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Examining the past and looking toward the future: The need for quality data in interventional pulmonology

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THORACIC ONCOLOGY AND CHEST PROCEDURES NETWORK

Interventional Procedures Section

During the last decade, the explosion of technological advancements in the field of interventional pulmonary (IP) has afforded patients the opportunity to undergo novel, minimally invasive diagnostic and therapeutic procedures. However, these unprecedented technological advances have often been introduced without the support of high-quality research on safety and efficacy, and without evaluating their impact on meaningful patient outcomes. Encouraging and participating in high-quality IP research should remain a top priority for those practicing in the field.

CHEST
Dr. Jennifer D. Duke

Structured research networks, such as the UK Pleural Society and more recently the Interventional Pulmonary Outcome Group, have facilitated the transition of IP research from observational case series and single-center experiences to multicenter, randomized controlled trials to generate level I evidence and inform patient care (Laskawiec-Szkonter M, et al. Br J Hosp Med (Lond). 2019 Apr 2;80[4]:186-7) (Maldonado F, et al. J Bronchology Interv Pulmonol. 2019 Jul;26(3):150-2). In the bronchoscopy space, important investigator-initiated clinical trial results anticipated in 2024 include VERITAS (NCT04250194), FROSTBITE2 (NCT05751278), and RELIANT (NCT05705544), among others. These research efforts complement industry-sponsored clinical trials (such as RheSolve, NCT04677465) and aim to emulate the extraordinary track record achieved in the field of pleural disease that has led to recently updated evidence-based guidelines for the management of challenging diseases like malignant pleural effusions, pleural space infections, and pneumothorax (Davies HE, et a l. JAMA. 2012 Jun 13;307[22]:2383-9, Mishra EK, et al. Am J Respir Crit Care Med. 2018 Feb 15;197[4]:502-8) (Rahman NM, et al. N Engl J Med. 2011 Aug 11;365[6]:518-26) (Hallifax RJ, et al. Lancet. 2020 Jul 4;396[10243]:39-49).

Ultimately, the rapidly evolving technological advancements in interventional pulmonology must be supported by research based on high-quality clinical trials, which will be contingent on appropriate trial funding requiring partnership with industry and federal funding agencies. Only through such collaboration can researchers design robust clinical trials based on complex methodology, which will advance patient care and lead to improved patient outcomes.

– Jennifer D. Duke, MD

Section Fellow-in-Training

– Fabien Maldonado, MD, MSc, FCCP

Section Member

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THORACIC ONCOLOGY AND CHEST PROCEDURES NETWORK

Interventional Procedures Section

During the last decade, the explosion of technological advancements in the field of interventional pulmonary (IP) has afforded patients the opportunity to undergo novel, minimally invasive diagnostic and therapeutic procedures. However, these unprecedented technological advances have often been introduced without the support of high-quality research on safety and efficacy, and without evaluating their impact on meaningful patient outcomes. Encouraging and participating in high-quality IP research should remain a top priority for those practicing in the field.

CHEST
Dr. Jennifer D. Duke

Structured research networks, such as the UK Pleural Society and more recently the Interventional Pulmonary Outcome Group, have facilitated the transition of IP research from observational case series and single-center experiences to multicenter, randomized controlled trials to generate level I evidence and inform patient care (Laskawiec-Szkonter M, et al. Br J Hosp Med (Lond). 2019 Apr 2;80[4]:186-7) (Maldonado F, et al. J Bronchology Interv Pulmonol. 2019 Jul;26(3):150-2). In the bronchoscopy space, important investigator-initiated clinical trial results anticipated in 2024 include VERITAS (NCT04250194), FROSTBITE2 (NCT05751278), and RELIANT (NCT05705544), among others. These research efforts complement industry-sponsored clinical trials (such as RheSolve, NCT04677465) and aim to emulate the extraordinary track record achieved in the field of pleural disease that has led to recently updated evidence-based guidelines for the management of challenging diseases like malignant pleural effusions, pleural space infections, and pneumothorax (Davies HE, et a l. JAMA. 2012 Jun 13;307[22]:2383-9, Mishra EK, et al. Am J Respir Crit Care Med. 2018 Feb 15;197[4]:502-8) (Rahman NM, et al. N Engl J Med. 2011 Aug 11;365[6]:518-26) (Hallifax RJ, et al. Lancet. 2020 Jul 4;396[10243]:39-49).

Ultimately, the rapidly evolving technological advancements in interventional pulmonology must be supported by research based on high-quality clinical trials, which will be contingent on appropriate trial funding requiring partnership with industry and federal funding agencies. Only through such collaboration can researchers design robust clinical trials based on complex methodology, which will advance patient care and lead to improved patient outcomes.

– Jennifer D. Duke, MD

Section Fellow-in-Training

– Fabien Maldonado, MD, MSc, FCCP

Section Member

 

THORACIC ONCOLOGY AND CHEST PROCEDURES NETWORK

Interventional Procedures Section

During the last decade, the explosion of technological advancements in the field of interventional pulmonary (IP) has afforded patients the opportunity to undergo novel, minimally invasive diagnostic and therapeutic procedures. However, these unprecedented technological advances have often been introduced without the support of high-quality research on safety and efficacy, and without evaluating their impact on meaningful patient outcomes. Encouraging and participating in high-quality IP research should remain a top priority for those practicing in the field.

CHEST
Dr. Jennifer D. Duke

Structured research networks, such as the UK Pleural Society and more recently the Interventional Pulmonary Outcome Group, have facilitated the transition of IP research from observational case series and single-center experiences to multicenter, randomized controlled trials to generate level I evidence and inform patient care (Laskawiec-Szkonter M, et al. Br J Hosp Med (Lond). 2019 Apr 2;80[4]:186-7) (Maldonado F, et al. J Bronchology Interv Pulmonol. 2019 Jul;26(3):150-2). In the bronchoscopy space, important investigator-initiated clinical trial results anticipated in 2024 include VERITAS (NCT04250194), FROSTBITE2 (NCT05751278), and RELIANT (NCT05705544), among others. These research efforts complement industry-sponsored clinical trials (such as RheSolve, NCT04677465) and aim to emulate the extraordinary track record achieved in the field of pleural disease that has led to recently updated evidence-based guidelines for the management of challenging diseases like malignant pleural effusions, pleural space infections, and pneumothorax (Davies HE, et a l. JAMA. 2012 Jun 13;307[22]:2383-9, Mishra EK, et al. Am J Respir Crit Care Med. 2018 Feb 15;197[4]:502-8) (Rahman NM, et al. N Engl J Med. 2011 Aug 11;365[6]:518-26) (Hallifax RJ, et al. Lancet. 2020 Jul 4;396[10243]:39-49).

Ultimately, the rapidly evolving technological advancements in interventional pulmonology must be supported by research based on high-quality clinical trials, which will be contingent on appropriate trial funding requiring partnership with industry and federal funding agencies. Only through such collaboration can researchers design robust clinical trials based on complex methodology, which will advance patient care and lead to improved patient outcomes.

– Jennifer D. Duke, MD

Section Fellow-in-Training

– Fabien Maldonado, MD, MSc, FCCP

Section Member

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Updates in evidence for rituximab in interstitial lung disease

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Wed, 02/07/2024 - 15:46

 

DIFFUSE LUNG DISEASE AND LUNG TRANSPLANT NETWORK

Interstitial Lung Disease Section

Interstitial lung diseases (ILD) are a heterogeneous group of fibro-inflammatory disorders that can be progressive despite available therapies. The cornerstones of pharmacologic therapy include immunosuppression and antifibrotics.

CHEST
Dr. Tessy K. Paul

Data on the use of rituximab, a B-lymphocyte-depleting monoclonal antibody, often utilized as rescue therapy in progressive and severe ILD, was limited until recently. The RECITAL trial reported the first randomized controlled trial investigating rituximab in severe or progressive autoimmune ILD. Though rituximab was not superior to cyclophosphamide, both agents improved forced vital capacity (FVC) at 24 weeks and respiratory-related quality of life. Rituximab was associated with less adverse events and lower corticosteroid exposure (Maher et al. Lancet Respir Med. 2023;11:45-54). In the DESIRES trial, patients with systemic sclerosis-associated ILD treated with rituximab had preservation of FVC at 24 and 48 weeks compared to placebo (Ebata et al. Lancet Rheumatol. 2021;3:e489-97; Lancet Rheumatol. 2022;4:e546-55). The EVER-ILD investigators compared mycophenolate mofetil (MMF) alone vs addition of rituximab in patients with autoimmune and idiopathic nonspecific interstitial pneumonia (NSIP). Combination therapy was superior to MMF alone in improving FVC and progression-free survival. Combination regimen was well tolerated though nonserious viral and bacterial infections were more frequent (Mankikian et al. Eur Respir J. 2023;61[6]:2202071).

These findings, primarily in autoimmune ILD, are promising and provide clinicians with evidence for utilizing rituximab in patients with severe and progressive ILD. Nonetheless, they highlight the need for additional research and standardized guidance regarding the target population who stands to most benefit from rituximab.
 

–Tessy K. Paul, MD

Section Member-at-Large

–Tejaswini Kulkarni, MD, MBBS, FCCP

Section Chair

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DIFFUSE LUNG DISEASE AND LUNG TRANSPLANT NETWORK

Interstitial Lung Disease Section

Interstitial lung diseases (ILD) are a heterogeneous group of fibro-inflammatory disorders that can be progressive despite available therapies. The cornerstones of pharmacologic therapy include immunosuppression and antifibrotics.

CHEST
Dr. Tessy K. Paul

Data on the use of rituximab, a B-lymphocyte-depleting monoclonal antibody, often utilized as rescue therapy in progressive and severe ILD, was limited until recently. The RECITAL trial reported the first randomized controlled trial investigating rituximab in severe or progressive autoimmune ILD. Though rituximab was not superior to cyclophosphamide, both agents improved forced vital capacity (FVC) at 24 weeks and respiratory-related quality of life. Rituximab was associated with less adverse events and lower corticosteroid exposure (Maher et al. Lancet Respir Med. 2023;11:45-54). In the DESIRES trial, patients with systemic sclerosis-associated ILD treated with rituximab had preservation of FVC at 24 and 48 weeks compared to placebo (Ebata et al. Lancet Rheumatol. 2021;3:e489-97; Lancet Rheumatol. 2022;4:e546-55). The EVER-ILD investigators compared mycophenolate mofetil (MMF) alone vs addition of rituximab in patients with autoimmune and idiopathic nonspecific interstitial pneumonia (NSIP). Combination therapy was superior to MMF alone in improving FVC and progression-free survival. Combination regimen was well tolerated though nonserious viral and bacterial infections were more frequent (Mankikian et al. Eur Respir J. 2023;61[6]:2202071).

These findings, primarily in autoimmune ILD, are promising and provide clinicians with evidence for utilizing rituximab in patients with severe and progressive ILD. Nonetheless, they highlight the need for additional research and standardized guidance regarding the target population who stands to most benefit from rituximab.
 

–Tessy K. Paul, MD

Section Member-at-Large

–Tejaswini Kulkarni, MD, MBBS, FCCP

Section Chair

 

DIFFUSE LUNG DISEASE AND LUNG TRANSPLANT NETWORK

Interstitial Lung Disease Section

Interstitial lung diseases (ILD) are a heterogeneous group of fibro-inflammatory disorders that can be progressive despite available therapies. The cornerstones of pharmacologic therapy include immunosuppression and antifibrotics.

CHEST
Dr. Tessy K. Paul

Data on the use of rituximab, a B-lymphocyte-depleting monoclonal antibody, often utilized as rescue therapy in progressive and severe ILD, was limited until recently. The RECITAL trial reported the first randomized controlled trial investigating rituximab in severe or progressive autoimmune ILD. Though rituximab was not superior to cyclophosphamide, both agents improved forced vital capacity (FVC) at 24 weeks and respiratory-related quality of life. Rituximab was associated with less adverse events and lower corticosteroid exposure (Maher et al. Lancet Respir Med. 2023;11:45-54). In the DESIRES trial, patients with systemic sclerosis-associated ILD treated with rituximab had preservation of FVC at 24 and 48 weeks compared to placebo (Ebata et al. Lancet Rheumatol. 2021;3:e489-97; Lancet Rheumatol. 2022;4:e546-55). The EVER-ILD investigators compared mycophenolate mofetil (MMF) alone vs addition of rituximab in patients with autoimmune and idiopathic nonspecific interstitial pneumonia (NSIP). Combination therapy was superior to MMF alone in improving FVC and progression-free survival. Combination regimen was well tolerated though nonserious viral and bacterial infections were more frequent (Mankikian et al. Eur Respir J. 2023;61[6]:2202071).

These findings, primarily in autoimmune ILD, are promising and provide clinicians with evidence for utilizing rituximab in patients with severe and progressive ILD. Nonetheless, they highlight the need for additional research and standardized guidance regarding the target population who stands to most benefit from rituximab.
 

–Tessy K. Paul, MD

Section Member-at-Large

–Tejaswini Kulkarni, MD, MBBS, FCCP

Section Chair

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Networks at CHEST 2023

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Tue, 12/05/2023 - 14:26

CHEST 2023 in Honolulu kicked off for Network Leadership during the Council of Networks meeting. Leadership from the seven Networks presented their plans for CHEST 2023, participation in proposed guidelines, CHEST projects completed over the past year, and other accomplishments.

We congratulated our Network leaders – Margaret Pisani, Council of Networks Vice-chair, who was awarded the Roger C. Bone Memorial Lecture in Critical Care; and Jean Elwing, Chair of the Pulmonary Vascular & Cardiovascular Network, for being awarded the Distinguished Scientist Honor Lecture in Cardiopulmonary Physiology. CHEST 2023 included excellent educational content by the Networks, including two Network highlights per each of the seven Networks, as well as an Experience CHEST submission from each of the 22 sections.

We also had the opportunity to meet face-to-face at the Network Open Forums, the Network Mixer, and the inaugural Fellow-in-Training Mixer in the Trainee Lounge. We saw a lot of familiar faces at these events, and 182 new individuals also signed up to become Network members.

There will be one final Council of Networks leadership meeting in December prior to our leadership transition in January.

We thank outgoing Network chairs, Dr. Marcos Restrepo of the Chest Infections & Disaster Response Network, Dr. Christopher Carroll of the Critical Care Network, Dr. Debbie Levine of the Diffuse Lung Disease & Lung Transplant Network, and Dr. Carolyn D’Ambrosio of the Sleep Medicine Network, for their leadership and hard work dedicated to the Networks that have greatly benefited from their service.



Cassie Kennedy, MD, FCCP – Chair, Council of Networks

Margaret Pisani, MD, MPH, FCCP – Vice-Chair, Council of Networks

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CHEST 2023 in Honolulu kicked off for Network Leadership during the Council of Networks meeting. Leadership from the seven Networks presented their plans for CHEST 2023, participation in proposed guidelines, CHEST projects completed over the past year, and other accomplishments.

We congratulated our Network leaders – Margaret Pisani, Council of Networks Vice-chair, who was awarded the Roger C. Bone Memorial Lecture in Critical Care; and Jean Elwing, Chair of the Pulmonary Vascular & Cardiovascular Network, for being awarded the Distinguished Scientist Honor Lecture in Cardiopulmonary Physiology. CHEST 2023 included excellent educational content by the Networks, including two Network highlights per each of the seven Networks, as well as an Experience CHEST submission from each of the 22 sections.

We also had the opportunity to meet face-to-face at the Network Open Forums, the Network Mixer, and the inaugural Fellow-in-Training Mixer in the Trainee Lounge. We saw a lot of familiar faces at these events, and 182 new individuals also signed up to become Network members.

There will be one final Council of Networks leadership meeting in December prior to our leadership transition in January.

We thank outgoing Network chairs, Dr. Marcos Restrepo of the Chest Infections & Disaster Response Network, Dr. Christopher Carroll of the Critical Care Network, Dr. Debbie Levine of the Diffuse Lung Disease & Lung Transplant Network, and Dr. Carolyn D’Ambrosio of the Sleep Medicine Network, for their leadership and hard work dedicated to the Networks that have greatly benefited from their service.



Cassie Kennedy, MD, FCCP – Chair, Council of Networks

Margaret Pisani, MD, MPH, FCCP – Vice-Chair, Council of Networks

CHEST 2023 in Honolulu kicked off for Network Leadership during the Council of Networks meeting. Leadership from the seven Networks presented their plans for CHEST 2023, participation in proposed guidelines, CHEST projects completed over the past year, and other accomplishments.

We congratulated our Network leaders – Margaret Pisani, Council of Networks Vice-chair, who was awarded the Roger C. Bone Memorial Lecture in Critical Care; and Jean Elwing, Chair of the Pulmonary Vascular & Cardiovascular Network, for being awarded the Distinguished Scientist Honor Lecture in Cardiopulmonary Physiology. CHEST 2023 included excellent educational content by the Networks, including two Network highlights per each of the seven Networks, as well as an Experience CHEST submission from each of the 22 sections.

We also had the opportunity to meet face-to-face at the Network Open Forums, the Network Mixer, and the inaugural Fellow-in-Training Mixer in the Trainee Lounge. We saw a lot of familiar faces at these events, and 182 new individuals also signed up to become Network members.

There will be one final Council of Networks leadership meeting in December prior to our leadership transition in January.

We thank outgoing Network chairs, Dr. Marcos Restrepo of the Chest Infections & Disaster Response Network, Dr. Christopher Carroll of the Critical Care Network, Dr. Debbie Levine of the Diffuse Lung Disease & Lung Transplant Network, and Dr. Carolyn D’Ambrosio of the Sleep Medicine Network, for their leadership and hard work dedicated to the Networks that have greatly benefited from their service.



Cassie Kennedy, MD, FCCP – Chair, Council of Networks

Margaret Pisani, MD, MPH, FCCP – Vice-Chair, Council of Networks

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Thoracic ultrasound advancements for the assessment and management of pleural disorders

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Mon, 11/06/2023 - 09:10

 

Thoracic Oncology Network

Ultrasound & Chest Imaging Section

Thoracic ultrasound (TUS) is standard of care for the detection of pleural effusion and guidance of pleural procedures. Recent advancements have further expanded the utility of TUS. TUS has better diagnostic performance than CT scan or chest radiograph for predicting complicated parapneumonic effusion (Svigals PZ, et al. Thorax. 2017;72[1]:94-5). This is likely because of better visualization of septation, but there are still limitations. In a study of 300 pleural ultrasounds, TUS was found to be inadequately reliable in the diagnosis of transudative pleural effusion as 56% of anechoic effusions were exudative, but complex appearing pleural effusion on TUS was found to have high predictive value for the diagnosis of exudative pleural effusion (Shkolnik B, et al. Chest2020;158[2]:692-7).

TUS may diagnose nonexpendable lung prior to drainage in malignant pleural effusions. Using M-mode to assess lung motion and speckled tracking for the assessment of lung stain, blunted cardio-phasic response of the lung was highly specific for the diagnosis of nonexpandable lung (Salamonsen MR, et al. Chest. 2014;146[5]:1286-93). TUS can also be used to assess the success of pleurodesis as measured by the adherence score (abolishment of pleural sliding). TUS guided pleurodesis approach was shown to decrease the hospital length of stay in patients undergoing pleurodesis for malignant pleural effusion (Psallidas I, et al. Lancet Respir Med. 2022;10[2]:139-48). Point-of-care TUS is evolving, and adapted use focusing on patient-centered outcomes will further enhance the utility of this indispensable tool.

Amit Chopra, MD, FCCP

Nicholas Villalobos, MD

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Thoracic Oncology Network

Ultrasound & Chest Imaging Section

Thoracic ultrasound (TUS) is standard of care for the detection of pleural effusion and guidance of pleural procedures. Recent advancements have further expanded the utility of TUS. TUS has better diagnostic performance than CT scan or chest radiograph for predicting complicated parapneumonic effusion (Svigals PZ, et al. Thorax. 2017;72[1]:94-5). This is likely because of better visualization of septation, but there are still limitations. In a study of 300 pleural ultrasounds, TUS was found to be inadequately reliable in the diagnosis of transudative pleural effusion as 56% of anechoic effusions were exudative, but complex appearing pleural effusion on TUS was found to have high predictive value for the diagnosis of exudative pleural effusion (Shkolnik B, et al. Chest2020;158[2]:692-7).

TUS may diagnose nonexpendable lung prior to drainage in malignant pleural effusions. Using M-mode to assess lung motion and speckled tracking for the assessment of lung stain, blunted cardio-phasic response of the lung was highly specific for the diagnosis of nonexpandable lung (Salamonsen MR, et al. Chest. 2014;146[5]:1286-93). TUS can also be used to assess the success of pleurodesis as measured by the adherence score (abolishment of pleural sliding). TUS guided pleurodesis approach was shown to decrease the hospital length of stay in patients undergoing pleurodesis for malignant pleural effusion (Psallidas I, et al. Lancet Respir Med. 2022;10[2]:139-48). Point-of-care TUS is evolving, and adapted use focusing on patient-centered outcomes will further enhance the utility of this indispensable tool.

Amit Chopra, MD, FCCP

Nicholas Villalobos, MD

 

Thoracic Oncology Network

Ultrasound & Chest Imaging Section

Thoracic ultrasound (TUS) is standard of care for the detection of pleural effusion and guidance of pleural procedures. Recent advancements have further expanded the utility of TUS. TUS has better diagnostic performance than CT scan or chest radiograph for predicting complicated parapneumonic effusion (Svigals PZ, et al. Thorax. 2017;72[1]:94-5). This is likely because of better visualization of septation, but there are still limitations. In a study of 300 pleural ultrasounds, TUS was found to be inadequately reliable in the diagnosis of transudative pleural effusion as 56% of anechoic effusions were exudative, but complex appearing pleural effusion on TUS was found to have high predictive value for the diagnosis of exudative pleural effusion (Shkolnik B, et al. Chest2020;158[2]:692-7).

TUS may diagnose nonexpendable lung prior to drainage in malignant pleural effusions. Using M-mode to assess lung motion and speckled tracking for the assessment of lung stain, blunted cardio-phasic response of the lung was highly specific for the diagnosis of nonexpandable lung (Salamonsen MR, et al. Chest. 2014;146[5]:1286-93). TUS can also be used to assess the success of pleurodesis as measured by the adherence score (abolishment of pleural sliding). TUS guided pleurodesis approach was shown to decrease the hospital length of stay in patients undergoing pleurodesis for malignant pleural effusion (Psallidas I, et al. Lancet Respir Med. 2022;10[2]:139-48). Point-of-care TUS is evolving, and adapted use focusing on patient-centered outcomes will further enhance the utility of this indispensable tool.

Amit Chopra, MD, FCCP

Nicholas Villalobos, MD

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Seasonal variations in sleep architecture

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Mon, 11/06/2023 - 09:39

 

Sleep Network

Non-Respiratory Sleep Section

Do you feel like you sleep worse in the spring and have more difficulty keeping your schedule on track? There are new data to support the way you feel based on our deeper understanding of seasonal variations in sleep architecture.

Patients in a recent study had 43 minutes less total sleep time and approximately 30 less minutes of REM sleep in the late spring when compared with the winter (Seidler A, et al. Front Neurosci. 2023 Feb 17:17:1105233). Accumulation of decreased sleep time and quality can lead to the sensation of ‘running-on-empty’ by early spring.

Experts believe these seasonal variations in sleep architecture are mainly secondary to circadian shifts. Our social synchronization overrides our natural alignment with daylight patterns and can lead to known consequences of circadian misalignment. Common consequences of poor circadian alignment include worsening sleep disturbances, cognitive impairments, occupational mistakes, and metabolic and mental health disturbances (Schmal C, et al. Front Physiol. 2020 Apr 28:11:334; Boivin D, et al. J Biol Rhythms. 2022 Feb;37[1]:3-28).

The effects of circadian misalignment can be particularly dramatic in children receiving less than their age-appropriate hours of sleep. Children with sleep deprivation are at increased risk of attention, behavior, and learning problems (Paruthi S, et al. J Clinl Sleep Med. 2016;12[6]:785-6).

To improve circadian alignment in spring, it is recommended to achieve morning bright light exposure and perform regular exercise. The elimination of daylight savings time to a consensus of permanent standard time will optimize circadian alignment.

Christopher Izzo, DO – Section Fellow-in-Training

William Healy, MD – Section Member-at-Large

Mariam Louis, MD – Section Chair

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Sleep Network

Non-Respiratory Sleep Section

Do you feel like you sleep worse in the spring and have more difficulty keeping your schedule on track? There are new data to support the way you feel based on our deeper understanding of seasonal variations in sleep architecture.

Patients in a recent study had 43 minutes less total sleep time and approximately 30 less minutes of REM sleep in the late spring when compared with the winter (Seidler A, et al. Front Neurosci. 2023 Feb 17:17:1105233). Accumulation of decreased sleep time and quality can lead to the sensation of ‘running-on-empty’ by early spring.

Experts believe these seasonal variations in sleep architecture are mainly secondary to circadian shifts. Our social synchronization overrides our natural alignment with daylight patterns and can lead to known consequences of circadian misalignment. Common consequences of poor circadian alignment include worsening sleep disturbances, cognitive impairments, occupational mistakes, and metabolic and mental health disturbances (Schmal C, et al. Front Physiol. 2020 Apr 28:11:334; Boivin D, et al. J Biol Rhythms. 2022 Feb;37[1]:3-28).

The effects of circadian misalignment can be particularly dramatic in children receiving less than their age-appropriate hours of sleep. Children with sleep deprivation are at increased risk of attention, behavior, and learning problems (Paruthi S, et al. J Clinl Sleep Med. 2016;12[6]:785-6).

To improve circadian alignment in spring, it is recommended to achieve morning bright light exposure and perform regular exercise. The elimination of daylight savings time to a consensus of permanent standard time will optimize circadian alignment.

Christopher Izzo, DO – Section Fellow-in-Training

William Healy, MD – Section Member-at-Large

Mariam Louis, MD – Section Chair

 

Sleep Network

Non-Respiratory Sleep Section

Do you feel like you sleep worse in the spring and have more difficulty keeping your schedule on track? There are new data to support the way you feel based on our deeper understanding of seasonal variations in sleep architecture.

Patients in a recent study had 43 minutes less total sleep time and approximately 30 less minutes of REM sleep in the late spring when compared with the winter (Seidler A, et al. Front Neurosci. 2023 Feb 17:17:1105233). Accumulation of decreased sleep time and quality can lead to the sensation of ‘running-on-empty’ by early spring.

Experts believe these seasonal variations in sleep architecture are mainly secondary to circadian shifts. Our social synchronization overrides our natural alignment with daylight patterns and can lead to known consequences of circadian misalignment. Common consequences of poor circadian alignment include worsening sleep disturbances, cognitive impairments, occupational mistakes, and metabolic and mental health disturbances (Schmal C, et al. Front Physiol. 2020 Apr 28:11:334; Boivin D, et al. J Biol Rhythms. 2022 Feb;37[1]:3-28).

The effects of circadian misalignment can be particularly dramatic in children receiving less than their age-appropriate hours of sleep. Children with sleep deprivation are at increased risk of attention, behavior, and learning problems (Paruthi S, et al. J Clinl Sleep Med. 2016;12[6]:785-6).

To improve circadian alignment in spring, it is recommended to achieve morning bright light exposure and perform regular exercise. The elimination of daylight savings time to a consensus of permanent standard time will optimize circadian alignment.

Christopher Izzo, DO – Section Fellow-in-Training

William Healy, MD – Section Member-at-Large

Mariam Louis, MD – Section Chair

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The crucial roles of inpatient vaccinations in preventing respiratory viral illnesses

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Fri, 11/03/2023 - 17:03

 

Chest Infections & Disaster Response Network

Disaster Response & Global Health Section

In recent years, the importance of inpatient vaccinations against respiratory viral illnesses has become increasingly clear. As the world grapples with the ever-present threat of contagious diseases like influenza, COVID-19, Respiratory Syncytial Virus (RSV) and other respiratory viruses, the significance of vaccinating individuals during hospital stays cannot be overstated. Notably, the rates of inpatient vaccinations have significantly increased in recent years.

Numerous studies have demonstrated the success of various strategies to boost vaccine delivery to hospitalized patients. These strategies include personalized catch-up plans, electronic medical record (EMR) prompts, visual reminders, staff education and training, and allowing nonphysicians to screen and order vaccines. The implementation of nonphysician protocols has proven effective in increasing inpatient influenza vaccinations in multiple studies (Mihalek AJ, et al. Hosp Pediatr. 2021 Dec 1. doi: 10.1542/hpeds.2021-005924; Skull S, et al. J Paediatr Child Health. 1999;35[5]:472).

Optimizing the delivery of vaccines to hospitalized patients carries substantial public health benefits. This is especially vital for patients who face challenges accessing primary care and during periods of health care systems disruptions, such as those experienced during the COVID-19 pandemic.

In conclusion, inpatient vaccinations against respiratory viral illnesses are supported by a growing body of evidence. These vaccinations not only prevent disease transmission within health care facilities but also protect vulnerable patients, alleviate the burden on health care systems and with the recent approval of the RSV vaccine, we have a new tool to combat respiratory viruses effectively. As we continue to navigate the challenges posed by respiratory viruses, prioritizing inpatient vaccinations is a wise and necessary step toward a healthier, safer future for all.

Stella Ogake, MD – Section Member-at-Large

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In recent years, the importance of inpatient vaccinations against respiratory viral illnesses has become increasingly clear. As the world grapples with the ever-present threat of contagious diseases like influenza, COVID-19, Respiratory Syncytial Virus (RSV) and other respiratory viruses, the significance of vaccinating individuals during hospital stays cannot be overstated. Notably, the rates of inpatient vaccinations have significantly increased in recent years.

Numerous studies have demonstrated the success of various strategies to boost vaccine delivery to hospitalized patients. These strategies include personalized catch-up plans, electronic medical record (EMR) prompts, visual reminders, staff education and training, and allowing nonphysicians to screen and order vaccines. The implementation of nonphysician protocols has proven effective in increasing inpatient influenza vaccinations in multiple studies (Mihalek AJ, et al. Hosp Pediatr. 2021 Dec 1. doi: 10.1542/hpeds.2021-005924; Skull S, et al. J Paediatr Child Health. 1999;35[5]:472).

Optimizing the delivery of vaccines to hospitalized patients carries substantial public health benefits. This is especially vital for patients who face challenges accessing primary care and during periods of health care systems disruptions, such as those experienced during the COVID-19 pandemic.

In conclusion, inpatient vaccinations against respiratory viral illnesses are supported by a growing body of evidence. These vaccinations not only prevent disease transmission within health care facilities but also protect vulnerable patients, alleviate the burden on health care systems and with the recent approval of the RSV vaccine, we have a new tool to combat respiratory viruses effectively. As we continue to navigate the challenges posed by respiratory viruses, prioritizing inpatient vaccinations is a wise and necessary step toward a healthier, safer future for all.

Stella Ogake, MD – Section Member-at-Large

 

Chest Infections & Disaster Response Network

Disaster Response & Global Health Section

In recent years, the importance of inpatient vaccinations against respiratory viral illnesses has become increasingly clear. As the world grapples with the ever-present threat of contagious diseases like influenza, COVID-19, Respiratory Syncytial Virus (RSV) and other respiratory viruses, the significance of vaccinating individuals during hospital stays cannot be overstated. Notably, the rates of inpatient vaccinations have significantly increased in recent years.

Numerous studies have demonstrated the success of various strategies to boost vaccine delivery to hospitalized patients. These strategies include personalized catch-up plans, electronic medical record (EMR) prompts, visual reminders, staff education and training, and allowing nonphysicians to screen and order vaccines. The implementation of nonphysician protocols has proven effective in increasing inpatient influenza vaccinations in multiple studies (Mihalek AJ, et al. Hosp Pediatr. 2021 Dec 1. doi: 10.1542/hpeds.2021-005924; Skull S, et al. J Paediatr Child Health. 1999;35[5]:472).

Optimizing the delivery of vaccines to hospitalized patients carries substantial public health benefits. This is especially vital for patients who face challenges accessing primary care and during periods of health care systems disruptions, such as those experienced during the COVID-19 pandemic.

In conclusion, inpatient vaccinations against respiratory viral illnesses are supported by a growing body of evidence. These vaccinations not only prevent disease transmission within health care facilities but also protect vulnerable patients, alleviate the burden on health care systems and with the recent approval of the RSV vaccine, we have a new tool to combat respiratory viruses effectively. As we continue to navigate the challenges posed by respiratory viruses, prioritizing inpatient vaccinations is a wise and necessary step toward a healthier, safer future for all.

Stella Ogake, MD – Section Member-at-Large

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Update on seasonal flu, RSV infections, and vaccines

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Fri, 11/03/2023 - 16:49

 

Chest Infections & Disaster Response Network

Chest Infections Section

November 12 marks World Pneumonia Day, and while it has long been recognized that viruses play a significant role in causing pneumonia, awareness has surged due to the COVID-19 pandemic. Furthermore, with the advent of rapid molecular diagnostics, the contribution of respiratory viral pathogens in pneumonia has become clearer (Seema J, et al. N Engl J Med. 2015 Jul 30;373[5]:415-27). Despite COVID-19 remaining a substantial threat, infection rates with other respiratory viruses are on the rise and will continue to increase during colder months. Here, we will provide an update on influenza and RSV:
 

Currently, influenza activity in the United States is low (National Center for Immunization and Respiratory Diseases. FluView. 2023 Oct 4. https://www.cdc.gov/flu/weekly/index.htm). Vaccination coverage for US adults during the previous influenza season stood at 47% (Centers for Disease Control and Prevention. FluVaxView Vaccination Dashboard. 2023 Oct 4. https://www.cdc.gov/flu/fluvaxview/dashboard/vaccination-dashboard.html). Hospitalizations were estimated to range between 300,000 and 650,000, a significant increase from the 2021-2022 season, which saw about 100,000 hospitalizations (Centers for Disease Control and Prevention. Preliminary In-Season Estimates of Influenza Burden. 2023 Oct 4. https://www.cdc.gov/flu/about/burden/preliminary-in-season-estimates.htm). Data from the Southern Hemisphere’s recent influenza season indicates a 52% vaccine efficacy in preventing influenza-associated hospitalizations (Fowlkes AL, et al. MMWR Morb Mortal Wkly Rep. 2023 Sep 15;72[37]:1010-5). Influenza hospitalization rates are likely returning to higher pre-COVID-19 levels.

Respiratory Syncytial Virus (RSV) is a seasonal pathogen causing substantial morbidity and mortality. This year, two new vaccines have become available to prevent RSV-associated lower respiratory tract diseases, boasting a vaccine effectiveness of over 80% for the first and over 70% for the second season post-administration (Melgar M, et al. MMWR Morb Mortal Wkly Rep. 2023 Jul 21;72[29]:793-801). The CDC’s Advisory Committee on Immunization Practices recommends a single dose for adults over 60, and one vaccine is FDA-approved for pregnant individuals (32-36 weeks gestation) to provide passive infant immunity.

In summary, both the current influenza vaccine and the new RSV vaccines demonstrate effectiveness and are strongly recommended, alongside an updated COVID-19 vaccine.

John Huston, MD

Jamie Felzer, MD, MPH – Section Fellow-in-Training

Charles Dela Cruz, MD – Section Member-at-Large

Sebastian Kurz, MD, FCCP – Network Member-at-Large

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Chest Infections Section

November 12 marks World Pneumonia Day, and while it has long been recognized that viruses play a significant role in causing pneumonia, awareness has surged due to the COVID-19 pandemic. Furthermore, with the advent of rapid molecular diagnostics, the contribution of respiratory viral pathogens in pneumonia has become clearer (Seema J, et al. N Engl J Med. 2015 Jul 30;373[5]:415-27). Despite COVID-19 remaining a substantial threat, infection rates with other respiratory viruses are on the rise and will continue to increase during colder months. Here, we will provide an update on influenza and RSV:
 

Currently, influenza activity in the United States is low (National Center for Immunization and Respiratory Diseases. FluView. 2023 Oct 4. https://www.cdc.gov/flu/weekly/index.htm). Vaccination coverage for US adults during the previous influenza season stood at 47% (Centers for Disease Control and Prevention. FluVaxView Vaccination Dashboard. 2023 Oct 4. https://www.cdc.gov/flu/fluvaxview/dashboard/vaccination-dashboard.html). Hospitalizations were estimated to range between 300,000 and 650,000, a significant increase from the 2021-2022 season, which saw about 100,000 hospitalizations (Centers for Disease Control and Prevention. Preliminary In-Season Estimates of Influenza Burden. 2023 Oct 4. https://www.cdc.gov/flu/about/burden/preliminary-in-season-estimates.htm). Data from the Southern Hemisphere’s recent influenza season indicates a 52% vaccine efficacy in preventing influenza-associated hospitalizations (Fowlkes AL, et al. MMWR Morb Mortal Wkly Rep. 2023 Sep 15;72[37]:1010-5). Influenza hospitalization rates are likely returning to higher pre-COVID-19 levels.

Respiratory Syncytial Virus (RSV) is a seasonal pathogen causing substantial morbidity and mortality. This year, two new vaccines have become available to prevent RSV-associated lower respiratory tract diseases, boasting a vaccine effectiveness of over 80% for the first and over 70% for the second season post-administration (Melgar M, et al. MMWR Morb Mortal Wkly Rep. 2023 Jul 21;72[29]:793-801). The CDC’s Advisory Committee on Immunization Practices recommends a single dose for adults over 60, and one vaccine is FDA-approved for pregnant individuals (32-36 weeks gestation) to provide passive infant immunity.

In summary, both the current influenza vaccine and the new RSV vaccines demonstrate effectiveness and are strongly recommended, alongside an updated COVID-19 vaccine.

John Huston, MD

Jamie Felzer, MD, MPH – Section Fellow-in-Training

Charles Dela Cruz, MD – Section Member-at-Large

Sebastian Kurz, MD, FCCP – Network Member-at-Large

 

Chest Infections & Disaster Response Network

Chest Infections Section

November 12 marks World Pneumonia Day, and while it has long been recognized that viruses play a significant role in causing pneumonia, awareness has surged due to the COVID-19 pandemic. Furthermore, with the advent of rapid molecular diagnostics, the contribution of respiratory viral pathogens in pneumonia has become clearer (Seema J, et al. N Engl J Med. 2015 Jul 30;373[5]:415-27). Despite COVID-19 remaining a substantial threat, infection rates with other respiratory viruses are on the rise and will continue to increase during colder months. Here, we will provide an update on influenza and RSV:
 

Currently, influenza activity in the United States is low (National Center for Immunization and Respiratory Diseases. FluView. 2023 Oct 4. https://www.cdc.gov/flu/weekly/index.htm). Vaccination coverage for US adults during the previous influenza season stood at 47% (Centers for Disease Control and Prevention. FluVaxView Vaccination Dashboard. 2023 Oct 4. https://www.cdc.gov/flu/fluvaxview/dashboard/vaccination-dashboard.html). Hospitalizations were estimated to range between 300,000 and 650,000, a significant increase from the 2021-2022 season, which saw about 100,000 hospitalizations (Centers for Disease Control and Prevention. Preliminary In-Season Estimates of Influenza Burden. 2023 Oct 4. https://www.cdc.gov/flu/about/burden/preliminary-in-season-estimates.htm). Data from the Southern Hemisphere’s recent influenza season indicates a 52% vaccine efficacy in preventing influenza-associated hospitalizations (Fowlkes AL, et al. MMWR Morb Mortal Wkly Rep. 2023 Sep 15;72[37]:1010-5). Influenza hospitalization rates are likely returning to higher pre-COVID-19 levels.

Respiratory Syncytial Virus (RSV) is a seasonal pathogen causing substantial morbidity and mortality. This year, two new vaccines have become available to prevent RSV-associated lower respiratory tract diseases, boasting a vaccine effectiveness of over 80% for the first and over 70% for the second season post-administration (Melgar M, et al. MMWR Morb Mortal Wkly Rep. 2023 Jul 21;72[29]:793-801). The CDC’s Advisory Committee on Immunization Practices recommends a single dose for adults over 60, and one vaccine is FDA-approved for pregnant individuals (32-36 weeks gestation) to provide passive infant immunity.

In summary, both the current influenza vaccine and the new RSV vaccines demonstrate effectiveness and are strongly recommended, alongside an updated COVID-19 vaccine.

John Huston, MD

Jamie Felzer, MD, MPH – Section Fellow-in-Training

Charles Dela Cruz, MD – Section Member-at-Large

Sebastian Kurz, MD, FCCP – Network Member-at-Large

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Updated pleural disease guidelines from the British Thoracic Society

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Fri, 10/13/2023 - 09:09

 

Thoracic Oncology & Chest Imaging Network

Pleural Disease Section

After more than a decade, the British Thoracic Society (BTS) released updated guidelines for pleural disease (Roberts ME , et al. Thorax 2023; 78, s1-s42). Their focus includes spontaneous pneumothorax, undiagnosed unilateral pleural effusion, pleural infections, and malignant pleural effusion (MPE). Separate statements for pleural procedures (Asciak R et al. Thorax. 2023;78:s43-s68) and pleural mesothelioma (Woolhouse I et al. Thorax. 2018;73:i1-i30) are available.

Major highlights of the recommendations are as follows:

  • Conservative management can be considered for minimally symptomatic primary spontaneous pneumothorax regardless of size. A multi-disciplinary approach and shared decision-making is vital, especially when deciding between needle aspiration, intercostal drainage or ambulatory devices. Special recommendations were for pregnancy, cystic fibrosis, catamenial, iatrogenic and familial.
  • Undiagnosed unilateral pleural effusion. Besides pleural fluid studies, in those with unclear etiology, thoracoscopic or image-guided pleural biopsy is recommended.
  • Pleural infection. Use of renal, age, purulence, infection source, dietary factors (RAPID) scoring may be considered for risk stratification. Drainage of the pleural space with catheter and intrapleural therapy with combination tissue plasminogen activator (TPA) and DNAse in residual pleural fluid should be considered. Medical thoracoscopy not supported due to lack of evidence.
  • MPE. Definitive pleural intervention based on symptoms and shared decision making was supported. Modality may include talc slurry via chest tube, talc poudrage via thoracoscopy or talc instillation via indwelling pleural catheter. Intrapleural chemotherapy should not be routinely used for treatment of MPE.

These guidelines provide a comprehensive consensus to the literature and reinforce prior recommendations of other professional societies (Gilbert CR et al. Chest. 2020;158:2221-8. Miller RJ et al.; J Bronchology Interv Pulmonol. 2020;27[4]:229-45. Feller-Kopman DJ et al.; Am J Respir Crit Care Med. 2018;198:839-49).

Munish Sharma, MD

Hiren Mehta, MD, Section Member-at-Large

Philip Ong, MD, Section Member-at-Large

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After more than a decade, the British Thoracic Society (BTS) released updated guidelines for pleural disease (Roberts ME , et al. Thorax 2023; 78, s1-s42). Their focus includes spontaneous pneumothorax, undiagnosed unilateral pleural effusion, pleural infections, and malignant pleural effusion (MPE). Separate statements for pleural procedures (Asciak R et al. Thorax. 2023;78:s43-s68) and pleural mesothelioma (Woolhouse I et al. Thorax. 2018;73:i1-i30) are available.

Major highlights of the recommendations are as follows:

  • Conservative management can be considered for minimally symptomatic primary spontaneous pneumothorax regardless of size. A multi-disciplinary approach and shared decision-making is vital, especially when deciding between needle aspiration, intercostal drainage or ambulatory devices. Special recommendations were for pregnancy, cystic fibrosis, catamenial, iatrogenic and familial.
  • Undiagnosed unilateral pleural effusion. Besides pleural fluid studies, in those with unclear etiology, thoracoscopic or image-guided pleural biopsy is recommended.
  • Pleural infection. Use of renal, age, purulence, infection source, dietary factors (RAPID) scoring may be considered for risk stratification. Drainage of the pleural space with catheter and intrapleural therapy with combination tissue plasminogen activator (TPA) and DNAse in residual pleural fluid should be considered. Medical thoracoscopy not supported due to lack of evidence.
  • MPE. Definitive pleural intervention based on symptoms and shared decision making was supported. Modality may include talc slurry via chest tube, talc poudrage via thoracoscopy or talc instillation via indwelling pleural catheter. Intrapleural chemotherapy should not be routinely used for treatment of MPE.

These guidelines provide a comprehensive consensus to the literature and reinforce prior recommendations of other professional societies (Gilbert CR et al. Chest. 2020;158:2221-8. Miller RJ et al.; J Bronchology Interv Pulmonol. 2020;27[4]:229-45. Feller-Kopman DJ et al.; Am J Respir Crit Care Med. 2018;198:839-49).

Munish Sharma, MD

Hiren Mehta, MD, Section Member-at-Large

Philip Ong, MD, Section Member-at-Large

 

Thoracic Oncology & Chest Imaging Network

Pleural Disease Section

After more than a decade, the British Thoracic Society (BTS) released updated guidelines for pleural disease (Roberts ME , et al. Thorax 2023; 78, s1-s42). Their focus includes spontaneous pneumothorax, undiagnosed unilateral pleural effusion, pleural infections, and malignant pleural effusion (MPE). Separate statements for pleural procedures (Asciak R et al. Thorax. 2023;78:s43-s68) and pleural mesothelioma (Woolhouse I et al. Thorax. 2018;73:i1-i30) are available.

Major highlights of the recommendations are as follows:

  • Conservative management can be considered for minimally symptomatic primary spontaneous pneumothorax regardless of size. A multi-disciplinary approach and shared decision-making is vital, especially when deciding between needle aspiration, intercostal drainage or ambulatory devices. Special recommendations were for pregnancy, cystic fibrosis, catamenial, iatrogenic and familial.
  • Undiagnosed unilateral pleural effusion. Besides pleural fluid studies, in those with unclear etiology, thoracoscopic or image-guided pleural biopsy is recommended.
  • Pleural infection. Use of renal, age, purulence, infection source, dietary factors (RAPID) scoring may be considered for risk stratification. Drainage of the pleural space with catheter and intrapleural therapy with combination tissue plasminogen activator (TPA) and DNAse in residual pleural fluid should be considered. Medical thoracoscopy not supported due to lack of evidence.
  • MPE. Definitive pleural intervention based on symptoms and shared decision making was supported. Modality may include talc slurry via chest tube, talc poudrage via thoracoscopy or talc instillation via indwelling pleural catheter. Intrapleural chemotherapy should not be routinely used for treatment of MPE.

These guidelines provide a comprehensive consensus to the literature and reinforce prior recommendations of other professional societies (Gilbert CR et al. Chest. 2020;158:2221-8. Miller RJ et al.; J Bronchology Interv Pulmonol. 2020;27[4]:229-45. Feller-Kopman DJ et al.; Am J Respir Crit Care Med. 2018;198:839-49).

Munish Sharma, MD

Hiren Mehta, MD, Section Member-at-Large

Philip Ong, MD, Section Member-at-Large

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CPAP in overlap syndrome: Unveiling the evidence

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Fri, 10/13/2023 - 14:27

 

Sleep Medicine Network

Respiratory-Related Sleep Disorders Section

The overlap syndrome (OS), which refers to the co-occurrence of OSA and COPD, was first described by Flenley in 1985 (Flenley DC. Clin Chest Med. 1985;6[4]:651). Over the years, numerous studies have demonstrated an increased risk of hospitalization and mortality in patients with OS (Brennan M, et al. 2022;1-10). Despite these findings, limited evidence exists regarding the optimal treatment approach for individuals with OS.

Dr. Kirat Gill

CPAP therapy has demonstrated various physiologic advantages for patients with OS (Srivali N, et al. Sleep Med. 2023;108:55-60), which contribute to diminished dyspnea symptoms, lowered pro-inflammatory markers, improved arterial blood gases, increased 6-minute walk distance, enhanced FEV1, and decreased mean pulmonary artery pressure (Suri TM, et al. FASEB BioAdv. 2021;3[9]:683-93). CPAP therapy in patients with OS has been linked to a reduction in COPD exacerbations (Voulgaris A, et al. Clin Respir Jour. 2023; 17[3]:165), fewer COPD-related hospitalizations (Marin JM, et al. Am J Respir Crit Care Med. 2010;182[3]:325-31), decreased cardiovascular events (Kendzerska T, et al. Ann ATS. 2019;16[1]:71), and an overall decline in mortality rates (Machado ML, et al. Eur Respir J. 2010;35[1]:132-7).

It is important to acknowledge that, as of now, no randomized clinical trial has specifically addressed the treatment of OS, leaving recommendations largely reliant on observational studies. Conversely, recent guidelines have proposed the utilization of high-intensity noninvasive ventilation (NIV) for hypercapnic patients with COPD. Thus, extensive research is warranted to characterize distinct sleep-related breathing disorders within the OS population and to investigate the effects of CPAP in comparison to other NIV modalities on patients with overlap syndrome.


Solmaz Ehteshami-Afshar, MD

Kirat Gill, MD, Section Member-at-Large

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Respiratory-Related Sleep Disorders Section

The overlap syndrome (OS), which refers to the co-occurrence of OSA and COPD, was first described by Flenley in 1985 (Flenley DC. Clin Chest Med. 1985;6[4]:651). Over the years, numerous studies have demonstrated an increased risk of hospitalization and mortality in patients with OS (Brennan M, et al. 2022;1-10). Despite these findings, limited evidence exists regarding the optimal treatment approach for individuals with OS.

Dr. Kirat Gill

CPAP therapy has demonstrated various physiologic advantages for patients with OS (Srivali N, et al. Sleep Med. 2023;108:55-60), which contribute to diminished dyspnea symptoms, lowered pro-inflammatory markers, improved arterial blood gases, increased 6-minute walk distance, enhanced FEV1, and decreased mean pulmonary artery pressure (Suri TM, et al. FASEB BioAdv. 2021;3[9]:683-93). CPAP therapy in patients with OS has been linked to a reduction in COPD exacerbations (Voulgaris A, et al. Clin Respir Jour. 2023; 17[3]:165), fewer COPD-related hospitalizations (Marin JM, et al. Am J Respir Crit Care Med. 2010;182[3]:325-31), decreased cardiovascular events (Kendzerska T, et al. Ann ATS. 2019;16[1]:71), and an overall decline in mortality rates (Machado ML, et al. Eur Respir J. 2010;35[1]:132-7).

It is important to acknowledge that, as of now, no randomized clinical trial has specifically addressed the treatment of OS, leaving recommendations largely reliant on observational studies. Conversely, recent guidelines have proposed the utilization of high-intensity noninvasive ventilation (NIV) for hypercapnic patients with COPD. Thus, extensive research is warranted to characterize distinct sleep-related breathing disorders within the OS population and to investigate the effects of CPAP in comparison to other NIV modalities on patients with overlap syndrome.


Solmaz Ehteshami-Afshar, MD

Kirat Gill, MD, Section Member-at-Large

 

Sleep Medicine Network

Respiratory-Related Sleep Disorders Section

The overlap syndrome (OS), which refers to the co-occurrence of OSA and COPD, was first described by Flenley in 1985 (Flenley DC. Clin Chest Med. 1985;6[4]:651). Over the years, numerous studies have demonstrated an increased risk of hospitalization and mortality in patients with OS (Brennan M, et al. 2022;1-10). Despite these findings, limited evidence exists regarding the optimal treatment approach for individuals with OS.

Dr. Kirat Gill

CPAP therapy has demonstrated various physiologic advantages for patients with OS (Srivali N, et al. Sleep Med. 2023;108:55-60), which contribute to diminished dyspnea symptoms, lowered pro-inflammatory markers, improved arterial blood gases, increased 6-minute walk distance, enhanced FEV1, and decreased mean pulmonary artery pressure (Suri TM, et al. FASEB BioAdv. 2021;3[9]:683-93). CPAP therapy in patients with OS has been linked to a reduction in COPD exacerbations (Voulgaris A, et al. Clin Respir Jour. 2023; 17[3]:165), fewer COPD-related hospitalizations (Marin JM, et al. Am J Respir Crit Care Med. 2010;182[3]:325-31), decreased cardiovascular events (Kendzerska T, et al. Ann ATS. 2019;16[1]:71), and an overall decline in mortality rates (Machado ML, et al. Eur Respir J. 2010;35[1]:132-7).

It is important to acknowledge that, as of now, no randomized clinical trial has specifically addressed the treatment of OS, leaving recommendations largely reliant on observational studies. Conversely, recent guidelines have proposed the utilization of high-intensity noninvasive ventilation (NIV) for hypercapnic patients with COPD. Thus, extensive research is warranted to characterize distinct sleep-related breathing disorders within the OS population and to investigate the effects of CPAP in comparison to other NIV modalities on patients with overlap syndrome.


Solmaz Ehteshami-Afshar, MD

Kirat Gill, MD, Section Member-at-Large

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Use of 6-minute walk distance as a clinical trial outcome in interstitial lung disease

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Changed
Fri, 10/13/2023 - 08:28

 

Diffuse Lung & Transplant Network

Pulmonary Physiology & Rehabilitation Section

Pulmonary arterial hypertension (PH) and more recently interstitial lung disease (ILD) trials use the 6-minute walk test (6MWT) as a primary outcome due to its ability to conveniently capture a patient’s functional capacity and quality of life. However, interpreting the 6MWT in complex and diverse diseases, such as ILD, presents significant challenges.

A recent article (Harari, et al. Eur Respir Rev. 2022 Aug 23;31(165):220087. doi: 10.1183/16000617.0087-2022) advocates for further research to determine the optimal use of the 6MWT as a clinical endpoint in ILD trials. A decline in 6MWT can represent progression of ILD; ILD-related PH; or musculoskeletal, hematologic, or cardiac etiologies related to the underlying cause of ILD.

To enhance sensitivity, the authors endorse the inclusion of additional parameters in the analysis, possibly as a composite outcome. This would involve integrating the oxygen desaturation profile, dyspnea scores, and heart rate recovery with changes in the 6MWT-distance. They propose this composite measure could serve as a primary endpoint when the study intervention’s impact on clinical performance – either improvement or stabilization of ILD or ILD-related PH – is clearly defined. The prognostic significance of these additional parameters in patients with ILD, however, requires further investigation.

Inter-test reliability requires a standardized 6MWT, as previously proposed for this population (Lancaster, et al. Contemporary Clin Trials. 2021;Nov 25,2020). The standardized test protocol that includes continuous pulse oximetry and heart rate measurement, oxygen titration, and end of test guidelines, will reduce variability and boost reproducibility.

In light of recent advancements in the affordability, convenience, and portability of oxygen consumption (VO2) gas analyzers, we believe that incorporating Vo2 measurements into the 6MWT is a needed incremental improvement. This integration will help define the disease process, its impact on patient performance, and clinical prognosis. Future work should focus on understanding how to effectively estimate Vo2 in combination with a standardized 6MWT to make this test a reliable clinical outcome in trials.

Ruchicka Sangani, MD, Section Fellow-in-Training

Saqib Baig, MD, Section Member-at-Large

 

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Pulmonary Physiology & Rehabilitation Section

Pulmonary arterial hypertension (PH) and more recently interstitial lung disease (ILD) trials use the 6-minute walk test (6MWT) as a primary outcome due to its ability to conveniently capture a patient’s functional capacity and quality of life. However, interpreting the 6MWT in complex and diverse diseases, such as ILD, presents significant challenges.

A recent article (Harari, et al. Eur Respir Rev. 2022 Aug 23;31(165):220087. doi: 10.1183/16000617.0087-2022) advocates for further research to determine the optimal use of the 6MWT as a clinical endpoint in ILD trials. A decline in 6MWT can represent progression of ILD; ILD-related PH; or musculoskeletal, hematologic, or cardiac etiologies related to the underlying cause of ILD.

To enhance sensitivity, the authors endorse the inclusion of additional parameters in the analysis, possibly as a composite outcome. This would involve integrating the oxygen desaturation profile, dyspnea scores, and heart rate recovery with changes in the 6MWT-distance. They propose this composite measure could serve as a primary endpoint when the study intervention’s impact on clinical performance – either improvement or stabilization of ILD or ILD-related PH – is clearly defined. The prognostic significance of these additional parameters in patients with ILD, however, requires further investigation.

Inter-test reliability requires a standardized 6MWT, as previously proposed for this population (Lancaster, et al. Contemporary Clin Trials. 2021;Nov 25,2020). The standardized test protocol that includes continuous pulse oximetry and heart rate measurement, oxygen titration, and end of test guidelines, will reduce variability and boost reproducibility.

In light of recent advancements in the affordability, convenience, and portability of oxygen consumption (VO2) gas analyzers, we believe that incorporating Vo2 measurements into the 6MWT is a needed incremental improvement. This integration will help define the disease process, its impact on patient performance, and clinical prognosis. Future work should focus on understanding how to effectively estimate Vo2 in combination with a standardized 6MWT to make this test a reliable clinical outcome in trials.

Ruchicka Sangani, MD, Section Fellow-in-Training

Saqib Baig, MD, Section Member-at-Large

 

 

Diffuse Lung & Transplant Network

Pulmonary Physiology & Rehabilitation Section

Pulmonary arterial hypertension (PH) and more recently interstitial lung disease (ILD) trials use the 6-minute walk test (6MWT) as a primary outcome due to its ability to conveniently capture a patient’s functional capacity and quality of life. However, interpreting the 6MWT in complex and diverse diseases, such as ILD, presents significant challenges.

A recent article (Harari, et al. Eur Respir Rev. 2022 Aug 23;31(165):220087. doi: 10.1183/16000617.0087-2022) advocates for further research to determine the optimal use of the 6MWT as a clinical endpoint in ILD trials. A decline in 6MWT can represent progression of ILD; ILD-related PH; or musculoskeletal, hematologic, or cardiac etiologies related to the underlying cause of ILD.

To enhance sensitivity, the authors endorse the inclusion of additional parameters in the analysis, possibly as a composite outcome. This would involve integrating the oxygen desaturation profile, dyspnea scores, and heart rate recovery with changes in the 6MWT-distance. They propose this composite measure could serve as a primary endpoint when the study intervention’s impact on clinical performance – either improvement or stabilization of ILD or ILD-related PH – is clearly defined. The prognostic significance of these additional parameters in patients with ILD, however, requires further investigation.

Inter-test reliability requires a standardized 6MWT, as previously proposed for this population (Lancaster, et al. Contemporary Clin Trials. 2021;Nov 25,2020). The standardized test protocol that includes continuous pulse oximetry and heart rate measurement, oxygen titration, and end of test guidelines, will reduce variability and boost reproducibility.

In light of recent advancements in the affordability, convenience, and portability of oxygen consumption (VO2) gas analyzers, we believe that incorporating Vo2 measurements into the 6MWT is a needed incremental improvement. This integration will help define the disease process, its impact on patient performance, and clinical prognosis. Future work should focus on understanding how to effectively estimate Vo2 in combination with a standardized 6MWT to make this test a reliable clinical outcome in trials.

Ruchicka Sangani, MD, Section Fellow-in-Training

Saqib Baig, MD, Section Member-at-Large

 

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