Society News

Oxygen therapy in patients with COPD with moderate desaturation

Two landmark trials from the early 1980s demonstrated survival benefit with long-term oxygen therapy (LTOT) in patients with COPD with severe resting hypoxemia [Sao₂ less than 89%; (Nocturnal Oxygen Therapy Trial Group. Ann Intern Med. 1980;93[3]:391) or Pao₂ 40-60 mm Hg and cor pulmonale (Report of the Medical Research Council Working Party. Lancet. 1981;1[8222]:681).

The potential benefits of LTOT in COPD with mild-moderate hypoxemia have not been clearly established. The LOTT trial (The Long-Term Oxygen Treatment Trial Research Group. N Engl J Med. 2016;375[17]:1617), a recent multicenter randomized study, attempted to answer this question. They studied 738 stable patients with COPD with mild to moderate resting desaturation (Spo₂ 89%-93%) or exercise-induced moderate desaturation (Spo₂ greater than or equal to 80% for greater than or equal to 5 minutes and Spo₂ less than 90% for greater than or equal to 10 seconds during 6- minute walk test). After a median follow-up of 18.4 months, LTOT did not demonstrate a decrease in the time to death or first hospitalization and did not show improvement in quality of life or functional status. Notable adverse events from oxygen included 23 instances of tripping over equipment, with two patients requiring hospitalization and six fires with one patient hospitalized for burns.

A Cochrane meta-analysis, which did not include LOTT data, revealed that oxygen relieved breathlessness during acute exercise in mildly-moderately hypoxemic patients with COPD, but there was insufficient evidence of benefit in daily life or in health-related quality of life (Cochrane Database Syst Rev. 2016;11:CD006429).

Whether or not to continue prescribing oxygen to patients with moderate desaturation remains a controversial issue. A trial of oxygen may be warranted in those who are already on maximal evidence-based therapy for COPD and still complain of severe breathlessness (Ekstrom M; N Engl J Med. 2016;375[17]:1683). Conversely, a patient with COPD and moderate desaturation who resists being placed on supplemental oxygen, can be reassured that this is a reasonable course based on current evidence (Baliksoon R. COPD. 2017;4:71).

Navitha Ramesh, MD, MBBS

Fellow-in-Training Steering Committee Member

Allen Blaivas, DO, FCCP

Steering Committee Member

Informed consent: Do we need to change our practice?

Informed consent is the keystone of clinical research and helps respect and protect the rights of the participants/subjects. While the informed consent process has been standardized, some challenges still remain, such as pieces of information that should be disclosed, how to disclose information and document understanding of participants, and how detailed that disclosure should be (Grady C. N Engl J Med. 2015;372[9]:855). Digital technology can and has been used to improve the process of obtaining informed consent. Smartphones now comprise 75% of all mobile phones sold worldwide. They are being used to reach a larger and diverse population to conduct trials.

Substituting long and complex written forms with electronic consent (e-consent), however, has issues. Few people read through online agreements before clicking “agree,” which may lead to participants consenting without a clear understanding of what they are consenting to. On the other hand, it is also possible to use e-consent to improve comprehension by including videos and graphics. Interactive quizzes can assess the understanding of the participants, and embedded links to audios or videos can further enhance the grasp of information. With e-consents, queries from participants can be answered via phone call or email, etc. When e-consent is obtained remotely, the identity can be confirmed by electronic signatures, username, password, or biometrics.

E-consent has advantages, can be done remotely, no paper is needed, etc. It has potential disadvantages like being costly, videos can add time to the process, and multicenter international trials can be difficult (Grady C, et al. N Engl J Med. 2017;376[20]:e43). Studying e-consents to identify gaps in communication between the researcher and the participant in the digitalized world may help improve the process and allow research to proceed with better understanding of the risks and benefits of involvement in clinical research.

Moshsin Ijaz, MD, FCCP

Steering Committee Member

Early ID and treatment in sepsis

PRISM, the latest meta-analysis of three multicenter trials (ProCESS, ARISE, and ProMISe) found no difference in mortality with early goal-directed therapy vs usual care (N Engl J Med. 2017; 376[23]:2223). These clinical trials promoted early recognition of sepsis and prompt delivery of IV fluids and antimicrobial agents before randomization. It seems that early identification and treatment of sepsis and the rapid administration of antibiotics (following the timing recommended for sepsis bundle protocols) are the most effective interventions in sepsis (Seymour WS, et al. N Engl J Med. 2017;376[23]:2235). Other interventions over the past decade designed to reduce mortality associated with sepsis have been unsuccessful.

Maximiliano Tamae Kakazu, MD, FCCP

Steering Committee Member

The changing landscape of home mechanical ventilation

The greatest advances in home mechanical ventilation for conditions associated with chronic respiratory failure have been associated with the implementation of noninvasivepositive pressure ventilation (NIPPV) via mask interface. This dynamic growth is accredited to NIPPV efficacy and technologic improvements in ventilator and mask. For neuromuscular and restrictive thoracic diseases, NIPPV has been shown to increase survival, decrease hospital admissions, and improve quality of life (Chatwin A, et al. Plos One. 2015;10[5]:e0125839; Annane D, et al. Cochrane Database Syst Rev. 2014;13[12]:CD001941). From this success, NIPPV has been extended to conditions associated with respiratory impairment (eg, COPD, obesity hypoventilation, sleep-disordered breathing). A recent randomized study comparing home oxygen therapy (HOT) plus NIPPV vs HOT alone in post-hospitalized patients with COPD with persistent hypercapnia showed that addition of NIPPV significantly prolonged time to readmission or death from 1.4 to 4.3 months (Murphy P, et al. JAMA. 2017;317[21]:2177). Overall, however, evidence to support NIPPV in these groups is less compelling.

Michelle Cao, DO, FCCP

Steering Committee Member

Improving diagnostic capabilities in diffuse parenchymal lung disease

With the approval of two antifibrotic drugs for the treatment of idiopathic pulmonary fibrosis, there has been renewed focus in the NetWork in improving diagnosis in interstitial lung disease. There is considerable interest in exploring novel techniques and paradigms in the classification and diagnosis of diffuse parenchymal lung diseases (DPLDs). Given the invasive nature of surgical lung biopsy and its associated morbidity in elderly patients, there is a need for safer techniques to obtain lung tissue for histopathologic analysis. Transbronchial cryobiopsy may be a safe and accurate alternative for obtaining lung tissue, and we hope to better understand the role of this procedure in disease diagnosis. It is also possible that in the future, we may be able to classify these diseases without having to obtain lung tissue. More studies are being done in novel imaging techniques, such as molecular imaging, optical coherence tomography, and confocal laser endomicroscopy, that may negate the need for lung tissue in the future. Biomarker discovery and identification of biomarker signatures that can help differentiate DPLDs and provide prognostic information are also a particular focus and of importance for our NetWork. With this increased focus on better diagnostic techniques for classification of DPLD, the NetWork is featuring a lecture at CHEST 2017 on “Molecular Endotyping of Pulmonary Fibrosis,” and two sessions that will explore the current diagnostic difficulties that confront clinicians. As we move forward in our understanding of how to classify and diagnose interstitial lung disease, there is potential for more targeted interventions in individual patients.

Tracy Luckhardt, MD

Steering Committee Member

Oxygen therapy in patients with COPD with moderate desaturation

Two landmark trials from the early 1980s demonstrated survival benefit with long-term oxygen therapy (LTOT) in patients with COPD with severe resting hypoxemia [Sao₂ less than 89%; (Nocturnal Oxygen Therapy Trial Group. Ann Intern Med. 1980;93[3]:391) or Pao₂ 40-60 mm Hg and cor pulmonale (Report of the Medical Research Council Working Party. Lancet. 1981;1[8222]:681).

The potential benefits of LTOT in COPD with mild-moderate hypoxemia have not been clearly established. The LOTT trial (The Long-Term Oxygen Treatment Trial Research Group. N Engl J Med. 2016;375[17]:1617), a recent multicenter randomized study, attempted to answer this question. They studied 738 stable patients with COPD with mild to moderate resting desaturation (Spo₂ 89%-93%) or exercise-induced moderate desaturation (Spo₂ greater than or equal to 80% for greater than or equal to 5 minutes and Spo₂ less than 90% for greater than or equal to 10 seconds during 6- minute walk test). After a median follow-up of 18.4 months, LTOT did not demonstrate a decrease in the time to death or first hospitalization and did not show improvement in quality of life or functional status. Notable adverse events from oxygen included 23 instances of tripping over equipment, with two patients requiring hospitalization and six fires with one patient hospitalized for burns.

A Cochrane meta-analysis, which did not include LOTT data, revealed that oxygen relieved breathlessness during acute exercise in mildly-moderately hypoxemic patients with COPD, but there was insufficient evidence of benefit in daily life or in health-related quality of life (Cochrane Database Syst Rev. 2016;11:CD006429).

Whether or not to continue prescribing oxygen to patients with moderate desaturation remains a controversial issue. A trial of oxygen may be warranted in those who are already on maximal evidence-based therapy for COPD and still complain of severe breathlessness (Ekstrom M; N Engl J Med. 2016;375[17]:1683). Conversely, a patient with COPD and moderate desaturation who resists being placed on supplemental oxygen, can be reassured that this is a reasonable course based on current evidence (Baliksoon R. COPD. 2017;4:71).

Navitha Ramesh, MD, MBBS

Fellow-in-Training Steering Committee Member

Allen Blaivas, DO, FCCP

Steering Committee Member

Informed consent: Do we need to change our practice?

Informed consent is the keystone of clinical research and helps respect and protect the rights of the participants/subjects. While the informed consent process has been standardized, some challenges still remain, such as pieces of information that should be disclosed, how to disclose information and document understanding of participants, and how detailed that disclosure should be (Grady C. N Engl J Med. 2015;372[9]:855). Digital technology can and has been used to improve the process of obtaining informed consent. Smartphones now comprise 75% of all mobile phones sold worldwide. They are being used to reach a larger and diverse population to conduct trials.

Substituting long and complex written forms with electronic consent (e-consent), however, has issues. Few people read through online agreements before clicking “agree,” which may lead to participants consenting without a clear understanding of what they are consenting to. On the other hand, it is also possible to use e-consent to improve comprehension by including videos and graphics. Interactive quizzes can assess the understanding of the participants, and embedded links to audios or videos can further enhance the grasp of information. With e-consents, queries from participants can be answered via phone call or email, etc. When e-consent is obtained remotely, the identity can be confirmed by electronic signatures, username, password, or biometrics.

E-consent has advantages, can be done remotely, no paper is needed, etc. It has potential disadvantages like being costly, videos can add time to the process, and multicenter international trials can be difficult (Grady C, et al. N Engl J Med. 2017;376[20]:e43). Studying e-consents to identify gaps in communication between the researcher and the participant in the digitalized world may help improve the process and allow research to proceed with better understanding of the risks and benefits of involvement in clinical research.

Moshsin Ijaz, MD, FCCP

Steering Committee Member

Early ID and treatment in sepsis

PRISM, the latest meta-analysis of three multicenter trials (ProCESS, ARISE, and ProMISe) found no difference in mortality with early goal-directed therapy vs usual care (N Engl J Med. 2017; 376[23]:2223). These clinical trials promoted early recognition of sepsis and prompt delivery of IV fluids and antimicrobial agents before randomization. It seems that early identification and treatment of sepsis and the rapid administration of antibiotics (following the timing recommended for sepsis bundle protocols) are the most effective interventions in sepsis (Seymour WS, et al. N Engl J Med. 2017;376[23]:2235). Other interventions over the past decade designed to reduce mortality associated with sepsis have been unsuccessful.

Maximiliano Tamae Kakazu, MD, FCCP

Steering Committee Member

The changing landscape of home mechanical ventilation

The greatest advances in home mechanical ventilation for conditions associated with chronic respiratory failure have been associated with the implementation of noninvasivepositive pressure ventilation (NIPPV) via mask interface. This dynamic growth is accredited to NIPPV efficacy and technologic improvements in ventilator and mask. For neuromuscular and restrictive thoracic diseases, NIPPV has been shown to increase survival, decrease hospital admissions, and improve quality of life (Chatwin A, et al. Plos One. 2015;10[5]:e0125839; Annane D, et al. Cochrane Database Syst Rev. 2014;13[12]:CD001941). From this success, NIPPV has been extended to conditions associated with respiratory impairment (eg, COPD, obesity hypoventilation, sleep-disordered breathing). A recent randomized study comparing home oxygen therapy (HOT) plus NIPPV vs HOT alone in post-hospitalized patients with COPD with persistent hypercapnia showed that addition of NIPPV significantly prolonged time to readmission or death from 1.4 to 4.3 months (Murphy P, et al. JAMA. 2017;317[21]:2177). Overall, however, evidence to support NIPPV in these groups is less compelling.

Michelle Cao, DO, FCCP

Steering Committee Member

Improving diagnostic capabilities in diffuse parenchymal lung disease

With the approval of two antifibrotic drugs for the treatment of idiopathic pulmonary fibrosis, there has been renewed focus in the NetWork in improving diagnosis in interstitial lung disease. There is considerable interest in exploring novel techniques and paradigms in the classification and diagnosis of diffuse parenchymal lung diseases (DPLDs). Given the invasive nature of surgical lung biopsy and its associated morbidity in elderly patients, there is a need for safer techniques to obtain lung tissue for histopathologic analysis. Transbronchial cryobiopsy may be a safe and accurate alternative for obtaining lung tissue, and we hope to better understand the role of this procedure in disease diagnosis. It is also possible that in the future, we may be able to classify these diseases without having to obtain lung tissue. More studies are being done in novel imaging techniques, such as molecular imaging, optical coherence tomography, and confocal laser endomicroscopy, that may negate the need for lung tissue in the future. Biomarker discovery and identification of biomarker signatures that can help differentiate DPLDs and provide prognostic information are also a particular focus and of importance for our NetWork. With this increased focus on better diagnostic techniques for classification of DPLD, the NetWork is featuring a lecture at CHEST 2017 on “Molecular Endotyping of Pulmonary Fibrosis,” and two sessions that will explore the current diagnostic difficulties that confront clinicians. As we move forward in our understanding of how to classify and diagnose interstitial lung disease, there is potential for more targeted interventions in individual patients.

Tracy Luckhardt, MD

Steering Committee Member

Oxygen therapy in patients with COPD with moderate desaturation

Two landmark trials from the early 1980s demonstrated survival benefit with long-term oxygen therapy (LTOT) in patients with COPD with severe resting hypoxemia [Sao₂ less than 89%; (Nocturnal Oxygen Therapy Trial Group. Ann Intern Med. 1980;93[3]:391) or Pao₂ 40-60 mm Hg and cor pulmonale (Report of the Medical Research Council Working Party. Lancet. 1981;1[8222]:681).

The potential benefits of LTOT in COPD with mild-moderate hypoxemia have not been clearly established. The LOTT trial (The Long-Term Oxygen Treatment Trial Research Group. N Engl J Med. 2016;375[17]:1617), a recent multicenter randomized study, attempted to answer this question. They studied 738 stable patients with COPD with mild to moderate resting desaturation (Spo₂ 89%-93%) or exercise-induced moderate desaturation (Spo₂ greater than or equal to 80% for greater than or equal to 5 minutes and Spo₂ less than 90% for greater than or equal to 10 seconds during 6- minute walk test). After a median follow-up of 18.4 months, LTOT did not demonstrate a decrease in the time to death or first hospitalization and did not show improvement in quality of life or functional status. Notable adverse events from oxygen included 23 instances of tripping over equipment, with two patients requiring hospitalization and six fires with one patient hospitalized for burns.

A Cochrane meta-analysis, which did not include LOTT data, revealed that oxygen relieved breathlessness during acute exercise in mildly-moderately hypoxemic patients with COPD, but there was insufficient evidence of benefit in daily life or in health-related quality of life (Cochrane Database Syst Rev. 2016;11:CD006429).

Whether or not to continue prescribing oxygen to patients with moderate desaturation remains a controversial issue. A trial of oxygen may be warranted in those who are already on maximal evidence-based therapy for COPD and still complain of severe breathlessness (Ekstrom M; N Engl J Med. 2016;375[17]:1683). Conversely, a patient with COPD and moderate desaturation who resists being placed on supplemental oxygen, can be reassured that this is a reasonable course based on current evidence (Baliksoon R. COPD. 2017;4:71).

Navitha Ramesh, MD, MBBS

Fellow-in-Training Steering Committee Member

Allen Blaivas, DO, FCCP

Steering Committee Member

Informed consent: Do we need to change our practice?

Informed consent is the keystone of clinical research and helps respect and protect the rights of the participants/subjects. While the informed consent process has been standardized, some challenges still remain, such as pieces of information that should be disclosed, how to disclose information and document understanding of participants, and how detailed that disclosure should be (Grady C. N Engl J Med. 2015;372[9]:855). Digital technology can and has been used to improve the process of obtaining informed consent. Smartphones now comprise 75% of all mobile phones sold worldwide. They are being used to reach a larger and diverse population to conduct trials.

Substituting long and complex written forms with electronic consent (e-consent), however, has issues. Few people read through online agreements before clicking “agree,” which may lead to participants consenting without a clear understanding of what they are consenting to. On the other hand, it is also possible to use e-consent to improve comprehension by including videos and graphics. Interactive quizzes can assess the understanding of the participants, and embedded links to audios or videos can further enhance the grasp of information. With e-consents, queries from participants can be answered via phone call or email, etc. When e-consent is obtained remotely, the identity can be confirmed by electronic signatures, username, password, or biometrics.

E-consent has advantages, can be done remotely, no paper is needed, etc. It has potential disadvantages like being costly, videos can add time to the process, and multicenter international trials can be difficult (Grady C, et al. N Engl J Med. 2017;376[20]:e43). Studying e-consents to identify gaps in communication between the researcher and the participant in the digitalized world may help improve the process and allow research to proceed with better understanding of the risks and benefits of involvement in clinical research.

Moshsin Ijaz, MD, FCCP

Steering Committee Member

Early ID and treatment in sepsis

PRISM, the latest meta-analysis of three multicenter trials (ProCESS, ARISE, and ProMISe) found no difference in mortality with early goal-directed therapy vs usual care (N Engl J Med. 2017; 376[23]:2223). These clinical trials promoted early recognition of sepsis and prompt delivery of IV fluids and antimicrobial agents before randomization. It seems that early identification and treatment of sepsis and the rapid administration of antibiotics (following the timing recommended for sepsis bundle protocols) are the most effective interventions in sepsis (Seymour WS, et al. N Engl J Med. 2017;376[23]:2235). Other interventions over the past decade designed to reduce mortality associated with sepsis have been unsuccessful.

Maximiliano Tamae Kakazu, MD, FCCP

Steering Committee Member

The changing landscape of home mechanical ventilation

The greatest advances in home mechanical ventilation for conditions associated with chronic respiratory failure have been associated with the implementation of noninvasivepositive pressure ventilation (NIPPV) via mask interface. This dynamic growth is accredited to NIPPV efficacy and technologic improvements in ventilator and mask. For neuromuscular and restrictive thoracic diseases, NIPPV has been shown to increase survival, decrease hospital admissions, and improve quality of life (Chatwin A, et al. Plos One. 2015;10[5]:e0125839; Annane D, et al. Cochrane Database Syst Rev. 2014;13[12]:CD001941). From this success, NIPPV has been extended to conditions associated with respiratory impairment (eg, COPD, obesity hypoventilation, sleep-disordered breathing). A recent randomized study comparing home oxygen therapy (HOT) plus NIPPV vs HOT alone in post-hospitalized patients with COPD with persistent hypercapnia showed that addition of NIPPV significantly prolonged time to readmission or death from 1.4 to 4.3 months (Murphy P, et al. JAMA. 2017;317[21]:2177). Overall, however, evidence to support NIPPV in these groups is less compelling.

Michelle Cao, DO, FCCP

Steering Committee Member

Improving diagnostic capabilities in diffuse parenchymal lung disease

With the approval of two antifibrotic drugs for the treatment of idiopathic pulmonary fibrosis, there has been renewed focus in the NetWork in improving diagnosis in interstitial lung disease. There is considerable interest in exploring novel techniques and paradigms in the classification and diagnosis of diffuse parenchymal lung diseases (DPLDs). Given the invasive nature of surgical lung biopsy and its associated morbidity in elderly patients, there is a need for safer techniques to obtain lung tissue for histopathologic analysis. Transbronchial cryobiopsy may be a safe and accurate alternative for obtaining lung tissue, and we hope to better understand the role of this procedure in disease diagnosis. It is also possible that in the future, we may be able to classify these diseases without having to obtain lung tissue. More studies are being done in novel imaging techniques, such as molecular imaging, optical coherence tomography, and confocal laser endomicroscopy, that may negate the need for lung tissue in the future. Biomarker discovery and identification of biomarker signatures that can help differentiate DPLDs and provide prognostic information are also a particular focus and of importance for our NetWork. With this increased focus on better diagnostic techniques for classification of DPLD, the NetWork is featuring a lecture at CHEST 2017 on “Molecular Endotyping of Pulmonary Fibrosis,” and two sessions that will explore the current diagnostic difficulties that confront clinicians. As we move forward in our understanding of how to classify and diagnose interstitial lung disease, there is potential for more targeted interventions in individual patients.

Tracy Luckhardt, MD

Steering Committee Member

CHEST has been informed of the following deaths.We extend our sincere condolences.
 

Henry J. Heimlich MD, FCCP (December 2016)

Sylvan Lee Weinberg, MD, FCCP (Past President-1983-84) (January 2017)

Clive Deutscher, MD, FCCP (January 2017)

Sandra Willsie, DO, FCCP (March 2017)

Arthur F. Reimann, MD, FCCP (March 2017)

Cynthia Ray, MD, FCCP (April 2017)

Brian J. Sproule, MD, MS, FCCP (April 2017)

Michael R. Bye, MD, FCCP (April 2017)

Paul J. Mathews, MD, FCCP (May 2017)

CHEST has been informed of the following deaths.We extend our sincere condolences.
 

Henry J. Heimlich MD, FCCP (December 2016)

Sylvan Lee Weinberg, MD, FCCP (Past President-1983-84) (January 2017)

Clive Deutscher, MD, FCCP (January 2017)

Sandra Willsie, DO, FCCP (March 2017)

Arthur F. Reimann, MD, FCCP (March 2017)

Cynthia Ray, MD, FCCP (April 2017)

Brian J. Sproule, MD, MS, FCCP (April 2017)

Michael R. Bye, MD, FCCP (April 2017)

Paul J. Mathews, MD, FCCP (May 2017)

CHEST has been informed of the following deaths.We extend our sincere condolences.
 

Henry J. Heimlich MD, FCCP (December 2016)

Sylvan Lee Weinberg, MD, FCCP (Past President-1983-84) (January 2017)

Clive Deutscher, MD, FCCP (January 2017)

Sandra Willsie, DO, FCCP (March 2017)

Arthur F. Reimann, MD, FCCP (March 2017)

Cynthia Ray, MD, FCCP (April 2017)

Brian J. Sproule, MD, MS, FCCP (April 2017)

Michael R. Bye, MD, FCCP (April 2017)

Paul J. Mathews, MD, FCCP (May 2017)

In 2017, we’ve continued to push our disease awareness efforts in lung cancer, sarcoidosis, asthma, and COPD, trading our “awareness months” for longer, more sustainable campaigns.

Lung Cancer

Our lung cancer disease awareness campaign launched mid-May and goes through World Lung Cancer Day on August 1, 2017. The foundation is partnering with the Bonnie J. Addarrio Lung Cancer Foundation and LUNGevity to produce:

• Biopsy-specific infographics

• An animated biopsy video to show the importance of collecting core tissue

Sharing these resources through the CHEST social media channels, we have so far been able to reach more than 34.2K social media accounts and earn 512 social interactions, including likes/reactions, clicks, and shares/retweets from Twitter, Facebook, and LinkedIn.

We are also excited to participate in a Lung Cancer Living Room discussion with the Bonnie J. Addario Lung Cancer Foundation. This presentation will bring lung cancer specialists, physicians, patients, and the public together to discuss lung cancer in a relaxed and comfortable setting. Attendees will have the opportunity to ask questions, share their stories, and discuss issues surrounding lung cancer. The event will also be live-streamed and archived on the Bonnie J. Addario Lung Cancer Foundation’s website.

Asthma

We launched our asthma campaign at “The Air We Breathe” Summit with The Atlantic. We were able to reach more than 24.2K social accounts through live tweeting during the event and follow up posts on CHEST’s Twitter and Facebook accounts. The Atlantic was able to earn an impressive reach of 868K social accounts through their own social media promotion for the event. To read more about the event that focused on the quality of our air and the implications on our health, visit chestfoundation.org/summit.

We continue to partner with the Allergy & Asthma Network to create and distribute our materials and messaging, which focus on severe and difficult-to-control asthma. This campaign has already garnered over 53.4K social media impressions through CHEST channels, and over 1.3K social interactions. New components to the campaign include:

• Severity assessment tool

• Shared decision making tool

• Patient testimonial videos

Our campaign also included an 8-minute segment on the Access Health program, which aired two times in May on Lifetime NetWork, with an additional 200+ airings via syndication throughout 100 US markets.
 

Sarcoidosis

For the third consecutive year, we’ve partnered with the Foundation for Sarcoidosis Research to spread awareness on the disease. We also partnered with the American Osteopathic Association, the COPD Foundation, and The Society of Thoracic Surgeons to create

In CHEST member communications, our campaign reached more than 20,000 people, and our social media posts have reached more than 61.7K social accounts. CHEST’s press release on sarcoidosis has reached well over 11.6M clinicians and patients.



We are very grateful and proud of the work our partners have done to help us spread awareness on these diseases, so clinicians and patients will be able to use our resources to champion lung health.

In 2017, we’ve continued to push our disease awareness efforts in lung cancer, sarcoidosis, asthma, and COPD, trading our “awareness months” for longer, more sustainable campaigns.

Lung Cancer

Our lung cancer disease awareness campaign launched mid-May and goes through World Lung Cancer Day on August 1, 2017. The foundation is partnering with the Bonnie J. Addarrio Lung Cancer Foundation and LUNGevity to produce:

• Biopsy-specific infographics

• An animated biopsy video to show the importance of collecting core tissue

Sharing these resources through the CHEST social media channels, we have so far been able to reach more than 34.2K social media accounts and earn 512 social interactions, including likes/reactions, clicks, and shares/retweets from Twitter, Facebook, and LinkedIn.

We are also excited to participate in a Lung Cancer Living Room discussion with the Bonnie J. Addario Lung Cancer Foundation. This presentation will bring lung cancer specialists, physicians, patients, and the public together to discuss lung cancer in a relaxed and comfortable setting. Attendees will have the opportunity to ask questions, share their stories, and discuss issues surrounding lung cancer. The event will also be live-streamed and archived on the Bonnie J. Addario Lung Cancer Foundation’s website.

Asthma

We launched our asthma campaign at “The Air We Breathe” Summit with The Atlantic. We were able to reach more than 24.2K social accounts through live tweeting during the event and follow up posts on CHEST’s Twitter and Facebook accounts. The Atlantic was able to earn an impressive reach of 868K social accounts through their own social media promotion for the event. To read more about the event that focused on the quality of our air and the implications on our health, visit chestfoundation.org/summit.

We continue to partner with the Allergy & Asthma Network to create and distribute our materials and messaging, which focus on severe and difficult-to-control asthma. This campaign has already garnered over 53.4K social media impressions through CHEST channels, and over 1.3K social interactions. New components to the campaign include:

• Severity assessment tool

• Shared decision making tool

• Patient testimonial videos

Our campaign also included an 8-minute segment on the Access Health program, which aired two times in May on Lifetime NetWork, with an additional 200+ airings via syndication throughout 100 US markets.
 

Sarcoidosis

For the third consecutive year, we’ve partnered with the Foundation for Sarcoidosis Research to spread awareness on the disease. We also partnered with the American Osteopathic Association, the COPD Foundation, and The Society of Thoracic Surgeons to create

In CHEST member communications, our campaign reached more than 20,000 people, and our social media posts have reached more than 61.7K social accounts. CHEST’s press release on sarcoidosis has reached well over 11.6M clinicians and patients.



We are very grateful and proud of the work our partners have done to help us spread awareness on these diseases, so clinicians and patients will be able to use our resources to champion lung health.

In 2017, we’ve continued to push our disease awareness efforts in lung cancer, sarcoidosis, asthma, and COPD, trading our “awareness months” for longer, more sustainable campaigns.

Lung Cancer

Our lung cancer disease awareness campaign launched mid-May and goes through World Lung Cancer Day on August 1, 2017. The foundation is partnering with the Bonnie J. Addarrio Lung Cancer Foundation and LUNGevity to produce:

• Biopsy-specific infographics

• An animated biopsy video to show the importance of collecting core tissue

Sharing these resources through the CHEST social media channels, we have so far been able to reach more than 34.2K social media accounts and earn 512 social interactions, including likes/reactions, clicks, and shares/retweets from Twitter, Facebook, and LinkedIn.

We are also excited to participate in a Lung Cancer Living Room discussion with the Bonnie J. Addario Lung Cancer Foundation. This presentation will bring lung cancer specialists, physicians, patients, and the public together to discuss lung cancer in a relaxed and comfortable setting. Attendees will have the opportunity to ask questions, share their stories, and discuss issues surrounding lung cancer. The event will also be live-streamed and archived on the Bonnie J. Addario Lung Cancer Foundation’s website.

Asthma

We launched our asthma campaign at “The Air We Breathe” Summit with The Atlantic. We were able to reach more than 24.2K social accounts through live tweeting during the event and follow up posts on CHEST’s Twitter and Facebook accounts. The Atlantic was able to earn an impressive reach of 868K social accounts through their own social media promotion for the event. To read more about the event that focused on the quality of our air and the implications on our health, visit chestfoundation.org/summit.

We continue to partner with the Allergy & Asthma Network to create and distribute our materials and messaging, which focus on severe and difficult-to-control asthma. This campaign has already garnered over 53.4K social media impressions through CHEST channels, and over 1.3K social interactions. New components to the campaign include:

• Severity assessment tool

• Shared decision making tool

• Patient testimonial videos

Our campaign also included an 8-minute segment on the Access Health program, which aired two times in May on Lifetime NetWork, with an additional 200+ airings via syndication throughout 100 US markets.
 

Sarcoidosis

For the third consecutive year, we’ve partnered with the Foundation for Sarcoidosis Research to spread awareness on the disease. We also partnered with the American Osteopathic Association, the COPD Foundation, and The Society of Thoracic Surgeons to create

In CHEST member communications, our campaign reached more than 20,000 people, and our social media posts have reached more than 61.7K social accounts. CHEST’s press release on sarcoidosis has reached well over 11.6M clinicians and patients.



We are very grateful and proud of the work our partners have done to help us spread awareness on these diseases, so clinicians and patients will be able to use our resources to champion lung health.

The AGA Research Foundation has partnered with the Rady Children’s Institute of Genomic Medicine to establish the AGA-Rady Children’s Institute of Genomic Medicine Research Scholar Award in Pediatric Genomics. This award will support one promising young investigator conducting research that utilizes genomics to enhance our fundamental understanding of childhood digestive diseases.

This newly established award will provide $90,000 per year for 3 years to one investigator. The funded research must be conducted at Rady Children’s Institute for Genomic Medicine in San Diego starting July 2018.

Stay tuned for additional details and information on how to apply for this grant in summer 2017. More information on this new award is available on the Rady Children’s Hospital website.
 

The AGA Research Foundation has partnered with the Rady Children’s Institute of Genomic Medicine to establish the AGA-Rady Children’s Institute of Genomic Medicine Research Scholar Award in Pediatric Genomics. This award will support one promising young investigator conducting research that utilizes genomics to enhance our fundamental understanding of childhood digestive diseases.

This newly established award will provide $90,000 per year for 3 years to one investigator. The funded research must be conducted at Rady Children’s Institute for Genomic Medicine in San Diego starting July 2018.

Stay tuned for additional details and information on how to apply for this grant in summer 2017. More information on this new award is available on the Rady Children’s Hospital website.
 

The AGA Research Foundation has partnered with the Rady Children’s Institute of Genomic Medicine to establish the AGA-Rady Children’s Institute of Genomic Medicine Research Scholar Award in Pediatric Genomics. This award will support one promising young investigator conducting research that utilizes genomics to enhance our fundamental understanding of childhood digestive diseases.

This newly established award will provide $90,000 per year for 3 years to one investigator. The funded research must be conducted at Rady Children’s Institute for Genomic Medicine in San Diego starting July 2018.

Stay tuned for additional details and information on how to apply for this grant in summer 2017. More information on this new award is available on the Rady Children’s Hospital website.
 

AGA recognizes members whose accomplishments demonstrate personal commitment to the field of gastroenterology with the distinction of fellowship. AGA fellowship helps open doors, creates connections, and offers widespread value and recognition. Applicants can choose to apply for fellowship in either clinical practice (private or academic) or in research (basic or clinical).

Gain recognition as a distinguished GI professional and apply today by visiting www.gastro.org/fellowship. This website includes the full list of benefits and criteria for fellowship.

Be honored for your contributions and commitment to the GI field. The deadline for submissions is Monday, July 31, 2017.
 

[email protected]

AGA recognizes members whose accomplishments demonstrate personal commitment to the field of gastroenterology with the distinction of fellowship. AGA fellowship helps open doors, creates connections, and offers widespread value and recognition. Applicants can choose to apply for fellowship in either clinical practice (private or academic) or in research (basic or clinical).

Gain recognition as a distinguished GI professional and apply today by visiting www.gastro.org/fellowship. This website includes the full list of benefits and criteria for fellowship.

Be honored for your contributions and commitment to the GI field. The deadline for submissions is Monday, July 31, 2017.
 

[email protected]

AGA recognizes members whose accomplishments demonstrate personal commitment to the field of gastroenterology with the distinction of fellowship. AGA fellowship helps open doors, creates connections, and offers widespread value and recognition. Applicants can choose to apply for fellowship in either clinical practice (private or academic) or in research (basic or clinical).

Gain recognition as a distinguished GI professional and apply today by visiting www.gastro.org/fellowship. This website includes the full list of benefits and criteria for fellowship.

Be honored for your contributions and commitment to the GI field. The deadline for submissions is Monday, July 31, 2017.
 

[email protected]

Gastroenterologists and patients rely on biologics to manage Crohn’s disease and ulcerative colitis. Biosimilar products, which are “highly similar” to the biologic, have begun to be approved by the FDA for such indications. The FDA is now developing a pathway for interchangeable products, which are biosimilars that “may be substituted for the reference product without the intervention of the health care provider who prescribed the reference product” according to Section 351(i) of the Public Health Service Act. AGA provided the FDA six recommendations in response to the agency’s draft guidance on demonstrating interchangeability focused on measures to enhance patient safety and ensure that physicians, not insurance companies, drive decisions about switching products. Here is a summary of our comments.

1. Extrapolation of data should not be allowed for any indication where the pathophysiology is known to be different or is yet to be elucidated.

Post-marketing evidence on interchangeability of biosimilar products would alleviate concerns as testing specific products in individual diseases is an important step in determining whether the product is effective and safe for that particular disease. AGA recommends that manufacturers should be required to seek licensure for all the same indications as the reference product to appropriately track adverse events should they arise.

2. The agency should use caution when allowing extrapolation for pediatric indications.

Pediatric patients are recognized as a vulnerable population for which a disease may differ from those of adult patients. In the absence of data specifically ensuring safety and efficacy in children, AGA recommends an exemption of pediatric patients from current FDA positions and guidance documents related to interchangeable products.

3. Sponsors should exclusively use U.S.-licensed reference products in switching studies.

Currently, the FDA’s draft guidance has wording that seems to signal that the agency is willing to entertain use of non-U.S.-licensed products in some cases, casting doubt on the true “interchangeability” of the product. AGA recommends that the guidance be amended to include specific scenarios where this may be acceptable or remove the clause altogether.

4. “Real world” data on biosimilar and interchangeable products must be collected through formal post-marketing observational studies to ensure the longitudinal safety and efficacy for all patient populations being treated with these products.

A central observational registry, like the AGA Fecal Microbiome Transplant National Registry, would ensure the capture of data on the safety and efficacy of interchangeable products for all manufacturers and their adverse effects on patients, if any. Such a registry would also allow the study of outcomes in patients who are switched among multiple products.

5. Gastroenterologists with appropriate disease expertise should be engaged by the FDA when interchangeable products are reviewed for approval.

AGA is part of the FDA’s Network of Experts and hopes that this relationship will continue to be proactively utilized when a proposed product is seeking a gastrointestinal indication.

6. Prescribing physicians must be empowered with the ability to prevent nonmedical switching from a reference product to an interchangeable product.

AGA has concerns over the section of the Public Health Service Act that states that an interchangeable product “may be substituted for the reference product without the intervention of the health care provider who prescribed the reference product.” Health care providers must be empowered to be aware of and prevent nonmedical switching if they believe that the patient’s safety and health is at risk. AGA encourages the FDA to consider making a statement encouraging states to protect physician discretion as it applies to interchangeable biosimilars.

AGA will continue to work with the FDA to ensure that the voice of gastroenterology is heard in relation to biosimilars and interchangeable products.

Gastroenterologists and patients rely on biologics to manage Crohn’s disease and ulcerative colitis. Biosimilar products, which are “highly similar” to the biologic, have begun to be approved by the FDA for such indications. The FDA is now developing a pathway for interchangeable products, which are biosimilars that “may be substituted for the reference product without the intervention of the health care provider who prescribed the reference product” according to Section 351(i) of the Public Health Service Act. AGA provided the FDA six recommendations in response to the agency’s draft guidance on demonstrating interchangeability focused on measures to enhance patient safety and ensure that physicians, not insurance companies, drive decisions about switching products. Here is a summary of our comments.

1. Extrapolation of data should not be allowed for any indication where the pathophysiology is known to be different or is yet to be elucidated.

Post-marketing evidence on interchangeability of biosimilar products would alleviate concerns as testing specific products in individual diseases is an important step in determining whether the product is effective and safe for that particular disease. AGA recommends that manufacturers should be required to seek licensure for all the same indications as the reference product to appropriately track adverse events should they arise.

2. The agency should use caution when allowing extrapolation for pediatric indications.

Pediatric patients are recognized as a vulnerable population for which a disease may differ from those of adult patients. In the absence of data specifically ensuring safety and efficacy in children, AGA recommends an exemption of pediatric patients from current FDA positions and guidance documents related to interchangeable products.

3. Sponsors should exclusively use U.S.-licensed reference products in switching studies.

Currently, the FDA’s draft guidance has wording that seems to signal that the agency is willing to entertain use of non-U.S.-licensed products in some cases, casting doubt on the true “interchangeability” of the product. AGA recommends that the guidance be amended to include specific scenarios where this may be acceptable or remove the clause altogether.

4. “Real world” data on biosimilar and interchangeable products must be collected through formal post-marketing observational studies to ensure the longitudinal safety and efficacy for all patient populations being treated with these products.

A central observational registry, like the AGA Fecal Microbiome Transplant National Registry, would ensure the capture of data on the safety and efficacy of interchangeable products for all manufacturers and their adverse effects on patients, if any. Such a registry would also allow the study of outcomes in patients who are switched among multiple products.

5. Gastroenterologists with appropriate disease expertise should be engaged by the FDA when interchangeable products are reviewed for approval.

AGA is part of the FDA’s Network of Experts and hopes that this relationship will continue to be proactively utilized when a proposed product is seeking a gastrointestinal indication.

6. Prescribing physicians must be empowered with the ability to prevent nonmedical switching from a reference product to an interchangeable product.

AGA has concerns over the section of the Public Health Service Act that states that an interchangeable product “may be substituted for the reference product without the intervention of the health care provider who prescribed the reference product.” Health care providers must be empowered to be aware of and prevent nonmedical switching if they believe that the patient’s safety and health is at risk. AGA encourages the FDA to consider making a statement encouraging states to protect physician discretion as it applies to interchangeable biosimilars.

AGA will continue to work with the FDA to ensure that the voice of gastroenterology is heard in relation to biosimilars and interchangeable products.

Gastroenterologists and patients rely on biologics to manage Crohn’s disease and ulcerative colitis. Biosimilar products, which are “highly similar” to the biologic, have begun to be approved by the FDA for such indications. The FDA is now developing a pathway for interchangeable products, which are biosimilars that “may be substituted for the reference product without the intervention of the health care provider who prescribed the reference product” according to Section 351(i) of the Public Health Service Act. AGA provided the FDA six recommendations in response to the agency’s draft guidance on demonstrating interchangeability focused on measures to enhance patient safety and ensure that physicians, not insurance companies, drive decisions about switching products. Here is a summary of our comments.

1. Extrapolation of data should not be allowed for any indication where the pathophysiology is known to be different or is yet to be elucidated.

Post-marketing evidence on interchangeability of biosimilar products would alleviate concerns as testing specific products in individual diseases is an important step in determining whether the product is effective and safe for that particular disease. AGA recommends that manufacturers should be required to seek licensure for all the same indications as the reference product to appropriately track adverse events should they arise.

2. The agency should use caution when allowing extrapolation for pediatric indications.

Pediatric patients are recognized as a vulnerable population for which a disease may differ from those of adult patients. In the absence of data specifically ensuring safety and efficacy in children, AGA recommends an exemption of pediatric patients from current FDA positions and guidance documents related to interchangeable products.

3. Sponsors should exclusively use U.S.-licensed reference products in switching studies.

Currently, the FDA’s draft guidance has wording that seems to signal that the agency is willing to entertain use of non-U.S.-licensed products in some cases, casting doubt on the true “interchangeability” of the product. AGA recommends that the guidance be amended to include specific scenarios where this may be acceptable or remove the clause altogether.

4. “Real world” data on biosimilar and interchangeable products must be collected through formal post-marketing observational studies to ensure the longitudinal safety and efficacy for all patient populations being treated with these products.

A central observational registry, like the AGA Fecal Microbiome Transplant National Registry, would ensure the capture of data on the safety and efficacy of interchangeable products for all manufacturers and their adverse effects on patients, if any. Such a registry would also allow the study of outcomes in patients who are switched among multiple products.

5. Gastroenterologists with appropriate disease expertise should be engaged by the FDA when interchangeable products are reviewed for approval.

AGA is part of the FDA’s Network of Experts and hopes that this relationship will continue to be proactively utilized when a proposed product is seeking a gastrointestinal indication.

6. Prescribing physicians must be empowered with the ability to prevent nonmedical switching from a reference product to an interchangeable product.

AGA has concerns over the section of the Public Health Service Act that states that an interchangeable product “may be substituted for the reference product without the intervention of the health care provider who prescribed the reference product.” Health care providers must be empowered to be aware of and prevent nonmedical switching if they believe that the patient’s safety and health is at risk. AGA encourages the FDA to consider making a statement encouraging states to protect physician discretion as it applies to interchangeable biosimilars.

AGA will continue to work with the FDA to ensure that the voice of gastroenterology is heard in relation to biosimilars and interchangeable products.