989.
The team then performed an independent validation analysis with 1465 participants, 732 with cancer and 733 with no cancer, and confirmed a high sensitivity and specificity of 0.874 and 0.978, respectively. The sensitivity increased incrementally by cancer stage — 0.768 for stage I, 0.840 for stage II, 0.923 for stage III, and 0.971 for stage IV.
The test identified the tissue of origin with high accuracy, the researchers noted, but cautioned that the test needs “to be further validated in a prospective cohort study.”
MCED in Low-Income Settings
The session also featured findings on a new affordable MCED test called OncoSeek, which could provide greater access to cancer testing in low- and middle-income countries.
The OncoSeek algorithm identifies the presence of cancer using seven protein tumor markers alongside clinical information, such as gender and age. Like other tests, the test also predicts the possible tissue of origin.
The test can be run on clinical protein assay instruments that are already widely available, such as Roche cobas analyzer, Mao Mao, MD, PhD, the founder and CEO of SeekIn, of Shenzhen, China, told this news organization.
This “feature makes the test accessible worldwide, even in low- and middle-income countries,” he said. “These instruments are fully-automated and part of today’s clinical practice. Therefore, the test does not require additional infrastructure building and lab personal training.”
Another notable advantage: the OncoSeek test only costs about $20, compared with other MCED tests, which can cost anywhere from $200 to $1000.
To validate the technology in a large, diverse cohort, Dr. Mao and colleagues enrolled approximately 10,000 participants, including 2003 cancer cases and 7888 non-cancer cases.
Peripheral blood was collected from each participant and analyzed using a panel of the seven protein tumor markers — AFP, CA125, CA15-3, CA19-9, CA72-4, CEA, and CYFRA 21-1.
To reduce the risk for false positive findings, the team designed the OncoSeek algorithm to achieve a specificity of 93%. Dr. Mao and colleagues found a sensitivity of 51.7%, resulting in an overall accuracy of 84.6%.
The performance was consistent in additional validation cohorts in Brazil, China, and the United States, with sensitivities ranging from 39.0% to 77.6% for detecting nine common cancer types, including breast, colorectal, liver, lung, lymphoma, esophagus, ovary, pancreas, and stomach. The sensitivity for pancreatic cancer was at the high end of 77.6%.
The test could predict the tissue of origin in about two thirds of cases.
Given its low cost, OncoSeek represents an affordable and accessible option for cancer screening, the authors concluded.
Overall, “I think MCEDs have the potential to enhance cancer screening,” Dr. Wood told this news organization.
Still, questions remain about the optimal use of these tests, such as whether they are best for average-risk or higher risk populations, and how to integrate them into standard screening, she said.
Dr. Wood also cautioned that the studies presented in the session represent early data, and it is likely that the numbers, such as sensitivity and specificity, will change with further prospective analyses.
And ultimately, these tests should complement, not replace, standard screening. “A negative testing should not be taken as a sign to avoid standard screening,” Dr. Wood said.
Dr. Yang is an employee of Geneseeq Technology, Inc., and Dr. Mao is an employee of SeekIn. Dr. Wood had no disclosures to report.
A version of this article appeared on Medscape.com.
Analyses presented during a session at the American Association for Cancer Research annual meeting, revealed that three new MCED tests — CanScan, MERCURY, and OncoSeek — could detect a range of cancers and recognize the tissue of origin with high accuracy. One — OncoSeek — could also provide an affordable cancer screening option for individuals living in lower-income countries.
The need for these noninvasive liquid biopsy tests that can accurately identify multiple cancer types with a single blood draw, especially cancers without routine screening strategies, is pressing. “We know that the current cancer standard of care screening will identify less than 50% of all cancers, while more than 50% of all cancer deaths occur in types of cancer with no recommended screening,” said co-moderator Marie E. Wood, MD, of the University of Colorado Anschutz Medical Campus, in Aurora, Colorado.
That being said, “the clinical utility of multicancer detection tests has not been established and we’re concerned about issues of overdiagnosis and overtreatment,” she noted.
The Early Data
One new MCED test called CanScan, developed by Geneseeq Technology, uses plasma cell-free DNA fragment patterns to detect cancer signals as well as identify the tissue of origin across 13 cancer types.
Overall, the CanScan test covers cancer types that contribute to two thirds of new cancer cases and 74% of morality globally, said presenter Shanshan Yang, of Geneseeq Research Institute, in Nanjing, China.
However, only five of these cancer types have screening recommendations issued by the US Preventive Services Task Force (USPSTF), Dr. Yang added.
The interim data comes from an ongoing large-scale prospective study evaluating the MCED test in a cohort of asymptomatic individuals between ages 45 and 75 years with an average risk for cancer and no cancer-related symptoms on enrollment.
Patients at baseline had their blood collected for the CanScan test and subsequently received annual routine physical exams once a year for 3 consecutive years, with an additional 2 years of follow-up.
The analysis included 3724 participants with analyzable samples at the data cutoff in September 2023. Among the 3724 participants, 29 had confirmed cancer diagnoses. Among these cases, 14 patients had their cancer confirmed through USPSTF recommended screening and 15 were detected through outside of standard USPSTF screening, such as a thyroid ultrasound, Dr. Yang explained.
Almost 90% of the cancers (26 of 29) were detected in the stage I or II, and eight (27.5%) were not one of the test’s 13 targeted cancer types.
The CanScan test had a sensitivity of 55.2%, identifying 16 of 29 of the patients with cancer, including 10 of 21 individuals with stage I (47.6%), and two of three with stage II (66.7%).
The test had a high specificity of 97.9%, meaning out of 100 people screened, only two had false negative findings.
Among the 15 patients who had their cancer detected outside of USPSTF screening recommendations, eight (53.3%) were found using a CanScan test, including patients with liver and endometrial cancers.
Compared with a positive predictive value of (PPV) of 1.6% with screening or physical exam methods alone, the CanScan test had a PPV of 17.4%, Dr. Yang reported.
“The MCED test holds significant potential for early cancer screening in asymptomatic populations,” Dr. Yang and colleagues concluded.
Another new MCED test called MERCURY, also developed by Geneseeq Technology and presented during the session, used a similar method to detect cancer signals and predict the tissue of origin across 13 cancer types.
The researchers initially validated the test using 3076 patients with cancer and 3477 healthy controls with a target specificity of 99%. In this group, researchers reported a sensitivity of 0.865 and a specificity of 0.989.
The team then performed an independent validation analysis with 1465 participants, 732 with cancer and 733 with no cancer, and confirmed a high sensitivity and specificity of 0.874 and 0.978, respectively. The sensitivity increased incrementally by cancer stage — 0.768 for stage I, 0.840 for stage II, 0.923 for stage III, and 0.971 for stage IV.
The test identified the tissue of origin with high accuracy, the researchers noted, but cautioned that the test needs “to be further validated in a prospective cohort study.”
MCED in Low-Income Settings
The session also featured findings on a new affordable MCED test called OncoSeek, which could provide greater access to cancer testing in low- and middle-income countries.
The OncoSeek algorithm identifies the presence of cancer using seven protein tumor markers alongside clinical information, such as gender and age. Like other tests, the test also predicts the possible tissue of origin.
The test can be run on clinical protein assay instruments that are already widely available, such as Roche cobas analyzer, Mao Mao, MD, PhD, the founder and CEO of SeekIn, of Shenzhen, China, told this news organization.
This “feature makes the test accessible worldwide, even in low- and middle-income countries,” he said. “These instruments are fully-automated and part of today’s clinical practice. Therefore, the test does not require additional infrastructure building and lab personal training.”
Another notable advantage: the OncoSeek test only costs about $20, compared with other MCED tests, which can cost anywhere from $200 to $1000.
To validate the technology in a large, diverse cohort, Dr. Mao and colleagues enrolled approximately 10,000 participants, including 2003 cancer cases and 7888 non-cancer cases.
Peripheral blood was collected from each participant and analyzed using a panel of the seven protein tumor markers — AFP, CA125, CA15-3, CA19-9, CA72-4, CEA, and CYFRA 21-1.
To reduce the risk for false positive findings, the team designed the OncoSeek algorithm to achieve a specificity of 93%. Dr. Mao and colleagues found a sensitivity of 51.7%, resulting in an overall accuracy of 84.6%.
The performance was consistent in additional validation cohorts in Brazil, China, and the United States, with sensitivities ranging from 39.0% to 77.6% for detecting nine common cancer types, including breast, colorectal, liver, lung, lymphoma, esophagus, ovary, pancreas, and stomach. The sensitivity for pancreatic cancer was at the high end of 77.6%.
The test could predict the tissue of origin in about two thirds of cases.
Given its low cost, OncoSeek represents an affordable and accessible option for cancer screening, the authors concluded.
Overall, “I think MCEDs have the potential to enhance cancer screening,” Dr. Wood told this news organization.
Still, questions remain about the optimal use of these tests, such as whether they are best for average-risk or higher risk populations, and how to integrate them into standard screening, she said.
Dr. Wood also cautioned that the studies presented in the session represent early data, and it is likely that the numbers, such as sensitivity and specificity, will change with further prospective analyses.
And ultimately, these tests should complement, not replace, standard screening. “A negative testing should not be taken as a sign to avoid standard screening,” Dr. Wood said.
Dr. Yang is an employee of Geneseeq Technology, Inc., and Dr. Mao is an employee of SeekIn. Dr. Wood had no disclosures to report.
A version of this article appeared on Medscape.com.
Analyses presented during a session at the American Association for Cancer Research annual meeting, revealed that three new MCED tests — CanScan, MERCURY, and OncoSeek — could detect a range of cancers and recognize the tissue of origin with high accuracy. One — OncoSeek — could also provide an affordable cancer screening option for individuals living in lower-income countries.
The need for these noninvasive liquid biopsy tests that can accurately identify multiple cancer types with a single blood draw, especially cancers without routine screening strategies, is pressing. “We know that the current cancer standard of care screening will identify less than 50% of all cancers, while more than 50% of all cancer deaths occur in types of cancer with no recommended screening,” said co-moderator Marie E. Wood, MD, of the University of Colorado Anschutz Medical Campus, in Aurora, Colorado.
That being said, “the clinical utility of multicancer detection tests has not been established and we’re concerned about issues of overdiagnosis and overtreatment,” she noted.
The Early Data
One new MCED test called CanScan, developed by Geneseeq Technology, uses plasma cell-free DNA fragment patterns to detect cancer signals as well as identify the tissue of origin across 13 cancer types.
Overall, the CanScan test covers cancer types that contribute to two thirds of new cancer cases and 74% of morality globally, said presenter Shanshan Yang, of Geneseeq Research Institute, in Nanjing, China.
However, only five of these cancer types have screening recommendations issued by the US Preventive Services Task Force (USPSTF), Dr. Yang added.
The interim data comes from an ongoing large-scale prospective study evaluating the MCED test in a cohort of asymptomatic individuals between ages 45 and 75 years with an average risk for cancer and no cancer-related symptoms on enrollment.
Patients at baseline had their blood collected for the CanScan test and subsequently received annual routine physical exams once a year for 3 consecutive years, with an additional 2 years of follow-up.
The analysis included 3724 participants with analyzable samples at the data cutoff in September 2023. Among the 3724 participants, 29 had confirmed cancer diagnoses. Among these cases, 14 patients had their cancer confirmed through USPSTF recommended screening and 15 were detected through outside of standard USPSTF screening, such as a thyroid ultrasound, Dr. Yang explained.
Almost 90% of the cancers (26 of 29) were detected in the stage I or II, and eight (27.5%) were not one of the test’s 13 targeted cancer types.
The CanScan test had a sensitivity of 55.2%, identifying 16 of 29 of the patients with cancer, including 10 of 21 individuals with stage I (47.6%), and two of three with stage II (66.7%).
The test had a high specificity of 97.9%, meaning out of 100 people screened, only two had false negative findings.
Among the 15 patients who had their cancer detected outside of USPSTF screening recommendations, eight (53.3%) were found using a CanScan test, including patients with liver and endometrial cancers.
Compared with a positive predictive value of (PPV) of 1.6% with screening or physical exam methods alone, the CanScan test had a PPV of 17.4%, Dr. Yang reported.
“The MCED test holds significant potential for early cancer screening in asymptomatic populations,” Dr. Yang and colleagues concluded.
Another new MCED test called MERCURY, also developed by Geneseeq Technology and presented during the session, used a similar method to detect cancer signals and predict the tissue of origin across 13 cancer types.
The researchers initially validated the test using 3076 patients with cancer and 3477 healthy controls with a target specificity of 99%. In this group, researchers reported a sensitivity of 0.865 and a specificity of 0.989.
The team then performed an independent validation analysis with 1465 participants, 732 with cancer and 733 with no cancer, and confirmed a high sensitivity and specificity of 0.874 and 0.978, respectively. The sensitivity increased incrementally by cancer stage — 0.768 for stage I, 0.840 for stage II, 0.923 for stage III, and 0.971 for stage IV.
The test identified the tissue of origin with high accuracy, the researchers noted, but cautioned that the test needs “to be further validated in a prospective cohort study.”
MCED in Low-Income Settings
The session also featured findings on a new affordable MCED test called OncoSeek, which could provide greater access to cancer testing in low- and middle-income countries.
The OncoSeek algorithm identifies the presence of cancer using seven protein tumor markers alongside clinical information, such as gender and age. Like other tests, the test also predicts the possible tissue of origin.
The test can be run on clinical protein assay instruments that are already widely available, such as Roche cobas analyzer, Mao Mao, MD, PhD, the founder and CEO of SeekIn, of Shenzhen, China, told this news organization.
This “feature makes the test accessible worldwide, even in low- and middle-income countries,” he said. “These instruments are fully-automated and part of today’s clinical practice. Therefore, the test does not require additional infrastructure building and lab personal training.”
Another notable advantage: the OncoSeek test only costs about $20, compared with other MCED tests, which can cost anywhere from $200 to $1000.
To validate the technology in a large, diverse cohort, Dr. Mao and colleagues enrolled approximately 10,000 participants, including 2003 cancer cases and 7888 non-cancer cases.
Peripheral blood was collected from each participant and analyzed using a panel of the seven protein tumor markers — AFP, CA125, CA15-3, CA19-9, CA72-4, CEA, and CYFRA 21-1.
To reduce the risk for false positive findings, the team designed the OncoSeek algorithm to achieve a specificity of 93%. Dr. Mao and colleagues found a sensitivity of 51.7%, resulting in an overall accuracy of 84.6%.
The performance was consistent in additional validation cohorts in Brazil, China, and the United States, with sensitivities ranging from 39.0% to 77.6% for detecting nine common cancer types, including breast, colorectal, liver, lung, lymphoma, esophagus, ovary, pancreas, and stomach. The sensitivity for pancreatic cancer was at the high end of 77.6%.
The test could predict the tissue of origin in about two thirds of cases.
Given its low cost, OncoSeek represents an affordable and accessible option for cancer screening, the authors concluded.
Overall, “I think MCEDs have the potential to enhance cancer screening,” Dr. Wood told this news organization.
Still, questions remain about the optimal use of these tests, such as whether they are best for average-risk or higher risk populations, and how to integrate them into standard screening, she said.
Dr. Wood also cautioned that the studies presented in the session represent early data, and it is likely that the numbers, such as sensitivity and specificity, will change with further prospective analyses.
And ultimately, these tests should complement, not replace, standard screening. “A negative testing should not be taken as a sign to avoid standard screening,” Dr. Wood said.
Dr. Yang is an employee of Geneseeq Technology, Inc., and Dr. Mao is an employee of SeekIn. Dr. Wood had no disclosures to report.
A version of this article appeared on Medscape.com.