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Ralinepag Offers Once Daily Oral Option for PAH
Ralinepag Offers Once Daily Oral Option for PAH
Treatment with ralinepag, an investigational prostacyclin receptor agonist, reduced the risk for clinical disease worsening by 55% compared to placebo in patients with pulmonary arterial hypertension (PAH), based on new data from the ADVANCE Outcomes study presented at the American Thoracic Society (ATS) 2026 International Conference.
Ralinepag works by restoring prostacyclin signaling and activating prostacyclin receptors to affect pathways that play a role in the progression of PAH. The drug was originally formulated as an immediate-release capsule but modified to the extended-release tablet used in the current study as a way to optimize once daily dosing.
“The prostacyclin pathway is foundational in the management of PAH, and advancing prostacyclin science has benefited patients over the years,” said lead author Vallerie V. McLaughlin, MD, professor of cardiovascular medicine and director of the Pulmonary Hypertension Program at the University of Michigan, Ann Arbor, Michigan, who presented the findings at the meeting. Although other oral prostacyclin pathway agents available, ralinepag has the advantages of high potency and longer half-life that could be effective and well-tolerated in a more patient-friendly once daily formulation, McLaughlin said.
The international study population included 687 adults with PAH from 30 countries across five continents. Participants were randomized to ralinepag or placebo in addition to their standard PAH background therapies. Ralinepag was orally dosed once daily and titrated for tolerability and response. The mean age of the participants was 52 years, 80% were White, and the median time since PAH diagnosis was 2.3 years. A majority of 62% had idiopathic or heritable PAH, 28.2% had PAH as a result of connective tissue disease, 4.1% had a congenital heart defect, 3.1% had drug- or toxin-induced PAH, and 2.6% had PAH as a result of HIV infection. More than two thirds were considered low risk (characterized as Functional Class II).
The primary endpoint was the time to first indication of clinical worsening, which was defined as death, hospital admission for worsening PAH, initiation of a parenteral or inhaled prostacyclin pathway agent for worsening PAH, or unsatisfactory long-term clinical response.
Overall, patients treated with ralinepag were significantly less likely to experience a clinical worsening event than placebo patients (hazard ratio [HR], 0.45; 95% CI, 0.33-0.62; P < .0001), and 47% more likely to achieve the secondary endpoint of clinical improvement (P = .015).
Patients treated with ralinepag also showed significant improvements over placebo patients in the secondary endpoints of pro-B-type natriuretic peptide levels (24.3% reduction from baseline to week 28 over placebo; P = .0013), and in the 6-minute walk test (a placebo-corrected difference of 20.4 m from baseline to week 28; P = .0033).
Although more than 90% of participants treated with ralinepag reported an adverse event related to the drug, approximately 5% experienced drug-related serious adverse events, and the overall safety profile reflected previous ralinepag studies, with a positive risk-benefit ratio, the investigators noted.
Support for Early Introduction
The researchers expected the efficacy associated with prostacyclin therapy, said McLaughlin. “We were very pleased to see such a strong treatment effect in a relatively low-risk population, primarily Functional Class II with a mean 6-minute walk of nearly 440 meters, with the majority of patients on dual oral therapy,” she said.
If approved, ralinepag could help optimized risk status in PAH, said McLaughlin. “Many patients do not get to low risk with first-line therapy, and oral and inhaled prostacyclin pathway agents are often used in addition to dual therapy with phosphodiesterase type-5 inhibitors and endothelin receptor antagonists,” she said. “The impressive treatment effect of ralinepag in patients primarily treated with dual oral therapy reflects this real-world scenario,” she added. The significant event reduction makes a case for earlier introduction of ralinepag in relatively low-risk patients; a highly effective therapy that targets the prostacyclin pathway may reduce the need for more cumbersome and invasive prostacyclin therapies, McLaughlin added.
Ralinepag remains an investigational drug, but the company plans to seek a New Drug Application from the FDA for the treatment of PAH by the second half of 2026, according to a press release.
The research team would like to continue evaluating the ADVANCE Outcomes database to learn more about dose response, tolerability, and subgroup response, said McLaughlin. At that point, real-world data would be useful, and additional research areas in that setting would include combination therapy with other agents such as sotatercept, as well as the use of ralinepag to transition patients on more complicated and invasive therapy, she said.
Attention to Adverse Effects
Prostacyclin therapies are often offered in oral, inhaled, and the most invasive intravenous/subcutaneous routes, but a gap remains between the strong efficacy seen with parenteral therapy and what many patients are willing or able to use in real-world practice, said Parth M. Rali, MD, director of the Temple University Health System Pulmonary Embolism Response Team Program, Section Temple Lung Pulmonary Vascular Disease Program, Philadelphia, who was not involved in the study.
“Ralinepag provides sustained activation of IP receptors and has very long effective half-life, giving drug exposure comparable to parenteral therapy, and offers the first daily treatment option, which is important for the patients with PAH who are often on multiple drugs therapies,” Rali said.
Given the encouraging phase 2 findings demonstrating meaningful reductions in pulmonary vascular resistance and signals toward clinical benefit, we would like to see a favorable outcome in the phase 3 program. Primary outcome studied was time to clinical worsening in the large, randomized trial that involved global populations from the US, Europe, Latin-America, and Asia Pacific Region. Ralinepag arm had 55% reduction in risk for clinical worsening (HR, ~ 0.45) compared to placebo arm. “The positive results of the trial were primarily driven by disease progression, initiation of prostacyclin therapy, and unsatisfactory long-term clinical response at 28 weeks in ralinepag group compared to placebo group,” Rali said.
Although ralinepag offers a good option for once-a-day oral prostacyclin options for the patients, the significant number of patients in the new study who discontinued because of adverse effects is notable, said Rali. “Treating clinicians will have to watch very closely, as the real-world patient population seems to be more complex than clinical trial populations,” he said. “At the same time, clinicians will have an option to weigh against growing list of inhaled prostacyclin pathway therapies that may not have systemic side effects of the oral agents,” he added.
“Given the strong scientific data in the ADVANCE trials, ralinepag may become drug of choice for oral prostacyclin pathway agents,” Rali added. However, its place in the treatment sequence, whether it is best used early in the disease course, as an add-on for patients already receiving dual oral therapy, or potentially part of upfront combination strategies, will call for some clinician judgement, Rali said. “Patient education and gradual dose titration will likely play a major role in improving adherence and limiting prostacyclin-related adverse effects,” he added.
Questions for future research include what percentage of the patients were able to tolerate the maximum dose of the drug, and whether any changes in primary or secondary outcomes occurred depending on the dose, said Rali. Other areas of interest include whether certain patient populations derive greater benefit than others, including connective tissue disease-associated PAH, idiopathic PAH, and higher-risk patient populations. “Comparative effectiveness data against currently available oral prostacyclin pathway agents and studies evaluating transition strategies from parenteral or inhaled therapies would help clinicians better understand where ralinepag ultimately fits in the PAH treatment algorithm,” Rali said. “I also would be curious to see what the authors thought of the failure to achieve the primary endpoint in cohorts of patients from Latin America and Asia Pacific regions,” he added.
The study was funded by United Therapeutics, and McLaughlin disclosed serving as a consultant for the company. Rali had no financial conflicts to disclose.
A version of this article first appeared on Medscape.com.
Treatment with ralinepag, an investigational prostacyclin receptor agonist, reduced the risk for clinical disease worsening by 55% compared to placebo in patients with pulmonary arterial hypertension (PAH), based on new data from the ADVANCE Outcomes study presented at the American Thoracic Society (ATS) 2026 International Conference.
Ralinepag works by restoring prostacyclin signaling and activating prostacyclin receptors to affect pathways that play a role in the progression of PAH. The drug was originally formulated as an immediate-release capsule but modified to the extended-release tablet used in the current study as a way to optimize once daily dosing.
“The prostacyclin pathway is foundational in the management of PAH, and advancing prostacyclin science has benefited patients over the years,” said lead author Vallerie V. McLaughlin, MD, professor of cardiovascular medicine and director of the Pulmonary Hypertension Program at the University of Michigan, Ann Arbor, Michigan, who presented the findings at the meeting. Although other oral prostacyclin pathway agents available, ralinepag has the advantages of high potency and longer half-life that could be effective and well-tolerated in a more patient-friendly once daily formulation, McLaughlin said.
The international study population included 687 adults with PAH from 30 countries across five continents. Participants were randomized to ralinepag or placebo in addition to their standard PAH background therapies. Ralinepag was orally dosed once daily and titrated for tolerability and response. The mean age of the participants was 52 years, 80% were White, and the median time since PAH diagnosis was 2.3 years. A majority of 62% had idiopathic or heritable PAH, 28.2% had PAH as a result of connective tissue disease, 4.1% had a congenital heart defect, 3.1% had drug- or toxin-induced PAH, and 2.6% had PAH as a result of HIV infection. More than two thirds were considered low risk (characterized as Functional Class II).
The primary endpoint was the time to first indication of clinical worsening, which was defined as death, hospital admission for worsening PAH, initiation of a parenteral or inhaled prostacyclin pathway agent for worsening PAH, or unsatisfactory long-term clinical response.
Overall, patients treated with ralinepag were significantly less likely to experience a clinical worsening event than placebo patients (hazard ratio [HR], 0.45; 95% CI, 0.33-0.62; P < .0001), and 47% more likely to achieve the secondary endpoint of clinical improvement (P = .015).
Patients treated with ralinepag also showed significant improvements over placebo patients in the secondary endpoints of pro-B-type natriuretic peptide levels (24.3% reduction from baseline to week 28 over placebo; P = .0013), and in the 6-minute walk test (a placebo-corrected difference of 20.4 m from baseline to week 28; P = .0033).
Although more than 90% of participants treated with ralinepag reported an adverse event related to the drug, approximately 5% experienced drug-related serious adverse events, and the overall safety profile reflected previous ralinepag studies, with a positive risk-benefit ratio, the investigators noted.
Support for Early Introduction
The researchers expected the efficacy associated with prostacyclin therapy, said McLaughlin. “We were very pleased to see such a strong treatment effect in a relatively low-risk population, primarily Functional Class II with a mean 6-minute walk of nearly 440 meters, with the majority of patients on dual oral therapy,” she said.
If approved, ralinepag could help optimized risk status in PAH, said McLaughlin. “Many patients do not get to low risk with first-line therapy, and oral and inhaled prostacyclin pathway agents are often used in addition to dual therapy with phosphodiesterase type-5 inhibitors and endothelin receptor antagonists,” she said. “The impressive treatment effect of ralinepag in patients primarily treated with dual oral therapy reflects this real-world scenario,” she added. The significant event reduction makes a case for earlier introduction of ralinepag in relatively low-risk patients; a highly effective therapy that targets the prostacyclin pathway may reduce the need for more cumbersome and invasive prostacyclin therapies, McLaughlin added.
Ralinepag remains an investigational drug, but the company plans to seek a New Drug Application from the FDA for the treatment of PAH by the second half of 2026, according to a press release.
The research team would like to continue evaluating the ADVANCE Outcomes database to learn more about dose response, tolerability, and subgroup response, said McLaughlin. At that point, real-world data would be useful, and additional research areas in that setting would include combination therapy with other agents such as sotatercept, as well as the use of ralinepag to transition patients on more complicated and invasive therapy, she said.
Attention to Adverse Effects
Prostacyclin therapies are often offered in oral, inhaled, and the most invasive intravenous/subcutaneous routes, but a gap remains between the strong efficacy seen with parenteral therapy and what many patients are willing or able to use in real-world practice, said Parth M. Rali, MD, director of the Temple University Health System Pulmonary Embolism Response Team Program, Section Temple Lung Pulmonary Vascular Disease Program, Philadelphia, who was not involved in the study.
“Ralinepag provides sustained activation of IP receptors and has very long effective half-life, giving drug exposure comparable to parenteral therapy, and offers the first daily treatment option, which is important for the patients with PAH who are often on multiple drugs therapies,” Rali said.
Given the encouraging phase 2 findings demonstrating meaningful reductions in pulmonary vascular resistance and signals toward clinical benefit, we would like to see a favorable outcome in the phase 3 program. Primary outcome studied was time to clinical worsening in the large, randomized trial that involved global populations from the US, Europe, Latin-America, and Asia Pacific Region. Ralinepag arm had 55% reduction in risk for clinical worsening (HR, ~ 0.45) compared to placebo arm. “The positive results of the trial were primarily driven by disease progression, initiation of prostacyclin therapy, and unsatisfactory long-term clinical response at 28 weeks in ralinepag group compared to placebo group,” Rali said.
Although ralinepag offers a good option for once-a-day oral prostacyclin options for the patients, the significant number of patients in the new study who discontinued because of adverse effects is notable, said Rali. “Treating clinicians will have to watch very closely, as the real-world patient population seems to be more complex than clinical trial populations,” he said. “At the same time, clinicians will have an option to weigh against growing list of inhaled prostacyclin pathway therapies that may not have systemic side effects of the oral agents,” he added.
“Given the strong scientific data in the ADVANCE trials, ralinepag may become drug of choice for oral prostacyclin pathway agents,” Rali added. However, its place in the treatment sequence, whether it is best used early in the disease course, as an add-on for patients already receiving dual oral therapy, or potentially part of upfront combination strategies, will call for some clinician judgement, Rali said. “Patient education and gradual dose titration will likely play a major role in improving adherence and limiting prostacyclin-related adverse effects,” he added.
Questions for future research include what percentage of the patients were able to tolerate the maximum dose of the drug, and whether any changes in primary or secondary outcomes occurred depending on the dose, said Rali. Other areas of interest include whether certain patient populations derive greater benefit than others, including connective tissue disease-associated PAH, idiopathic PAH, and higher-risk patient populations. “Comparative effectiveness data against currently available oral prostacyclin pathway agents and studies evaluating transition strategies from parenteral or inhaled therapies would help clinicians better understand where ralinepag ultimately fits in the PAH treatment algorithm,” Rali said. “I also would be curious to see what the authors thought of the failure to achieve the primary endpoint in cohorts of patients from Latin America and Asia Pacific regions,” he added.
The study was funded by United Therapeutics, and McLaughlin disclosed serving as a consultant for the company. Rali had no financial conflicts to disclose.
A version of this article first appeared on Medscape.com.
Treatment with ralinepag, an investigational prostacyclin receptor agonist, reduced the risk for clinical disease worsening by 55% compared to placebo in patients with pulmonary arterial hypertension (PAH), based on new data from the ADVANCE Outcomes study presented at the American Thoracic Society (ATS) 2026 International Conference.
Ralinepag works by restoring prostacyclin signaling and activating prostacyclin receptors to affect pathways that play a role in the progression of PAH. The drug was originally formulated as an immediate-release capsule but modified to the extended-release tablet used in the current study as a way to optimize once daily dosing.
“The prostacyclin pathway is foundational in the management of PAH, and advancing prostacyclin science has benefited patients over the years,” said lead author Vallerie V. McLaughlin, MD, professor of cardiovascular medicine and director of the Pulmonary Hypertension Program at the University of Michigan, Ann Arbor, Michigan, who presented the findings at the meeting. Although other oral prostacyclin pathway agents available, ralinepag has the advantages of high potency and longer half-life that could be effective and well-tolerated in a more patient-friendly once daily formulation, McLaughlin said.
The international study population included 687 adults with PAH from 30 countries across five continents. Participants were randomized to ralinepag or placebo in addition to their standard PAH background therapies. Ralinepag was orally dosed once daily and titrated for tolerability and response. The mean age of the participants was 52 years, 80% were White, and the median time since PAH diagnosis was 2.3 years. A majority of 62% had idiopathic or heritable PAH, 28.2% had PAH as a result of connective tissue disease, 4.1% had a congenital heart defect, 3.1% had drug- or toxin-induced PAH, and 2.6% had PAH as a result of HIV infection. More than two thirds were considered low risk (characterized as Functional Class II).
The primary endpoint was the time to first indication of clinical worsening, which was defined as death, hospital admission for worsening PAH, initiation of a parenteral or inhaled prostacyclin pathway agent for worsening PAH, or unsatisfactory long-term clinical response.
Overall, patients treated with ralinepag were significantly less likely to experience a clinical worsening event than placebo patients (hazard ratio [HR], 0.45; 95% CI, 0.33-0.62; P < .0001), and 47% more likely to achieve the secondary endpoint of clinical improvement (P = .015).
Patients treated with ralinepag also showed significant improvements over placebo patients in the secondary endpoints of pro-B-type natriuretic peptide levels (24.3% reduction from baseline to week 28 over placebo; P = .0013), and in the 6-minute walk test (a placebo-corrected difference of 20.4 m from baseline to week 28; P = .0033).
Although more than 90% of participants treated with ralinepag reported an adverse event related to the drug, approximately 5% experienced drug-related serious adverse events, and the overall safety profile reflected previous ralinepag studies, with a positive risk-benefit ratio, the investigators noted.
Support for Early Introduction
The researchers expected the efficacy associated with prostacyclin therapy, said McLaughlin. “We were very pleased to see such a strong treatment effect in a relatively low-risk population, primarily Functional Class II with a mean 6-minute walk of nearly 440 meters, with the majority of patients on dual oral therapy,” she said.
If approved, ralinepag could help optimized risk status in PAH, said McLaughlin. “Many patients do not get to low risk with first-line therapy, and oral and inhaled prostacyclin pathway agents are often used in addition to dual therapy with phosphodiesterase type-5 inhibitors and endothelin receptor antagonists,” she said. “The impressive treatment effect of ralinepag in patients primarily treated with dual oral therapy reflects this real-world scenario,” she added. The significant event reduction makes a case for earlier introduction of ralinepag in relatively low-risk patients; a highly effective therapy that targets the prostacyclin pathway may reduce the need for more cumbersome and invasive prostacyclin therapies, McLaughlin added.
Ralinepag remains an investigational drug, but the company plans to seek a New Drug Application from the FDA for the treatment of PAH by the second half of 2026, according to a press release.
The research team would like to continue evaluating the ADVANCE Outcomes database to learn more about dose response, tolerability, and subgroup response, said McLaughlin. At that point, real-world data would be useful, and additional research areas in that setting would include combination therapy with other agents such as sotatercept, as well as the use of ralinepag to transition patients on more complicated and invasive therapy, she said.
Attention to Adverse Effects
Prostacyclin therapies are often offered in oral, inhaled, and the most invasive intravenous/subcutaneous routes, but a gap remains between the strong efficacy seen with parenteral therapy and what many patients are willing or able to use in real-world practice, said Parth M. Rali, MD, director of the Temple University Health System Pulmonary Embolism Response Team Program, Section Temple Lung Pulmonary Vascular Disease Program, Philadelphia, who was not involved in the study.
“Ralinepag provides sustained activation of IP receptors and has very long effective half-life, giving drug exposure comparable to parenteral therapy, and offers the first daily treatment option, which is important for the patients with PAH who are often on multiple drugs therapies,” Rali said.
Given the encouraging phase 2 findings demonstrating meaningful reductions in pulmonary vascular resistance and signals toward clinical benefit, we would like to see a favorable outcome in the phase 3 program. Primary outcome studied was time to clinical worsening in the large, randomized trial that involved global populations from the US, Europe, Latin-America, and Asia Pacific Region. Ralinepag arm had 55% reduction in risk for clinical worsening (HR, ~ 0.45) compared to placebo arm. “The positive results of the trial were primarily driven by disease progression, initiation of prostacyclin therapy, and unsatisfactory long-term clinical response at 28 weeks in ralinepag group compared to placebo group,” Rali said.
Although ralinepag offers a good option for once-a-day oral prostacyclin options for the patients, the significant number of patients in the new study who discontinued because of adverse effects is notable, said Rali. “Treating clinicians will have to watch very closely, as the real-world patient population seems to be more complex than clinical trial populations,” he said. “At the same time, clinicians will have an option to weigh against growing list of inhaled prostacyclin pathway therapies that may not have systemic side effects of the oral agents,” he added.
“Given the strong scientific data in the ADVANCE trials, ralinepag may become drug of choice for oral prostacyclin pathway agents,” Rali added. However, its place in the treatment sequence, whether it is best used early in the disease course, as an add-on for patients already receiving dual oral therapy, or potentially part of upfront combination strategies, will call for some clinician judgement, Rali said. “Patient education and gradual dose titration will likely play a major role in improving adherence and limiting prostacyclin-related adverse effects,” he added.
Questions for future research include what percentage of the patients were able to tolerate the maximum dose of the drug, and whether any changes in primary or secondary outcomes occurred depending on the dose, said Rali. Other areas of interest include whether certain patient populations derive greater benefit than others, including connective tissue disease-associated PAH, idiopathic PAH, and higher-risk patient populations. “Comparative effectiveness data against currently available oral prostacyclin pathway agents and studies evaluating transition strategies from parenteral or inhaled therapies would help clinicians better understand where ralinepag ultimately fits in the PAH treatment algorithm,” Rali said. “I also would be curious to see what the authors thought of the failure to achieve the primary endpoint in cohorts of patients from Latin America and Asia Pacific regions,” he added.
The study was funded by United Therapeutics, and McLaughlin disclosed serving as a consultant for the company. Rali had no financial conflicts to disclose.
A version of this article first appeared on Medscape.com.
Ralinepag Offers Once Daily Oral Option for PAH
Ralinepag Offers Once Daily Oral Option for PAH
Simple Blood Count May Help Predict Flare-Up Risk in Asthma
Simple Blood Count May Help Predict Flare-Up Risk in Asthma
TOPLINE:
Higher baseline counts of blood eosinophils (EOS) were associated with an increased risk for exacerbations in patients with asthma over 1 year, and higher baseline levels of fractional exhaled nitric oxide (FeNO) were linked to increased odds of exacerbations treated with only oral corticosteroids (OCS) in asthma and asthma plus chronic obstructive pulmonary disease (COPD) but linked to a decreased risk for all exacerbations in COPD.
METHODOLOGY:
- Researchers analyzed data from the multinational NOVELTY study to assess whether blood EOS counts and FeNO levels, alone and together, predict the risk for future exacerbations in patients with asthma, COPD, or both.
- Overall, 4319 patients were included in the EOS analysis (2138 with asthma, 1541 with COPD, and 640 with asthma plus COPD), and 7770 patients were included in the FeNO analysis (4166 with asthma, 2588 with COPD, and 1016 with asthma plus COPD).
- Baseline data included demographics, treatments, exacerbations, and lung function (spirometry and FeNO levels).
- Outcomes were assessed over the first year of follow‑up, and patients received usual care from their treating physicians.
- Exacerbation subtypes were categorized as all exacerbations, exacerbations treated with only antibiotics, and exacerbations treated with only OCS.
TAKEAWAY:
- Higher EOS counts at baseline were associated with an increased risk for all exacerbations in asthma (incidence rate ratio [IRR], 1.09; P = .033), meaning each doubling of the count corresponded to a 9% higher exacerbation rate; a similar trend of higher risk was seen in COPD that did not reach statistical significance.
- Higher FeNO levels at baseline were associated with a lower risk for all exacerbations in COPD (IRR, 0.91; P = .025). In asthma, FeNO levels showed no association with an overall risk for exacerbations; in asthma plus COPD, neither biomarker predicted the overall risk.
- In asthma, higher FeNO levels at baseline were linked to increased odds of exacerbations treated with only OCS (odds ratio [OR], 1.16) but decreased odds of exacerbations treated with only antibiotics (OR, 0.75); in asthma plus COPD, higher FeNO levels were also linked to increased odds of exacerbations treated with only OCS (OR, 1.55; P < .05 for all).
- In an analysis including both biomarkers, higher EOS counts at baseline independently predicted all exacerbations in asthma; however, both higher EOS counts and lower FeNO levels were independently associated with a higher risk for all exacerbations in COPD (P < .05 for all).
IN PRACTICE:
“[The study] finding is of importance for future studies and daily clinical practice as it indicates that assessment of exacerbation subtype might improve personalized treatment management,” the authors wrote.
SOURCE:
This study was led by Susan Muiser, University Medical Centre Groningen, Groningen, Netherlands. It was published online on April 21, 2026, in Thorax.
LIMITATIONS:
Diagnoses were assigned by treating physicians without standardized diagnostic criteria. Physicians had access to type 2 inflammation biomarker results, which may have influenced treatment decisions. Exacerbation subtypes were categorized using medical records and patient-reported information, introducing a potential recall bias.
DISCLOSURES:
The NOVELTY study was funded by AstraZeneca. Four authors reported being employees of AstraZeneca, with 2 of them also being shareholders. Several authors disclosed receiving travel grants, research grants, consulting fees, honoraria, and support to attend meetings; serving on advisory boards; and holding stock or stock options with multiple pharmaceutical companies and organizations, including AstraZeneca and WebMD Global.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
A version of this article first appeared on Medscape.com.
TOPLINE:
Higher baseline counts of blood eosinophils (EOS) were associated with an increased risk for exacerbations in patients with asthma over 1 year, and higher baseline levels of fractional exhaled nitric oxide (FeNO) were linked to increased odds of exacerbations treated with only oral corticosteroids (OCS) in asthma and asthma plus chronic obstructive pulmonary disease (COPD) but linked to a decreased risk for all exacerbations in COPD.
METHODOLOGY:
- Researchers analyzed data from the multinational NOVELTY study to assess whether blood EOS counts and FeNO levels, alone and together, predict the risk for future exacerbations in patients with asthma, COPD, or both.
- Overall, 4319 patients were included in the EOS analysis (2138 with asthma, 1541 with COPD, and 640 with asthma plus COPD), and 7770 patients were included in the FeNO analysis (4166 with asthma, 2588 with COPD, and 1016 with asthma plus COPD).
- Baseline data included demographics, treatments, exacerbations, and lung function (spirometry and FeNO levels).
- Outcomes were assessed over the first year of follow‑up, and patients received usual care from their treating physicians.
- Exacerbation subtypes were categorized as all exacerbations, exacerbations treated with only antibiotics, and exacerbations treated with only OCS.
TAKEAWAY:
- Higher EOS counts at baseline were associated with an increased risk for all exacerbations in asthma (incidence rate ratio [IRR], 1.09; P = .033), meaning each doubling of the count corresponded to a 9% higher exacerbation rate; a similar trend of higher risk was seen in COPD that did not reach statistical significance.
- Higher FeNO levels at baseline were associated with a lower risk for all exacerbations in COPD (IRR, 0.91; P = .025). In asthma, FeNO levels showed no association with an overall risk for exacerbations; in asthma plus COPD, neither biomarker predicted the overall risk.
- In asthma, higher FeNO levels at baseline were linked to increased odds of exacerbations treated with only OCS (odds ratio [OR], 1.16) but decreased odds of exacerbations treated with only antibiotics (OR, 0.75); in asthma plus COPD, higher FeNO levels were also linked to increased odds of exacerbations treated with only OCS (OR, 1.55; P < .05 for all).
- In an analysis including both biomarkers, higher EOS counts at baseline independently predicted all exacerbations in asthma; however, both higher EOS counts and lower FeNO levels were independently associated with a higher risk for all exacerbations in COPD (P < .05 for all).
IN PRACTICE:
“[The study] finding is of importance for future studies and daily clinical practice as it indicates that assessment of exacerbation subtype might improve personalized treatment management,” the authors wrote.
SOURCE:
This study was led by Susan Muiser, University Medical Centre Groningen, Groningen, Netherlands. It was published online on April 21, 2026, in Thorax.
LIMITATIONS:
Diagnoses were assigned by treating physicians without standardized diagnostic criteria. Physicians had access to type 2 inflammation biomarker results, which may have influenced treatment decisions. Exacerbation subtypes were categorized using medical records and patient-reported information, introducing a potential recall bias.
DISCLOSURES:
The NOVELTY study was funded by AstraZeneca. Four authors reported being employees of AstraZeneca, with 2 of them also being shareholders. Several authors disclosed receiving travel grants, research grants, consulting fees, honoraria, and support to attend meetings; serving on advisory boards; and holding stock or stock options with multiple pharmaceutical companies and organizations, including AstraZeneca and WebMD Global.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
A version of this article first appeared on Medscape.com.
TOPLINE:
Higher baseline counts of blood eosinophils (EOS) were associated with an increased risk for exacerbations in patients with asthma over 1 year, and higher baseline levels of fractional exhaled nitric oxide (FeNO) were linked to increased odds of exacerbations treated with only oral corticosteroids (OCS) in asthma and asthma plus chronic obstructive pulmonary disease (COPD) but linked to a decreased risk for all exacerbations in COPD.
METHODOLOGY:
- Researchers analyzed data from the multinational NOVELTY study to assess whether blood EOS counts and FeNO levels, alone and together, predict the risk for future exacerbations in patients with asthma, COPD, or both.
- Overall, 4319 patients were included in the EOS analysis (2138 with asthma, 1541 with COPD, and 640 with asthma plus COPD), and 7770 patients were included in the FeNO analysis (4166 with asthma, 2588 with COPD, and 1016 with asthma plus COPD).
- Baseline data included demographics, treatments, exacerbations, and lung function (spirometry and FeNO levels).
- Outcomes were assessed over the first year of follow‑up, and patients received usual care from their treating physicians.
- Exacerbation subtypes were categorized as all exacerbations, exacerbations treated with only antibiotics, and exacerbations treated with only OCS.
TAKEAWAY:
- Higher EOS counts at baseline were associated with an increased risk for all exacerbations in asthma (incidence rate ratio [IRR], 1.09; P = .033), meaning each doubling of the count corresponded to a 9% higher exacerbation rate; a similar trend of higher risk was seen in COPD that did not reach statistical significance.
- Higher FeNO levels at baseline were associated with a lower risk for all exacerbations in COPD (IRR, 0.91; P = .025). In asthma, FeNO levels showed no association with an overall risk for exacerbations; in asthma plus COPD, neither biomarker predicted the overall risk.
- In asthma, higher FeNO levels at baseline were linked to increased odds of exacerbations treated with only OCS (odds ratio [OR], 1.16) but decreased odds of exacerbations treated with only antibiotics (OR, 0.75); in asthma plus COPD, higher FeNO levels were also linked to increased odds of exacerbations treated with only OCS (OR, 1.55; P < .05 for all).
- In an analysis including both biomarkers, higher EOS counts at baseline independently predicted all exacerbations in asthma; however, both higher EOS counts and lower FeNO levels were independently associated with a higher risk for all exacerbations in COPD (P < .05 for all).
IN PRACTICE:
“[The study] finding is of importance for future studies and daily clinical practice as it indicates that assessment of exacerbation subtype might improve personalized treatment management,” the authors wrote.
SOURCE:
This study was led by Susan Muiser, University Medical Centre Groningen, Groningen, Netherlands. It was published online on April 21, 2026, in Thorax.
LIMITATIONS:
Diagnoses were assigned by treating physicians without standardized diagnostic criteria. Physicians had access to type 2 inflammation biomarker results, which may have influenced treatment decisions. Exacerbation subtypes were categorized using medical records and patient-reported information, introducing a potential recall bias.
DISCLOSURES:
The NOVELTY study was funded by AstraZeneca. Four authors reported being employees of AstraZeneca, with 2 of them also being shareholders. Several authors disclosed receiving travel grants, research grants, consulting fees, honoraria, and support to attend meetings; serving on advisory boards; and holding stock or stock options with multiple pharmaceutical companies and organizations, including AstraZeneca and WebMD Global.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
A version of this article first appeared on Medscape.com.
Simple Blood Count May Help Predict Flare-Up Risk in Asthma
Simple Blood Count May Help Predict Flare-Up Risk in Asthma
Don't Ignore Mild Asthma in Children
Don't Ignore Mild Asthma in Children
Mild asthma is not benign. Underdiagnosis in children exposes them to preventable morbidity — including impaired lung growth that can lead to fixed airway obstruction and a higher lifetime risk for chronic obstructive pulmonary disease (COPD), as well as severe exacerbations and increased need for systemic corticosteroids. Experts at the 21st Francophone Allergy Congress 2026 said preserving respiratory function depends on early diagnosis and disease control.
Mild asthma is retrospectively defined as the level of treatment required to achieve and maintain disease control. It corresponds to asthma controlled with a low dose of inhaled corticosteroids or with a combination of inhaled corticosteroids and formoterol as needed (Global Initiative for Asthma(GINA)/French Society of Pediatric Pulmonology and Allergology, steps 1-2).
Mélisande Bourgoin-Heck, MD, PhD, Department of Pediatric Allergology, Armand Trousseau University Hospital, Sorbonne University, AP-HP, Paris, France, emphasized a fundamental distinction: “While control is based on symptoms, exacerbations, activity limitations, and quality of life, severity corresponds to the level of treatment required to achieve this control. The term mild therefore depends on the treatment required and not solely on the frequency or intensity of symptoms.”
How to Identify It?
Clinically, asthma most often presents with wheezing, cough, shortness of breath, and chest tightness, with symptoms that fluctuate in frequency and severity. Nighttime symptoms are common. Symptoms often start or worsen with viral infections, physical exertion (including after exercise), laughter, or exposure to allergens or cold air. “Symptoms are often dismissed as minor and intermittent,” the pediatrician said, “which leads to delayed diagnosis.”
That’s why recognizing risk factors is important because they help guide diagnosis: male sex, a first-degree family history of asthma, exposure to secondhand smoke, prematurity, maternal obesity, living in group settings or having school-aged siblings which raise the risk for early infections, a history of severe bronchiolitis, and an atopic tendency, demonstrated by atopic dermatitis, allergic rhinitis, or sensitization to food and respiratory allergens.
How Much Should We Trust Predictive Scores?
Several clinical scores for predicting asthma exist, notably the Asthma Predictive Index, the modified Asthma Predictive Index, and the Pediatric Asthma Risk Score; the latter demonstrates better overall discrimination, making it useful for children at low-to-moderate risk.
“These scores place significant emphasis on the atopic predisposition,” noted Bourgoin-Heck, “including allergic sensitivities, allergic rhinitis, and atopic dermatitis. Their performance varies by age and clinical phenotype. They are highly specific for the diagnosis of allergic asthma, with a positive score associated with a high risk of asthma. However, their sensitivity is not up to par: A negative score does not rule out the diagnosis, leading to a risk of overlooking nonallergic forms.”
A chest x-ray is used to rule out differential diagnoses. It may be normal or reveal chest distension or bronchial signs. During follow-up, it is only recommended in cases of fever or severe illness to look for complications such as bronchopulmonary superinfection, pneumothorax, pneumomediastinum, subcutaneous emphysema and ventilation disorders/atelectasis.
Normal Spirometry: Could Asthma Really be Ruled Out?
Pulmonary function tests (PFTs) may be normal and do not rule out asthma. Spirometry can be performed around age 6 years and is often normal. “The reversibility test is a diagnostic indicator but may be negative in cases of normal forced expiratory volume in 1 second (FEV1),” warned the specialist.
Provocation tests are useful in cases of doubt.
In children unable to perform a forced exhalation, spirometry is impossible or unreliable, which justifies the use of respiratory resistance measurements (starting at age 3). Several methods are then used: flow-interruption resistance (FIR) identifies bronchial obstruction with an expiratory FIR > 2 Z scores (how many SDs a result is from the predicted value for a child’s age/height/sex). Oscillometry, suitable for young children, is considered pathologic for values exceeding 150% of the predicted value. Plethysmography indicates obstruction with a Raw value > 150% of the predicted value or an sRaw value > 180%.
Interpretation is based on standards adapted to the technique and the study population, with thresholds varying by method (threshold values for PFTs, page e4).
When in Doubt, How Useful Are Biomarkers?
As a biomarker of atopy, a blood eosinophil count of at least 150/mm3 is associated with asthma symptoms and exacerbations. Specific Immunoglobulin E (IgE) indicates allergic sensitization associated with asthma. Finally, elevated fractional concentration of exhaled nitric oxide (> 20-25 parts per billion depending on age) is associated with wheezing, corticosteroid use, and persistent asthma. The combination of atopy markers — including maternal allergy, eczema, wheezing, positive specific IgE levels, and eosinophilia — significantly increases the likelihood of asthma.
“However, when diagnostic uncertainty persists in a child younger than 5 years (absence of atopy; normal PFTs — which is common), a trial of treatment based on initial symptoms may be recommended according to GINA 2025 (Box 10-2),” explained Bourgoin-Heck.
In the presence of mild and intermittent symptoms, a short-acting bronchodilator challenge test on demand is indicated for a maximum duration of 2-3 months. This strategy applies to infrequent wheezing episodes, without the need for emergency care and therefore without any severe exacerbations, with symptoms occurring twice or less per week. Treatment consists of administering two puffs when symptoms occur (to be repeated as needed), with an assessment of improvement within 20-60 minutes. In cases of a history of a severe wheezing episode within the past year (systemic corticosteroids, emergency department visit, and hospitalization) or symptoms more than twice a week, the therapeutic trial involves long-term inhaled corticosteroids (eg, fluticasone 100 µg/d to 250 µg/d) combined with a short-acting bronchodilator as needed for 2-3 months. If the response is favorable, treatment is adjusted to the minimum effective dose.
Monitoring of clinical progress relies on asthma control scores such as the Asthma Control Test, considering both parental perception and the child’s self-assessment. Because the goal in mild asthma is indeed to achieve complete control.
Mild Asthma: Behind the Triviality, Real Risks
Mild childhood asthma is the most common form of asthma. It is by no means benign and carries a risk for exacerbations requiring systemic corticosteroids and potential long-term consequences.
Asthma is often missed — an estimated 20% of children age ≥ 6 years to 70% by age 1 year are not identified — and therefore go untreated, leading to a lower quality of life from attacks and persistent symptoms between episodes that could limit activity and disrupt sleep.
Even seemingly mild asthma is associated with a risk for severe exacerbation, including in patients with infrequent and mild symptoms.
There is also impaired lung growth, with a decrease in peak lung function and the potential for progression to fixed bronchial obstruction, which can lead to COPD. However, it has been shown that early treatment reduces chronic inflammation, limits bronchial remodeling, and prevents the decline in lung function.
In a Danish neonatal cohort 9125 infants, were followed at 1, 3, and 6 years of age and analyzed at 50 years of age via the Danish COPD patient registry, early asthma symptoms were associated with a decrease in FEV1 (-3.36%) and the FEV1/ Forced Vital Capacity ratio (-1.28), as well as an increased risk for a COPD diagnosis in adulthood (odds ratio [OR], 1.96).
Epidemiologic data confirm this: A history of asthma increases the risk of developing COPD by 10-30 times, and a reduced peak FEV1 in early adulthood is associated with an increased risk for early‑onset COPD and greater severity.
“Asthma is associated with a decline in lung function that can begin as early as infancy,” noted the pediatrician, “or even during the prenatal period, persists throughout childhood, continues into adulthood, and predisposes individuals to established bronchial obstruction.”
Early Inhaled Corticosteroids Reduced Exacerbations
In the inhaled steroid treatment as regular therapy in early asthma trial, which enrolled about 7000 adults and children and included a subgroup of 1900 children aged < 11 years with recent-onset mild asthma, inhaled budesonide was compared with placebo. Over 3 years of follow-up, the placebo group showed poorer lung function, whereas those treated with budesonide had improved FEV1 and about a 40% reduction in severe exacerbations. A partial functional “catch-up” was observed when treatment was initiated in the third year.
However, the study does not allow for conclusions regarding the very long-term prevention of functional decline, due to the lack of sufficient follow-up time.
Delayed Treatment Increases Risks
Furthermore, delayed treatment is associated with an increased use of short-acting bronchodilators and systemic corticosteroids, carrying a risk for complications. The specialist warned: “Adverse effects appear after just a few courses of oral corticosteroids, notably an increased risk of fractures (odds ratio, 2.15 for low doses of prednisolone < 70 mg; OR, 3.09 for higher doses > 70 mg). These risks are real and emerge quickly.”
Another study confirms the adverse effects of oral corticosteroid therapy: A cumulative dose of 500 mg to 1000 mg (approximately four to five courses of systemic corticosteroids over a lifetime) already increases the risk. Complications include osteoporosis, diabetes, cataracts, heart failure, and pneumonia. “Cumulative exposure, even intermittent, is associated with increased morbidity, which can be prevented through appropriate management of mild asthma,” she added. “Yet it has been clearly demonstrated that inhaled therapy reduces the need for oral corticosteroids.”
This story was translated from Medscape’s French edition.
A version of this story first appeared on Medscape.com.
Mild asthma is not benign. Underdiagnosis in children exposes them to preventable morbidity — including impaired lung growth that can lead to fixed airway obstruction and a higher lifetime risk for chronic obstructive pulmonary disease (COPD), as well as severe exacerbations and increased need for systemic corticosteroids. Experts at the 21st Francophone Allergy Congress 2026 said preserving respiratory function depends on early diagnosis and disease control.
Mild asthma is retrospectively defined as the level of treatment required to achieve and maintain disease control. It corresponds to asthma controlled with a low dose of inhaled corticosteroids or with a combination of inhaled corticosteroids and formoterol as needed (Global Initiative for Asthma(GINA)/French Society of Pediatric Pulmonology and Allergology, steps 1-2).
Mélisande Bourgoin-Heck, MD, PhD, Department of Pediatric Allergology, Armand Trousseau University Hospital, Sorbonne University, AP-HP, Paris, France, emphasized a fundamental distinction: “While control is based on symptoms, exacerbations, activity limitations, and quality of life, severity corresponds to the level of treatment required to achieve this control. The term mild therefore depends on the treatment required and not solely on the frequency or intensity of symptoms.”
How to Identify It?
Clinically, asthma most often presents with wheezing, cough, shortness of breath, and chest tightness, with symptoms that fluctuate in frequency and severity. Nighttime symptoms are common. Symptoms often start or worsen with viral infections, physical exertion (including after exercise), laughter, or exposure to allergens or cold air. “Symptoms are often dismissed as minor and intermittent,” the pediatrician said, “which leads to delayed diagnosis.”
That’s why recognizing risk factors is important because they help guide diagnosis: male sex, a first-degree family history of asthma, exposure to secondhand smoke, prematurity, maternal obesity, living in group settings or having school-aged siblings which raise the risk for early infections, a history of severe bronchiolitis, and an atopic tendency, demonstrated by atopic dermatitis, allergic rhinitis, or sensitization to food and respiratory allergens.
How Much Should We Trust Predictive Scores?
Several clinical scores for predicting asthma exist, notably the Asthma Predictive Index, the modified Asthma Predictive Index, and the Pediatric Asthma Risk Score; the latter demonstrates better overall discrimination, making it useful for children at low-to-moderate risk.
“These scores place significant emphasis on the atopic predisposition,” noted Bourgoin-Heck, “including allergic sensitivities, allergic rhinitis, and atopic dermatitis. Their performance varies by age and clinical phenotype. They are highly specific for the diagnosis of allergic asthma, with a positive score associated with a high risk of asthma. However, their sensitivity is not up to par: A negative score does not rule out the diagnosis, leading to a risk of overlooking nonallergic forms.”
A chest x-ray is used to rule out differential diagnoses. It may be normal or reveal chest distension or bronchial signs. During follow-up, it is only recommended in cases of fever or severe illness to look for complications such as bronchopulmonary superinfection, pneumothorax, pneumomediastinum, subcutaneous emphysema and ventilation disorders/atelectasis.
Normal Spirometry: Could Asthma Really be Ruled Out?
Pulmonary function tests (PFTs) may be normal and do not rule out asthma. Spirometry can be performed around age 6 years and is often normal. “The reversibility test is a diagnostic indicator but may be negative in cases of normal forced expiratory volume in 1 second (FEV1),” warned the specialist.
Provocation tests are useful in cases of doubt.
In children unable to perform a forced exhalation, spirometry is impossible or unreliable, which justifies the use of respiratory resistance measurements (starting at age 3). Several methods are then used: flow-interruption resistance (FIR) identifies bronchial obstruction with an expiratory FIR > 2 Z scores (how many SDs a result is from the predicted value for a child’s age/height/sex). Oscillometry, suitable for young children, is considered pathologic for values exceeding 150% of the predicted value. Plethysmography indicates obstruction with a Raw value > 150% of the predicted value or an sRaw value > 180%.
Interpretation is based on standards adapted to the technique and the study population, with thresholds varying by method (threshold values for PFTs, page e4).
When in Doubt, How Useful Are Biomarkers?
As a biomarker of atopy, a blood eosinophil count of at least 150/mm3 is associated with asthma symptoms and exacerbations. Specific Immunoglobulin E (IgE) indicates allergic sensitization associated with asthma. Finally, elevated fractional concentration of exhaled nitric oxide (> 20-25 parts per billion depending on age) is associated with wheezing, corticosteroid use, and persistent asthma. The combination of atopy markers — including maternal allergy, eczema, wheezing, positive specific IgE levels, and eosinophilia — significantly increases the likelihood of asthma.
“However, when diagnostic uncertainty persists in a child younger than 5 years (absence of atopy; normal PFTs — which is common), a trial of treatment based on initial symptoms may be recommended according to GINA 2025 (Box 10-2),” explained Bourgoin-Heck.
In the presence of mild and intermittent symptoms, a short-acting bronchodilator challenge test on demand is indicated for a maximum duration of 2-3 months. This strategy applies to infrequent wheezing episodes, without the need for emergency care and therefore without any severe exacerbations, with symptoms occurring twice or less per week. Treatment consists of administering two puffs when symptoms occur (to be repeated as needed), with an assessment of improvement within 20-60 minutes. In cases of a history of a severe wheezing episode within the past year (systemic corticosteroids, emergency department visit, and hospitalization) or symptoms more than twice a week, the therapeutic trial involves long-term inhaled corticosteroids (eg, fluticasone 100 µg/d to 250 µg/d) combined with a short-acting bronchodilator as needed for 2-3 months. If the response is favorable, treatment is adjusted to the minimum effective dose.
Monitoring of clinical progress relies on asthma control scores such as the Asthma Control Test, considering both parental perception and the child’s self-assessment. Because the goal in mild asthma is indeed to achieve complete control.
Mild Asthma: Behind the Triviality, Real Risks
Mild childhood asthma is the most common form of asthma. It is by no means benign and carries a risk for exacerbations requiring systemic corticosteroids and potential long-term consequences.
Asthma is often missed — an estimated 20% of children age ≥ 6 years to 70% by age 1 year are not identified — and therefore go untreated, leading to a lower quality of life from attacks and persistent symptoms between episodes that could limit activity and disrupt sleep.
Even seemingly mild asthma is associated with a risk for severe exacerbation, including in patients with infrequent and mild symptoms.
There is also impaired lung growth, with a decrease in peak lung function and the potential for progression to fixed bronchial obstruction, which can lead to COPD. However, it has been shown that early treatment reduces chronic inflammation, limits bronchial remodeling, and prevents the decline in lung function.
In a Danish neonatal cohort 9125 infants, were followed at 1, 3, and 6 years of age and analyzed at 50 years of age via the Danish COPD patient registry, early asthma symptoms were associated with a decrease in FEV1 (-3.36%) and the FEV1/ Forced Vital Capacity ratio (-1.28), as well as an increased risk for a COPD diagnosis in adulthood (odds ratio [OR], 1.96).
Epidemiologic data confirm this: A history of asthma increases the risk of developing COPD by 10-30 times, and a reduced peak FEV1 in early adulthood is associated with an increased risk for early‑onset COPD and greater severity.
“Asthma is associated with a decline in lung function that can begin as early as infancy,” noted the pediatrician, “or even during the prenatal period, persists throughout childhood, continues into adulthood, and predisposes individuals to established bronchial obstruction.”
Early Inhaled Corticosteroids Reduced Exacerbations
In the inhaled steroid treatment as regular therapy in early asthma trial, which enrolled about 7000 adults and children and included a subgroup of 1900 children aged < 11 years with recent-onset mild asthma, inhaled budesonide was compared with placebo. Over 3 years of follow-up, the placebo group showed poorer lung function, whereas those treated with budesonide had improved FEV1 and about a 40% reduction in severe exacerbations. A partial functional “catch-up” was observed when treatment was initiated in the third year.
However, the study does not allow for conclusions regarding the very long-term prevention of functional decline, due to the lack of sufficient follow-up time.
Delayed Treatment Increases Risks
Furthermore, delayed treatment is associated with an increased use of short-acting bronchodilators and systemic corticosteroids, carrying a risk for complications. The specialist warned: “Adverse effects appear after just a few courses of oral corticosteroids, notably an increased risk of fractures (odds ratio, 2.15 for low doses of prednisolone < 70 mg; OR, 3.09 for higher doses > 70 mg). These risks are real and emerge quickly.”
Another study confirms the adverse effects of oral corticosteroid therapy: A cumulative dose of 500 mg to 1000 mg (approximately four to five courses of systemic corticosteroids over a lifetime) already increases the risk. Complications include osteoporosis, diabetes, cataracts, heart failure, and pneumonia. “Cumulative exposure, even intermittent, is associated with increased morbidity, which can be prevented through appropriate management of mild asthma,” she added. “Yet it has been clearly demonstrated that inhaled therapy reduces the need for oral corticosteroids.”
This story was translated from Medscape’s French edition.
A version of this story first appeared on Medscape.com.
Mild asthma is not benign. Underdiagnosis in children exposes them to preventable morbidity — including impaired lung growth that can lead to fixed airway obstruction and a higher lifetime risk for chronic obstructive pulmonary disease (COPD), as well as severe exacerbations and increased need for systemic corticosteroids. Experts at the 21st Francophone Allergy Congress 2026 said preserving respiratory function depends on early diagnosis and disease control.
Mild asthma is retrospectively defined as the level of treatment required to achieve and maintain disease control. It corresponds to asthma controlled with a low dose of inhaled corticosteroids or with a combination of inhaled corticosteroids and formoterol as needed (Global Initiative for Asthma(GINA)/French Society of Pediatric Pulmonology and Allergology, steps 1-2).
Mélisande Bourgoin-Heck, MD, PhD, Department of Pediatric Allergology, Armand Trousseau University Hospital, Sorbonne University, AP-HP, Paris, France, emphasized a fundamental distinction: “While control is based on symptoms, exacerbations, activity limitations, and quality of life, severity corresponds to the level of treatment required to achieve this control. The term mild therefore depends on the treatment required and not solely on the frequency or intensity of symptoms.”
How to Identify It?
Clinically, asthma most often presents with wheezing, cough, shortness of breath, and chest tightness, with symptoms that fluctuate in frequency and severity. Nighttime symptoms are common. Symptoms often start or worsen with viral infections, physical exertion (including after exercise), laughter, or exposure to allergens or cold air. “Symptoms are often dismissed as minor and intermittent,” the pediatrician said, “which leads to delayed diagnosis.”
That’s why recognizing risk factors is important because they help guide diagnosis: male sex, a first-degree family history of asthma, exposure to secondhand smoke, prematurity, maternal obesity, living in group settings or having school-aged siblings which raise the risk for early infections, a history of severe bronchiolitis, and an atopic tendency, demonstrated by atopic dermatitis, allergic rhinitis, or sensitization to food and respiratory allergens.
How Much Should We Trust Predictive Scores?
Several clinical scores for predicting asthma exist, notably the Asthma Predictive Index, the modified Asthma Predictive Index, and the Pediatric Asthma Risk Score; the latter demonstrates better overall discrimination, making it useful for children at low-to-moderate risk.
“These scores place significant emphasis on the atopic predisposition,” noted Bourgoin-Heck, “including allergic sensitivities, allergic rhinitis, and atopic dermatitis. Their performance varies by age and clinical phenotype. They are highly specific for the diagnosis of allergic asthma, with a positive score associated with a high risk of asthma. However, their sensitivity is not up to par: A negative score does not rule out the diagnosis, leading to a risk of overlooking nonallergic forms.”
A chest x-ray is used to rule out differential diagnoses. It may be normal or reveal chest distension or bronchial signs. During follow-up, it is only recommended in cases of fever or severe illness to look for complications such as bronchopulmonary superinfection, pneumothorax, pneumomediastinum, subcutaneous emphysema and ventilation disorders/atelectasis.
Normal Spirometry: Could Asthma Really be Ruled Out?
Pulmonary function tests (PFTs) may be normal and do not rule out asthma. Spirometry can be performed around age 6 years and is often normal. “The reversibility test is a diagnostic indicator but may be negative in cases of normal forced expiratory volume in 1 second (FEV1),” warned the specialist.
Provocation tests are useful in cases of doubt.
In children unable to perform a forced exhalation, spirometry is impossible or unreliable, which justifies the use of respiratory resistance measurements (starting at age 3). Several methods are then used: flow-interruption resistance (FIR) identifies bronchial obstruction with an expiratory FIR > 2 Z scores (how many SDs a result is from the predicted value for a child’s age/height/sex). Oscillometry, suitable for young children, is considered pathologic for values exceeding 150% of the predicted value. Plethysmography indicates obstruction with a Raw value > 150% of the predicted value or an sRaw value > 180%.
Interpretation is based on standards adapted to the technique and the study population, with thresholds varying by method (threshold values for PFTs, page e4).
When in Doubt, How Useful Are Biomarkers?
As a biomarker of atopy, a blood eosinophil count of at least 150/mm3 is associated with asthma symptoms and exacerbations. Specific Immunoglobulin E (IgE) indicates allergic sensitization associated with asthma. Finally, elevated fractional concentration of exhaled nitric oxide (> 20-25 parts per billion depending on age) is associated with wheezing, corticosteroid use, and persistent asthma. The combination of atopy markers — including maternal allergy, eczema, wheezing, positive specific IgE levels, and eosinophilia — significantly increases the likelihood of asthma.
“However, when diagnostic uncertainty persists in a child younger than 5 years (absence of atopy; normal PFTs — which is common), a trial of treatment based on initial symptoms may be recommended according to GINA 2025 (Box 10-2),” explained Bourgoin-Heck.
In the presence of mild and intermittent symptoms, a short-acting bronchodilator challenge test on demand is indicated for a maximum duration of 2-3 months. This strategy applies to infrequent wheezing episodes, without the need for emergency care and therefore without any severe exacerbations, with symptoms occurring twice or less per week. Treatment consists of administering two puffs when symptoms occur (to be repeated as needed), with an assessment of improvement within 20-60 minutes. In cases of a history of a severe wheezing episode within the past year (systemic corticosteroids, emergency department visit, and hospitalization) or symptoms more than twice a week, the therapeutic trial involves long-term inhaled corticosteroids (eg, fluticasone 100 µg/d to 250 µg/d) combined with a short-acting bronchodilator as needed for 2-3 months. If the response is favorable, treatment is adjusted to the minimum effective dose.
Monitoring of clinical progress relies on asthma control scores such as the Asthma Control Test, considering both parental perception and the child’s self-assessment. Because the goal in mild asthma is indeed to achieve complete control.
Mild Asthma: Behind the Triviality, Real Risks
Mild childhood asthma is the most common form of asthma. It is by no means benign and carries a risk for exacerbations requiring systemic corticosteroids and potential long-term consequences.
Asthma is often missed — an estimated 20% of children age ≥ 6 years to 70% by age 1 year are not identified — and therefore go untreated, leading to a lower quality of life from attacks and persistent symptoms between episodes that could limit activity and disrupt sleep.
Even seemingly mild asthma is associated with a risk for severe exacerbation, including in patients with infrequent and mild symptoms.
There is also impaired lung growth, with a decrease in peak lung function and the potential for progression to fixed bronchial obstruction, which can lead to COPD. However, it has been shown that early treatment reduces chronic inflammation, limits bronchial remodeling, and prevents the decline in lung function.
In a Danish neonatal cohort 9125 infants, were followed at 1, 3, and 6 years of age and analyzed at 50 years of age via the Danish COPD patient registry, early asthma symptoms were associated with a decrease in FEV1 (-3.36%) and the FEV1/ Forced Vital Capacity ratio (-1.28), as well as an increased risk for a COPD diagnosis in adulthood (odds ratio [OR], 1.96).
Epidemiologic data confirm this: A history of asthma increases the risk of developing COPD by 10-30 times, and a reduced peak FEV1 in early adulthood is associated with an increased risk for early‑onset COPD and greater severity.
“Asthma is associated with a decline in lung function that can begin as early as infancy,” noted the pediatrician, “or even during the prenatal period, persists throughout childhood, continues into adulthood, and predisposes individuals to established bronchial obstruction.”
Early Inhaled Corticosteroids Reduced Exacerbations
In the inhaled steroid treatment as regular therapy in early asthma trial, which enrolled about 7000 adults and children and included a subgroup of 1900 children aged < 11 years with recent-onset mild asthma, inhaled budesonide was compared with placebo. Over 3 years of follow-up, the placebo group showed poorer lung function, whereas those treated with budesonide had improved FEV1 and about a 40% reduction in severe exacerbations. A partial functional “catch-up” was observed when treatment was initiated in the third year.
However, the study does not allow for conclusions regarding the very long-term prevention of functional decline, due to the lack of sufficient follow-up time.
Delayed Treatment Increases Risks
Furthermore, delayed treatment is associated with an increased use of short-acting bronchodilators and systemic corticosteroids, carrying a risk for complications. The specialist warned: “Adverse effects appear after just a few courses of oral corticosteroids, notably an increased risk of fractures (odds ratio, 2.15 for low doses of prednisolone < 70 mg; OR, 3.09 for higher doses > 70 mg). These risks are real and emerge quickly.”
Another study confirms the adverse effects of oral corticosteroid therapy: A cumulative dose of 500 mg to 1000 mg (approximately four to five courses of systemic corticosteroids over a lifetime) already increases the risk. Complications include osteoporosis, diabetes, cataracts, heart failure, and pneumonia. “Cumulative exposure, even intermittent, is associated with increased morbidity, which can be prevented through appropriate management of mild asthma,” she added. “Yet it has been clearly demonstrated that inhaled therapy reduces the need for oral corticosteroids.”
This story was translated from Medscape’s French edition.
A version of this story first appeared on Medscape.com.
Don't Ignore Mild Asthma in Children
Don't Ignore Mild Asthma in Children
Screening for Respiratory Diseases in Post-9/11 Veterans
Screening for Respiratory Diseases in Post-9/11 Veterans
TOPLINE:
Military veterans exposed to burn pits during deployment are > 4 times higher risk for persistent cough and 3 times higher risk for dyspnea and wheezing compared with unexposed veterans. Following clinical evaluation, nearly half of veterans received diagnoses of respiratory diseases, including asthma (about 30%), chronic obstructive pulmonary disease (about 13%), and bronchitis (about 12%). Diagnostic uncertainty remains common, with nearly one-third of symptomatic veterans still lacking a specific diagnosis after extensive noninvasive testing.
METHODOLOGY:
- Focused review that proposed an assessment and monitoring strategy for deployed US military veterans with unexplained dyspnea that incorporates multidisciplinary review and patient discussion.
- Analysis included data from the Study of Active Duty Military for Pulmonary Disease Related to Environmental Deployment Exposures (STAMPEDE), which evaluated respiratory symptoms in military personnel within 6 months of returning from Southwest Asia.
- Registry and survey input included Airborne Hazards and Open Burn Pit Registry clinical evaluations in 24,578 veterans in addition to a survey of 479 veterans.
- Biopsy guidance emphasized case-by-case decisions after review; supporting examples include 49 symptomatic veterans undergoing high-resolution computed tomography in STAMPEDE and 38 veterans with biopsy-proven constrictive bronchiolitis, many with normal or near normal pulmonary function tests (PFTs).
TAKEAWAY:
- Veterans with persistent unexplained cough, dyspnea, or chest tightness for > 3 months, reduced exercise tolerance, or abnormal PFTs should be referred to a pulmonary specialist for diagnostic evaluation.
- Among 380 military personnel with chronic respiratory symptoms in STAMPEDE III, 22.9% had diagnoses of asthma, 15.0% had airway hyperreactivity, 10.8% had upper and large airways disorders, and 32.0% did not meet criteria for a specific diagnosis after extensive noninvasive testing.
- Standard testing can miss disease: among 38 veterans with biopsy-proven constrictive bronchiolitis, 19 had normal or near normal PFTs compared with the general population, despite reductions vs a historical asymptomatic military cohort.
- Long-term management centers on follow-up, with proposed PFT monitoring every 6 to 12 months in symptomatic patients even when initial findings are normal.
IN PRACTICE:
“Significant gaps remain in the provision of health care and benefits,” the authors wrote. “The assessment of veterans with suspected lung disease should be comprehensive, involving a thorough medical and exposure history, as well as PFTs and imaging.
SOURCE:
The study was led by Robert M. Tighe, MD, Duke University Medical Center in Durham, North Carolina; Le Roy Torres, Burn Pits 360 in Robstown, Texas; and Robert Miller, Vanderbilt University Medical Center in Nashville, Tennessee. It was published online in Annals of the American Thoracic Society.
LIMITATIONS:
This article synthesizes existing literature and expert recommendations without presenting new primary data or statistical analyses. The review acknowledges that diagnosing deployment-related respiratory disorders can be challenging as symptoms are often nonspecific and may present months or years after deployment with variable latency. The current Post-Deployment Cardiopulmonary Evaluation Network structure does not have the capacity to evaluate the large number of veterans with respiratory disorders and is limited to those who have registered symptoms through the Airborne Hazards and Open Burn Pit Registry.
DISCLOSURES:
Writing support was provided by Julie Fleming and Wendy Morris of Fleishman-Hillard, which was contracted and funded by Boehringer Ingelheim Pharmaceuticals. Boehringer Ingelheim was given the opportunity to review the article for medical and scientific accuracy as well as intellectual property considerations. No disclosures or conflict of interest statements for the individual authors are provided in the study.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
TOPLINE:
Military veterans exposed to burn pits during deployment are > 4 times higher risk for persistent cough and 3 times higher risk for dyspnea and wheezing compared with unexposed veterans. Following clinical evaluation, nearly half of veterans received diagnoses of respiratory diseases, including asthma (about 30%), chronic obstructive pulmonary disease (about 13%), and bronchitis (about 12%). Diagnostic uncertainty remains common, with nearly one-third of symptomatic veterans still lacking a specific diagnosis after extensive noninvasive testing.
METHODOLOGY:
- Focused review that proposed an assessment and monitoring strategy for deployed US military veterans with unexplained dyspnea that incorporates multidisciplinary review and patient discussion.
- Analysis included data from the Study of Active Duty Military for Pulmonary Disease Related to Environmental Deployment Exposures (STAMPEDE), which evaluated respiratory symptoms in military personnel within 6 months of returning from Southwest Asia.
- Registry and survey input included Airborne Hazards and Open Burn Pit Registry clinical evaluations in 24,578 veterans in addition to a survey of 479 veterans.
- Biopsy guidance emphasized case-by-case decisions after review; supporting examples include 49 symptomatic veterans undergoing high-resolution computed tomography in STAMPEDE and 38 veterans with biopsy-proven constrictive bronchiolitis, many with normal or near normal pulmonary function tests (PFTs).
TAKEAWAY:
- Veterans with persistent unexplained cough, dyspnea, or chest tightness for > 3 months, reduced exercise tolerance, or abnormal PFTs should be referred to a pulmonary specialist for diagnostic evaluation.
- Among 380 military personnel with chronic respiratory symptoms in STAMPEDE III, 22.9% had diagnoses of asthma, 15.0% had airway hyperreactivity, 10.8% had upper and large airways disorders, and 32.0% did not meet criteria for a specific diagnosis after extensive noninvasive testing.
- Standard testing can miss disease: among 38 veterans with biopsy-proven constrictive bronchiolitis, 19 had normal or near normal PFTs compared with the general population, despite reductions vs a historical asymptomatic military cohort.
- Long-term management centers on follow-up, with proposed PFT monitoring every 6 to 12 months in symptomatic patients even when initial findings are normal.
IN PRACTICE:
“Significant gaps remain in the provision of health care and benefits,” the authors wrote. “The assessment of veterans with suspected lung disease should be comprehensive, involving a thorough medical and exposure history, as well as PFTs and imaging.
SOURCE:
The study was led by Robert M. Tighe, MD, Duke University Medical Center in Durham, North Carolina; Le Roy Torres, Burn Pits 360 in Robstown, Texas; and Robert Miller, Vanderbilt University Medical Center in Nashville, Tennessee. It was published online in Annals of the American Thoracic Society.
LIMITATIONS:
This article synthesizes existing literature and expert recommendations without presenting new primary data or statistical analyses. The review acknowledges that diagnosing deployment-related respiratory disorders can be challenging as symptoms are often nonspecific and may present months or years after deployment with variable latency. The current Post-Deployment Cardiopulmonary Evaluation Network structure does not have the capacity to evaluate the large number of veterans with respiratory disorders and is limited to those who have registered symptoms through the Airborne Hazards and Open Burn Pit Registry.
DISCLOSURES:
Writing support was provided by Julie Fleming and Wendy Morris of Fleishman-Hillard, which was contracted and funded by Boehringer Ingelheim Pharmaceuticals. Boehringer Ingelheim was given the opportunity to review the article for medical and scientific accuracy as well as intellectual property considerations. No disclosures or conflict of interest statements for the individual authors are provided in the study.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
TOPLINE:
Military veterans exposed to burn pits during deployment are > 4 times higher risk for persistent cough and 3 times higher risk for dyspnea and wheezing compared with unexposed veterans. Following clinical evaluation, nearly half of veterans received diagnoses of respiratory diseases, including asthma (about 30%), chronic obstructive pulmonary disease (about 13%), and bronchitis (about 12%). Diagnostic uncertainty remains common, with nearly one-third of symptomatic veterans still lacking a specific diagnosis after extensive noninvasive testing.
METHODOLOGY:
- Focused review that proposed an assessment and monitoring strategy for deployed US military veterans with unexplained dyspnea that incorporates multidisciplinary review and patient discussion.
- Analysis included data from the Study of Active Duty Military for Pulmonary Disease Related to Environmental Deployment Exposures (STAMPEDE), which evaluated respiratory symptoms in military personnel within 6 months of returning from Southwest Asia.
- Registry and survey input included Airborne Hazards and Open Burn Pit Registry clinical evaluations in 24,578 veterans in addition to a survey of 479 veterans.
- Biopsy guidance emphasized case-by-case decisions after review; supporting examples include 49 symptomatic veterans undergoing high-resolution computed tomography in STAMPEDE and 38 veterans with biopsy-proven constrictive bronchiolitis, many with normal or near normal pulmonary function tests (PFTs).
TAKEAWAY:
- Veterans with persistent unexplained cough, dyspnea, or chest tightness for > 3 months, reduced exercise tolerance, or abnormal PFTs should be referred to a pulmonary specialist for diagnostic evaluation.
- Among 380 military personnel with chronic respiratory symptoms in STAMPEDE III, 22.9% had diagnoses of asthma, 15.0% had airway hyperreactivity, 10.8% had upper and large airways disorders, and 32.0% did not meet criteria for a specific diagnosis after extensive noninvasive testing.
- Standard testing can miss disease: among 38 veterans with biopsy-proven constrictive bronchiolitis, 19 had normal or near normal PFTs compared with the general population, despite reductions vs a historical asymptomatic military cohort.
- Long-term management centers on follow-up, with proposed PFT monitoring every 6 to 12 months in symptomatic patients even when initial findings are normal.
IN PRACTICE:
“Significant gaps remain in the provision of health care and benefits,” the authors wrote. “The assessment of veterans with suspected lung disease should be comprehensive, involving a thorough medical and exposure history, as well as PFTs and imaging.
SOURCE:
The study was led by Robert M. Tighe, MD, Duke University Medical Center in Durham, North Carolina; Le Roy Torres, Burn Pits 360 in Robstown, Texas; and Robert Miller, Vanderbilt University Medical Center in Nashville, Tennessee. It was published online in Annals of the American Thoracic Society.
LIMITATIONS:
This article synthesizes existing literature and expert recommendations without presenting new primary data or statistical analyses. The review acknowledges that diagnosing deployment-related respiratory disorders can be challenging as symptoms are often nonspecific and may present months or years after deployment with variable latency. The current Post-Deployment Cardiopulmonary Evaluation Network structure does not have the capacity to evaluate the large number of veterans with respiratory disorders and is limited to those who have registered symptoms through the Airborne Hazards and Open Burn Pit Registry.
DISCLOSURES:
Writing support was provided by Julie Fleming and Wendy Morris of Fleishman-Hillard, which was contracted and funded by Boehringer Ingelheim Pharmaceuticals. Boehringer Ingelheim was given the opportunity to review the article for medical and scientific accuracy as well as intellectual property considerations. No disclosures or conflict of interest statements for the individual authors are provided in the study.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
Screening for Respiratory Diseases in Post-9/11 Veterans
Screening for Respiratory Diseases in Post-9/11 Veterans
Can Fasting Around Chemo Improve Ovarian Cancer Outcomes?
Can Fasting Around Chemo Improve Ovarian Cancer Outcomes?
A few days of fasting around chemotherapy sessions may improve treatment response and outcomes for some patients with advanced ovarian cancer, a small phase 2 trial suggests.
The study, of 36 patients with stage III or IV high-grade ovarian cancer, found that those randomly assigned to fast for 36 hours before chemotherapy and 24 hours afterward had stronger pathologic responses to chemotherapy and longer progression-free survival than patients who ate normally during treatment.
The findings, reported at a press briefing ahead the American Society of Clinical Oncology (ASCO) 2026, hint at a straightforward measure to potentially improve patients’ outcomes.
The working theory is that short-term fasting boosts chemotherapy response by lowering insulin and IGF-1 levels, both of which are implicated in tumor growth and chemotherapy resistance, said study presenter Claudia Marchetti, MD, of Agostino Gemelli University in Rome, Italy.
Speaking at the briefing, ASCO President Eric Small, MD, of the University of California San Francisco, called the study “a great example of a very simple intervention that has benefit and can be undertaken and implemented anywhere in the world.”
“It’s not an expensive new drug,” he said, “and yet it has the potential to really have an impact on this cancer.”
Ovarian cancer affects more than 324,000 women worldwide each year and causes more than 206,000 deaths annually. Around 80% of patients are diagnosed at an advanced stage, and up to 60% receive neoadjuvant chemotherapy to reduce tumor size and facilitate surgery.
Despite advances in surgery and chemotherapy, patients with advanced disease still face poor outcomes. There is, Marchetti said, “an urgent need for safe, low-cost, and easily implementable strategies that can enhance treatment efficacy and improve patient prognosis.”
Given evidence on the role of insulin in tumor growth and chemotherapy response, her team hypothesized that short bouts of fasting around the time of treatment might have benefits.
To test that idea, the researchers recruited 36 patients with newly diagnosed stage III or IV high-grade serous ovarian carcinoma who were not candidates for primary cytoreduction. All were in good general health, with a mean age of 62 years.
All patients received 3 rounds of carboplatin and paclitaxel before surgery. Prior to starting chemotherapy, half were randomly assigned to fast for 36 hours before and 24 hours after chemotherapy, whereas the other half ate normally throughout treatment.
Patients in the fasting group consumed no more than 350 calories per day during the fasting window. They were allowed to have unrestricted water, herbal tea, limited vegetable juice, and small amounts of light vegetable broth. (A ketogenic diet group had initially been planned but was closed early because of poor patient compliance.)
The study met its primary endpoint of change in insulin levels during chemotherapy, Marchetti reported. Baseline insulin levels were comparable between the 2 groups, but after 3 rounds of chemotherapy, they’d dipped by an average of 1.12 µIU/mL in the fasting group and increased by 9.76 µIU/mL in the control group (P = .01).
Fasting also improved clinical outcomes. Specifically, Marchetti said, 59% of fasting patients achieved a chemotherapy response score of 3 — indicating complete or near-complete tumor response before surgery — compared with 17% of patients in the control group.
Median progression-free survival was significantly longer in the fasting group, at 38 vs 24 months.
Importantly, Marchetti said, the fasting protocol was feasible, well tolerated, and safe: All patients assigned to the fasting group completed treatment, and rates of chemotherapy-related toxicities were similar between the 2 groups.
Additional analyses shed more light on the possible mechanisms underlying the fasting group’s improved outcomes: The researchers found that those patients tended to have lower levels of circulating suppressor granulocyte and monocyte populations that have been linked to tumor immune escape, which suggests, Marchetti said, fasting may have set the stage for a “more favorable immune environment” during chemotherapy.
However, she cautioned that much more research is needed. Her team is planning a larger multicenter trial to validate the current findings, and longer-term follow-up is necessary to see whether fasting ultimately impacts patients’ survival, Marchetti said.
In a statement, Eleonora Teplinsky, MD, an ASCO expert in gynecologic cancers, said these early findings are “encouraging, support earlier data, and highlight a promising area of cancer research.”
But she, too, emphasized the need for larger clinical trials to build on the results.
The study had no commercial funding. Marchetti disclosed having relationships with Arquer Diagnostics, AstraZeneca, Clovis Oncology, and other companies. Small disclosed having relationships with Janssen, Johnson & Johnson, and others. Teplinsky had no disclosures.
A version of this article first appeared on Medscape.com.
A few days of fasting around chemotherapy sessions may improve treatment response and outcomes for some patients with advanced ovarian cancer, a small phase 2 trial suggests.
The study, of 36 patients with stage III or IV high-grade ovarian cancer, found that those randomly assigned to fast for 36 hours before chemotherapy and 24 hours afterward had stronger pathologic responses to chemotherapy and longer progression-free survival than patients who ate normally during treatment.
The findings, reported at a press briefing ahead the American Society of Clinical Oncology (ASCO) 2026, hint at a straightforward measure to potentially improve patients’ outcomes.
The working theory is that short-term fasting boosts chemotherapy response by lowering insulin and IGF-1 levels, both of which are implicated in tumor growth and chemotherapy resistance, said study presenter Claudia Marchetti, MD, of Agostino Gemelli University in Rome, Italy.
Speaking at the briefing, ASCO President Eric Small, MD, of the University of California San Francisco, called the study “a great example of a very simple intervention that has benefit and can be undertaken and implemented anywhere in the world.”
“It’s not an expensive new drug,” he said, “and yet it has the potential to really have an impact on this cancer.”
Ovarian cancer affects more than 324,000 women worldwide each year and causes more than 206,000 deaths annually. Around 80% of patients are diagnosed at an advanced stage, and up to 60% receive neoadjuvant chemotherapy to reduce tumor size and facilitate surgery.
Despite advances in surgery and chemotherapy, patients with advanced disease still face poor outcomes. There is, Marchetti said, “an urgent need for safe, low-cost, and easily implementable strategies that can enhance treatment efficacy and improve patient prognosis.”
Given evidence on the role of insulin in tumor growth and chemotherapy response, her team hypothesized that short bouts of fasting around the time of treatment might have benefits.
To test that idea, the researchers recruited 36 patients with newly diagnosed stage III or IV high-grade serous ovarian carcinoma who were not candidates for primary cytoreduction. All were in good general health, with a mean age of 62 years.
All patients received 3 rounds of carboplatin and paclitaxel before surgery. Prior to starting chemotherapy, half were randomly assigned to fast for 36 hours before and 24 hours after chemotherapy, whereas the other half ate normally throughout treatment.
Patients in the fasting group consumed no more than 350 calories per day during the fasting window. They were allowed to have unrestricted water, herbal tea, limited vegetable juice, and small amounts of light vegetable broth. (A ketogenic diet group had initially been planned but was closed early because of poor patient compliance.)
The study met its primary endpoint of change in insulin levels during chemotherapy, Marchetti reported. Baseline insulin levels were comparable between the 2 groups, but after 3 rounds of chemotherapy, they’d dipped by an average of 1.12 µIU/mL in the fasting group and increased by 9.76 µIU/mL in the control group (P = .01).
Fasting also improved clinical outcomes. Specifically, Marchetti said, 59% of fasting patients achieved a chemotherapy response score of 3 — indicating complete or near-complete tumor response before surgery — compared with 17% of patients in the control group.
Median progression-free survival was significantly longer in the fasting group, at 38 vs 24 months.
Importantly, Marchetti said, the fasting protocol was feasible, well tolerated, and safe: All patients assigned to the fasting group completed treatment, and rates of chemotherapy-related toxicities were similar between the 2 groups.
Additional analyses shed more light on the possible mechanisms underlying the fasting group’s improved outcomes: The researchers found that those patients tended to have lower levels of circulating suppressor granulocyte and monocyte populations that have been linked to tumor immune escape, which suggests, Marchetti said, fasting may have set the stage for a “more favorable immune environment” during chemotherapy.
However, she cautioned that much more research is needed. Her team is planning a larger multicenter trial to validate the current findings, and longer-term follow-up is necessary to see whether fasting ultimately impacts patients’ survival, Marchetti said.
In a statement, Eleonora Teplinsky, MD, an ASCO expert in gynecologic cancers, said these early findings are “encouraging, support earlier data, and highlight a promising area of cancer research.”
But she, too, emphasized the need for larger clinical trials to build on the results.
The study had no commercial funding. Marchetti disclosed having relationships with Arquer Diagnostics, AstraZeneca, Clovis Oncology, and other companies. Small disclosed having relationships with Janssen, Johnson & Johnson, and others. Teplinsky had no disclosures.
A version of this article first appeared on Medscape.com.
A few days of fasting around chemotherapy sessions may improve treatment response and outcomes for some patients with advanced ovarian cancer, a small phase 2 trial suggests.
The study, of 36 patients with stage III or IV high-grade ovarian cancer, found that those randomly assigned to fast for 36 hours before chemotherapy and 24 hours afterward had stronger pathologic responses to chemotherapy and longer progression-free survival than patients who ate normally during treatment.
The findings, reported at a press briefing ahead the American Society of Clinical Oncology (ASCO) 2026, hint at a straightforward measure to potentially improve patients’ outcomes.
The working theory is that short-term fasting boosts chemotherapy response by lowering insulin and IGF-1 levels, both of which are implicated in tumor growth and chemotherapy resistance, said study presenter Claudia Marchetti, MD, of Agostino Gemelli University in Rome, Italy.
Speaking at the briefing, ASCO President Eric Small, MD, of the University of California San Francisco, called the study “a great example of a very simple intervention that has benefit and can be undertaken and implemented anywhere in the world.”
“It’s not an expensive new drug,” he said, “and yet it has the potential to really have an impact on this cancer.”
Ovarian cancer affects more than 324,000 women worldwide each year and causes more than 206,000 deaths annually. Around 80% of patients are diagnosed at an advanced stage, and up to 60% receive neoadjuvant chemotherapy to reduce tumor size and facilitate surgery.
Despite advances in surgery and chemotherapy, patients with advanced disease still face poor outcomes. There is, Marchetti said, “an urgent need for safe, low-cost, and easily implementable strategies that can enhance treatment efficacy and improve patient prognosis.”
Given evidence on the role of insulin in tumor growth and chemotherapy response, her team hypothesized that short bouts of fasting around the time of treatment might have benefits.
To test that idea, the researchers recruited 36 patients with newly diagnosed stage III or IV high-grade serous ovarian carcinoma who were not candidates for primary cytoreduction. All were in good general health, with a mean age of 62 years.
All patients received 3 rounds of carboplatin and paclitaxel before surgery. Prior to starting chemotherapy, half were randomly assigned to fast for 36 hours before and 24 hours after chemotherapy, whereas the other half ate normally throughout treatment.
Patients in the fasting group consumed no more than 350 calories per day during the fasting window. They were allowed to have unrestricted water, herbal tea, limited vegetable juice, and small amounts of light vegetable broth. (A ketogenic diet group had initially been planned but was closed early because of poor patient compliance.)
The study met its primary endpoint of change in insulin levels during chemotherapy, Marchetti reported. Baseline insulin levels were comparable between the 2 groups, but after 3 rounds of chemotherapy, they’d dipped by an average of 1.12 µIU/mL in the fasting group and increased by 9.76 µIU/mL in the control group (P = .01).
Fasting also improved clinical outcomes. Specifically, Marchetti said, 59% of fasting patients achieved a chemotherapy response score of 3 — indicating complete or near-complete tumor response before surgery — compared with 17% of patients in the control group.
Median progression-free survival was significantly longer in the fasting group, at 38 vs 24 months.
Importantly, Marchetti said, the fasting protocol was feasible, well tolerated, and safe: All patients assigned to the fasting group completed treatment, and rates of chemotherapy-related toxicities were similar between the 2 groups.
Additional analyses shed more light on the possible mechanisms underlying the fasting group’s improved outcomes: The researchers found that those patients tended to have lower levels of circulating suppressor granulocyte and monocyte populations that have been linked to tumor immune escape, which suggests, Marchetti said, fasting may have set the stage for a “more favorable immune environment” during chemotherapy.
However, she cautioned that much more research is needed. Her team is planning a larger multicenter trial to validate the current findings, and longer-term follow-up is necessary to see whether fasting ultimately impacts patients’ survival, Marchetti said.
In a statement, Eleonora Teplinsky, MD, an ASCO expert in gynecologic cancers, said these early findings are “encouraging, support earlier data, and highlight a promising area of cancer research.”
But she, too, emphasized the need for larger clinical trials to build on the results.
The study had no commercial funding. Marchetti disclosed having relationships with Arquer Diagnostics, AstraZeneca, Clovis Oncology, and other companies. Small disclosed having relationships with Janssen, Johnson & Johnson, and others. Teplinsky had no disclosures.
A version of this article first appeared on Medscape.com.
Can Fasting Around Chemo Improve Ovarian Cancer Outcomes?
Can Fasting Around Chemo Improve Ovarian Cancer Outcomes?
Nurse Practitioner-Led Outreach Boosts Cancer Screening Rates Among Women Veterans in Rural Settings
Nurse Practitioner-Led Outreach Boosts Cancer Screening Rates Among Women Veterans in Rural Settings
TOPLINE:
Telephone outreach by a nurse practitioner (NP) providing counseling and care coordination reduced the gaps in breast and cervical cancer screenings among women veterans in rural areas, according to a retrospective study.
METHODOLOGY:
- Researchers conducted a retrospective chart review of 55 women veterans who received interventions related to breast or cervical cancer screening at a rural Veterans Health Administration health care system.
- A Boost team, including an NP, a medical director, a program coordinator, and a program evaluation team, was established to provide care coordination and counseling for these participants.
- The NP conducted outreach by telephone to these participants receiving care at five community-based outpatient clinics located in rural counties and helped coordinate access to screening appointments through the Office of Community Care.
- Outcomes included the number of veterans due for breast or cervical cancer screening at the time of outreach and the number of mammograms and Pap smears completed in the 12-month period following the intervention.
TAKEAWAY:
- Of the 55 veterans who received Boost interventions related to cancer screening, 35 (64%) were due for breast cancer screening and 27 (49%) were due for cervical cancer screening before the intervention.
- Following the Boost intervention, the number of veterans due for breast cancer and cervical cancer screenings decreased to 18 (32%) and 16 (29%), respectively.
- Among veterans due for breast cancer screening, 29 (83%) received counseling regarding screening and 17 (59%) of counseled participants completed mammography; however, among those due for cervical cancer screening, 22 (81%) received counseling and 11 (50%) completed screening.
- None of the veterans who were due for screening but did not receive counseling completed their screening, demonstrating the critical role of clinician-provided education and counseling.
IN PRACTICE:
“We hope to expand Boost outreach from one NP working part-time across two health systems to a national partnership of licensed independent providers conducting clinician-initiated outreach to a broader and geographically more diverse group of veterans,” the authors wrote.
SOURCE:
This study was led by Lina Vadlamani, MD, MBA, San Francisco Internal Medicine Residency Program, University of California, San Francisco. It was published online on April 24, 2026, in Military Medicine.
LIMITATIONS:
This study was a secondary analysis in which participants were not randomly assigned, limiting causal inferences. Veterans who answered the phone and engaged with the NP were likely easier to reach and potentially more proactive about their health than those who did not engage, and this selection bias may have limited the generalizability of the findings.
DISCLOSURES:
This study was funded by the Department of Veterans Affairs, Veterans Health Administration, and Office of Rural Health. The authors reported having no relevant conflicts of interest.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
A version of this article first appeared on Medscape.com.
TOPLINE:
Telephone outreach by a nurse practitioner (NP) providing counseling and care coordination reduced the gaps in breast and cervical cancer screenings among women veterans in rural areas, according to a retrospective study.
METHODOLOGY:
- Researchers conducted a retrospective chart review of 55 women veterans who received interventions related to breast or cervical cancer screening at a rural Veterans Health Administration health care system.
- A Boost team, including an NP, a medical director, a program coordinator, and a program evaluation team, was established to provide care coordination and counseling for these participants.
- The NP conducted outreach by telephone to these participants receiving care at five community-based outpatient clinics located in rural counties and helped coordinate access to screening appointments through the Office of Community Care.
- Outcomes included the number of veterans due for breast or cervical cancer screening at the time of outreach and the number of mammograms and Pap smears completed in the 12-month period following the intervention.
TAKEAWAY:
- Of the 55 veterans who received Boost interventions related to cancer screening, 35 (64%) were due for breast cancer screening and 27 (49%) were due for cervical cancer screening before the intervention.
- Following the Boost intervention, the number of veterans due for breast cancer and cervical cancer screenings decreased to 18 (32%) and 16 (29%), respectively.
- Among veterans due for breast cancer screening, 29 (83%) received counseling regarding screening and 17 (59%) of counseled participants completed mammography; however, among those due for cervical cancer screening, 22 (81%) received counseling and 11 (50%) completed screening.
- None of the veterans who were due for screening but did not receive counseling completed their screening, demonstrating the critical role of clinician-provided education and counseling.
IN PRACTICE:
“We hope to expand Boost outreach from one NP working part-time across two health systems to a national partnership of licensed independent providers conducting clinician-initiated outreach to a broader and geographically more diverse group of veterans,” the authors wrote.
SOURCE:
This study was led by Lina Vadlamani, MD, MBA, San Francisco Internal Medicine Residency Program, University of California, San Francisco. It was published online on April 24, 2026, in Military Medicine.
LIMITATIONS:
This study was a secondary analysis in which participants were not randomly assigned, limiting causal inferences. Veterans who answered the phone and engaged with the NP were likely easier to reach and potentially more proactive about their health than those who did not engage, and this selection bias may have limited the generalizability of the findings.
DISCLOSURES:
This study was funded by the Department of Veterans Affairs, Veterans Health Administration, and Office of Rural Health. The authors reported having no relevant conflicts of interest.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
A version of this article first appeared on Medscape.com.
TOPLINE:
Telephone outreach by a nurse practitioner (NP) providing counseling and care coordination reduced the gaps in breast and cervical cancer screenings among women veterans in rural areas, according to a retrospective study.
METHODOLOGY:
- Researchers conducted a retrospective chart review of 55 women veterans who received interventions related to breast or cervical cancer screening at a rural Veterans Health Administration health care system.
- A Boost team, including an NP, a medical director, a program coordinator, and a program evaluation team, was established to provide care coordination and counseling for these participants.
- The NP conducted outreach by telephone to these participants receiving care at five community-based outpatient clinics located in rural counties and helped coordinate access to screening appointments through the Office of Community Care.
- Outcomes included the number of veterans due for breast or cervical cancer screening at the time of outreach and the number of mammograms and Pap smears completed in the 12-month period following the intervention.
TAKEAWAY:
- Of the 55 veterans who received Boost interventions related to cancer screening, 35 (64%) were due for breast cancer screening and 27 (49%) were due for cervical cancer screening before the intervention.
- Following the Boost intervention, the number of veterans due for breast cancer and cervical cancer screenings decreased to 18 (32%) and 16 (29%), respectively.
- Among veterans due for breast cancer screening, 29 (83%) received counseling regarding screening and 17 (59%) of counseled participants completed mammography; however, among those due for cervical cancer screening, 22 (81%) received counseling and 11 (50%) completed screening.
- None of the veterans who were due for screening but did not receive counseling completed their screening, demonstrating the critical role of clinician-provided education and counseling.
IN PRACTICE:
“We hope to expand Boost outreach from one NP working part-time across two health systems to a national partnership of licensed independent providers conducting clinician-initiated outreach to a broader and geographically more diverse group of veterans,” the authors wrote.
SOURCE:
This study was led by Lina Vadlamani, MD, MBA, San Francisco Internal Medicine Residency Program, University of California, San Francisco. It was published online on April 24, 2026, in Military Medicine.
LIMITATIONS:
This study was a secondary analysis in which participants were not randomly assigned, limiting causal inferences. Veterans who answered the phone and engaged with the NP were likely easier to reach and potentially more proactive about their health than those who did not engage, and this selection bias may have limited the generalizability of the findings.
DISCLOSURES:
This study was funded by the Department of Veterans Affairs, Veterans Health Administration, and Office of Rural Health. The authors reported having no relevant conflicts of interest.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
A version of this article first appeared on Medscape.com.
Nurse Practitioner-Led Outreach Boosts Cancer Screening Rates Among Women Veterans in Rural Settings
Nurse Practitioner-Led Outreach Boosts Cancer Screening Rates Among Women Veterans in Rural Settings
Veterans With COPD Improve After 12-Week Telehealth Rehab
TOPLINE: Veterans with chronic obstructive pulmonary disease (COPD) who had follow-up outcome data after completing a 12-week telehealth pulmonary rehabilitation program had improved functional capacity, with 6-minute walk distance increasing by 41.3 m (15.7%) and quality-of-life scores improving by 27.9% to 42.7%. The virtual program had an 86% completion rate, suggesting telehealth rehabilitation may be a feasible alternative to traditional in-person programs.
METHODOLOGY:
A 12-week single-arm cohort intervention evaluated effectiveness, acceptability, and feasibility of in-home, supervised telehealth pulmonary rehabilitation delivered via US Department of Veterans Affairs (VA) Video Connect in Houston, Texas.
Participants included 51 veterans with COPD aged ≥ 18 years and referred to the program; exclusions included mobility-limiting surgery, neurologic disease impairing walking, likely nonadherence, or unwillingness to consent.
Intervention consisted of 1 session weekly for about 120 minutes led by a licensed physical therapist and respiratory therapist, with home monitoring of blood pressure, heart rate, SpO₂, respiratory rate, and exertion.
In-person outcome assessments occurred at baseline and 12 weeks; the primary outcome was the 6-minute walk test, and secondary outcomes included Timed Up & Go test, Five Times Sit-to-Stand test, and quality of life via the St. George’s Respiratory Questionnaire and COPD Assessment Test.
TAKEAWAY:
Functional capacity improved significantly with a mean increase of 41.3 m in 6-minute walk distance, a 15.7% improvement (P < .001; d = 0.76), surpassing the minimal clinically important difference of 25 m for patients with COPD.
COPD-affected quality of life improved, with St. George’s Respiratory Questionnaire scores decreasing by 18.2 points, a 27.9% improvement (P < .001), and COPD Assessment Test scores decreasing by 12.1 points, a 42.7% improvement (P < .001).
Functional mobility and lower-body strength also improved, with Timed Up and Go test completion time decreasing by 1.2 seconds (9.9% faster; P = .02) and Five Times Sit-to-Stand test time improving by 1.2 seconds (9.0% faster; P = .02).
Program retention was high, with 44 of 51 participants (86.3%) completing the full intervention. When excluding COVID-19 pandemic–related dropouts, the retention rate increased to 90.2%
IN PRACTICE: “Our study not only highlights the effectiveness of pulmonary rehabilitation in improving the functional performance of COPD patients but also emphasizes the potential use of telehealth-rehabilitation as a viable alternative to traditional in-clinic programs,” the authors wrote.
SOURCE:The study’s first author was Abderrahman Ouattas, Interdisciplinary Consortium on Advanced Motion Performance, Michael E. DeBakey VA Medical Center, Baylor College of Medicine in Houston. It was published online in Scientific Reports.
LIMITATIONS: According to the authors, the study lacked a control group and included predominantly male participants, which may limit generalizability. The modest sample size and insufficient exploration of potential confounding factors further constrain the generalizability of findings. Additionally, the study was limited to veterans living within 80 miles of Houston, creating an unusual proximity requirement for telehealth programs that could introduce selection bias. The researchers noted that actively recruiting during the COVID-19 pandemic presented unforeseen challenges, and the absence of remote biomechanical data collection may have limited the ability to monitor rehabilitation progress and make necessary adjustments.
DISCLOSURES: The authors report no commercial or financial relationships that could be construed as potential conflicts of interest. No specific funding sources or financial disclosures were mentioned.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
TOPLINE: Veterans with chronic obstructive pulmonary disease (COPD) who had follow-up outcome data after completing a 12-week telehealth pulmonary rehabilitation program had improved functional capacity, with 6-minute walk distance increasing by 41.3 m (15.7%) and quality-of-life scores improving by 27.9% to 42.7%. The virtual program had an 86% completion rate, suggesting telehealth rehabilitation may be a feasible alternative to traditional in-person programs.
METHODOLOGY:
A 12-week single-arm cohort intervention evaluated effectiveness, acceptability, and feasibility of in-home, supervised telehealth pulmonary rehabilitation delivered via US Department of Veterans Affairs (VA) Video Connect in Houston, Texas.
Participants included 51 veterans with COPD aged ≥ 18 years and referred to the program; exclusions included mobility-limiting surgery, neurologic disease impairing walking, likely nonadherence, or unwillingness to consent.
Intervention consisted of 1 session weekly for about 120 minutes led by a licensed physical therapist and respiratory therapist, with home monitoring of blood pressure, heart rate, SpO₂, respiratory rate, and exertion.
In-person outcome assessments occurred at baseline and 12 weeks; the primary outcome was the 6-minute walk test, and secondary outcomes included Timed Up & Go test, Five Times Sit-to-Stand test, and quality of life via the St. George’s Respiratory Questionnaire and COPD Assessment Test.
TAKEAWAY:
Functional capacity improved significantly with a mean increase of 41.3 m in 6-minute walk distance, a 15.7% improvement (P < .001; d = 0.76), surpassing the minimal clinically important difference of 25 m for patients with COPD.
COPD-affected quality of life improved, with St. George’s Respiratory Questionnaire scores decreasing by 18.2 points, a 27.9% improvement (P < .001), and COPD Assessment Test scores decreasing by 12.1 points, a 42.7% improvement (P < .001).
Functional mobility and lower-body strength also improved, with Timed Up and Go test completion time decreasing by 1.2 seconds (9.9% faster; P = .02) and Five Times Sit-to-Stand test time improving by 1.2 seconds (9.0% faster; P = .02).
Program retention was high, with 44 of 51 participants (86.3%) completing the full intervention. When excluding COVID-19 pandemic–related dropouts, the retention rate increased to 90.2%
IN PRACTICE: “Our study not only highlights the effectiveness of pulmonary rehabilitation in improving the functional performance of COPD patients but also emphasizes the potential use of telehealth-rehabilitation as a viable alternative to traditional in-clinic programs,” the authors wrote.
SOURCE:The study’s first author was Abderrahman Ouattas, Interdisciplinary Consortium on Advanced Motion Performance, Michael E. DeBakey VA Medical Center, Baylor College of Medicine in Houston. It was published online in Scientific Reports.
LIMITATIONS: According to the authors, the study lacked a control group and included predominantly male participants, which may limit generalizability. The modest sample size and insufficient exploration of potential confounding factors further constrain the generalizability of findings. Additionally, the study was limited to veterans living within 80 miles of Houston, creating an unusual proximity requirement for telehealth programs that could introduce selection bias. The researchers noted that actively recruiting during the COVID-19 pandemic presented unforeseen challenges, and the absence of remote biomechanical data collection may have limited the ability to monitor rehabilitation progress and make necessary adjustments.
DISCLOSURES: The authors report no commercial or financial relationships that could be construed as potential conflicts of interest. No specific funding sources or financial disclosures were mentioned.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
TOPLINE: Veterans with chronic obstructive pulmonary disease (COPD) who had follow-up outcome data after completing a 12-week telehealth pulmonary rehabilitation program had improved functional capacity, with 6-minute walk distance increasing by 41.3 m (15.7%) and quality-of-life scores improving by 27.9% to 42.7%. The virtual program had an 86% completion rate, suggesting telehealth rehabilitation may be a feasible alternative to traditional in-person programs.
METHODOLOGY:
A 12-week single-arm cohort intervention evaluated effectiveness, acceptability, and feasibility of in-home, supervised telehealth pulmonary rehabilitation delivered via US Department of Veterans Affairs (VA) Video Connect in Houston, Texas.
Participants included 51 veterans with COPD aged ≥ 18 years and referred to the program; exclusions included mobility-limiting surgery, neurologic disease impairing walking, likely nonadherence, or unwillingness to consent.
Intervention consisted of 1 session weekly for about 120 minutes led by a licensed physical therapist and respiratory therapist, with home monitoring of blood pressure, heart rate, SpO₂, respiratory rate, and exertion.
In-person outcome assessments occurred at baseline and 12 weeks; the primary outcome was the 6-minute walk test, and secondary outcomes included Timed Up & Go test, Five Times Sit-to-Stand test, and quality of life via the St. George’s Respiratory Questionnaire and COPD Assessment Test.
TAKEAWAY:
Functional capacity improved significantly with a mean increase of 41.3 m in 6-minute walk distance, a 15.7% improvement (P < .001; d = 0.76), surpassing the minimal clinically important difference of 25 m for patients with COPD.
COPD-affected quality of life improved, with St. George’s Respiratory Questionnaire scores decreasing by 18.2 points, a 27.9% improvement (P < .001), and COPD Assessment Test scores decreasing by 12.1 points, a 42.7% improvement (P < .001).
Functional mobility and lower-body strength also improved, with Timed Up and Go test completion time decreasing by 1.2 seconds (9.9% faster; P = .02) and Five Times Sit-to-Stand test time improving by 1.2 seconds (9.0% faster; P = .02).
Program retention was high, with 44 of 51 participants (86.3%) completing the full intervention. When excluding COVID-19 pandemic–related dropouts, the retention rate increased to 90.2%
IN PRACTICE: “Our study not only highlights the effectiveness of pulmonary rehabilitation in improving the functional performance of COPD patients but also emphasizes the potential use of telehealth-rehabilitation as a viable alternative to traditional in-clinic programs,” the authors wrote.
SOURCE:The study’s first author was Abderrahman Ouattas, Interdisciplinary Consortium on Advanced Motion Performance, Michael E. DeBakey VA Medical Center, Baylor College of Medicine in Houston. It was published online in Scientific Reports.
LIMITATIONS: According to the authors, the study lacked a control group and included predominantly male participants, which may limit generalizability. The modest sample size and insufficient exploration of potential confounding factors further constrain the generalizability of findings. Additionally, the study was limited to veterans living within 80 miles of Houston, creating an unusual proximity requirement for telehealth programs that could introduce selection bias. The researchers noted that actively recruiting during the COVID-19 pandemic presented unforeseen challenges, and the absence of remote biomechanical data collection may have limited the ability to monitor rehabilitation progress and make necessary adjustments.
DISCLOSURES: The authors report no commercial or financial relationships that could be construed as potential conflicts of interest. No specific funding sources or financial disclosures were mentioned.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
Hospital Ownership Status Affects Pulmonary Outcomes
Hospital Ownership Status Affects Pulmonary Outcomes
Patients treated for chronic obstructive pulmonary disease (COPD) or pneumonia experienced worse outcomes when treated at hospitals acquired by private equity firms, based on data from a new study presented at the American Thoracic Society (ATS) 2026 International Conference.
“Previous studies have linked private equity acquisition of hospitals to worse patient experiences and higher rates of hospital-acquired adverse events, such as falls, although findings for specific medical conditions have been more variable,” according to lead author Stephen Mein, MD, a pulmonologist at Beth Israel Deaconess Medical Center in Boston.
“We wanted to understand whether private equity acquisitions impacted outcomes for patients hospitalized with COPD and pneumonia because these conditions are among the most common reasons for hospitalization and they are widely included in measures of hospital care quality,” he said.
Mein and colleagues reviewed data from Medicare fee-for-service claims data from 41 private equity hospitals and 192 matched control hospitals between 2010 and 2019, including 146,904 COPD visits and 194,993 pneumonia visits.
The study population was Medicare beneficiaries aged 65 years or older who had at least one hospital encounter (defined as observation stay or inpatient admission) for asthma, COPD, or pneumonia. The clinical outcomes were in-hospital mortality, 30-day mortality, and 30-day hospital revisit rates. The researchers compared changes in outcomes across 3 years before and after acquisition in a linear regression analysis. Models adjusted for patient age, sex, race and ethnicity, clinical risk score, and dual eligibility status.
Overall, no changes in patient age, sex, clinical risk scores or dual-eligibility status across all conditions at private equity hospitals were noted compared with control hospitals. However, 30-day hospital revisits among patients with asthma increased significantly at private equity hospitals compared to control hospitals (difference-in-differences, + 8.3 percentage points; 95% CI, 4.0-12.7). No significant changes were noted for in-hospital mortality or 30-day mortality.
Similarly, 30-day hospital revisits were significantly higher for patients with COPD at private equity hospitals than at control hospitals (+ 0.9 percentage points; 95% CI, 0.1-1.6). Patients with pneumonia had an increased in-hospital mortality at private equity hospitals compared with control hospitals (+ 0.7 percentage points; 95% CI, 0.2-1.2), with no differences in 30-day mortality or revisits.
The findings that patients treated for COPD at private equity-acquired hospitals more often returned to the hospital within 30 days after hospital discharge and that patients with pneumonia were more likely to die during their hospital stay were surprising, Mein noted. “The 1-percentage-point increase in deaths among patients with pneumonia is especially concerning as the baseline in-hospital mortality rate for this condition was only 3%-4%,” he said.
“Our findings add to growing concerns around the potential negative effects of private equity ownership in healthcare and highlight the need for stronger oversight of these acquisitions to help protect our patients, and the results have implications for many patients as private equity acquisitions of US hospitals are becoming more common,” Mein said.
The findings were limited by the focus on older adults with Medicare insurance, and may not be generalizable to other patient populations, said Mein. “In addition, we were unable to account for differences in private equity firm practices or identify potential heterogeneity in outcomes across hospitals acquired by different private equity firms,” he said. More research is needed to understand the factors contributing to worse outcomes at private equity-acquired hospitals in the current study and other published work, Mein added.
Vigilance is Needed to Optimize Outcomes
“Given the rapid increase in acquisitions of US hospitals by private equity firms, it is important to evaluate how these acquisitions affect patient health outcomes,” said Arianne K. Baldomero, MD, MS, a pulmonologist, critical care physician, and assistant professor of medicine at the University of Minnesota, Minneapolis.
“The worse outcomes observed among patients hospitalized in privately acquired hospitals were not entirely unexpected,” said Baldomero, who was not involved in the study. “Although not explicitly stated in the abstract, these acquisitions may involve cost-containment strategies, such as potential reductions in staffing. particularly nursing and support staff, changes in supply chain management, or the scaling back of less profitable services, which likely contribute to worse patient outcomes,” she said.
More research is needed to identify the potential etiologies driving these differences in outcomes, which would help inform strategies for improvement, said Baldomero. However, the results of the new study suggest that clinicians managing patients discharged from acquired hospitals should be vigilant about discharge planning, transitions, and follow-up to mitigate poor health outcomes, she said.
The study received no outside funding. The researchers and Baldomero had no financial conflicts to disclose.
A version of this article first appeared on Medscape.com.
Patients treated for chronic obstructive pulmonary disease (COPD) or pneumonia experienced worse outcomes when treated at hospitals acquired by private equity firms, based on data from a new study presented at the American Thoracic Society (ATS) 2026 International Conference.
“Previous studies have linked private equity acquisition of hospitals to worse patient experiences and higher rates of hospital-acquired adverse events, such as falls, although findings for specific medical conditions have been more variable,” according to lead author Stephen Mein, MD, a pulmonologist at Beth Israel Deaconess Medical Center in Boston.
“We wanted to understand whether private equity acquisitions impacted outcomes for patients hospitalized with COPD and pneumonia because these conditions are among the most common reasons for hospitalization and they are widely included in measures of hospital care quality,” he said.
Mein and colleagues reviewed data from Medicare fee-for-service claims data from 41 private equity hospitals and 192 matched control hospitals between 2010 and 2019, including 146,904 COPD visits and 194,993 pneumonia visits.
The study population was Medicare beneficiaries aged 65 years or older who had at least one hospital encounter (defined as observation stay or inpatient admission) for asthma, COPD, or pneumonia. The clinical outcomes were in-hospital mortality, 30-day mortality, and 30-day hospital revisit rates. The researchers compared changes in outcomes across 3 years before and after acquisition in a linear regression analysis. Models adjusted for patient age, sex, race and ethnicity, clinical risk score, and dual eligibility status.
Overall, no changes in patient age, sex, clinical risk scores or dual-eligibility status across all conditions at private equity hospitals were noted compared with control hospitals. However, 30-day hospital revisits among patients with asthma increased significantly at private equity hospitals compared to control hospitals (difference-in-differences, + 8.3 percentage points; 95% CI, 4.0-12.7). No significant changes were noted for in-hospital mortality or 30-day mortality.
Similarly, 30-day hospital revisits were significantly higher for patients with COPD at private equity hospitals than at control hospitals (+ 0.9 percentage points; 95% CI, 0.1-1.6). Patients with pneumonia had an increased in-hospital mortality at private equity hospitals compared with control hospitals (+ 0.7 percentage points; 95% CI, 0.2-1.2), with no differences in 30-day mortality or revisits.
The findings that patients treated for COPD at private equity-acquired hospitals more often returned to the hospital within 30 days after hospital discharge and that patients with pneumonia were more likely to die during their hospital stay were surprising, Mein noted. “The 1-percentage-point increase in deaths among patients with pneumonia is especially concerning as the baseline in-hospital mortality rate for this condition was only 3%-4%,” he said.
“Our findings add to growing concerns around the potential negative effects of private equity ownership in healthcare and highlight the need for stronger oversight of these acquisitions to help protect our patients, and the results have implications for many patients as private equity acquisitions of US hospitals are becoming more common,” Mein said.
The findings were limited by the focus on older adults with Medicare insurance, and may not be generalizable to other patient populations, said Mein. “In addition, we were unable to account for differences in private equity firm practices or identify potential heterogeneity in outcomes across hospitals acquired by different private equity firms,” he said. More research is needed to understand the factors contributing to worse outcomes at private equity-acquired hospitals in the current study and other published work, Mein added.
Vigilance is Needed to Optimize Outcomes
“Given the rapid increase in acquisitions of US hospitals by private equity firms, it is important to evaluate how these acquisitions affect patient health outcomes,” said Arianne K. Baldomero, MD, MS, a pulmonologist, critical care physician, and assistant professor of medicine at the University of Minnesota, Minneapolis.
“The worse outcomes observed among patients hospitalized in privately acquired hospitals were not entirely unexpected,” said Baldomero, who was not involved in the study. “Although not explicitly stated in the abstract, these acquisitions may involve cost-containment strategies, such as potential reductions in staffing. particularly nursing and support staff, changes in supply chain management, or the scaling back of less profitable services, which likely contribute to worse patient outcomes,” she said.
More research is needed to identify the potential etiologies driving these differences in outcomes, which would help inform strategies for improvement, said Baldomero. However, the results of the new study suggest that clinicians managing patients discharged from acquired hospitals should be vigilant about discharge planning, transitions, and follow-up to mitigate poor health outcomes, she said.
The study received no outside funding. The researchers and Baldomero had no financial conflicts to disclose.
A version of this article first appeared on Medscape.com.
Patients treated for chronic obstructive pulmonary disease (COPD) or pneumonia experienced worse outcomes when treated at hospitals acquired by private equity firms, based on data from a new study presented at the American Thoracic Society (ATS) 2026 International Conference.
“Previous studies have linked private equity acquisition of hospitals to worse patient experiences and higher rates of hospital-acquired adverse events, such as falls, although findings for specific medical conditions have been more variable,” according to lead author Stephen Mein, MD, a pulmonologist at Beth Israel Deaconess Medical Center in Boston.
“We wanted to understand whether private equity acquisitions impacted outcomes for patients hospitalized with COPD and pneumonia because these conditions are among the most common reasons for hospitalization and they are widely included in measures of hospital care quality,” he said.
Mein and colleagues reviewed data from Medicare fee-for-service claims data from 41 private equity hospitals and 192 matched control hospitals between 2010 and 2019, including 146,904 COPD visits and 194,993 pneumonia visits.
The study population was Medicare beneficiaries aged 65 years or older who had at least one hospital encounter (defined as observation stay or inpatient admission) for asthma, COPD, or pneumonia. The clinical outcomes were in-hospital mortality, 30-day mortality, and 30-day hospital revisit rates. The researchers compared changes in outcomes across 3 years before and after acquisition in a linear regression analysis. Models adjusted for patient age, sex, race and ethnicity, clinical risk score, and dual eligibility status.
Overall, no changes in patient age, sex, clinical risk scores or dual-eligibility status across all conditions at private equity hospitals were noted compared with control hospitals. However, 30-day hospital revisits among patients with asthma increased significantly at private equity hospitals compared to control hospitals (difference-in-differences, + 8.3 percentage points; 95% CI, 4.0-12.7). No significant changes were noted for in-hospital mortality or 30-day mortality.
Similarly, 30-day hospital revisits were significantly higher for patients with COPD at private equity hospitals than at control hospitals (+ 0.9 percentage points; 95% CI, 0.1-1.6). Patients with pneumonia had an increased in-hospital mortality at private equity hospitals compared with control hospitals (+ 0.7 percentage points; 95% CI, 0.2-1.2), with no differences in 30-day mortality or revisits.
The findings that patients treated for COPD at private equity-acquired hospitals more often returned to the hospital within 30 days after hospital discharge and that patients with pneumonia were more likely to die during their hospital stay were surprising, Mein noted. “The 1-percentage-point increase in deaths among patients with pneumonia is especially concerning as the baseline in-hospital mortality rate for this condition was only 3%-4%,” he said.
“Our findings add to growing concerns around the potential negative effects of private equity ownership in healthcare and highlight the need for stronger oversight of these acquisitions to help protect our patients, and the results have implications for many patients as private equity acquisitions of US hospitals are becoming more common,” Mein said.
The findings were limited by the focus on older adults with Medicare insurance, and may not be generalizable to other patient populations, said Mein. “In addition, we were unable to account for differences in private equity firm practices or identify potential heterogeneity in outcomes across hospitals acquired by different private equity firms,” he said. More research is needed to understand the factors contributing to worse outcomes at private equity-acquired hospitals in the current study and other published work, Mein added.
Vigilance is Needed to Optimize Outcomes
“Given the rapid increase in acquisitions of US hospitals by private equity firms, it is important to evaluate how these acquisitions affect patient health outcomes,” said Arianne K. Baldomero, MD, MS, a pulmonologist, critical care physician, and assistant professor of medicine at the University of Minnesota, Minneapolis.
“The worse outcomes observed among patients hospitalized in privately acquired hospitals were not entirely unexpected,” said Baldomero, who was not involved in the study. “Although not explicitly stated in the abstract, these acquisitions may involve cost-containment strategies, such as potential reductions in staffing. particularly nursing and support staff, changes in supply chain management, or the scaling back of less profitable services, which likely contribute to worse patient outcomes,” she said.
More research is needed to identify the potential etiologies driving these differences in outcomes, which would help inform strategies for improvement, said Baldomero. However, the results of the new study suggest that clinicians managing patients discharged from acquired hospitals should be vigilant about discharge planning, transitions, and follow-up to mitigate poor health outcomes, she said.
The study received no outside funding. The researchers and Baldomero had no financial conflicts to disclose.
A version of this article first appeared on Medscape.com.
Hospital Ownership Status Affects Pulmonary Outcomes
Hospital Ownership Status Affects Pulmonary Outcomes
AI Scribes or VHA Docs: Which Created Better Clinical Notes?
Artificial intelligence (AI) scribes produced lower-quality documentation of clinical notes than human clinicians, and especially struggled in settings with background noise or clinicians wearing masks, a new Veterans Health Administration (VHA) study finds.
In 5 simulated clinical cases, notes written by various AI programs scored lower than reports produced by humans on the modified Physician Documentation Quality Instrument (PDQI-9), a measurement of note quality scale, reported Ashok Reddy, MD, MSc, of the University of Washington and Veterans Affairs Puget Sound Health Care System, Seattle, et al in the April issue of Annals of Internal Medicine.
AI scribes scored lower compared with humans across all domains, including accuracy, thoroughness, and usefulness. There was an especially large gap in scores on the 50-point PDQI-9 in an acute low back pain case (human, 43.8 points; AI, 20.3 points; difference, 23.5 points).
“For clinicians, AI scribes should be regarded as tools for generating draft documentation that requires review and editing, rather than as a substitute for clinician-authored notes,” the authors wrote. “Although ambient AI scribes hold promise for reducing clinician burden, rigorous and ongoing evaluation of their quality is essential to ensure that these tools enhance rather than compromise the quality of clinical care.”
AI Scribe Use is Widespread
Taylor N. Anderson, MD, a clinical informatics fellow at Oregon Health & Science University, Portland, is familiar with the study findings and noted that the use of AI scribes in medicine has grown rapidly. All major health organizations are either using it or facing “enormous pressure” from clinicians to do so, she told Federal Practitioner.
Previous research has linked the use of AI scribes for clinical notes to less electronic health record usage and documentation time for clinicians, leading to more time for patient visits. Still, the quality of clinical notes written by AI is “quite variable across vendors,” Anderson said.
Anderson led a 2025 study that examined 5 AI scribe platforms and found an average of 3.0 errors per case with “potential for moderate-to-severe harm.”
For the new study on the simulated cases, part of a VHA-sponsored “technology sprint” via Challenge.gov, researchers developed audio descriptions of 5 clinical cases reflecting common patient encounters in primary care: acute low back pain, chest pain, a new diagnosis of diabetes, a pharmacy consultation, and a follow-up with a nurse case manager for heart failure.
Two cases included non-English accents, 1 included background noise, and 1 featured speech through a medical mask. All the “patients” were played by what the authors described as “trained standardized patient actors.”
For each case, 3 humans and 11 AI scribe programs produced clinical notes. The clinical notes were then evaluated by 6 raters.
Researchers found that AI scribe-generated notes scored worse than human-generated notes across all 10 domains of the modified PDQI-9 (accuracy, thoroughness, usefulness, organization, comprehensiveness, succinctness, synthesization, internal consistency, and freedom from hallucination and bias).
There were especially large gaps between the AI and human notes in the domains of thoroughness, organization, and usefulness. Even wider gaps were observed for the encounters with noise and mask usage.
“These findings highlight that although ambient AI scribes can generate complete notes, the overall quality remains broadly below that of human-authored documentation,” the authors wrote.
No Comparison Between AI Scribes
The researchers noted that “given contractual limitations, we cannot interpret the results for specific vendors.” They also noted that the study did not use professional scribes, who may produce even higher-quality results, and the humans were not producing notes in a real-world clinical environment.
Anderson, the clinical informatics fellow, pointed out that the study does not examine the common scenario in which a clinician edits notes produced by an AI scribe. In fact, she said, there is no current research on this, failing to examine “the postediting note that would actually go into the chart.”
In an accompanying commentary, collaborative scientist Aaron Tierney, PhD, and Kristine Lee, MD, an associate executive director, both with the Permanente Medical Group, California, called for future research to focus on “real-world performance, promote the development of documentation policies that prioritize patient care over billing requirements, and systematically incorporate patient perspectives into assessments of quality.”
Why AI Misses the Mark
In an interview with Federal Practitioner, AI researcher Maxim Topaz, PhD, RN, MA, an associate professor of Nursing and Data Science at Columbia University School of Nursing, New York City, who is familiar with the study but did not participate in it, praised the research.
He pointed out that AI has trouble accurately representing clinical encounters because they “tend to fill gaps with plausible-sounding language, which can mask omissions and make errors harder to catch.” Also, “ambient scribes can only document what is verbalized aloud. Physical exam findings the clinician notices but does not narrate, nonverbal cues, and patient-initiated concerns that drift past in conversation are systematically underrepresented.”
Moving forward, Topaz advised clinicians to “treat AI-generated notes as a first draft, not a finished product. Read them carefully, especially for omissions, which the current evidence suggests are by far the most common error type and which are harder to spot than fabrications because the surrounding note still reads coherently.”
Two study authors disclosed employment by the US Department of Veterans Affairs. Other authors had no disclosures. The commentary authors have no disclosures. Anderson has no disclosures. Topaz discloses relationships with the National Institutes of Health and other federal sources.
Artificial intelligence (AI) scribes produced lower-quality documentation of clinical notes than human clinicians, and especially struggled in settings with background noise or clinicians wearing masks, a new Veterans Health Administration (VHA) study finds.
In 5 simulated clinical cases, notes written by various AI programs scored lower than reports produced by humans on the modified Physician Documentation Quality Instrument (PDQI-9), a measurement of note quality scale, reported Ashok Reddy, MD, MSc, of the University of Washington and Veterans Affairs Puget Sound Health Care System, Seattle, et al in the April issue of Annals of Internal Medicine.
AI scribes scored lower compared with humans across all domains, including accuracy, thoroughness, and usefulness. There was an especially large gap in scores on the 50-point PDQI-9 in an acute low back pain case (human, 43.8 points; AI, 20.3 points; difference, 23.5 points).
“For clinicians, AI scribes should be regarded as tools for generating draft documentation that requires review and editing, rather than as a substitute for clinician-authored notes,” the authors wrote. “Although ambient AI scribes hold promise for reducing clinician burden, rigorous and ongoing evaluation of their quality is essential to ensure that these tools enhance rather than compromise the quality of clinical care.”
AI Scribe Use is Widespread
Taylor N. Anderson, MD, a clinical informatics fellow at Oregon Health & Science University, Portland, is familiar with the study findings and noted that the use of AI scribes in medicine has grown rapidly. All major health organizations are either using it or facing “enormous pressure” from clinicians to do so, she told Federal Practitioner.
Previous research has linked the use of AI scribes for clinical notes to less electronic health record usage and documentation time for clinicians, leading to more time for patient visits. Still, the quality of clinical notes written by AI is “quite variable across vendors,” Anderson said.
Anderson led a 2025 study that examined 5 AI scribe platforms and found an average of 3.0 errors per case with “potential for moderate-to-severe harm.”
For the new study on the simulated cases, part of a VHA-sponsored “technology sprint” via Challenge.gov, researchers developed audio descriptions of 5 clinical cases reflecting common patient encounters in primary care: acute low back pain, chest pain, a new diagnosis of diabetes, a pharmacy consultation, and a follow-up with a nurse case manager for heart failure.
Two cases included non-English accents, 1 included background noise, and 1 featured speech through a medical mask. All the “patients” were played by what the authors described as “trained standardized patient actors.”
For each case, 3 humans and 11 AI scribe programs produced clinical notes. The clinical notes were then evaluated by 6 raters.
Researchers found that AI scribe-generated notes scored worse than human-generated notes across all 10 domains of the modified PDQI-9 (accuracy, thoroughness, usefulness, organization, comprehensiveness, succinctness, synthesization, internal consistency, and freedom from hallucination and bias).
There were especially large gaps between the AI and human notes in the domains of thoroughness, organization, and usefulness. Even wider gaps were observed for the encounters with noise and mask usage.
“These findings highlight that although ambient AI scribes can generate complete notes, the overall quality remains broadly below that of human-authored documentation,” the authors wrote.
No Comparison Between AI Scribes
The researchers noted that “given contractual limitations, we cannot interpret the results for specific vendors.” They also noted that the study did not use professional scribes, who may produce even higher-quality results, and the humans were not producing notes in a real-world clinical environment.
Anderson, the clinical informatics fellow, pointed out that the study does not examine the common scenario in which a clinician edits notes produced by an AI scribe. In fact, she said, there is no current research on this, failing to examine “the postediting note that would actually go into the chart.”
In an accompanying commentary, collaborative scientist Aaron Tierney, PhD, and Kristine Lee, MD, an associate executive director, both with the Permanente Medical Group, California, called for future research to focus on “real-world performance, promote the development of documentation policies that prioritize patient care over billing requirements, and systematically incorporate patient perspectives into assessments of quality.”
Why AI Misses the Mark
In an interview with Federal Practitioner, AI researcher Maxim Topaz, PhD, RN, MA, an associate professor of Nursing and Data Science at Columbia University School of Nursing, New York City, who is familiar with the study but did not participate in it, praised the research.
He pointed out that AI has trouble accurately representing clinical encounters because they “tend to fill gaps with plausible-sounding language, which can mask omissions and make errors harder to catch.” Also, “ambient scribes can only document what is verbalized aloud. Physical exam findings the clinician notices but does not narrate, nonverbal cues, and patient-initiated concerns that drift past in conversation are systematically underrepresented.”
Moving forward, Topaz advised clinicians to “treat AI-generated notes as a first draft, not a finished product. Read them carefully, especially for omissions, which the current evidence suggests are by far the most common error type and which are harder to spot than fabrications because the surrounding note still reads coherently.”
Two study authors disclosed employment by the US Department of Veterans Affairs. Other authors had no disclosures. The commentary authors have no disclosures. Anderson has no disclosures. Topaz discloses relationships with the National Institutes of Health and other federal sources.
Artificial intelligence (AI) scribes produced lower-quality documentation of clinical notes than human clinicians, and especially struggled in settings with background noise or clinicians wearing masks, a new Veterans Health Administration (VHA) study finds.
In 5 simulated clinical cases, notes written by various AI programs scored lower than reports produced by humans on the modified Physician Documentation Quality Instrument (PDQI-9), a measurement of note quality scale, reported Ashok Reddy, MD, MSc, of the University of Washington and Veterans Affairs Puget Sound Health Care System, Seattle, et al in the April issue of Annals of Internal Medicine.
AI scribes scored lower compared with humans across all domains, including accuracy, thoroughness, and usefulness. There was an especially large gap in scores on the 50-point PDQI-9 in an acute low back pain case (human, 43.8 points; AI, 20.3 points; difference, 23.5 points).
“For clinicians, AI scribes should be regarded as tools for generating draft documentation that requires review and editing, rather than as a substitute for clinician-authored notes,” the authors wrote. “Although ambient AI scribes hold promise for reducing clinician burden, rigorous and ongoing evaluation of their quality is essential to ensure that these tools enhance rather than compromise the quality of clinical care.”
AI Scribe Use is Widespread
Taylor N. Anderson, MD, a clinical informatics fellow at Oregon Health & Science University, Portland, is familiar with the study findings and noted that the use of AI scribes in medicine has grown rapidly. All major health organizations are either using it or facing “enormous pressure” from clinicians to do so, she told Federal Practitioner.
Previous research has linked the use of AI scribes for clinical notes to less electronic health record usage and documentation time for clinicians, leading to more time for patient visits. Still, the quality of clinical notes written by AI is “quite variable across vendors,” Anderson said.
Anderson led a 2025 study that examined 5 AI scribe platforms and found an average of 3.0 errors per case with “potential for moderate-to-severe harm.”
For the new study on the simulated cases, part of a VHA-sponsored “technology sprint” via Challenge.gov, researchers developed audio descriptions of 5 clinical cases reflecting common patient encounters in primary care: acute low back pain, chest pain, a new diagnosis of diabetes, a pharmacy consultation, and a follow-up with a nurse case manager for heart failure.
Two cases included non-English accents, 1 included background noise, and 1 featured speech through a medical mask. All the “patients” were played by what the authors described as “trained standardized patient actors.”
For each case, 3 humans and 11 AI scribe programs produced clinical notes. The clinical notes were then evaluated by 6 raters.
Researchers found that AI scribe-generated notes scored worse than human-generated notes across all 10 domains of the modified PDQI-9 (accuracy, thoroughness, usefulness, organization, comprehensiveness, succinctness, synthesization, internal consistency, and freedom from hallucination and bias).
There were especially large gaps between the AI and human notes in the domains of thoroughness, organization, and usefulness. Even wider gaps were observed for the encounters with noise and mask usage.
“These findings highlight that although ambient AI scribes can generate complete notes, the overall quality remains broadly below that of human-authored documentation,” the authors wrote.
No Comparison Between AI Scribes
The researchers noted that “given contractual limitations, we cannot interpret the results for specific vendors.” They also noted that the study did not use professional scribes, who may produce even higher-quality results, and the humans were not producing notes in a real-world clinical environment.
Anderson, the clinical informatics fellow, pointed out that the study does not examine the common scenario in which a clinician edits notes produced by an AI scribe. In fact, she said, there is no current research on this, failing to examine “the postediting note that would actually go into the chart.”
In an accompanying commentary, collaborative scientist Aaron Tierney, PhD, and Kristine Lee, MD, an associate executive director, both with the Permanente Medical Group, California, called for future research to focus on “real-world performance, promote the development of documentation policies that prioritize patient care over billing requirements, and systematically incorporate patient perspectives into assessments of quality.”
Why AI Misses the Mark
In an interview with Federal Practitioner, AI researcher Maxim Topaz, PhD, RN, MA, an associate professor of Nursing and Data Science at Columbia University School of Nursing, New York City, who is familiar with the study but did not participate in it, praised the research.
He pointed out that AI has trouble accurately representing clinical encounters because they “tend to fill gaps with plausible-sounding language, which can mask omissions and make errors harder to catch.” Also, “ambient scribes can only document what is verbalized aloud. Physical exam findings the clinician notices but does not narrate, nonverbal cues, and patient-initiated concerns that drift past in conversation are systematically underrepresented.”
Moving forward, Topaz advised clinicians to “treat AI-generated notes as a first draft, not a finished product. Read them carefully, especially for omissions, which the current evidence suggests are by far the most common error type and which are harder to spot than fabrications because the surrounding note still reads coherently.”
Two study authors disclosed employment by the US Department of Veterans Affairs. Other authors had no disclosures. The commentary authors have no disclosures. Anderson has no disclosures. Topaz discloses relationships with the National Institutes of Health and other federal sources.
State Firearm Laws Linked to Veteran Suicide Rates
TOPLINE: Among veterans and demographically matched nonveterans from 2002 to 2019, higher state household firearm ownership was associated with higher rates of deaths by suicide, while greater state firearm law restrictiveness was associated with lower rates of deaths by suicide. In 2017 to 2019 models, these associations were seen for both veterans and matched nonveterans and driven primarily by firearm deaths by suicide rates.
METHODOLOGY:
US state-level data across 6 consecutive 3-year periods from 2002-2019, stratified suicide rates by veteran status (veteran vs matched nonveterans) and method (firearm vs nonfirearm).
Data sources included US Department of Veterans Affairs (VA) Office of Mental Health and Suicide Prevention counts matched to the National Death Index, plus Centers for Disease Control suicide counts and population estimates by sex and age.
Participants included veterans with state- and period-specific death suicide counts and population denominators from the VetPop model, and a matched nonveteran comparison created by comparing state deaths by suicide data to veterans’ age and gender distributions.
Exposure measures included annual state household firearm ownership rate estimates carried forward to 2017-2019, and a 7-item state firearm policy restrictiveness index derived from the RAND Corporation state firearm law database.
TAKEAWAY:
Average death by suicide rates from 2002-2019 were 28.2 per 100,000 for veterans and 27.5 per 100,000 for matched nonveterans, with most deaths involving a firearm.
Across states, the maximum average death by suicide rate was about 3 times the minimum over the study period, and veteran and matched nonveteran state patterns aligned closely.
Higher household firearm ownership was associated with higher firearm death by suicide rates for veterans and matched nonveterans from 2017-2019.
Greater firearm law restrictiveness, equivalent to 3 additional restrictive laws, was associated with fewer firearm deaths by suicide for veterans and matched nonveterans from 2017-2019.
IN PRACTICE: “The results suggest that changes to state firearm laws and policies should be investigated as a possibly cost-effective primary prevention strategy for reducing suicide rates among veterans and nonveterans,” the authors wrote.
SOURCE:The study was led by Andrew R. Morral, PhD, RAND Corporation in Arlington, Virginia, and Terry L. Schell, PhD, and Adam Scherling, RAND Corporation in Santa Monica, California and published online in Injury Prevention.
LIMITATIONS: The estimates are correlational and should not be interpreted as causal effect estimates, as most interstate variation in gun ownership and firearm laws predates the beginning of the available VA death by suicide data, limiting the analytical approach to identify causal effects. VA does not share microdata on veteran suicide, requiring construction of a matched comparison sample of nonveterans by estimating veteran decedent removal from general population suicide totals within cells of a 5-way table based on publicly released 3-way tables, introducing imprecision. Veteran suicide counts are known to undercount suicides among veterans who separated from the military prior to 1974, likely resulting in a slight underestimate of veteran suicide rates for the oldest cohort of veterans, particularly in earlier study periods. Restricting analysis to identify modeled effects solely through limited changes in state firearm ownership and policies during the study period yields imprecise effect estimates.
DISCLOSURES: This work received support from a grant provided by The RAND Epstein Family Veterans Policy Research Institute, established through a contribution from Daniel J. Epstein via the Epstein Family Foundation. Neither the Institute, the Foundation, nor Mr. Epstein participated in the design, conduct, analysis, or drafting of this report. The authors disclosed no relevant conflicts of interest.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
TOPLINE: Among veterans and demographically matched nonveterans from 2002 to 2019, higher state household firearm ownership was associated with higher rates of deaths by suicide, while greater state firearm law restrictiveness was associated with lower rates of deaths by suicide. In 2017 to 2019 models, these associations were seen for both veterans and matched nonveterans and driven primarily by firearm deaths by suicide rates.
METHODOLOGY:
US state-level data across 6 consecutive 3-year periods from 2002-2019, stratified suicide rates by veteran status (veteran vs matched nonveterans) and method (firearm vs nonfirearm).
Data sources included US Department of Veterans Affairs (VA) Office of Mental Health and Suicide Prevention counts matched to the National Death Index, plus Centers for Disease Control suicide counts and population estimates by sex and age.
Participants included veterans with state- and period-specific death suicide counts and population denominators from the VetPop model, and a matched nonveteran comparison created by comparing state deaths by suicide data to veterans’ age and gender distributions.
Exposure measures included annual state household firearm ownership rate estimates carried forward to 2017-2019, and a 7-item state firearm policy restrictiveness index derived from the RAND Corporation state firearm law database.
TAKEAWAY:
Average death by suicide rates from 2002-2019 were 28.2 per 100,000 for veterans and 27.5 per 100,000 for matched nonveterans, with most deaths involving a firearm.
Across states, the maximum average death by suicide rate was about 3 times the minimum over the study period, and veteran and matched nonveteran state patterns aligned closely.
Higher household firearm ownership was associated with higher firearm death by suicide rates for veterans and matched nonveterans from 2017-2019.
Greater firearm law restrictiveness, equivalent to 3 additional restrictive laws, was associated with fewer firearm deaths by suicide for veterans and matched nonveterans from 2017-2019.
IN PRACTICE: “The results suggest that changes to state firearm laws and policies should be investigated as a possibly cost-effective primary prevention strategy for reducing suicide rates among veterans and nonveterans,” the authors wrote.
SOURCE:The study was led by Andrew R. Morral, PhD, RAND Corporation in Arlington, Virginia, and Terry L. Schell, PhD, and Adam Scherling, RAND Corporation in Santa Monica, California and published online in Injury Prevention.
LIMITATIONS: The estimates are correlational and should not be interpreted as causal effect estimates, as most interstate variation in gun ownership and firearm laws predates the beginning of the available VA death by suicide data, limiting the analytical approach to identify causal effects. VA does not share microdata on veteran suicide, requiring construction of a matched comparison sample of nonveterans by estimating veteran decedent removal from general population suicide totals within cells of a 5-way table based on publicly released 3-way tables, introducing imprecision. Veteran suicide counts are known to undercount suicides among veterans who separated from the military prior to 1974, likely resulting in a slight underestimate of veteran suicide rates for the oldest cohort of veterans, particularly in earlier study periods. Restricting analysis to identify modeled effects solely through limited changes in state firearm ownership and policies during the study period yields imprecise effect estimates.
DISCLOSURES: This work received support from a grant provided by The RAND Epstein Family Veterans Policy Research Institute, established through a contribution from Daniel J. Epstein via the Epstein Family Foundation. Neither the Institute, the Foundation, nor Mr. Epstein participated in the design, conduct, analysis, or drafting of this report. The authors disclosed no relevant conflicts of interest.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
TOPLINE: Among veterans and demographically matched nonveterans from 2002 to 2019, higher state household firearm ownership was associated with higher rates of deaths by suicide, while greater state firearm law restrictiveness was associated with lower rates of deaths by suicide. In 2017 to 2019 models, these associations were seen for both veterans and matched nonveterans and driven primarily by firearm deaths by suicide rates.
METHODOLOGY:
US state-level data across 6 consecutive 3-year periods from 2002-2019, stratified suicide rates by veteran status (veteran vs matched nonveterans) and method (firearm vs nonfirearm).
Data sources included US Department of Veterans Affairs (VA) Office of Mental Health and Suicide Prevention counts matched to the National Death Index, plus Centers for Disease Control suicide counts and population estimates by sex and age.
Participants included veterans with state- and period-specific death suicide counts and population denominators from the VetPop model, and a matched nonveteran comparison created by comparing state deaths by suicide data to veterans’ age and gender distributions.
Exposure measures included annual state household firearm ownership rate estimates carried forward to 2017-2019, and a 7-item state firearm policy restrictiveness index derived from the RAND Corporation state firearm law database.
TAKEAWAY:
Average death by suicide rates from 2002-2019 were 28.2 per 100,000 for veterans and 27.5 per 100,000 for matched nonveterans, with most deaths involving a firearm.
Across states, the maximum average death by suicide rate was about 3 times the minimum over the study period, and veteran and matched nonveteran state patterns aligned closely.
Higher household firearm ownership was associated with higher firearm death by suicide rates for veterans and matched nonveterans from 2017-2019.
Greater firearm law restrictiveness, equivalent to 3 additional restrictive laws, was associated with fewer firearm deaths by suicide for veterans and matched nonveterans from 2017-2019.
IN PRACTICE: “The results suggest that changes to state firearm laws and policies should be investigated as a possibly cost-effective primary prevention strategy for reducing suicide rates among veterans and nonveterans,” the authors wrote.
SOURCE:The study was led by Andrew R. Morral, PhD, RAND Corporation in Arlington, Virginia, and Terry L. Schell, PhD, and Adam Scherling, RAND Corporation in Santa Monica, California and published online in Injury Prevention.
LIMITATIONS: The estimates are correlational and should not be interpreted as causal effect estimates, as most interstate variation in gun ownership and firearm laws predates the beginning of the available VA death by suicide data, limiting the analytical approach to identify causal effects. VA does not share microdata on veteran suicide, requiring construction of a matched comparison sample of nonveterans by estimating veteran decedent removal from general population suicide totals within cells of a 5-way table based on publicly released 3-way tables, introducing imprecision. Veteran suicide counts are known to undercount suicides among veterans who separated from the military prior to 1974, likely resulting in a slight underestimate of veteran suicide rates for the oldest cohort of veterans, particularly in earlier study periods. Restricting analysis to identify modeled effects solely through limited changes in state firearm ownership and policies during the study period yields imprecise effect estimates.
DISCLOSURES: This work received support from a grant provided by The RAND Epstein Family Veterans Policy Research Institute, established through a contribution from Daniel J. Epstein via the Epstein Family Foundation. Neither the Institute, the Foundation, nor Mr. Epstein participated in the design, conduct, analysis, or drafting of this report. The authors disclosed no relevant conflicts of interest.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.