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In-hospital mortality increased in COPD patients with acute exacerbations and high serum phosphate levels
found significantly higher in-hospital mortality among AECOPD patients with high serum phosphate levels. The finding, according to Siqi Li et al. in a preproof HELIYON article, suggests that hyperphosphatemia may be a high-risk factor for AECOPD-related in-hospital mortality.
Phosphorus is key to several physiological processes, among them energy metabolism, bone mineralization, membrane transport, and intracellular signaling. Li et al. pointed out that in patients with multiple diseases, hyperphosphatemia is associated with increased mortality. In the development of COPD specifically, acute exacerbations have been shown in several recent studies to be an important adverse event conferring heightened mortality risk. Despite many efforts, AECOPD mortality rates remain high, making identification of potential factors, Li et al. stated, crucial for improving outcomes in high-risk patients.
The electronic Intensive Care Unit Collaborative Research Database (eICU-CRD) holds data associated with over 200,000 patient stays, providing a large sample size for research studies. To determine the relationship between serum phosphate and in-hospital mortality in AECOPD patients, investigators analyzed data from a total of 1,199 AECOPD patients (mean age, 68 years; ~55% female) enrolled in eICU-CRD and divided them into three groups according to serum phosphate level tertiles: lowest tertile (serum phosphate ≤ 3.0 mg/dL, n = 445), median tertile (serum phosphate > 3.0 mg/dL and ≤ 4.0 mg/dL, n = 378), and highest tertile (serum phosphate > 4.0 mg/dL, n = 376). The Li et al. study’s primary outcome was all-cause in-hospital mortality, defined as survival to hospital discharge. Secondary outcomes included length of stay (LOS) in the intensive care unit (ICU), LOS in the hospital, and all-cause ICU mortality.
The Li et al. analysis of patient characteristics showed that patients in the highest tertile of serum phosphate had significantly higher body mass index (BMI) (P < .001), lower temperature (P < .001), lower heart rate (P < .001), lower mean arterial blood pressure (P = .011), higher creatinine (P < .001), higher potassium (P < .001), higher sequential organ failure assessment (SOFA) (P < .001), higher acute physiology and chronic health evaluation (APACHE IV) (P < .001), and higher ICU mortality (P < .001). Also, patients with higher serum phosphate levels were more likely to receive renal replacement therapy (RRT) (P < .001) and vasoactive drugs (P = .003) than those in the lower serum phosphate group. Such differences were also observed for age (P = .021), calcium level (P = .023), sodium level (P = .039), hypertension (P = .014), coronary artery disease (P = .004), diabetes (P = .017), and chronic kidney disease (P < .001). No significant differences were observed for gender, respiration rate, SpO2, white blood cell count, hemoglobin, platelets, cirrhosis, stroke, ventilation, LOS in ICU, and LOS in hospital (P > .05).
A univariate logistic regression analysis performed to determine the relationship between serum phosphate level and risk of in-hospital mortality revealed that higher serum phosphate level correlated with increased in-hospital mortality (odds ratio, 1.30; 95% confidence interval, 1.16-1.46; P < .001).
Li et al. posited that several mechanisms may explain increased mortality at higher serum phosphate levels in AECOPD patients: increased serum phosphate induces vascular calcification and endothelial dysfunction, leading to organ dysfunction; hyperphosphatemia causes oxidative stress, cell apoptosis, and inflammation, all of which are involved in the pathogenesis of AECOPD, and a higher phosphate diet exacerbates aging and lung emphysema phenotypes; restriction of phosphate intake and absorption relieves these phenotypes and alveolar destruction, which might contribute to the development of AECOPD.
Li et al. concluded: “Reducing serum phosphate levels may be a therapeutic strategy to improve prognosis of AECOPD patients.”
“This large retrospective analysis on eICU database in the U.S. revealed elevated serum phosphate levels with increased in-hospital mortality among patients experiencing acute exacerbation of COPD,” commented Dharani Narendra, MD, assistant professor in medicine, at Baylor College of Medicine, Houston. “This association, previously observed in various chronic conditions including COPD, particularly in men, is now noted to apply to both genders, irrespective of chronic kidney disease. The study also hints at potential mechanisms for elevated phosphate levels, such as inflammation, oxidative stress, and cell apoptosis in AECOPD, as well as a high-phosphate diet.”
She told this news organization also, “It remains imperative to ascertain whether treating hyperphosphatemia or implementing dietary phosphate restrictions can reduce mortality or prevent AECOPD episodes. These demand additional clinical trials to establish a definitive cause-and-effect relationship and to guide potential treatment and prevention strategies.”
Noting study limitations, Li et al. stated that many variables, such as smoking, exacerbation frequency, severity, PH, PaO2, PaCO2, and lactate, were not included in this study owing to more than 20% missing values.
This work was supported by the National Natural Science Foundation of China, Scientific Research Fund of Hunan Provincial Education Department, Hunan Provincial Natural Science Foundation, and Special fund for rehabilitation medicine of the National Clinical Research Center for Geriatric Disorders Clinical Research Fund. The authors declare no competing interests.
found significantly higher in-hospital mortality among AECOPD patients with high serum phosphate levels. The finding, according to Siqi Li et al. in a preproof HELIYON article, suggests that hyperphosphatemia may be a high-risk factor for AECOPD-related in-hospital mortality.
Phosphorus is key to several physiological processes, among them energy metabolism, bone mineralization, membrane transport, and intracellular signaling. Li et al. pointed out that in patients with multiple diseases, hyperphosphatemia is associated with increased mortality. In the development of COPD specifically, acute exacerbations have been shown in several recent studies to be an important adverse event conferring heightened mortality risk. Despite many efforts, AECOPD mortality rates remain high, making identification of potential factors, Li et al. stated, crucial for improving outcomes in high-risk patients.
The electronic Intensive Care Unit Collaborative Research Database (eICU-CRD) holds data associated with over 200,000 patient stays, providing a large sample size for research studies. To determine the relationship between serum phosphate and in-hospital mortality in AECOPD patients, investigators analyzed data from a total of 1,199 AECOPD patients (mean age, 68 years; ~55% female) enrolled in eICU-CRD and divided them into three groups according to serum phosphate level tertiles: lowest tertile (serum phosphate ≤ 3.0 mg/dL, n = 445), median tertile (serum phosphate > 3.0 mg/dL and ≤ 4.0 mg/dL, n = 378), and highest tertile (serum phosphate > 4.0 mg/dL, n = 376). The Li et al. study’s primary outcome was all-cause in-hospital mortality, defined as survival to hospital discharge. Secondary outcomes included length of stay (LOS) in the intensive care unit (ICU), LOS in the hospital, and all-cause ICU mortality.
The Li et al. analysis of patient characteristics showed that patients in the highest tertile of serum phosphate had significantly higher body mass index (BMI) (P < .001), lower temperature (P < .001), lower heart rate (P < .001), lower mean arterial blood pressure (P = .011), higher creatinine (P < .001), higher potassium (P < .001), higher sequential organ failure assessment (SOFA) (P < .001), higher acute physiology and chronic health evaluation (APACHE IV) (P < .001), and higher ICU mortality (P < .001). Also, patients with higher serum phosphate levels were more likely to receive renal replacement therapy (RRT) (P < .001) and vasoactive drugs (P = .003) than those in the lower serum phosphate group. Such differences were also observed for age (P = .021), calcium level (P = .023), sodium level (P = .039), hypertension (P = .014), coronary artery disease (P = .004), diabetes (P = .017), and chronic kidney disease (P < .001). No significant differences were observed for gender, respiration rate, SpO2, white blood cell count, hemoglobin, platelets, cirrhosis, stroke, ventilation, LOS in ICU, and LOS in hospital (P > .05).
A univariate logistic regression analysis performed to determine the relationship between serum phosphate level and risk of in-hospital mortality revealed that higher serum phosphate level correlated with increased in-hospital mortality (odds ratio, 1.30; 95% confidence interval, 1.16-1.46; P < .001).
Li et al. posited that several mechanisms may explain increased mortality at higher serum phosphate levels in AECOPD patients: increased serum phosphate induces vascular calcification and endothelial dysfunction, leading to organ dysfunction; hyperphosphatemia causes oxidative stress, cell apoptosis, and inflammation, all of which are involved in the pathogenesis of AECOPD, and a higher phosphate diet exacerbates aging and lung emphysema phenotypes; restriction of phosphate intake and absorption relieves these phenotypes and alveolar destruction, which might contribute to the development of AECOPD.
Li et al. concluded: “Reducing serum phosphate levels may be a therapeutic strategy to improve prognosis of AECOPD patients.”
“This large retrospective analysis on eICU database in the U.S. revealed elevated serum phosphate levels with increased in-hospital mortality among patients experiencing acute exacerbation of COPD,” commented Dharani Narendra, MD, assistant professor in medicine, at Baylor College of Medicine, Houston. “This association, previously observed in various chronic conditions including COPD, particularly in men, is now noted to apply to both genders, irrespective of chronic kidney disease. The study also hints at potential mechanisms for elevated phosphate levels, such as inflammation, oxidative stress, and cell apoptosis in AECOPD, as well as a high-phosphate diet.”
She told this news organization also, “It remains imperative to ascertain whether treating hyperphosphatemia or implementing dietary phosphate restrictions can reduce mortality or prevent AECOPD episodes. These demand additional clinical trials to establish a definitive cause-and-effect relationship and to guide potential treatment and prevention strategies.”
Noting study limitations, Li et al. stated that many variables, such as smoking, exacerbation frequency, severity, PH, PaO2, PaCO2, and lactate, were not included in this study owing to more than 20% missing values.
This work was supported by the National Natural Science Foundation of China, Scientific Research Fund of Hunan Provincial Education Department, Hunan Provincial Natural Science Foundation, and Special fund for rehabilitation medicine of the National Clinical Research Center for Geriatric Disorders Clinical Research Fund. The authors declare no competing interests.
found significantly higher in-hospital mortality among AECOPD patients with high serum phosphate levels. The finding, according to Siqi Li et al. in a preproof HELIYON article, suggests that hyperphosphatemia may be a high-risk factor for AECOPD-related in-hospital mortality.
Phosphorus is key to several physiological processes, among them energy metabolism, bone mineralization, membrane transport, and intracellular signaling. Li et al. pointed out that in patients with multiple diseases, hyperphosphatemia is associated with increased mortality. In the development of COPD specifically, acute exacerbations have been shown in several recent studies to be an important adverse event conferring heightened mortality risk. Despite many efforts, AECOPD mortality rates remain high, making identification of potential factors, Li et al. stated, crucial for improving outcomes in high-risk patients.
The electronic Intensive Care Unit Collaborative Research Database (eICU-CRD) holds data associated with over 200,000 patient stays, providing a large sample size for research studies. To determine the relationship between serum phosphate and in-hospital mortality in AECOPD patients, investigators analyzed data from a total of 1,199 AECOPD patients (mean age, 68 years; ~55% female) enrolled in eICU-CRD and divided them into three groups according to serum phosphate level tertiles: lowest tertile (serum phosphate ≤ 3.0 mg/dL, n = 445), median tertile (serum phosphate > 3.0 mg/dL and ≤ 4.0 mg/dL, n = 378), and highest tertile (serum phosphate > 4.0 mg/dL, n = 376). The Li et al. study’s primary outcome was all-cause in-hospital mortality, defined as survival to hospital discharge. Secondary outcomes included length of stay (LOS) in the intensive care unit (ICU), LOS in the hospital, and all-cause ICU mortality.
The Li et al. analysis of patient characteristics showed that patients in the highest tertile of serum phosphate had significantly higher body mass index (BMI) (P < .001), lower temperature (P < .001), lower heart rate (P < .001), lower mean arterial blood pressure (P = .011), higher creatinine (P < .001), higher potassium (P < .001), higher sequential organ failure assessment (SOFA) (P < .001), higher acute physiology and chronic health evaluation (APACHE IV) (P < .001), and higher ICU mortality (P < .001). Also, patients with higher serum phosphate levels were more likely to receive renal replacement therapy (RRT) (P < .001) and vasoactive drugs (P = .003) than those in the lower serum phosphate group. Such differences were also observed for age (P = .021), calcium level (P = .023), sodium level (P = .039), hypertension (P = .014), coronary artery disease (P = .004), diabetes (P = .017), and chronic kidney disease (P < .001). No significant differences were observed for gender, respiration rate, SpO2, white blood cell count, hemoglobin, platelets, cirrhosis, stroke, ventilation, LOS in ICU, and LOS in hospital (P > .05).
A univariate logistic regression analysis performed to determine the relationship between serum phosphate level and risk of in-hospital mortality revealed that higher serum phosphate level correlated with increased in-hospital mortality (odds ratio, 1.30; 95% confidence interval, 1.16-1.46; P < .001).
Li et al. posited that several mechanisms may explain increased mortality at higher serum phosphate levels in AECOPD patients: increased serum phosphate induces vascular calcification and endothelial dysfunction, leading to organ dysfunction; hyperphosphatemia causes oxidative stress, cell apoptosis, and inflammation, all of which are involved in the pathogenesis of AECOPD, and a higher phosphate diet exacerbates aging and lung emphysema phenotypes; restriction of phosphate intake and absorption relieves these phenotypes and alveolar destruction, which might contribute to the development of AECOPD.
Li et al. concluded: “Reducing serum phosphate levels may be a therapeutic strategy to improve prognosis of AECOPD patients.”
“This large retrospective analysis on eICU database in the U.S. revealed elevated serum phosphate levels with increased in-hospital mortality among patients experiencing acute exacerbation of COPD,” commented Dharani Narendra, MD, assistant professor in medicine, at Baylor College of Medicine, Houston. “This association, previously observed in various chronic conditions including COPD, particularly in men, is now noted to apply to both genders, irrespective of chronic kidney disease. The study also hints at potential mechanisms for elevated phosphate levels, such as inflammation, oxidative stress, and cell apoptosis in AECOPD, as well as a high-phosphate diet.”
She told this news organization also, “It remains imperative to ascertain whether treating hyperphosphatemia or implementing dietary phosphate restrictions can reduce mortality or prevent AECOPD episodes. These demand additional clinical trials to establish a definitive cause-and-effect relationship and to guide potential treatment and prevention strategies.”
Noting study limitations, Li et al. stated that many variables, such as smoking, exacerbation frequency, severity, PH, PaO2, PaCO2, and lactate, were not included in this study owing to more than 20% missing values.
This work was supported by the National Natural Science Foundation of China, Scientific Research Fund of Hunan Provincial Education Department, Hunan Provincial Natural Science Foundation, and Special fund for rehabilitation medicine of the National Clinical Research Center for Geriatric Disorders Clinical Research Fund. The authors declare no competing interests.
FROM HELIYON
Home oxygen therapy: What does the data show?
Inhalers, nebulizers, antibiotics, and steroids – these are some of the most common tools in our pulmonary arsenal that we deploy on a daily basis. But, there is no treatment more fundamental to a pulmonary practitioner than oxygen. So how is it that something that naturally occurs and comprises 21% of ambient air has become so medicalized?
It is difficult (perhaps impossible) to find a pulmonologist or a hospitalist who has not included the phrase “obtain ambulatory saturation to qualify the patient for home oxygen” in at least one of their progress notes on a daily basis. Chronic obstructive pulmonary disease (COPD) is the most common reason for the prescription of long-term oxygen therapy (LTOT), a large industry tightly regulated by the Centers for Medicare & Medicaid Services (CMS).
The evidence for the use of LTOT in patients with COPD dates back to two seminal papers published in 1980 and 1981. The British Medical Research Council Working Party conducted the BMRC trial, in which 87 patients with a Pa
Another study published around the same time, the Continuous or nocturnal oxygen therapy in hypoxemic chronic obstructive lung disease (NOTT) trial (Ann Intern Med. 1980;93[3]:391-8) directly compared continuous 24-hour to nocturnal home oxygen therapy in patients with COPD and severe hypoxemia with a Pa
Afterward, it became universally accepted dogma that patients with COPD and severe hypoxemia stood to substantially benefit from LTOT. For years, it was the only therapy associated with a mortality reduction. The LOTT study (Albert RK, et al. N Engl J Med. 2016;375[17]:1617-27) included 768 patients with stable COPD and a resting or nocturnal Sp
The INOX (Lacasse Y, et al. N Engl J Med. 2020;383[12]:1129-38) trial, in which 243 patients with oxygen saturation less than 90% for at least 30% of the night were assigned to receive nocturnal vs sham oxygen, found similar results. There was no difference in the composite outcome of all-cause mortality and progression to 24-7 oxygen requirement (according to the criteria originally defined by NOTT). A 2022 systematic review and meta-analysis including six studies designed to assess the role of LTOT in patients with COPD and moderate desaturation, including LOTT and INOX, found no benefit to providing LTOT (Lacasse Y, et al. Lancet Respir Med. 2022;10[11]:1029-37).
Based on these studies, a resting Sp
COPD management has changed significantly in the 40 years since NOTT was published. In the early 1980s, standard of care included an inhaled beta-agonist and oral theophylline. We now prescribe a regimen of modern-day inhaler combinations, which can lead to a mortality benefit in the correct population. Additionally, rates of smoking are markedly lower now than they were in 1980. In the Minnesota Heart Survey, the prevalence of being an ever-smoking man or woman in 1980 compared with 2009 dropped from 71.6% and 54.7% to 44.2% and 39.6%, respectively (Filion KB, et al. Am J Public Health. 2012;102[4]:705-13). Treatment of common comorbid conditions has also dramatically improved.
A report containing all fee-for-service data published in 2021 by CMS reported oxygen therapy accounted for 9.8% of all DME costs covered by CMS and totaled approximately $800,000,000 (Centers for Medicare & Medicaid Services. FFS Data. 2021. This represents a significant financial burden to our health system and government.
Two of the eligible groups per CMS (those with isolated ambulatory or nocturnal hypoxemia) do not benefit from LTOT in RCTs. The other two groups are eligible based on trial data from a small number of patients who were studied more than 40 years ago. These facts raise serious questions about the cost-efficacy of LTOT.
So where does this leave us?
There are significant barriers to repeating large randomized oxygen trials. Due to broad inclusion criteria for LTOT by CMS, there are undoubtedly many people prescribed LTOT for whom there is minimal to no benefit. Patients often feel restricted in their mobility and may feel isolated being tethered to medical equipment. It is good practice to think about LTOT the same way we do any other therapy we provide - as a medicine with associated risks, benefits, and costs.
Despite its ubiquity, oxygen remains an important therapeutic tool. Still, choosing wisely means recognizing that not all patients who qualify for LTOT by CMS criteria will benefit.
Drs. Kreisel and Sonti are with the Division of Pulmonary, Critical Care, and Sleep Medicine, MedStar Georgetown University Hospital, Washington, DC.
Inhalers, nebulizers, antibiotics, and steroids – these are some of the most common tools in our pulmonary arsenal that we deploy on a daily basis. But, there is no treatment more fundamental to a pulmonary practitioner than oxygen. So how is it that something that naturally occurs and comprises 21% of ambient air has become so medicalized?
It is difficult (perhaps impossible) to find a pulmonologist or a hospitalist who has not included the phrase “obtain ambulatory saturation to qualify the patient for home oxygen” in at least one of their progress notes on a daily basis. Chronic obstructive pulmonary disease (COPD) is the most common reason for the prescription of long-term oxygen therapy (LTOT), a large industry tightly regulated by the Centers for Medicare & Medicaid Services (CMS).
The evidence for the use of LTOT in patients with COPD dates back to two seminal papers published in 1980 and 1981. The British Medical Research Council Working Party conducted the BMRC trial, in which 87 patients with a Pa
Another study published around the same time, the Continuous or nocturnal oxygen therapy in hypoxemic chronic obstructive lung disease (NOTT) trial (Ann Intern Med. 1980;93[3]:391-8) directly compared continuous 24-hour to nocturnal home oxygen therapy in patients with COPD and severe hypoxemia with a Pa
Afterward, it became universally accepted dogma that patients with COPD and severe hypoxemia stood to substantially benefit from LTOT. For years, it was the only therapy associated with a mortality reduction. The LOTT study (Albert RK, et al. N Engl J Med. 2016;375[17]:1617-27) included 768 patients with stable COPD and a resting or nocturnal Sp
The INOX (Lacasse Y, et al. N Engl J Med. 2020;383[12]:1129-38) trial, in which 243 patients with oxygen saturation less than 90% for at least 30% of the night were assigned to receive nocturnal vs sham oxygen, found similar results. There was no difference in the composite outcome of all-cause mortality and progression to 24-7 oxygen requirement (according to the criteria originally defined by NOTT). A 2022 systematic review and meta-analysis including six studies designed to assess the role of LTOT in patients with COPD and moderate desaturation, including LOTT and INOX, found no benefit to providing LTOT (Lacasse Y, et al. Lancet Respir Med. 2022;10[11]:1029-37).
Based on these studies, a resting Sp
COPD management has changed significantly in the 40 years since NOTT was published. In the early 1980s, standard of care included an inhaled beta-agonist and oral theophylline. We now prescribe a regimen of modern-day inhaler combinations, which can lead to a mortality benefit in the correct population. Additionally, rates of smoking are markedly lower now than they were in 1980. In the Minnesota Heart Survey, the prevalence of being an ever-smoking man or woman in 1980 compared with 2009 dropped from 71.6% and 54.7% to 44.2% and 39.6%, respectively (Filion KB, et al. Am J Public Health. 2012;102[4]:705-13). Treatment of common comorbid conditions has also dramatically improved.
A report containing all fee-for-service data published in 2021 by CMS reported oxygen therapy accounted for 9.8% of all DME costs covered by CMS and totaled approximately $800,000,000 (Centers for Medicare & Medicaid Services. FFS Data. 2021. This represents a significant financial burden to our health system and government.
Two of the eligible groups per CMS (those with isolated ambulatory or nocturnal hypoxemia) do not benefit from LTOT in RCTs. The other two groups are eligible based on trial data from a small number of patients who were studied more than 40 years ago. These facts raise serious questions about the cost-efficacy of LTOT.
So where does this leave us?
There are significant barriers to repeating large randomized oxygen trials. Due to broad inclusion criteria for LTOT by CMS, there are undoubtedly many people prescribed LTOT for whom there is minimal to no benefit. Patients often feel restricted in their mobility and may feel isolated being tethered to medical equipment. It is good practice to think about LTOT the same way we do any other therapy we provide - as a medicine with associated risks, benefits, and costs.
Despite its ubiquity, oxygen remains an important therapeutic tool. Still, choosing wisely means recognizing that not all patients who qualify for LTOT by CMS criteria will benefit.
Drs. Kreisel and Sonti are with the Division of Pulmonary, Critical Care, and Sleep Medicine, MedStar Georgetown University Hospital, Washington, DC.
Inhalers, nebulizers, antibiotics, and steroids – these are some of the most common tools in our pulmonary arsenal that we deploy on a daily basis. But, there is no treatment more fundamental to a pulmonary practitioner than oxygen. So how is it that something that naturally occurs and comprises 21% of ambient air has become so medicalized?
It is difficult (perhaps impossible) to find a pulmonologist or a hospitalist who has not included the phrase “obtain ambulatory saturation to qualify the patient for home oxygen” in at least one of their progress notes on a daily basis. Chronic obstructive pulmonary disease (COPD) is the most common reason for the prescription of long-term oxygen therapy (LTOT), a large industry tightly regulated by the Centers for Medicare & Medicaid Services (CMS).
The evidence for the use of LTOT in patients with COPD dates back to two seminal papers published in 1980 and 1981. The British Medical Research Council Working Party conducted the BMRC trial, in which 87 patients with a Pa
Another study published around the same time, the Continuous or nocturnal oxygen therapy in hypoxemic chronic obstructive lung disease (NOTT) trial (Ann Intern Med. 1980;93[3]:391-8) directly compared continuous 24-hour to nocturnal home oxygen therapy in patients with COPD and severe hypoxemia with a Pa
Afterward, it became universally accepted dogma that patients with COPD and severe hypoxemia stood to substantially benefit from LTOT. For years, it was the only therapy associated with a mortality reduction. The LOTT study (Albert RK, et al. N Engl J Med. 2016;375[17]:1617-27) included 768 patients with stable COPD and a resting or nocturnal Sp
The INOX (Lacasse Y, et al. N Engl J Med. 2020;383[12]:1129-38) trial, in which 243 patients with oxygen saturation less than 90% for at least 30% of the night were assigned to receive nocturnal vs sham oxygen, found similar results. There was no difference in the composite outcome of all-cause mortality and progression to 24-7 oxygen requirement (according to the criteria originally defined by NOTT). A 2022 systematic review and meta-analysis including six studies designed to assess the role of LTOT in patients with COPD and moderate desaturation, including LOTT and INOX, found no benefit to providing LTOT (Lacasse Y, et al. Lancet Respir Med. 2022;10[11]:1029-37).
Based on these studies, a resting Sp
COPD management has changed significantly in the 40 years since NOTT was published. In the early 1980s, standard of care included an inhaled beta-agonist and oral theophylline. We now prescribe a regimen of modern-day inhaler combinations, which can lead to a mortality benefit in the correct population. Additionally, rates of smoking are markedly lower now than they were in 1980. In the Minnesota Heart Survey, the prevalence of being an ever-smoking man or woman in 1980 compared with 2009 dropped from 71.6% and 54.7% to 44.2% and 39.6%, respectively (Filion KB, et al. Am J Public Health. 2012;102[4]:705-13). Treatment of common comorbid conditions has also dramatically improved.
A report containing all fee-for-service data published in 2021 by CMS reported oxygen therapy accounted for 9.8% of all DME costs covered by CMS and totaled approximately $800,000,000 (Centers for Medicare & Medicaid Services. FFS Data. 2021. This represents a significant financial burden to our health system and government.
Two of the eligible groups per CMS (those with isolated ambulatory or nocturnal hypoxemia) do not benefit from LTOT in RCTs. The other two groups are eligible based on trial data from a small number of patients who were studied more than 40 years ago. These facts raise serious questions about the cost-efficacy of LTOT.
So where does this leave us?
There are significant barriers to repeating large randomized oxygen trials. Due to broad inclusion criteria for LTOT by CMS, there are undoubtedly many people prescribed LTOT for whom there is minimal to no benefit. Patients often feel restricted in their mobility and may feel isolated being tethered to medical equipment. It is good practice to think about LTOT the same way we do any other therapy we provide - as a medicine with associated risks, benefits, and costs.
Despite its ubiquity, oxygen remains an important therapeutic tool. Still, choosing wisely means recognizing that not all patients who qualify for LTOT by CMS criteria will benefit.
Drs. Kreisel and Sonti are with the Division of Pulmonary, Critical Care, and Sleep Medicine, MedStar Georgetown University Hospital, Washington, DC.
Wastewater can signal upswing in flu, RSV
according to new research reported at an annual scientific meeting on infectious diseases.
The analysis of wastewater in Calgary (Alta.) found a “positive correlation” between positivity rates for these three viruses in wastewater and weekly laboratory-confirmed clinical cases and test positivity rates, study investigator Kristine Du, with Cumming School of Medicine, University of Calgary, told this news organization.
Wastewater monitoring of viral activity has become an established tool for COVID-19 pandemic monitoring, providing a leading indicator to cases and hospitalizations. However, less is known about its potential for monitoring endemic respiratory viruses.
The new study shows that wastewater-based surveillance is a “robust and adaptable” tool for community-level surveillance of seasonal respiratory viruses – “one that can complement health care clinical testing because it’s independent from testing biases, and we can actually correlate our cases very well with it,” Ms. Du said during a preconference media briefing.
Tracking community trends
For the study, Ms. Du and colleagues assessed the occurrence of influenza A, influenza B, and RSV RNA in all three wastewater treatment plants in Calgary between March 2022 and April 2023 and its correlation with clinical disease.
They found that viral signals in Calgary’s wastewater for influenza A and B and RSV correlated significantly with weekly confirmed clinical cases in Calgary residents.
Influenza A peaked in Calgary’s wastewater between November and December 2022; influenza B peaked between February and April 2023; and RSV between November 2022 and February 2023.
“Wastewater gives us unbiased, objective, and comprehensive data. It can be used in addition to other testing for assessing the community burden that disease may have, and it is complementary to clinical testing,” Ms. Du said.
Their team, Ms. Du said, is continuing to proactively monitor wastewater for influenza and RSV, as well as other agents of “pandemic potential to make sure we know what could affect humans – and make sure everyone is aware of that.”
Commenting on the research, briefing moderator Belinda Ostrowsky, MD, MPH, Albert Einstein College of Medicine, New York, said, “Wastewater surveillance illustrates how understanding community levels of viral trends can identify hotspots, inform local public health decision-making, and prepare clinicians and hospitals for potential outreach. This topic is particularly timely as we head into the flu and RSV season.”
The study had no commercial funding. Ms. Du and Dr. Ostrowsky report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
according to new research reported at an annual scientific meeting on infectious diseases.
The analysis of wastewater in Calgary (Alta.) found a “positive correlation” between positivity rates for these three viruses in wastewater and weekly laboratory-confirmed clinical cases and test positivity rates, study investigator Kristine Du, with Cumming School of Medicine, University of Calgary, told this news organization.
Wastewater monitoring of viral activity has become an established tool for COVID-19 pandemic monitoring, providing a leading indicator to cases and hospitalizations. However, less is known about its potential for monitoring endemic respiratory viruses.
The new study shows that wastewater-based surveillance is a “robust and adaptable” tool for community-level surveillance of seasonal respiratory viruses – “one that can complement health care clinical testing because it’s independent from testing biases, and we can actually correlate our cases very well with it,” Ms. Du said during a preconference media briefing.
Tracking community trends
For the study, Ms. Du and colleagues assessed the occurrence of influenza A, influenza B, and RSV RNA in all three wastewater treatment plants in Calgary between March 2022 and April 2023 and its correlation with clinical disease.
They found that viral signals in Calgary’s wastewater for influenza A and B and RSV correlated significantly with weekly confirmed clinical cases in Calgary residents.
Influenza A peaked in Calgary’s wastewater between November and December 2022; influenza B peaked between February and April 2023; and RSV between November 2022 and February 2023.
“Wastewater gives us unbiased, objective, and comprehensive data. It can be used in addition to other testing for assessing the community burden that disease may have, and it is complementary to clinical testing,” Ms. Du said.
Their team, Ms. Du said, is continuing to proactively monitor wastewater for influenza and RSV, as well as other agents of “pandemic potential to make sure we know what could affect humans – and make sure everyone is aware of that.”
Commenting on the research, briefing moderator Belinda Ostrowsky, MD, MPH, Albert Einstein College of Medicine, New York, said, “Wastewater surveillance illustrates how understanding community levels of viral trends can identify hotspots, inform local public health decision-making, and prepare clinicians and hospitals for potential outreach. This topic is particularly timely as we head into the flu and RSV season.”
The study had no commercial funding. Ms. Du and Dr. Ostrowsky report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
according to new research reported at an annual scientific meeting on infectious diseases.
The analysis of wastewater in Calgary (Alta.) found a “positive correlation” between positivity rates for these three viruses in wastewater and weekly laboratory-confirmed clinical cases and test positivity rates, study investigator Kristine Du, with Cumming School of Medicine, University of Calgary, told this news organization.
Wastewater monitoring of viral activity has become an established tool for COVID-19 pandemic monitoring, providing a leading indicator to cases and hospitalizations. However, less is known about its potential for monitoring endemic respiratory viruses.
The new study shows that wastewater-based surveillance is a “robust and adaptable” tool for community-level surveillance of seasonal respiratory viruses – “one that can complement health care clinical testing because it’s independent from testing biases, and we can actually correlate our cases very well with it,” Ms. Du said during a preconference media briefing.
Tracking community trends
For the study, Ms. Du and colleagues assessed the occurrence of influenza A, influenza B, and RSV RNA in all three wastewater treatment plants in Calgary between March 2022 and April 2023 and its correlation with clinical disease.
They found that viral signals in Calgary’s wastewater for influenza A and B and RSV correlated significantly with weekly confirmed clinical cases in Calgary residents.
Influenza A peaked in Calgary’s wastewater between November and December 2022; influenza B peaked between February and April 2023; and RSV between November 2022 and February 2023.
“Wastewater gives us unbiased, objective, and comprehensive data. It can be used in addition to other testing for assessing the community burden that disease may have, and it is complementary to clinical testing,” Ms. Du said.
Their team, Ms. Du said, is continuing to proactively monitor wastewater for influenza and RSV, as well as other agents of “pandemic potential to make sure we know what could affect humans – and make sure everyone is aware of that.”
Commenting on the research, briefing moderator Belinda Ostrowsky, MD, MPH, Albert Einstein College of Medicine, New York, said, “Wastewater surveillance illustrates how understanding community levels of viral trends can identify hotspots, inform local public health decision-making, and prepare clinicians and hospitals for potential outreach. This topic is particularly timely as we head into the flu and RSV season.”
The study had no commercial funding. Ms. Du and Dr. Ostrowsky report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM IDWEEK 2023
Highlights of the 2024 Medicare Physician Fee Schedule proposed rule
The suggested Medicare Physician Fee Schedule for calendar year (CY) 2024 was announced by the Centers for Medicare & Medicaid Services (CMS) in July 2023. Physicians who specialize in pulmonary, critical care, and sleep medicine will be impacted by a number of policy and payment changes. Additionally, keep in mind that this is the proposed rule. Following are some of the key points for our readers:
1. The conversion factor that CMS is suggesting for 2024 is $32.75, which represents a $1.14 (–3.34%) reduction. The current conversion factor is $33.89. This is specifically meant to lower total Medicare spending.
2. It is forecast that pulmonary specialists will experience an estimated 1.09% reduction in Medicare reimbursements if the proposed changes are approved. Medicare reimbursements for critical care specialists will be reduced by 2.51%, and sleep medicine specialists will be seeing a 0.75% increase.
3. Interestingly, CMS is proposing a Healthcare Common Procedure Coding System (HCPCS) code G2211 that will have a distinct add-on payment starting on January 1, 2024. With the help of this add-on code, the resource costs of evaluation and management visits for primary care and long-term treatment of difficult patients will be more accurately recognized. In general, it will be used as an additional payment for outpatient office visits in recognition of the potential expenditures that doctors may face when treating a patient’s single, significant, or complex chronic condition over time. Payment for this add-on code would have a redistributive impact on all other CY 2024 payments, which are still lower than what was previously predicted for this policy in CY 2021 under the Medicare Physician Fee Schedule, which was not implemented at the request of various surgical specialties.
4. As you all are aware, split (or shared) E/M visits in hospitals and other institutional settings are those that are provided in part by doctors and in part by other practitioners of the same specialty but billed under a single provider. Thankfully CMS is recommending delaying the application of the “substantive portion” definition of more than 50% of the total period to at least December 31, 2024. Instead, they are going to keep the present definition of the “substantive portion” for CY 2024, which permits use of either more than half of the visit’s total time or one of the three major components (history, exam, or MDM) to determine who bills the visit. Please remember that Critical Care services (99291/99292) may also be shared or split; however, in this case, billing is based only on time.
5. According to CMS’s current regulatory stance, teaching physicians have to be physically present to charge for services involving residents at the end of the COVID-19 Public Health Emergency. Congress, on the other hand, stepped in and passed legislation to expand Medicare coverage of a number of telehealth services. In accordance with the expanded telehealth policies adopted by Congress, CMS is recommending that teaching physicians be permitted to employ audio/video real-time communications technology when the resident physician provides telehealth services to Medicare beneficiaries for CY 2024.
The CMS’s document is fairly comprehensive, so please visit this link for more information
The suggested Medicare Physician Fee Schedule for calendar year (CY) 2024 was announced by the Centers for Medicare & Medicaid Services (CMS) in July 2023. Physicians who specialize in pulmonary, critical care, and sleep medicine will be impacted by a number of policy and payment changes. Additionally, keep in mind that this is the proposed rule. Following are some of the key points for our readers:
1. The conversion factor that CMS is suggesting for 2024 is $32.75, which represents a $1.14 (–3.34%) reduction. The current conversion factor is $33.89. This is specifically meant to lower total Medicare spending.
2. It is forecast that pulmonary specialists will experience an estimated 1.09% reduction in Medicare reimbursements if the proposed changes are approved. Medicare reimbursements for critical care specialists will be reduced by 2.51%, and sleep medicine specialists will be seeing a 0.75% increase.
3. Interestingly, CMS is proposing a Healthcare Common Procedure Coding System (HCPCS) code G2211 that will have a distinct add-on payment starting on January 1, 2024. With the help of this add-on code, the resource costs of evaluation and management visits for primary care and long-term treatment of difficult patients will be more accurately recognized. In general, it will be used as an additional payment for outpatient office visits in recognition of the potential expenditures that doctors may face when treating a patient’s single, significant, or complex chronic condition over time. Payment for this add-on code would have a redistributive impact on all other CY 2024 payments, which are still lower than what was previously predicted for this policy in CY 2021 under the Medicare Physician Fee Schedule, which was not implemented at the request of various surgical specialties.
4. As you all are aware, split (or shared) E/M visits in hospitals and other institutional settings are those that are provided in part by doctors and in part by other practitioners of the same specialty but billed under a single provider. Thankfully CMS is recommending delaying the application of the “substantive portion” definition of more than 50% of the total period to at least December 31, 2024. Instead, they are going to keep the present definition of the “substantive portion” for CY 2024, which permits use of either more than half of the visit’s total time or one of the three major components (history, exam, or MDM) to determine who bills the visit. Please remember that Critical Care services (99291/99292) may also be shared or split; however, in this case, billing is based only on time.
5. According to CMS’s current regulatory stance, teaching physicians have to be physically present to charge for services involving residents at the end of the COVID-19 Public Health Emergency. Congress, on the other hand, stepped in and passed legislation to expand Medicare coverage of a number of telehealth services. In accordance with the expanded telehealth policies adopted by Congress, CMS is recommending that teaching physicians be permitted to employ audio/video real-time communications technology when the resident physician provides telehealth services to Medicare beneficiaries for CY 2024.
The CMS’s document is fairly comprehensive, so please visit this link for more information
The suggested Medicare Physician Fee Schedule for calendar year (CY) 2024 was announced by the Centers for Medicare & Medicaid Services (CMS) in July 2023. Physicians who specialize in pulmonary, critical care, and sleep medicine will be impacted by a number of policy and payment changes. Additionally, keep in mind that this is the proposed rule. Following are some of the key points for our readers:
1. The conversion factor that CMS is suggesting for 2024 is $32.75, which represents a $1.14 (–3.34%) reduction. The current conversion factor is $33.89. This is specifically meant to lower total Medicare spending.
2. It is forecast that pulmonary specialists will experience an estimated 1.09% reduction in Medicare reimbursements if the proposed changes are approved. Medicare reimbursements for critical care specialists will be reduced by 2.51%, and sleep medicine specialists will be seeing a 0.75% increase.
3. Interestingly, CMS is proposing a Healthcare Common Procedure Coding System (HCPCS) code G2211 that will have a distinct add-on payment starting on January 1, 2024. With the help of this add-on code, the resource costs of evaluation and management visits for primary care and long-term treatment of difficult patients will be more accurately recognized. In general, it will be used as an additional payment for outpatient office visits in recognition of the potential expenditures that doctors may face when treating a patient’s single, significant, or complex chronic condition over time. Payment for this add-on code would have a redistributive impact on all other CY 2024 payments, which are still lower than what was previously predicted for this policy in CY 2021 under the Medicare Physician Fee Schedule, which was not implemented at the request of various surgical specialties.
4. As you all are aware, split (or shared) E/M visits in hospitals and other institutional settings are those that are provided in part by doctors and in part by other practitioners of the same specialty but billed under a single provider. Thankfully CMS is recommending delaying the application of the “substantive portion” definition of more than 50% of the total period to at least December 31, 2024. Instead, they are going to keep the present definition of the “substantive portion” for CY 2024, which permits use of either more than half of the visit’s total time or one of the three major components (history, exam, or MDM) to determine who bills the visit. Please remember that Critical Care services (99291/99292) may also be shared or split; however, in this case, billing is based only on time.
5. According to CMS’s current regulatory stance, teaching physicians have to be physically present to charge for services involving residents at the end of the COVID-19 Public Health Emergency. Congress, on the other hand, stepped in and passed legislation to expand Medicare coverage of a number of telehealth services. In accordance with the expanded telehealth policies adopted by Congress, CMS is recommending that teaching physicians be permitted to employ audio/video real-time communications technology when the resident physician provides telehealth services to Medicare beneficiaries for CY 2024.
The CMS’s document is fairly comprehensive, so please visit this link for more information
CHEST launches sepsis resources in partnership with the CDC
Earlier this year, CHEST released new clinical resources on sepsis and antibiotic stewardship developed by the Sepsis Resources Steering Committee with grant support from the US Centers for Disease Control and Prevention (CDC).
The resources – including infographics, videos, podcasts, and research commentaries – aim to help clinicians increase their knowledge of sepsis prevention and treatment, especially when considering the use of antibiotics.
According to CHEST Past President, Steven Q. Simpson, MD, FCCP, who serves as Chair of the Sepsis Resources Steering Committee, sepsis is the number one cause of death in U.S. hospitals . It’s also the most expensive condition treated in those hospitals.
“Perhaps the single most important tool we have to fight sepsis is our array of antimicrobial therapies, including antibacterial, antifungal, and antiviral agents,” Dr. Simpson said. “It is vital that we use the antibiotics we have wisely and preserve them for future use.”
He pointed to the apparent tension between the need to administer broad-spectrum antimicrobials quickly to patients with sepsis and the need to limit the use of broad-spectrum agents as much as possible. But these concepts aren’t at odds with each another, he said. They’re allies in the sepsis war.
CHEST’s new resources can help clinicians practice good antimicrobial stewardship as they balance these needs. Included in the collection is a two-part video discussion exploring conservative and aggressive approaches to antibiotic use in suspected sepsis. A series of podcasts delves into complex sepsis cases, and easy-reference infographics outline key components of an antimicrobial stewardship program, rapid diagnostics for infectious diseases in the ICU, and sepsis mimics.
Steering committee members were chosen from CHEST’s membership for their clinical expertise in sepsis, infectious diseases, and antimicrobial stewardship. The committee selected topics based on current practice and knowledge gaps where education is most needed.
Working with the CDC increases CHEST’s impact in this area. Much of the care of patients with sepsis happens before they reach the ICU. The CDC’s broad reach with general and specialty medical audiences allows CHEST to share these resources with a wide array of clinicians who practice inside and outside of the ICU.
“Cooperation with the CDC gives us an opportunity to spread CHEST’s knowledge and expertise to a much broader audience, making the CDC a powerful partner and allowing us to serve the nation and beyond in a way that we cannot do by ourselves,” Dr. Simpson said.
Access the full collection of sepsis resources at chestnet.org/topic-collections/sepsis.
Earlier this year, CHEST released new clinical resources on sepsis and antibiotic stewardship developed by the Sepsis Resources Steering Committee with grant support from the US Centers for Disease Control and Prevention (CDC).
The resources – including infographics, videos, podcasts, and research commentaries – aim to help clinicians increase their knowledge of sepsis prevention and treatment, especially when considering the use of antibiotics.
According to CHEST Past President, Steven Q. Simpson, MD, FCCP, who serves as Chair of the Sepsis Resources Steering Committee, sepsis is the number one cause of death in U.S. hospitals . It’s also the most expensive condition treated in those hospitals.
“Perhaps the single most important tool we have to fight sepsis is our array of antimicrobial therapies, including antibacterial, antifungal, and antiviral agents,” Dr. Simpson said. “It is vital that we use the antibiotics we have wisely and preserve them for future use.”
He pointed to the apparent tension between the need to administer broad-spectrum antimicrobials quickly to patients with sepsis and the need to limit the use of broad-spectrum agents as much as possible. But these concepts aren’t at odds with each another, he said. They’re allies in the sepsis war.
CHEST’s new resources can help clinicians practice good antimicrobial stewardship as they balance these needs. Included in the collection is a two-part video discussion exploring conservative and aggressive approaches to antibiotic use in suspected sepsis. A series of podcasts delves into complex sepsis cases, and easy-reference infographics outline key components of an antimicrobial stewardship program, rapid diagnostics for infectious diseases in the ICU, and sepsis mimics.
Steering committee members were chosen from CHEST’s membership for their clinical expertise in sepsis, infectious diseases, and antimicrobial stewardship. The committee selected topics based on current practice and knowledge gaps where education is most needed.
Working with the CDC increases CHEST’s impact in this area. Much of the care of patients with sepsis happens before they reach the ICU. The CDC’s broad reach with general and specialty medical audiences allows CHEST to share these resources with a wide array of clinicians who practice inside and outside of the ICU.
“Cooperation with the CDC gives us an opportunity to spread CHEST’s knowledge and expertise to a much broader audience, making the CDC a powerful partner and allowing us to serve the nation and beyond in a way that we cannot do by ourselves,” Dr. Simpson said.
Access the full collection of sepsis resources at chestnet.org/topic-collections/sepsis.
Earlier this year, CHEST released new clinical resources on sepsis and antibiotic stewardship developed by the Sepsis Resources Steering Committee with grant support from the US Centers for Disease Control and Prevention (CDC).
The resources – including infographics, videos, podcasts, and research commentaries – aim to help clinicians increase their knowledge of sepsis prevention and treatment, especially when considering the use of antibiotics.
According to CHEST Past President, Steven Q. Simpson, MD, FCCP, who serves as Chair of the Sepsis Resources Steering Committee, sepsis is the number one cause of death in U.S. hospitals . It’s also the most expensive condition treated in those hospitals.
“Perhaps the single most important tool we have to fight sepsis is our array of antimicrobial therapies, including antibacterial, antifungal, and antiviral agents,” Dr. Simpson said. “It is vital that we use the antibiotics we have wisely and preserve them for future use.”
He pointed to the apparent tension between the need to administer broad-spectrum antimicrobials quickly to patients with sepsis and the need to limit the use of broad-spectrum agents as much as possible. But these concepts aren’t at odds with each another, he said. They’re allies in the sepsis war.
CHEST’s new resources can help clinicians practice good antimicrobial stewardship as they balance these needs. Included in the collection is a two-part video discussion exploring conservative and aggressive approaches to antibiotic use in suspected sepsis. A series of podcasts delves into complex sepsis cases, and easy-reference infographics outline key components of an antimicrobial stewardship program, rapid diagnostics for infectious diseases in the ICU, and sepsis mimics.
Steering committee members were chosen from CHEST’s membership for their clinical expertise in sepsis, infectious diseases, and antimicrobial stewardship. The committee selected topics based on current practice and knowledge gaps where education is most needed.
Working with the CDC increases CHEST’s impact in this area. Much of the care of patients with sepsis happens before they reach the ICU. The CDC’s broad reach with general and specialty medical audiences allows CHEST to share these resources with a wide array of clinicians who practice inside and outside of the ICU.
“Cooperation with the CDC gives us an opportunity to spread CHEST’s knowledge and expertise to a much broader audience, making the CDC a powerful partner and allowing us to serve the nation and beyond in a way that we cannot do by ourselves,” Dr. Simpson said.
Access the full collection of sepsis resources at chestnet.org/topic-collections/sepsis.
CHEST philanthropy: Moving into the future
In an ideal world, change would be progressive, the direction would be clear, and adoption would be easy. We learned in these past few years that sometimes change cannot wait. The vulnerabilities of the health care system were laid bare by the pandemic, including vast disparities in treatment and the urgent need to grow our profession.
In the light of these truths, CHEST looked within and asked a difficult question: Are we doing everything we can? This question probably sounds very familiar – one you ask every day, one you know the importance of asking. It was time we asked it of ourselves.
Milestones are a good time to reevaluate
Philanthropy is not new to CHEST. We celebrated 25 years of the CHEST Foundation in Nashville during CHEST 2022. Stories about community and clinical research grants were circulated in website blogs, emails, and newsletters and on social media for years. Our committee member volunteers worked hard developing accurate and credible patient education content for the CHEST Foundation website. Because of our faithful donors, communities around the world had access to better medical care and healthier environments.
This is amazing work, but it was time to ask:
- What can CHEST provide that others cannot?
- Where are the gaps we can fill?
- What is our community passionate about changing?
Working collectively, CHEST and CHEST Foundation leadership, along with staff, rigorously reviewed the success of our past fundraising efforts, areas of commitment our donors had specified, and the direction of interest our membership was leading us toward – like social accountability, growth and diversification of our profession, grassroots community impact, and partnerships to expand our reach. The process took nearly a year to complete – but, in the realm of big changes, that’s equal to the time needed for one good, deep breath.
Focusing on significant change means narrowing our scope
Meeting these goals would mean changing how we worked and letting go of areas better served elsewhere. CHEST needed to:
1. Align philanthropy with our mission to elevate the value placed on giving, making it a core priority and responsibility of CHEST as an organization.
2. Consolidate philanthropy under CHEST to reduce administrative costs and create efficiencies, allowing more funds to go directly to our philanthropic efforts.
3. Establish clear and transparent areas of giving that resonate with our members as a way to grow our impact and make real change.
With the full support of the CHEST Board of Regents, the CHEST Foundation Board of Advisors – under the guidance of Advisory Chair, Robert De Marco, MD, FCCP, and CHEST Foundation President, Ian Nathanson, MD, FCCP – approved a merger of the CHEST Foundation with CHEST.
In order to increase our impact and create greater awareness of CHEST philanthropic efforts, the Board of Advisors got to work defining a giving strategy that would meet the philanthropic goals and priorities of the CHEST membership. Four areas were defined and are referred to as our philanthropic pillars: clinical research, community impact, support of the profession, and dedication to education.
These pillars were approved by the Board of Regents at their spring leadership meeting.
Giving goals without support are just dreams
This transition puts the responsibility for funding the giving pillars in the hands of CHEST. The first step is ensuring the members see the impact of their donations.
“When you see your donation in action, you never doubt that you made a good decision,” said CHEST CEO, Robert A. Musacchio, PhD. “If we can show that to every member, the next 25 years of CHEST philanthropy are limitless.”
Helping connect donors to that experience is Meggie Cramer, the new Director of Philanthropy and Advancement , who has experience working directly with health care systems like Rush University Medical Center in Chicago and Hospital Sister Health System in Green Bay, Wisconsin.
“When you are giving to programs you are passionate about, you feel good about being a part of making a difference,” explained Cramer. “That’s my goal – to help our members find areas they care about and know their gift is part of creating real change.”
For frequently asked questions about the transition, please visit our website.
In an ideal world, change would be progressive, the direction would be clear, and adoption would be easy. We learned in these past few years that sometimes change cannot wait. The vulnerabilities of the health care system were laid bare by the pandemic, including vast disparities in treatment and the urgent need to grow our profession.
In the light of these truths, CHEST looked within and asked a difficult question: Are we doing everything we can? This question probably sounds very familiar – one you ask every day, one you know the importance of asking. It was time we asked it of ourselves.
Milestones are a good time to reevaluate
Philanthropy is not new to CHEST. We celebrated 25 years of the CHEST Foundation in Nashville during CHEST 2022. Stories about community and clinical research grants were circulated in website blogs, emails, and newsletters and on social media for years. Our committee member volunteers worked hard developing accurate and credible patient education content for the CHEST Foundation website. Because of our faithful donors, communities around the world had access to better medical care and healthier environments.
This is amazing work, but it was time to ask:
- What can CHEST provide that others cannot?
- Where are the gaps we can fill?
- What is our community passionate about changing?
Working collectively, CHEST and CHEST Foundation leadership, along with staff, rigorously reviewed the success of our past fundraising efforts, areas of commitment our donors had specified, and the direction of interest our membership was leading us toward – like social accountability, growth and diversification of our profession, grassroots community impact, and partnerships to expand our reach. The process took nearly a year to complete – but, in the realm of big changes, that’s equal to the time needed for one good, deep breath.
Focusing on significant change means narrowing our scope
Meeting these goals would mean changing how we worked and letting go of areas better served elsewhere. CHEST needed to:
1. Align philanthropy with our mission to elevate the value placed on giving, making it a core priority and responsibility of CHEST as an organization.
2. Consolidate philanthropy under CHEST to reduce administrative costs and create efficiencies, allowing more funds to go directly to our philanthropic efforts.
3. Establish clear and transparent areas of giving that resonate with our members as a way to grow our impact and make real change.
With the full support of the CHEST Board of Regents, the CHEST Foundation Board of Advisors – under the guidance of Advisory Chair, Robert De Marco, MD, FCCP, and CHEST Foundation President, Ian Nathanson, MD, FCCP – approved a merger of the CHEST Foundation with CHEST.
In order to increase our impact and create greater awareness of CHEST philanthropic efforts, the Board of Advisors got to work defining a giving strategy that would meet the philanthropic goals and priorities of the CHEST membership. Four areas were defined and are referred to as our philanthropic pillars: clinical research, community impact, support of the profession, and dedication to education.
These pillars were approved by the Board of Regents at their spring leadership meeting.
Giving goals without support are just dreams
This transition puts the responsibility for funding the giving pillars in the hands of CHEST. The first step is ensuring the members see the impact of their donations.
“When you see your donation in action, you never doubt that you made a good decision,” said CHEST CEO, Robert A. Musacchio, PhD. “If we can show that to every member, the next 25 years of CHEST philanthropy are limitless.”
Helping connect donors to that experience is Meggie Cramer, the new Director of Philanthropy and Advancement , who has experience working directly with health care systems like Rush University Medical Center in Chicago and Hospital Sister Health System in Green Bay, Wisconsin.
“When you are giving to programs you are passionate about, you feel good about being a part of making a difference,” explained Cramer. “That’s my goal – to help our members find areas they care about and know their gift is part of creating real change.”
For frequently asked questions about the transition, please visit our website.
In an ideal world, change would be progressive, the direction would be clear, and adoption would be easy. We learned in these past few years that sometimes change cannot wait. The vulnerabilities of the health care system were laid bare by the pandemic, including vast disparities in treatment and the urgent need to grow our profession.
In the light of these truths, CHEST looked within and asked a difficult question: Are we doing everything we can? This question probably sounds very familiar – one you ask every day, one you know the importance of asking. It was time we asked it of ourselves.
Milestones are a good time to reevaluate
Philanthropy is not new to CHEST. We celebrated 25 years of the CHEST Foundation in Nashville during CHEST 2022. Stories about community and clinical research grants were circulated in website blogs, emails, and newsletters and on social media for years. Our committee member volunteers worked hard developing accurate and credible patient education content for the CHEST Foundation website. Because of our faithful donors, communities around the world had access to better medical care and healthier environments.
This is amazing work, but it was time to ask:
- What can CHEST provide that others cannot?
- Where are the gaps we can fill?
- What is our community passionate about changing?
Working collectively, CHEST and CHEST Foundation leadership, along with staff, rigorously reviewed the success of our past fundraising efforts, areas of commitment our donors had specified, and the direction of interest our membership was leading us toward – like social accountability, growth and diversification of our profession, grassroots community impact, and partnerships to expand our reach. The process took nearly a year to complete – but, in the realm of big changes, that’s equal to the time needed for one good, deep breath.
Focusing on significant change means narrowing our scope
Meeting these goals would mean changing how we worked and letting go of areas better served elsewhere. CHEST needed to:
1. Align philanthropy with our mission to elevate the value placed on giving, making it a core priority and responsibility of CHEST as an organization.
2. Consolidate philanthropy under CHEST to reduce administrative costs and create efficiencies, allowing more funds to go directly to our philanthropic efforts.
3. Establish clear and transparent areas of giving that resonate with our members as a way to grow our impact and make real change.
With the full support of the CHEST Board of Regents, the CHEST Foundation Board of Advisors – under the guidance of Advisory Chair, Robert De Marco, MD, FCCP, and CHEST Foundation President, Ian Nathanson, MD, FCCP – approved a merger of the CHEST Foundation with CHEST.
In order to increase our impact and create greater awareness of CHEST philanthropic efforts, the Board of Advisors got to work defining a giving strategy that would meet the philanthropic goals and priorities of the CHEST membership. Four areas were defined and are referred to as our philanthropic pillars: clinical research, community impact, support of the profession, and dedication to education.
These pillars were approved by the Board of Regents at their spring leadership meeting.
Giving goals without support are just dreams
This transition puts the responsibility for funding the giving pillars in the hands of CHEST. The first step is ensuring the members see the impact of their donations.
“When you see your donation in action, you never doubt that you made a good decision,” said CHEST CEO, Robert A. Musacchio, PhD. “If we can show that to every member, the next 25 years of CHEST philanthropy are limitless.”
Helping connect donors to that experience is Meggie Cramer, the new Director of Philanthropy and Advancement , who has experience working directly with health care systems like Rush University Medical Center in Chicago and Hospital Sister Health System in Green Bay, Wisconsin.
“When you are giving to programs you are passionate about, you feel good about being a part of making a difference,” explained Cramer. “That’s my goal – to help our members find areas they care about and know their gift is part of creating real change.”
For frequently asked questions about the transition, please visit our website.
CHEST Advocates raises awareness against tobacco use
“Ew, gross.”
“Um, no way.”
“Of course not.”
Earlier this summer, I partnered with Dr. Melissa Keene, the medical director of a federally qualified health center in southwest Virginia, to talk about tobacco with middle school students. A few minutes after our arrival, it was clear to us that cigarettes weren’t cool anymore.
We asked hundreds of kids if they or their friends smoked cigarettes. The above quoted responses were repeated over and over.
Tobacco health advocates have spent decades working on public health messaging surrounding cigarette use, which is clearly working in this Virginian middle school.
But our patients, friends, and family who are already dependent on tobacco products still face addiction, morbidity, and premature mortality. And the ever-changing forms of tobacco delivery pose new challenges for our collective cessation efforts.
The Summer 2023 issue of CHEST Advocates features parents, lawyers, doctors, and nonprofit leaders who all share their inspiring stories of action in the fight against tobacco use.
Learn from tobacco experts, Dr. Susan Walley and Dr. Evan Stepp, about evidence-based approaches to tobacco cessation in young people –including why we should start having conversations by age 11 about smoking or vaping and why it’s important to inform youth about big tobacco marketing strategies.
Read an interview with Dr. Anne Melzer, who shares lessons from her career in tobacco advocacy centered in a US veteran population. Dr. Melzer suggests free resources that are available to all clinicians who sometimes struggle to help patients find the best way to quit.
Watch a video of Dr. Iyaad Hasan and Dr. Roy St. John, who run The Breathing Association, a nonprofit in Ohio serving individuals who are underinsured or uninsured. This organization offers a mobile medical unit that provides a free, evidenced-based program to help with smoking cessation via education, counseling, and personalized quit plans.
Learn from Natasha Phelps, JD, the Director of Equity-Centered Policies at The Center for Black Health & Equity. For more than 2 decades, this organization has focused on building community capacity to give local constituents the tools needed for sustainable health improvements, including tobacco cessation.
Hear from Dr. Panagiotis Behrakis, who – after decades of advocacy against tobacco use—the World Health Organization recognized in May for his Smoke Free Greece program. He explains why his work focuses on a two-pronged approach that places equal emphasis on both cessation and prevention.
Listen to a podcast featuring an amazing organization called Parents Against Vaping e-cigarettes, which started in response to a predatory marketing strategy by a tobacco company in a school system.
See how CHEST is fighting the battle against smoking and vaping, as told by Dr. Frank Leone, Chair of the Tobacco/Vaping Work Group for the CHEST Health Policy and Advocacy Committee. And, lastly, interact with a timeline of CHEST’s advocacy work in tobacco cessation and regulation through the decades.
As Dr. Melzer so eloquently stated in her interview featured in this issue, “tobacco cessation is a process that belongs to everybody, and, therefore, sometimes to nobody.” We hope this issue will inspire you to advocate for your patients and partner with your communities in our shared mission to improve education, awareness, and action against tobacco use.
“Ew, gross.”
“Um, no way.”
“Of course not.”
Earlier this summer, I partnered with Dr. Melissa Keene, the medical director of a federally qualified health center in southwest Virginia, to talk about tobacco with middle school students. A few minutes after our arrival, it was clear to us that cigarettes weren’t cool anymore.
We asked hundreds of kids if they or their friends smoked cigarettes. The above quoted responses were repeated over and over.
Tobacco health advocates have spent decades working on public health messaging surrounding cigarette use, which is clearly working in this Virginian middle school.
But our patients, friends, and family who are already dependent on tobacco products still face addiction, morbidity, and premature mortality. And the ever-changing forms of tobacco delivery pose new challenges for our collective cessation efforts.
The Summer 2023 issue of CHEST Advocates features parents, lawyers, doctors, and nonprofit leaders who all share their inspiring stories of action in the fight against tobacco use.
Learn from tobacco experts, Dr. Susan Walley and Dr. Evan Stepp, about evidence-based approaches to tobacco cessation in young people –including why we should start having conversations by age 11 about smoking or vaping and why it’s important to inform youth about big tobacco marketing strategies.
Read an interview with Dr. Anne Melzer, who shares lessons from her career in tobacco advocacy centered in a US veteran population. Dr. Melzer suggests free resources that are available to all clinicians who sometimes struggle to help patients find the best way to quit.
Watch a video of Dr. Iyaad Hasan and Dr. Roy St. John, who run The Breathing Association, a nonprofit in Ohio serving individuals who are underinsured or uninsured. This organization offers a mobile medical unit that provides a free, evidenced-based program to help with smoking cessation via education, counseling, and personalized quit plans.
Learn from Natasha Phelps, JD, the Director of Equity-Centered Policies at The Center for Black Health & Equity. For more than 2 decades, this organization has focused on building community capacity to give local constituents the tools needed for sustainable health improvements, including tobacco cessation.
Hear from Dr. Panagiotis Behrakis, who – after decades of advocacy against tobacco use—the World Health Organization recognized in May for his Smoke Free Greece program. He explains why his work focuses on a two-pronged approach that places equal emphasis on both cessation and prevention.
Listen to a podcast featuring an amazing organization called Parents Against Vaping e-cigarettes, which started in response to a predatory marketing strategy by a tobacco company in a school system.
See how CHEST is fighting the battle against smoking and vaping, as told by Dr. Frank Leone, Chair of the Tobacco/Vaping Work Group for the CHEST Health Policy and Advocacy Committee. And, lastly, interact with a timeline of CHEST’s advocacy work in tobacco cessation and regulation through the decades.
As Dr. Melzer so eloquently stated in her interview featured in this issue, “tobacco cessation is a process that belongs to everybody, and, therefore, sometimes to nobody.” We hope this issue will inspire you to advocate for your patients and partner with your communities in our shared mission to improve education, awareness, and action against tobacco use.
“Ew, gross.”
“Um, no way.”
“Of course not.”
Earlier this summer, I partnered with Dr. Melissa Keene, the medical director of a federally qualified health center in southwest Virginia, to talk about tobacco with middle school students. A few minutes after our arrival, it was clear to us that cigarettes weren’t cool anymore.
We asked hundreds of kids if they or their friends smoked cigarettes. The above quoted responses were repeated over and over.
Tobacco health advocates have spent decades working on public health messaging surrounding cigarette use, which is clearly working in this Virginian middle school.
But our patients, friends, and family who are already dependent on tobacco products still face addiction, morbidity, and premature mortality. And the ever-changing forms of tobacco delivery pose new challenges for our collective cessation efforts.
The Summer 2023 issue of CHEST Advocates features parents, lawyers, doctors, and nonprofit leaders who all share their inspiring stories of action in the fight against tobacco use.
Learn from tobacco experts, Dr. Susan Walley and Dr. Evan Stepp, about evidence-based approaches to tobacco cessation in young people –including why we should start having conversations by age 11 about smoking or vaping and why it’s important to inform youth about big tobacco marketing strategies.
Read an interview with Dr. Anne Melzer, who shares lessons from her career in tobacco advocacy centered in a US veteran population. Dr. Melzer suggests free resources that are available to all clinicians who sometimes struggle to help patients find the best way to quit.
Watch a video of Dr. Iyaad Hasan and Dr. Roy St. John, who run The Breathing Association, a nonprofit in Ohio serving individuals who are underinsured or uninsured. This organization offers a mobile medical unit that provides a free, evidenced-based program to help with smoking cessation via education, counseling, and personalized quit plans.
Learn from Natasha Phelps, JD, the Director of Equity-Centered Policies at The Center for Black Health & Equity. For more than 2 decades, this organization has focused on building community capacity to give local constituents the tools needed for sustainable health improvements, including tobacco cessation.
Hear from Dr. Panagiotis Behrakis, who – after decades of advocacy against tobacco use—the World Health Organization recognized in May for his Smoke Free Greece program. He explains why his work focuses on a two-pronged approach that places equal emphasis on both cessation and prevention.
Listen to a podcast featuring an amazing organization called Parents Against Vaping e-cigarettes, which started in response to a predatory marketing strategy by a tobacco company in a school system.
See how CHEST is fighting the battle against smoking and vaping, as told by Dr. Frank Leone, Chair of the Tobacco/Vaping Work Group for the CHEST Health Policy and Advocacy Committee. And, lastly, interact with a timeline of CHEST’s advocacy work in tobacco cessation and regulation through the decades.
As Dr. Melzer so eloquently stated in her interview featured in this issue, “tobacco cessation is a process that belongs to everybody, and, therefore, sometimes to nobody.” We hope this issue will inspire you to advocate for your patients and partner with your communities in our shared mission to improve education, awareness, and action against tobacco use.
Pediatric sleep-disordered breathing linked to multilevel risk factors
In the first study evaluating pediatric sleep-disordered breathing (SDB) from both indoor environment and neighborhood perspectives, multilevel risk factors were revealed as being associated with SDB-related symptoms. Beyond known associations with environmental tobacco smoke (ETS), .
Although it has been well known that pediatric SDB affects low socioeconomic status (SES) children disproportionately, the roles of multilevel risk factor drivers including individual health, household SES, indoor exposures to environmental tobacco smoke, pests, and neighborhood characteristics have not been well studied, Gueye-Ndiaye et al. wrote in CHEST Pulmonary.
Pediatric SDB, a known risk factor for many health, neurobehavioral, and functional outcomes, includes habitual snoring and obstructive sleep apnea and may contribute to health disparities. Adenotonsillar hypertrophy and obesity are the most commonly recognized risk factors for SDB in generally healthy school-aged children. A role for other risk factors, however, is suggested by the fact that Black children have a fourfold increased risk for obstructive sleep apnea (OSA), compared with White children, unexplained by obesity, and have decreased response to treatment of OSA with adenotonsillectomy, compared with White children. Several studies point in the direction of neighborhood disadvantages as factors in heightened SDB prevalence or severity, Gueye-Ndiaye et al. stated.
The authors performed cross-sectional analyses on data recorded from 303 children (aged 6-12 years) enrolled in the Environmental Assessment of Sleep Youth (EASY) study from 2018 to 2022. Among them, 39% were Hispanic, Latino, Latina, or Spanish origin, 30% were Black or African American, 22% were White, and 11% were other. Maternal education attainment of a high school diploma or less was reported in 27%, and 65% of the sample lived in disadvantaged neighborhoods. Twenty-eight percent of children met criteria for objective SDB (Apnea-Hypopnea Index/Oxygen Desaturation Index ≥ 5/hr). Exposure documentation was informed by caregiver reports, assays of measured settled dust from the child’s bedroom, and neighborhood-level census data from which the Childhood Opportunity Index characterizing neighborhood disadvantage (ND) was derived. The study primary outcome was the SDB-related symptom burden assessed by the OSA-18 questionnaire total score.
Compared with children with no adverse indoor exposures to ETS and pests, children with such exposures had an approximately 4-12 point increase in total OSA-18 scores, and the increase among those with exposure to both ETS and pests was about 20 points (approximately a 1.3 standard deviation increase), Gueye-Ndiaye et al. reported.
In models adjusted for age, sex, minority race, and ethnicity, low maternal education was associated with a 7.55 (95% confidence interval, 3.44-11.66; P < .01) increased OSA-18 score. In models adjusted for sociodemographics including maternal education, history of asthma and allergic rhinitis were associated with a 13.63 (95% CI, 9.44-17.82; P < .01) and a 6.95 (95% CI, 2.62-11.29; P < .02) increased OSA-18 score, respectively. The authors noted that prior Canadian studies have shown OSA to be three times as likely in children with mothers reporting less than a high school education than in children with university educated mothers.
Speculating on the drivers of this association, they noted that the poor air quality due to tobacco smoke and allergen exposures to rodents, mold, and cockroaches are known contributors to asthma symptoms. Despite the differing pathogenesis of OSA and asthma, they suggest overlapping risk factors. Irritants and allergens may exacerbate SDB by stimulating immune responses manifested as adenotonsillar hypertrophy and by amplifying nasopharyngeal inflammation, adversely affecting upper airway patency. While ETS was not common in the sample, it was associated strongly with SDB. Gueye-Ndiaye et al. also showed associations between pest exposure, bedroom dust, and SDB symptoms. The findings, they concluded, support the importance of household- and bedroom-environmental conditions and sleep health.
OSA-18 scores were also elevated by about 7-14 points with allergic rhinitis and asthma, respectively. The findings, Gueye-Ndiaye et al. stated, underscore that asthma prevention strategies can be leveraged to address SDB disparities. No amplification of pest exposure effects, however, was found for asthma or allergic rhinitis.
“This is an incredibly important study, one that adds to our understanding of the risk factors that contribute to pediatric sleep health disparities,” said assistant professor of pediatrics Anne C. Coates, MD, Tufts University, Boston. “We have previously understood risk factors for sleep-disordered breathing like adenotonsillar hypertrophy, but this adds other elements like environmental tobacco smoke, pests, and home and neighborhood factors,” she told this news organization. “One of the most important takeaways is that beyond the importance of accurate diagnosis, there is the importance of advocating for our patients to ensure that they have the healthiest homes and neighborhoods. We need to inspire our colleagues to be advocates – for example – for pest mitigation, for antismoking policies, for every policy preventing the factors that contribute to the burden of disease.”
Dr. Coates is coauthor of “Advocacy and Health Equity: The Role of the Pediatric Pulmonologist,” currently in press (Clinics in Chest Medicine), and a member of the CHEST Physician Editorial Board.
The authors noted that a study limitation was that the sample was from one geographic area (Boston). Neither the authors nor Dr. Coates listed any conflicts.
In the first study evaluating pediatric sleep-disordered breathing (SDB) from both indoor environment and neighborhood perspectives, multilevel risk factors were revealed as being associated with SDB-related symptoms. Beyond known associations with environmental tobacco smoke (ETS), .
Although it has been well known that pediatric SDB affects low socioeconomic status (SES) children disproportionately, the roles of multilevel risk factor drivers including individual health, household SES, indoor exposures to environmental tobacco smoke, pests, and neighborhood characteristics have not been well studied, Gueye-Ndiaye et al. wrote in CHEST Pulmonary.
Pediatric SDB, a known risk factor for many health, neurobehavioral, and functional outcomes, includes habitual snoring and obstructive sleep apnea and may contribute to health disparities. Adenotonsillar hypertrophy and obesity are the most commonly recognized risk factors for SDB in generally healthy school-aged children. A role for other risk factors, however, is suggested by the fact that Black children have a fourfold increased risk for obstructive sleep apnea (OSA), compared with White children, unexplained by obesity, and have decreased response to treatment of OSA with adenotonsillectomy, compared with White children. Several studies point in the direction of neighborhood disadvantages as factors in heightened SDB prevalence or severity, Gueye-Ndiaye et al. stated.
The authors performed cross-sectional analyses on data recorded from 303 children (aged 6-12 years) enrolled in the Environmental Assessment of Sleep Youth (EASY) study from 2018 to 2022. Among them, 39% were Hispanic, Latino, Latina, or Spanish origin, 30% were Black or African American, 22% were White, and 11% were other. Maternal education attainment of a high school diploma or less was reported in 27%, and 65% of the sample lived in disadvantaged neighborhoods. Twenty-eight percent of children met criteria for objective SDB (Apnea-Hypopnea Index/Oxygen Desaturation Index ≥ 5/hr). Exposure documentation was informed by caregiver reports, assays of measured settled dust from the child’s bedroom, and neighborhood-level census data from which the Childhood Opportunity Index characterizing neighborhood disadvantage (ND) was derived. The study primary outcome was the SDB-related symptom burden assessed by the OSA-18 questionnaire total score.
Compared with children with no adverse indoor exposures to ETS and pests, children with such exposures had an approximately 4-12 point increase in total OSA-18 scores, and the increase among those with exposure to both ETS and pests was about 20 points (approximately a 1.3 standard deviation increase), Gueye-Ndiaye et al. reported.
In models adjusted for age, sex, minority race, and ethnicity, low maternal education was associated with a 7.55 (95% confidence interval, 3.44-11.66; P < .01) increased OSA-18 score. In models adjusted for sociodemographics including maternal education, history of asthma and allergic rhinitis were associated with a 13.63 (95% CI, 9.44-17.82; P < .01) and a 6.95 (95% CI, 2.62-11.29; P < .02) increased OSA-18 score, respectively. The authors noted that prior Canadian studies have shown OSA to be three times as likely in children with mothers reporting less than a high school education than in children with university educated mothers.
Speculating on the drivers of this association, they noted that the poor air quality due to tobacco smoke and allergen exposures to rodents, mold, and cockroaches are known contributors to asthma symptoms. Despite the differing pathogenesis of OSA and asthma, they suggest overlapping risk factors. Irritants and allergens may exacerbate SDB by stimulating immune responses manifested as adenotonsillar hypertrophy and by amplifying nasopharyngeal inflammation, adversely affecting upper airway patency. While ETS was not common in the sample, it was associated strongly with SDB. Gueye-Ndiaye et al. also showed associations between pest exposure, bedroom dust, and SDB symptoms. The findings, they concluded, support the importance of household- and bedroom-environmental conditions and sleep health.
OSA-18 scores were also elevated by about 7-14 points with allergic rhinitis and asthma, respectively. The findings, Gueye-Ndiaye et al. stated, underscore that asthma prevention strategies can be leveraged to address SDB disparities. No amplification of pest exposure effects, however, was found for asthma or allergic rhinitis.
“This is an incredibly important study, one that adds to our understanding of the risk factors that contribute to pediatric sleep health disparities,” said assistant professor of pediatrics Anne C. Coates, MD, Tufts University, Boston. “We have previously understood risk factors for sleep-disordered breathing like adenotonsillar hypertrophy, but this adds other elements like environmental tobacco smoke, pests, and home and neighborhood factors,” she told this news organization. “One of the most important takeaways is that beyond the importance of accurate diagnosis, there is the importance of advocating for our patients to ensure that they have the healthiest homes and neighborhoods. We need to inspire our colleagues to be advocates – for example – for pest mitigation, for antismoking policies, for every policy preventing the factors that contribute to the burden of disease.”
Dr. Coates is coauthor of “Advocacy and Health Equity: The Role of the Pediatric Pulmonologist,” currently in press (Clinics in Chest Medicine), and a member of the CHEST Physician Editorial Board.
The authors noted that a study limitation was that the sample was from one geographic area (Boston). Neither the authors nor Dr. Coates listed any conflicts.
In the first study evaluating pediatric sleep-disordered breathing (SDB) from both indoor environment and neighborhood perspectives, multilevel risk factors were revealed as being associated with SDB-related symptoms. Beyond known associations with environmental tobacco smoke (ETS), .
Although it has been well known that pediatric SDB affects low socioeconomic status (SES) children disproportionately, the roles of multilevel risk factor drivers including individual health, household SES, indoor exposures to environmental tobacco smoke, pests, and neighborhood characteristics have not been well studied, Gueye-Ndiaye et al. wrote in CHEST Pulmonary.
Pediatric SDB, a known risk factor for many health, neurobehavioral, and functional outcomes, includes habitual snoring and obstructive sleep apnea and may contribute to health disparities. Adenotonsillar hypertrophy and obesity are the most commonly recognized risk factors for SDB in generally healthy school-aged children. A role for other risk factors, however, is suggested by the fact that Black children have a fourfold increased risk for obstructive sleep apnea (OSA), compared with White children, unexplained by obesity, and have decreased response to treatment of OSA with adenotonsillectomy, compared with White children. Several studies point in the direction of neighborhood disadvantages as factors in heightened SDB prevalence or severity, Gueye-Ndiaye et al. stated.
The authors performed cross-sectional analyses on data recorded from 303 children (aged 6-12 years) enrolled in the Environmental Assessment of Sleep Youth (EASY) study from 2018 to 2022. Among them, 39% were Hispanic, Latino, Latina, or Spanish origin, 30% were Black or African American, 22% were White, and 11% were other. Maternal education attainment of a high school diploma or less was reported in 27%, and 65% of the sample lived in disadvantaged neighborhoods. Twenty-eight percent of children met criteria for objective SDB (Apnea-Hypopnea Index/Oxygen Desaturation Index ≥ 5/hr). Exposure documentation was informed by caregiver reports, assays of measured settled dust from the child’s bedroom, and neighborhood-level census data from which the Childhood Opportunity Index characterizing neighborhood disadvantage (ND) was derived. The study primary outcome was the SDB-related symptom burden assessed by the OSA-18 questionnaire total score.
Compared with children with no adverse indoor exposures to ETS and pests, children with such exposures had an approximately 4-12 point increase in total OSA-18 scores, and the increase among those with exposure to both ETS and pests was about 20 points (approximately a 1.3 standard deviation increase), Gueye-Ndiaye et al. reported.
In models adjusted for age, sex, minority race, and ethnicity, low maternal education was associated with a 7.55 (95% confidence interval, 3.44-11.66; P < .01) increased OSA-18 score. In models adjusted for sociodemographics including maternal education, history of asthma and allergic rhinitis were associated with a 13.63 (95% CI, 9.44-17.82; P < .01) and a 6.95 (95% CI, 2.62-11.29; P < .02) increased OSA-18 score, respectively. The authors noted that prior Canadian studies have shown OSA to be three times as likely in children with mothers reporting less than a high school education than in children with university educated mothers.
Speculating on the drivers of this association, they noted that the poor air quality due to tobacco smoke and allergen exposures to rodents, mold, and cockroaches are known contributors to asthma symptoms. Despite the differing pathogenesis of OSA and asthma, they suggest overlapping risk factors. Irritants and allergens may exacerbate SDB by stimulating immune responses manifested as adenotonsillar hypertrophy and by amplifying nasopharyngeal inflammation, adversely affecting upper airway patency. While ETS was not common in the sample, it was associated strongly with SDB. Gueye-Ndiaye et al. also showed associations between pest exposure, bedroom dust, and SDB symptoms. The findings, they concluded, support the importance of household- and bedroom-environmental conditions and sleep health.
OSA-18 scores were also elevated by about 7-14 points with allergic rhinitis and asthma, respectively. The findings, Gueye-Ndiaye et al. stated, underscore that asthma prevention strategies can be leveraged to address SDB disparities. No amplification of pest exposure effects, however, was found for asthma or allergic rhinitis.
“This is an incredibly important study, one that adds to our understanding of the risk factors that contribute to pediatric sleep health disparities,” said assistant professor of pediatrics Anne C. Coates, MD, Tufts University, Boston. “We have previously understood risk factors for sleep-disordered breathing like adenotonsillar hypertrophy, but this adds other elements like environmental tobacco smoke, pests, and home and neighborhood factors,” she told this news organization. “One of the most important takeaways is that beyond the importance of accurate diagnosis, there is the importance of advocating for our patients to ensure that they have the healthiest homes and neighborhoods. We need to inspire our colleagues to be advocates – for example – for pest mitigation, for antismoking policies, for every policy preventing the factors that contribute to the burden of disease.”
Dr. Coates is coauthor of “Advocacy and Health Equity: The Role of the Pediatric Pulmonologist,” currently in press (Clinics in Chest Medicine), and a member of the CHEST Physician Editorial Board.
The authors noted that a study limitation was that the sample was from one geographic area (Boston). Neither the authors nor Dr. Coates listed any conflicts.
FROM CHEST PULMONARY
Biologics linked to fewer hospitalizations after asthma exacerbation
In a real-world study of asthma patients,
The data fill a gap, according to Sushan Gupta, MD, who presented the results at the annual meeting of the American College of Chest Physicians. “There’s some ample real-world data that shows that biologics reduce the incidence of asthma exacerbation, but the data regarding what happens after an exacerbation is still lacking, especially real-world data,” said Dr. Gupta, who is a resident at Carle Foundation Hospital in Champaign, Ill.
The findings were encouraging. “Patients with severe asthma on biologics fare well even after an exacerbation event, which includes a reduced incidence of hospitalization, ICU admission, and need for mechanical ventilation. We did not have any patient in the biologic group that required intubation, so that is pretty significant as compared to other patients who did not receive biologics,” said Dr. Gupta.
The results weren’t surprising, but underscore the benefits of biologics, according to Brittany Duchene, MD, who moderated the session where the results were presented. “I think it reinforced that they’re really good drugs,” said Dr. Duchene, who is a pulmonary critical care physician at Northeastern Vermont Regional Hospital, St. Johnsbury.
Although the study was retrospective, it suggests that the threshold for initiating biologics could potentially be lowered for patients with uncontrolled asthma despite adequate use of inhalers, according to Dr. Gupta. “Should that threshold be lower, and would that improve the overall morbidity and eventually the health care cost of utilization? Our study does not prove any of those data, but moving forward that data will also come out.”
Dr. Duchene noted that the accumulating scientific and clinical data for biologics is “really, really strong.” She also speculated that biologics could be used increasingly in the acute setting, which she admitted is a controversial topic. “I think there’s going to be a lot more push to early initiation, and you can see from the [new] study that it decreased a lot of hospitalizations.”
Dr. Gupta emphasized the need for prospective studies, and Dr. Duchene agreed that any such change would need to be patient centric, considering the diversity of available biologics. “It depends what their true issue is. The broader the biologic [mechanism of action], probably the more success you’ll have. I’ve found there’s not a pure allergic or a pure eosinophilic asthma patient. They’re usually more a combination.”
Some key questions remain about biologics treatment, especially in the long term. These include when a patient should be switched from one biologic to another, and whether biologic treatment should be continued over the patient’s lifetime and potential long-term side effects. “I think that data is still evolving and will come to us with time,” said Dr. Gupta.
The researchers analyzed retrospective data from 316 asthma patients treated with biologics and 9,645 treated with nonbiologic therapy between February 2018 and February 2023 at a tertiary care teaching hospital in the Midwest. There was a higher proportion of females in the biologics (69.7%) and nonbiologics groups (63.8%, P = .032), but there was no significant difference in the proportion of Whites in the biologics and nonbiologics groups (78.2% vs. 74.3%, P = .103).
The lack of a difference in racial groups was a surprise, according to Dr. Duchene, especially since other studies have noted disparities in biologic therapy among asthma patients.
Among the biologics group, 0.9% were hospitalized during the study period, compared with 6.5% of the nonbiologics group (P = .00006). They also had fewer ICU visits (0.3% vs. 1.8%; P = .04).
Dr. Gupta’s team attempted to subdivide the data by individual biologic, but there was no statistical significance in outcomes between biologics, perhaps because of the relatively small sample size.
Dr. Gupta noted that his group’s results are generally similar to other studies, including a U.S. study that found a decrease in exacerbation rates after staring or switching biologics and a slightly higher prevalence of biologics use among White patients (77% of biologic users versus 71% of nonbiologics users). A study in southwestern England found fewer ED visits and hospitalizations among patients on biologics.
Dr. Gupta and Dr. Duchene have no relevant financial disclosures.
In a real-world study of asthma patients,
The data fill a gap, according to Sushan Gupta, MD, who presented the results at the annual meeting of the American College of Chest Physicians. “There’s some ample real-world data that shows that biologics reduce the incidence of asthma exacerbation, but the data regarding what happens after an exacerbation is still lacking, especially real-world data,” said Dr. Gupta, who is a resident at Carle Foundation Hospital in Champaign, Ill.
The findings were encouraging. “Patients with severe asthma on biologics fare well even after an exacerbation event, which includes a reduced incidence of hospitalization, ICU admission, and need for mechanical ventilation. We did not have any patient in the biologic group that required intubation, so that is pretty significant as compared to other patients who did not receive biologics,” said Dr. Gupta.
The results weren’t surprising, but underscore the benefits of biologics, according to Brittany Duchene, MD, who moderated the session where the results were presented. “I think it reinforced that they’re really good drugs,” said Dr. Duchene, who is a pulmonary critical care physician at Northeastern Vermont Regional Hospital, St. Johnsbury.
Although the study was retrospective, it suggests that the threshold for initiating biologics could potentially be lowered for patients with uncontrolled asthma despite adequate use of inhalers, according to Dr. Gupta. “Should that threshold be lower, and would that improve the overall morbidity and eventually the health care cost of utilization? Our study does not prove any of those data, but moving forward that data will also come out.”
Dr. Duchene noted that the accumulating scientific and clinical data for biologics is “really, really strong.” She also speculated that biologics could be used increasingly in the acute setting, which she admitted is a controversial topic. “I think there’s going to be a lot more push to early initiation, and you can see from the [new] study that it decreased a lot of hospitalizations.”
Dr. Gupta emphasized the need for prospective studies, and Dr. Duchene agreed that any such change would need to be patient centric, considering the diversity of available biologics. “It depends what their true issue is. The broader the biologic [mechanism of action], probably the more success you’ll have. I’ve found there’s not a pure allergic or a pure eosinophilic asthma patient. They’re usually more a combination.”
Some key questions remain about biologics treatment, especially in the long term. These include when a patient should be switched from one biologic to another, and whether biologic treatment should be continued over the patient’s lifetime and potential long-term side effects. “I think that data is still evolving and will come to us with time,” said Dr. Gupta.
The researchers analyzed retrospective data from 316 asthma patients treated with biologics and 9,645 treated with nonbiologic therapy between February 2018 and February 2023 at a tertiary care teaching hospital in the Midwest. There was a higher proportion of females in the biologics (69.7%) and nonbiologics groups (63.8%, P = .032), but there was no significant difference in the proportion of Whites in the biologics and nonbiologics groups (78.2% vs. 74.3%, P = .103).
The lack of a difference in racial groups was a surprise, according to Dr. Duchene, especially since other studies have noted disparities in biologic therapy among asthma patients.
Among the biologics group, 0.9% were hospitalized during the study period, compared with 6.5% of the nonbiologics group (P = .00006). They also had fewer ICU visits (0.3% vs. 1.8%; P = .04).
Dr. Gupta’s team attempted to subdivide the data by individual biologic, but there was no statistical significance in outcomes between biologics, perhaps because of the relatively small sample size.
Dr. Gupta noted that his group’s results are generally similar to other studies, including a U.S. study that found a decrease in exacerbation rates after staring or switching biologics and a slightly higher prevalence of biologics use among White patients (77% of biologic users versus 71% of nonbiologics users). A study in southwestern England found fewer ED visits and hospitalizations among patients on biologics.
Dr. Gupta and Dr. Duchene have no relevant financial disclosures.
In a real-world study of asthma patients,
The data fill a gap, according to Sushan Gupta, MD, who presented the results at the annual meeting of the American College of Chest Physicians. “There’s some ample real-world data that shows that biologics reduce the incidence of asthma exacerbation, but the data regarding what happens after an exacerbation is still lacking, especially real-world data,” said Dr. Gupta, who is a resident at Carle Foundation Hospital in Champaign, Ill.
The findings were encouraging. “Patients with severe asthma on biologics fare well even after an exacerbation event, which includes a reduced incidence of hospitalization, ICU admission, and need for mechanical ventilation. We did not have any patient in the biologic group that required intubation, so that is pretty significant as compared to other patients who did not receive biologics,” said Dr. Gupta.
The results weren’t surprising, but underscore the benefits of biologics, according to Brittany Duchene, MD, who moderated the session where the results were presented. “I think it reinforced that they’re really good drugs,” said Dr. Duchene, who is a pulmonary critical care physician at Northeastern Vermont Regional Hospital, St. Johnsbury.
Although the study was retrospective, it suggests that the threshold for initiating biologics could potentially be lowered for patients with uncontrolled asthma despite adequate use of inhalers, according to Dr. Gupta. “Should that threshold be lower, and would that improve the overall morbidity and eventually the health care cost of utilization? Our study does not prove any of those data, but moving forward that data will also come out.”
Dr. Duchene noted that the accumulating scientific and clinical data for biologics is “really, really strong.” She also speculated that biologics could be used increasingly in the acute setting, which she admitted is a controversial topic. “I think there’s going to be a lot more push to early initiation, and you can see from the [new] study that it decreased a lot of hospitalizations.”
Dr. Gupta emphasized the need for prospective studies, and Dr. Duchene agreed that any such change would need to be patient centric, considering the diversity of available biologics. “It depends what their true issue is. The broader the biologic [mechanism of action], probably the more success you’ll have. I’ve found there’s not a pure allergic or a pure eosinophilic asthma patient. They’re usually more a combination.”
Some key questions remain about biologics treatment, especially in the long term. These include when a patient should be switched from one biologic to another, and whether biologic treatment should be continued over the patient’s lifetime and potential long-term side effects. “I think that data is still evolving and will come to us with time,” said Dr. Gupta.
The researchers analyzed retrospective data from 316 asthma patients treated with biologics and 9,645 treated with nonbiologic therapy between February 2018 and February 2023 at a tertiary care teaching hospital in the Midwest. There was a higher proportion of females in the biologics (69.7%) and nonbiologics groups (63.8%, P = .032), but there was no significant difference in the proportion of Whites in the biologics and nonbiologics groups (78.2% vs. 74.3%, P = .103).
The lack of a difference in racial groups was a surprise, according to Dr. Duchene, especially since other studies have noted disparities in biologic therapy among asthma patients.
Among the biologics group, 0.9% were hospitalized during the study period, compared with 6.5% of the nonbiologics group (P = .00006). They also had fewer ICU visits (0.3% vs. 1.8%; P = .04).
Dr. Gupta’s team attempted to subdivide the data by individual biologic, but there was no statistical significance in outcomes between biologics, perhaps because of the relatively small sample size.
Dr. Gupta noted that his group’s results are generally similar to other studies, including a U.S. study that found a decrease in exacerbation rates after staring or switching biologics and a slightly higher prevalence of biologics use among White patients (77% of biologic users versus 71% of nonbiologics users). A study in southwestern England found fewer ED visits and hospitalizations among patients on biologics.
Dr. Gupta and Dr. Duchene have no relevant financial disclosures.
FROM CHEST 2023
Nintedanib dose reductions in IPF may do no harm
HONOLULU – nintedanib (Ofev) for patients with idiopathic pulmonary fibrosis (IPF) who can’t tolerate the full 150-mg twice-daily dose.
An analysis of data from a large administrative claims database showed that there were no significant differences in either all-cause mortality or hospitalization rates between patients with IPF treated at the full 150-mg twice-daily dose and those treated with a reduced twice-daily dose of 100 mg nintedanib.
Although the results need to be confirmed by additional prospective and registry studies, they suggest that patients with IPF can still fare just as well with a reduced-dose nintedanib regimen, ideally with fewer gastrointestinal side effects such as diarrhea, reported Andrew Limper, MD, of the Mayo Clinic in Rochester, Minn.
“At least on this preliminary data you could ... rest assured,” Dr. Limper told his colleagues in an oral abstract session at the American College of Chest Physicians (CHEST) 2023 annual meeting.
“This is not definitive proof, I’m not making more out of this than it is, but we all put people on 100 mg twice daily because their guts don’t tolerate it; they live in the bathroom and they don’t want to live that way,” Dr. Limper said.
Hard to take
Nintedanib is approved in the United States for the treatment of IPF, chronic fibrosing interstitial lung diseases (ILD) with a progressive phenotype, and systemic sclerosis-associated ILD. For IPF, the standard dose established in randomized clinical trials is 150 mg twice daily.
However, nintedanib is associated with a number of side effects, including hepatic and other gastrointestinal toxicities, arterial thromboembolic events, and proteinuria within the nephrotic range. As a result, clinicians often reduce the dose to 100 mg twice daily, but there is a lack of data to indicate whether it’s safe to do so or if efficacy will be compromised.
To see whether dose reductions might result in poorer outcomes for patients with IPF, Dr. Limper and colleagues analyzed data from the OptumLabs Data Warehouse, a large administrative claims database, to compare outcomes for patients treated with IPF at either the 150-mg or 100-mg twice-daily doses.
They used propensity-score matching to account for differences among individuals according to age, sex, race/ethnicity, residence, insurance type, additional medication use, oxygen use, smoking status, health care use, and comorbidities. The final cohort included 346 patients in each dosing group.
There was no difference between the dosing groups for the primary outcome of all-cause mortality at 18 months, with a nonsignificant hazard ratio of 0.65 (P = .313), and no significant difference over 24 months in risk of hospitalization, with a hazard ratio of 0.98 (P = .899).
“This is not randomized controlled data; I doubt that [nintedanib maker Boehringer Ingelheim] is ever going to do a 150 vs. 100 milligram head-to-head trial, but it does give us some ground to start to look at this,” Dr. Limper said.
Not so sure
Session comoderator Misbah Baqir, MBBS, also from the Mayo Clinic, told this news organization that she would need to see more data from prospective studies using endpoints other than mortality before she could be convinced that nintedanib dose reductions do not adversely affect efficacy. She was not involved in the study.
“I feel that the endpoint should be different, either it should be forced vital capacity change, quality of life, or something else. The problem with a database study is that you don’t have everything in it. You have to play with what you have, and you don’t have forced vital capacity. You have to go into the charts to get it,” she said.
It would be more helpful to objectively compare, for example, diarrhea episodes or other adverse events to see whether they were significantly reduced with the 100-mg dose, she added.
In an interview, Dr. Limper said that he and his colleagues plan to gather additional observational data including the newly available Medicare fee-for-service data set, registry data, and other sources.
“If we get all of that, and it really still looks compelling – and that’s an if – then I think that would be the foothold to go back to the manufacturer and say, ‘Hey, maybe you ought to think about doing a prospective trial to prove it with lung function and other endpoints such as 6-minute walks,’ ” he said.
The study was supported by a grant from Three Lakes Foundation. Dr. Limper and Dr. Baqir have disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
HONOLULU – nintedanib (Ofev) for patients with idiopathic pulmonary fibrosis (IPF) who can’t tolerate the full 150-mg twice-daily dose.
An analysis of data from a large administrative claims database showed that there were no significant differences in either all-cause mortality or hospitalization rates between patients with IPF treated at the full 150-mg twice-daily dose and those treated with a reduced twice-daily dose of 100 mg nintedanib.
Although the results need to be confirmed by additional prospective and registry studies, they suggest that patients with IPF can still fare just as well with a reduced-dose nintedanib regimen, ideally with fewer gastrointestinal side effects such as diarrhea, reported Andrew Limper, MD, of the Mayo Clinic in Rochester, Minn.
“At least on this preliminary data you could ... rest assured,” Dr. Limper told his colleagues in an oral abstract session at the American College of Chest Physicians (CHEST) 2023 annual meeting.
“This is not definitive proof, I’m not making more out of this than it is, but we all put people on 100 mg twice daily because their guts don’t tolerate it; they live in the bathroom and they don’t want to live that way,” Dr. Limper said.
Hard to take
Nintedanib is approved in the United States for the treatment of IPF, chronic fibrosing interstitial lung diseases (ILD) with a progressive phenotype, and systemic sclerosis-associated ILD. For IPF, the standard dose established in randomized clinical trials is 150 mg twice daily.
However, nintedanib is associated with a number of side effects, including hepatic and other gastrointestinal toxicities, arterial thromboembolic events, and proteinuria within the nephrotic range. As a result, clinicians often reduce the dose to 100 mg twice daily, but there is a lack of data to indicate whether it’s safe to do so or if efficacy will be compromised.
To see whether dose reductions might result in poorer outcomes for patients with IPF, Dr. Limper and colleagues analyzed data from the OptumLabs Data Warehouse, a large administrative claims database, to compare outcomes for patients treated with IPF at either the 150-mg or 100-mg twice-daily doses.
They used propensity-score matching to account for differences among individuals according to age, sex, race/ethnicity, residence, insurance type, additional medication use, oxygen use, smoking status, health care use, and comorbidities. The final cohort included 346 patients in each dosing group.
There was no difference between the dosing groups for the primary outcome of all-cause mortality at 18 months, with a nonsignificant hazard ratio of 0.65 (P = .313), and no significant difference over 24 months in risk of hospitalization, with a hazard ratio of 0.98 (P = .899).
“This is not randomized controlled data; I doubt that [nintedanib maker Boehringer Ingelheim] is ever going to do a 150 vs. 100 milligram head-to-head trial, but it does give us some ground to start to look at this,” Dr. Limper said.
Not so sure
Session comoderator Misbah Baqir, MBBS, also from the Mayo Clinic, told this news organization that she would need to see more data from prospective studies using endpoints other than mortality before she could be convinced that nintedanib dose reductions do not adversely affect efficacy. She was not involved in the study.
“I feel that the endpoint should be different, either it should be forced vital capacity change, quality of life, or something else. The problem with a database study is that you don’t have everything in it. You have to play with what you have, and you don’t have forced vital capacity. You have to go into the charts to get it,” she said.
It would be more helpful to objectively compare, for example, diarrhea episodes or other adverse events to see whether they were significantly reduced with the 100-mg dose, she added.
In an interview, Dr. Limper said that he and his colleagues plan to gather additional observational data including the newly available Medicare fee-for-service data set, registry data, and other sources.
“If we get all of that, and it really still looks compelling – and that’s an if – then I think that would be the foothold to go back to the manufacturer and say, ‘Hey, maybe you ought to think about doing a prospective trial to prove it with lung function and other endpoints such as 6-minute walks,’ ” he said.
The study was supported by a grant from Three Lakes Foundation. Dr. Limper and Dr. Baqir have disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
HONOLULU – nintedanib (Ofev) for patients with idiopathic pulmonary fibrosis (IPF) who can’t tolerate the full 150-mg twice-daily dose.
An analysis of data from a large administrative claims database showed that there were no significant differences in either all-cause mortality or hospitalization rates between patients with IPF treated at the full 150-mg twice-daily dose and those treated with a reduced twice-daily dose of 100 mg nintedanib.
Although the results need to be confirmed by additional prospective and registry studies, they suggest that patients with IPF can still fare just as well with a reduced-dose nintedanib regimen, ideally with fewer gastrointestinal side effects such as diarrhea, reported Andrew Limper, MD, of the Mayo Clinic in Rochester, Minn.
“At least on this preliminary data you could ... rest assured,” Dr. Limper told his colleagues in an oral abstract session at the American College of Chest Physicians (CHEST) 2023 annual meeting.
“This is not definitive proof, I’m not making more out of this than it is, but we all put people on 100 mg twice daily because their guts don’t tolerate it; they live in the bathroom and they don’t want to live that way,” Dr. Limper said.
Hard to take
Nintedanib is approved in the United States for the treatment of IPF, chronic fibrosing interstitial lung diseases (ILD) with a progressive phenotype, and systemic sclerosis-associated ILD. For IPF, the standard dose established in randomized clinical trials is 150 mg twice daily.
However, nintedanib is associated with a number of side effects, including hepatic and other gastrointestinal toxicities, arterial thromboembolic events, and proteinuria within the nephrotic range. As a result, clinicians often reduce the dose to 100 mg twice daily, but there is a lack of data to indicate whether it’s safe to do so or if efficacy will be compromised.
To see whether dose reductions might result in poorer outcomes for patients with IPF, Dr. Limper and colleagues analyzed data from the OptumLabs Data Warehouse, a large administrative claims database, to compare outcomes for patients treated with IPF at either the 150-mg or 100-mg twice-daily doses.
They used propensity-score matching to account for differences among individuals according to age, sex, race/ethnicity, residence, insurance type, additional medication use, oxygen use, smoking status, health care use, and comorbidities. The final cohort included 346 patients in each dosing group.
There was no difference between the dosing groups for the primary outcome of all-cause mortality at 18 months, with a nonsignificant hazard ratio of 0.65 (P = .313), and no significant difference over 24 months in risk of hospitalization, with a hazard ratio of 0.98 (P = .899).
“This is not randomized controlled data; I doubt that [nintedanib maker Boehringer Ingelheim] is ever going to do a 150 vs. 100 milligram head-to-head trial, but it does give us some ground to start to look at this,” Dr. Limper said.
Not so sure
Session comoderator Misbah Baqir, MBBS, also from the Mayo Clinic, told this news organization that she would need to see more data from prospective studies using endpoints other than mortality before she could be convinced that nintedanib dose reductions do not adversely affect efficacy. She was not involved in the study.
“I feel that the endpoint should be different, either it should be forced vital capacity change, quality of life, or something else. The problem with a database study is that you don’t have everything in it. You have to play with what you have, and you don’t have forced vital capacity. You have to go into the charts to get it,” she said.
It would be more helpful to objectively compare, for example, diarrhea episodes or other adverse events to see whether they were significantly reduced with the 100-mg dose, she added.
In an interview, Dr. Limper said that he and his colleagues plan to gather additional observational data including the newly available Medicare fee-for-service data set, registry data, and other sources.
“If we get all of that, and it really still looks compelling – and that’s an if – then I think that would be the foothold to go back to the manufacturer and say, ‘Hey, maybe you ought to think about doing a prospective trial to prove it with lung function and other endpoints such as 6-minute walks,’ ” he said.
The study was supported by a grant from Three Lakes Foundation. Dr. Limper and Dr. Baqir have disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
AT CHEST 2023