NIH releases COPD National Action Plan

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– The National Institutes of Health on Monday released its first COPD National Action Plan, a five-point initiative to reduce the burden of chronic obstructive pulmonary disease and increase research into prevention and treatment.

On the same day, the National Heart, Lung, and Blood Institute and other supporters of the plan described its evolution and why they thought the plan’s implementation was important.

Dr. James Kiley
“Today, we are here to announce for the first time a COPD National Action Plan, which has been developed with input from the entire COPD community,” said James Kiley, PhD, director of the division of lung diseases at NHLBI, during a press conference at an international conference of the American Thoracic Society. “It provides goals and objectives everyone in the nation affected by and interested in COPD can work toward to help reduce the burden of this disease. Each goal is designed to address a different aspect of the disease and the part of the community with the capacity to address it.”

The plan’s five goals are:

  • Empower people with COPD, their families, and caregivers to recognize and reduce the burden of COPD.
  • Improve the prevention, diagnosis, treatment, and management of COPD by increasing the quality of care delivered across the health care continuum.
  • Collect, analyze, report, and disseminate COPD-related public health data that drive change and track progress.
  • Increase and sustain research to better understand the prevention, pathogenesis, diagnosis, treatment, and management of COPD.
  • Translate national policy, educational, and program recommendations into research and public health care actions.

“Chronic obstructive pulmonary disease is the third-leading cause of death in this country; it’s just behind heart disease and cancer,” Dr. Kiley noted. “What’s really disappointing and discouraging is it’s the only cause of death in this country where the numbers are not declining.”

COPD “got the attention of Congress a number of years ago,” he added. “They encouraged the National Institutes of Health to work with the community stakeholders and other federal agencies to develop a national action plan to respond to the growing burden of this disease.”

COPD’s stakeholder community, the federal government, and other partners worked together to develop a set of core goals that the National Action Plan would address, Dr. Kiley continued. “It was meant to obtain the broadest amount of input possible so that we could get it right from the start.”

Another of the plan’s advocates, MeiLan Han, MD, medical director of the women’s respiratory health program at the University of Michigan, Ann Arbor, illustrated the need to increase and sustain COPD research related to the disease.

[polldaddy:9806142]

“I see the suffering and disease toll that this takes on my patients, and I can’t convince you enough of the level of frustration that I have as a physician in not being able to provide the level of care that I want to be able to provide,” said Dr. Han, who served as a panelist at the press conference.

“We face some serious barriers to being able to provide adequate care for patients,” she added. Those barriers include lack of access to providers who are knowledgeable about COPD, as well as lack of access to affordable and conveniently located pulmonology rehabilitation and education materials. From a research standpoint, Dr. Han added, medicine still doesn’t know enough about the disease. “We certainly have good treatments, but we need better treatments,” she said.

“What’s clear is that we as society can no longer afford to brush this under the table and ignore this problem,” Dr. Han added.

The National Action Plan and information about how to get involved are available at copd.nih.gov.

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– The National Institutes of Health on Monday released its first COPD National Action Plan, a five-point initiative to reduce the burden of chronic obstructive pulmonary disease and increase research into prevention and treatment.

On the same day, the National Heart, Lung, and Blood Institute and other supporters of the plan described its evolution and why they thought the plan’s implementation was important.

Dr. James Kiley
“Today, we are here to announce for the first time a COPD National Action Plan, which has been developed with input from the entire COPD community,” said James Kiley, PhD, director of the division of lung diseases at NHLBI, during a press conference at an international conference of the American Thoracic Society. “It provides goals and objectives everyone in the nation affected by and interested in COPD can work toward to help reduce the burden of this disease. Each goal is designed to address a different aspect of the disease and the part of the community with the capacity to address it.”

The plan’s five goals are:

  • Empower people with COPD, their families, and caregivers to recognize and reduce the burden of COPD.
  • Improve the prevention, diagnosis, treatment, and management of COPD by increasing the quality of care delivered across the health care continuum.
  • Collect, analyze, report, and disseminate COPD-related public health data that drive change and track progress.
  • Increase and sustain research to better understand the prevention, pathogenesis, diagnosis, treatment, and management of COPD.
  • Translate national policy, educational, and program recommendations into research and public health care actions.

“Chronic obstructive pulmonary disease is the third-leading cause of death in this country; it’s just behind heart disease and cancer,” Dr. Kiley noted. “What’s really disappointing and discouraging is it’s the only cause of death in this country where the numbers are not declining.”

COPD “got the attention of Congress a number of years ago,” he added. “They encouraged the National Institutes of Health to work with the community stakeholders and other federal agencies to develop a national action plan to respond to the growing burden of this disease.”

COPD’s stakeholder community, the federal government, and other partners worked together to develop a set of core goals that the National Action Plan would address, Dr. Kiley continued. “It was meant to obtain the broadest amount of input possible so that we could get it right from the start.”

Another of the plan’s advocates, MeiLan Han, MD, medical director of the women’s respiratory health program at the University of Michigan, Ann Arbor, illustrated the need to increase and sustain COPD research related to the disease.

[polldaddy:9806142]

“I see the suffering and disease toll that this takes on my patients, and I can’t convince you enough of the level of frustration that I have as a physician in not being able to provide the level of care that I want to be able to provide,” said Dr. Han, who served as a panelist at the press conference.

“We face some serious barriers to being able to provide adequate care for patients,” she added. Those barriers include lack of access to providers who are knowledgeable about COPD, as well as lack of access to affordable and conveniently located pulmonology rehabilitation and education materials. From a research standpoint, Dr. Han added, medicine still doesn’t know enough about the disease. “We certainly have good treatments, but we need better treatments,” she said.

“What’s clear is that we as society can no longer afford to brush this under the table and ignore this problem,” Dr. Han added.

The National Action Plan and information about how to get involved are available at copd.nih.gov.

 

– The National Institutes of Health on Monday released its first COPD National Action Plan, a five-point initiative to reduce the burden of chronic obstructive pulmonary disease and increase research into prevention and treatment.

On the same day, the National Heart, Lung, and Blood Institute and other supporters of the plan described its evolution and why they thought the plan’s implementation was important.

Dr. James Kiley
“Today, we are here to announce for the first time a COPD National Action Plan, which has been developed with input from the entire COPD community,” said James Kiley, PhD, director of the division of lung diseases at NHLBI, during a press conference at an international conference of the American Thoracic Society. “It provides goals and objectives everyone in the nation affected by and interested in COPD can work toward to help reduce the burden of this disease. Each goal is designed to address a different aspect of the disease and the part of the community with the capacity to address it.”

The plan’s five goals are:

  • Empower people with COPD, their families, and caregivers to recognize and reduce the burden of COPD.
  • Improve the prevention, diagnosis, treatment, and management of COPD by increasing the quality of care delivered across the health care continuum.
  • Collect, analyze, report, and disseminate COPD-related public health data that drive change and track progress.
  • Increase and sustain research to better understand the prevention, pathogenesis, diagnosis, treatment, and management of COPD.
  • Translate national policy, educational, and program recommendations into research and public health care actions.

“Chronic obstructive pulmonary disease is the third-leading cause of death in this country; it’s just behind heart disease and cancer,” Dr. Kiley noted. “What’s really disappointing and discouraging is it’s the only cause of death in this country where the numbers are not declining.”

COPD “got the attention of Congress a number of years ago,” he added. “They encouraged the National Institutes of Health to work with the community stakeholders and other federal agencies to develop a national action plan to respond to the growing burden of this disease.”

COPD’s stakeholder community, the federal government, and other partners worked together to develop a set of core goals that the National Action Plan would address, Dr. Kiley continued. “It was meant to obtain the broadest amount of input possible so that we could get it right from the start.”

Another of the plan’s advocates, MeiLan Han, MD, medical director of the women’s respiratory health program at the University of Michigan, Ann Arbor, illustrated the need to increase and sustain COPD research related to the disease.

[polldaddy:9806142]

“I see the suffering and disease toll that this takes on my patients, and I can’t convince you enough of the level of frustration that I have as a physician in not being able to provide the level of care that I want to be able to provide,” said Dr. Han, who served as a panelist at the press conference.

“We face some serious barriers to being able to provide adequate care for patients,” she added. Those barriers include lack of access to providers who are knowledgeable about COPD, as well as lack of access to affordable and conveniently located pulmonology rehabilitation and education materials. From a research standpoint, Dr. Han added, medicine still doesn’t know enough about the disease. “We certainly have good treatments, but we need better treatments,” she said.

“What’s clear is that we as society can no longer afford to brush this under the table and ignore this problem,” Dr. Han added.

The National Action Plan and information about how to get involved are available at copd.nih.gov.

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App may improve CPAP adherence

Comment by Dr. David Schulman, FCCP
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Use of a mobile app may help sleep apnea patients adhere to continuous positive airway pressure (CPAP) therapy, a small study suggests.

The app – SleepMapper (SM) – has interactive algorithms that are modeled on the same theories of behavior change that have improved adherence to CPAP when delivered in person or through telephone-linked communication, wrote Jordanna M. Hostler of Walter Reed National Military Medical Center, Bethesda, Md., and her coinvestigators (J Sleep Res. 2017;26:139-46).

“Despite our small sample size, patients in the SM group were more than three times as likely to meet Medicare criteria for [CPAP] adherence (greater than 4 hours per night for 70% of nights), a trend that just missed statistical significance (P = .06),” the researchers noted.

“The magnitude of the increase [in CPAP use] indicates likely clinical benefit,” they added.

SleepMapper allows patients to self-monitor the outcomes of positive airway pressure (PAP) therapy by providing information on their adherence, Apnea-Hypopnea Index, and mask leak. The app, which can be downloaded on a smartphone or personal computer, also includes training modules on how to use PAP. The system, owned by Phillips Respironics, will sync with Philips Respironics’ Encore Anywhere software program.

The study comprised 61 patients who had been diagnosed with obstructive sleep apnea (OSA) via overnight, in-lab polysomnography. The patients were initiating PAP for the first time at Walter Reed National Military Medical Center’s Sleep Disorders Center in Bethesda, Md., as participants in the center’s program. Such a program included group sessions with instruction on sleep hygiene and training in the use of PAP, an initial one-on-one meeting with a physician, and a follow-up appointment with a physician 4 weeks after initiating the therapy.

Thirty of the program participants included in the study used SleepMapper in addition to the center’s standard education and follow-up. The researchers analyzed 11 weeks of data for all 61 study participants.

Patients in the SleepMapper group used their PAP machines for a greater percentage of days and achieved more than 4 hours of use on more days of participation in the program, compared with patients who did not use the app. The patients using the app also showed a trend toward using PAP for more hours per night overall. Specifically, nine of the patients in the app group used their PAP machines greater than 4 hours per night for 70% of nights, versus three of the patients in the control group (P = .06). SleepMapper usage remained significantly associated with percentage of nights including greater than 4 hours of PAP use, in a multivariate linear regression analysis.

The researchers observed many similarities between patients using the app and patients in the control group, including Apnea-Hypopnea Index scores, central apnea index scores, and percentages of time spent in periodic breathing.

Some additional advantages to use of SleepMapper over simply participating in the center’s educational program are that the app provides ongoing coaching and immediate access to Apnea-Hypopnea Index and PAP use data, according to the researchers. They touted the app’s educational videos about OSA and PAP therapy and “structured motivational enhancement techniques such as feedback and goal setting, which have shown benefit when delivered by health care professionals in other studies.”

The researchers called for an additional study of the app’s usefulness in a larger group of patients.

The authors did not receive any funding or support for this study.

Body

Feedback to patients regarding their clinical status is rarely a bad thing. I’m a big fan of tools that give patients information on their CPAP adherence and outcomes, of which several now exist, including some that are not affiliated with any particular respiratory device company, and are able to read a number of different device downloads.

Dr. David Schulman
The referenced study by Hostler et al. showed a statistically significant improvement in the number of nights adherent (defined as greater than 4 hours of CPAP use) at 54% for the intervention group versus 37% for the standard group (P = .02), even though improvement in the percentage documented as adherent by Medicare standards did not reach statistical significance. While this latter finding is an important outcome for economic purposes, any improvement in adherence at all should be looked upon as a favorable endpoint.


In the end, the use of technology for monitoring CPAP adherence is here to stay, and the incremental cost of making it available to our patients is low. Taking the time to educate patients who are newly prescribed CPAP about interpreting their outcome data is likely to be time well spent.

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Feedback to patients regarding their clinical status is rarely a bad thing. I’m a big fan of tools that give patients information on their CPAP adherence and outcomes, of which several now exist, including some that are not affiliated with any particular respiratory device company, and are able to read a number of different device downloads.

Dr. David Schulman
The referenced study by Hostler et al. showed a statistically significant improvement in the number of nights adherent (defined as greater than 4 hours of CPAP use) at 54% for the intervention group versus 37% for the standard group (P = .02), even though improvement in the percentage documented as adherent by Medicare standards did not reach statistical significance. While this latter finding is an important outcome for economic purposes, any improvement in adherence at all should be looked upon as a favorable endpoint.


In the end, the use of technology for monitoring CPAP adherence is here to stay, and the incremental cost of making it available to our patients is low. Taking the time to educate patients who are newly prescribed CPAP about interpreting their outcome data is likely to be time well spent.

Body

Feedback to patients regarding their clinical status is rarely a bad thing. I’m a big fan of tools that give patients information on their CPAP adherence and outcomes, of which several now exist, including some that are not affiliated with any particular respiratory device company, and are able to read a number of different device downloads.

Dr. David Schulman
The referenced study by Hostler et al. showed a statistically significant improvement in the number of nights adherent (defined as greater than 4 hours of CPAP use) at 54% for the intervention group versus 37% for the standard group (P = .02), even though improvement in the percentage documented as adherent by Medicare standards did not reach statistical significance. While this latter finding is an important outcome for economic purposes, any improvement in adherence at all should be looked upon as a favorable endpoint.


In the end, the use of technology for monitoring CPAP adherence is here to stay, and the incremental cost of making it available to our patients is low. Taking the time to educate patients who are newly prescribed CPAP about interpreting their outcome data is likely to be time well spent.

Title
Comment by Dr. David Schulman, FCCP
Comment by Dr. David Schulman, FCCP

 

Use of a mobile app may help sleep apnea patients adhere to continuous positive airway pressure (CPAP) therapy, a small study suggests.

The app – SleepMapper (SM) – has interactive algorithms that are modeled on the same theories of behavior change that have improved adherence to CPAP when delivered in person or through telephone-linked communication, wrote Jordanna M. Hostler of Walter Reed National Military Medical Center, Bethesda, Md., and her coinvestigators (J Sleep Res. 2017;26:139-46).

“Despite our small sample size, patients in the SM group were more than three times as likely to meet Medicare criteria for [CPAP] adherence (greater than 4 hours per night for 70% of nights), a trend that just missed statistical significance (P = .06),” the researchers noted.

“The magnitude of the increase [in CPAP use] indicates likely clinical benefit,” they added.

SleepMapper allows patients to self-monitor the outcomes of positive airway pressure (PAP) therapy by providing information on their adherence, Apnea-Hypopnea Index, and mask leak. The app, which can be downloaded on a smartphone or personal computer, also includes training modules on how to use PAP. The system, owned by Phillips Respironics, will sync with Philips Respironics’ Encore Anywhere software program.

The study comprised 61 patients who had been diagnosed with obstructive sleep apnea (OSA) via overnight, in-lab polysomnography. The patients were initiating PAP for the first time at Walter Reed National Military Medical Center’s Sleep Disorders Center in Bethesda, Md., as participants in the center’s program. Such a program included group sessions with instruction on sleep hygiene and training in the use of PAP, an initial one-on-one meeting with a physician, and a follow-up appointment with a physician 4 weeks after initiating the therapy.

Thirty of the program participants included in the study used SleepMapper in addition to the center’s standard education and follow-up. The researchers analyzed 11 weeks of data for all 61 study participants.

Patients in the SleepMapper group used their PAP machines for a greater percentage of days and achieved more than 4 hours of use on more days of participation in the program, compared with patients who did not use the app. The patients using the app also showed a trend toward using PAP for more hours per night overall. Specifically, nine of the patients in the app group used their PAP machines greater than 4 hours per night for 70% of nights, versus three of the patients in the control group (P = .06). SleepMapper usage remained significantly associated with percentage of nights including greater than 4 hours of PAP use, in a multivariate linear regression analysis.

The researchers observed many similarities between patients using the app and patients in the control group, including Apnea-Hypopnea Index scores, central apnea index scores, and percentages of time spent in periodic breathing.

Some additional advantages to use of SleepMapper over simply participating in the center’s educational program are that the app provides ongoing coaching and immediate access to Apnea-Hypopnea Index and PAP use data, according to the researchers. They touted the app’s educational videos about OSA and PAP therapy and “structured motivational enhancement techniques such as feedback and goal setting, which have shown benefit when delivered by health care professionals in other studies.”

The researchers called for an additional study of the app’s usefulness in a larger group of patients.

The authors did not receive any funding or support for this study.

 

Use of a mobile app may help sleep apnea patients adhere to continuous positive airway pressure (CPAP) therapy, a small study suggests.

The app – SleepMapper (SM) – has interactive algorithms that are modeled on the same theories of behavior change that have improved adherence to CPAP when delivered in person or through telephone-linked communication, wrote Jordanna M. Hostler of Walter Reed National Military Medical Center, Bethesda, Md., and her coinvestigators (J Sleep Res. 2017;26:139-46).

“Despite our small sample size, patients in the SM group were more than three times as likely to meet Medicare criteria for [CPAP] adherence (greater than 4 hours per night for 70% of nights), a trend that just missed statistical significance (P = .06),” the researchers noted.

“The magnitude of the increase [in CPAP use] indicates likely clinical benefit,” they added.

SleepMapper allows patients to self-monitor the outcomes of positive airway pressure (PAP) therapy by providing information on their adherence, Apnea-Hypopnea Index, and mask leak. The app, which can be downloaded on a smartphone or personal computer, also includes training modules on how to use PAP. The system, owned by Phillips Respironics, will sync with Philips Respironics’ Encore Anywhere software program.

The study comprised 61 patients who had been diagnosed with obstructive sleep apnea (OSA) via overnight, in-lab polysomnography. The patients were initiating PAP for the first time at Walter Reed National Military Medical Center’s Sleep Disorders Center in Bethesda, Md., as participants in the center’s program. Such a program included group sessions with instruction on sleep hygiene and training in the use of PAP, an initial one-on-one meeting with a physician, and a follow-up appointment with a physician 4 weeks after initiating the therapy.

Thirty of the program participants included in the study used SleepMapper in addition to the center’s standard education and follow-up. The researchers analyzed 11 weeks of data for all 61 study participants.

Patients in the SleepMapper group used their PAP machines for a greater percentage of days and achieved more than 4 hours of use on more days of participation in the program, compared with patients who did not use the app. The patients using the app also showed a trend toward using PAP for more hours per night overall. Specifically, nine of the patients in the app group used their PAP machines greater than 4 hours per night for 70% of nights, versus three of the patients in the control group (P = .06). SleepMapper usage remained significantly associated with percentage of nights including greater than 4 hours of PAP use, in a multivariate linear regression analysis.

The researchers observed many similarities between patients using the app and patients in the control group, including Apnea-Hypopnea Index scores, central apnea index scores, and percentages of time spent in periodic breathing.

Some additional advantages to use of SleepMapper over simply participating in the center’s educational program are that the app provides ongoing coaching and immediate access to Apnea-Hypopnea Index and PAP use data, according to the researchers. They touted the app’s educational videos about OSA and PAP therapy and “structured motivational enhancement techniques such as feedback and goal setting, which have shown benefit when delivered by health care professionals in other studies.”

The researchers called for an additional study of the app’s usefulness in a larger group of patients.

The authors did not receive any funding or support for this study.

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CHEST names Stephen J. Welch as EVP and CEO

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The Board of Regents of the American College of Chest Physicians (CHEST) has finalized the appointment of Stephen J. Welch as executive vice president and chief executive officer.

Stephen J. Welch
Stephen J. Welch
Welch had been serving as the interim Executive Vice President and CEO for the Glenview, Illinois–based organization since May 2016. Prior to this appointment, he served in senior staff roles at CHEST for 22 years. One of these roles was publisher and senior vice president of Publications and Digital Content, which includes managing the organization’s flagship scientific journal, CHEST®.

“We appreciate the exceptional performance of Steve, his senior team, and the entire CHEST staff during this transition in executive leadership. We are excited about the opportunity to work with Steve in his new role going forward, as we begin outlining CHEST’s strategic plan for the next 5 years,” said CHEST President Gerard A. Silvestri, MD, MS, FCCP, in a statement.

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The Board of Regents of the American College of Chest Physicians (CHEST) has finalized the appointment of Stephen J. Welch as executive vice president and chief executive officer.

Stephen J. Welch
Stephen J. Welch
Welch had been serving as the interim Executive Vice President and CEO for the Glenview, Illinois–based organization since May 2016. Prior to this appointment, he served in senior staff roles at CHEST for 22 years. One of these roles was publisher and senior vice president of Publications and Digital Content, which includes managing the organization’s flagship scientific journal, CHEST®.

“We appreciate the exceptional performance of Steve, his senior team, and the entire CHEST staff during this transition in executive leadership. We are excited about the opportunity to work with Steve in his new role going forward, as we begin outlining CHEST’s strategic plan for the next 5 years,” said CHEST President Gerard A. Silvestri, MD, MS, FCCP, in a statement.

 

The Board of Regents of the American College of Chest Physicians (CHEST) has finalized the appointment of Stephen J. Welch as executive vice president and chief executive officer.

Stephen J. Welch
Stephen J. Welch
Welch had been serving as the interim Executive Vice President and CEO for the Glenview, Illinois–based organization since May 2016. Prior to this appointment, he served in senior staff roles at CHEST for 22 years. One of these roles was publisher and senior vice president of Publications and Digital Content, which includes managing the organization’s flagship scientific journal, CHEST®.

“We appreciate the exceptional performance of Steve, his senior team, and the entire CHEST staff during this transition in executive leadership. We are excited about the opportunity to work with Steve in his new role going forward, as we begin outlining CHEST’s strategic plan for the next 5 years,” said CHEST President Gerard A. Silvestri, MD, MS, FCCP, in a statement.

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Children with poor lung function develop ACOS

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Children with poor lung function will be more likely to develop asthma-chronic obstructive pulmonary disease (COPD) overlap syndrome (ACOS), suggesting that prevention of this disease should be attempted in early life, a study shows.

While other research has found that patients with poor lung function in early life have poor lung function as adults, this was the first study to investigate the relationship between childhood lung function and ACOS in adult life, according to Dinh S. Bui of the University of Melbourne, and his colleagues.

The study, published in the American Journal of Respiratory and Critical Care Medicine, used multinomial regression models to investigate associations between childhood lung parameters at age 7 years and asthma, COPD, and ACOS at age 45 years (Am J Respir Crit Care Med. 2017 Feb 1. doi: 10.1164/rccm.201606-1272OC).

“We found that ACOS participants showed evidence of persistently lower FEV1 [forced expiratory volume in 1 second] and FEV1/FVC [forced vital capacity] from childhood. This suggests that poorer childhood lung function tracked to early adult life, leading to impaired maximally attained lung function,” the researchers said.

“The study highlights that low childhood lung function is a risk factor for COPD (and ACOS) independent of smoking,” they noted.

The 1,355 study participants who had postbronchodilator (post-BD) lung function available were categorized into the following four mutually exclusive groups at age 45 years based on their asthma and COPD status: having neither asthma nor COPD (unaffected) (n = 959); having asthma alone (n = 269); having COPD alone (n = 59); having ACOS (n = 68).

Once adjusted for the sampling weights, the prevalence of current asthma alone was 13.5%, COPD alone was 4.1%, and ACOS was 2.9%. The researchers defined COPD at age 45 years as post-BD FEV1/FVC less than the Global Lung Initiative lower limit of normal. Because the associations between childhood lung function and both ACOS and COPD alone were nonlinear, the patients were grouped into quartiles based on their characteristics, such as their percent predicted FEV1 and percent predicted FEV1/FVC at 7 years, the investigators said.

Patients in the lowest quartile for FEV1 percent predicted at 7 years were 2.93 times more likely to have ACOS, compared with patients in the other quartiles for FEV1 percent predicted. Patients in the lowest quartile for FEV1/FVC percent predicted at 7 years were 16.3 times more likely to have ACOS and 5.76 times more likely to have COPD alone, compared with patients in the higher quartiles.

The researchers found large variation in childhood lung function among patients in the lowest quartiles for FEV1 and FEV1/FVC. To account for this, they conducted a sensitivity analysis, which excluded those with less than 80% predicted FEV1 and FEV1/FVC (n = 76 and 13, respectively).The associations between lung function measures and diseases in adulthood for patients in the lowest quartiles differed slightly following this adjustment. The sensitivity analysis showed that patients in the lowest quartile for FEV1 had an odds ratio of 2.4 for ACOS and that those patients in the lowest quartile for FEV1/FVC had an odds ratio of 5.2 for COPD alone and 15.1 for ACOS.

A sensitivity analysis that excluded patients with remitted asthma from the unaffected group showed childhood FEV1 was more strongly associated with ACOS for patients in the lowest quartile, compared with patients in the highest quartile (OR: 7.0, 95% CI: 2.7-18.3). This same analysis found that patients from the lowest quartile and second quartile for childhood FEV1/FVC were 6.8 and 3.9 times more likely to have COPD, respectively, compared with patients in the other quartiles. This sensitivity analysis also found that patients in the first quartile for FEV1/FVC were 19.1 times more likely to have ACOS, and patients in the second quartile for FEV1/FVC were 5.3 times more likely to have ACOS.

The researchers analyzed data from the Tasmanian Longitudinal Health Study, which began in 1968 when Tasmanian children born in 1961 and attending school in Tasmania were studied with respiratory health surveys and prebronchodilator (pre-BD) spirometry measurements. The most recent survey started in 2002. Survey respondents who had participated in past follow-up studies and/or reported symptoms of asthma or cough were invited to participate in a more detailed laboratory study from 2006 to 2008. That study included completing a questionnaire, pre-BD and post-BD spirometry, and skin prick testing. The predicted and percent predicted values for spirometry were derived from the Global Lung Initiative reference equations.

The final multinomial model was adjusted for various factors including childhood asthma, maternal smoking, and paternal smoking during childhood.

History of active smoking was significantly more frequent in patients with ACOS (73.5%) and COPD alone (73%) than in the unaffected (57%) groups. Childhood asthma, maternal asthma and atopy were more prevalent in the ACOS and asthma alone groups. ACOS and COPD participants had a higher prevalence of maternal smoking during childhood.

Individuals with ACOS had the lowest pre-BD FEV1 (percent predicted values) over time. Those with COPD alone or ACOS had significantly lower pre-BD FEV1/FVC (percent predicted values) at all time points, when patients were assessed, compared with unaffected participants. “Participants with COPD alone had significantly higher FVC at 7 and 13 years, while ACOS participants had significantly lower FVC at 45 years,” the researchers said.

“There was no evidence of effect modification by childhood lung infections, childhood asthma, maternal asthma, maternal smoking, or paternal smoking during childhood on the associations between childhood lung and the disease groups,” they noted.

The study was limited by its “relatively small sample sizes for the ACOS and COPD alone groups” and the absence of post-BD spirometry at 7 years, they added.

The researchers concluded that “screening of lung function in school-aged children may provide an opportunity to detect children likely to have ongoing poorer lung health, such as those with lung function below the lower limit of normal,” and that “[multifaceted] intervention strategies could then be implemented to reduce the burden of COPD and ACOS in adulthood.”

Dr. Aparna Swaminathan
Asked to comment on the study, Aparna Swaminathan, MD, a pulmonary/critical care fellow at Duke University, Durham, N.C., and an incoming Duke Clinical Research Institute fellow, said she would want to know “what is driving the effects in the study” before designing an intervention.

“I suspect that genetics may play a big role in the results, and there is increasing interest in learning how genetics are involved in COPD. A better understanding of the risk factors for lower lung function in children may also provide targets of intervention. The groups with ACOS and COPD have higher rates of maternal smoking, and while this study determined that the association between childhood low lung function and development of COPD and ACOS is independent of maternal smoking, maternal smoking still seems like a good area to target,” she said in an interview.

It would also be interesting to further study the first quartile of patients, she added. “The clinical disease for this quartile of patients covers a wide range of severities. I would be interested in dividing this group up further and learning the outcomes of their lung function and development of COPD and ACOS.”

Dr. Eric J. Gartman
Dr. Eric J. Gartman
Aggressively treating childhood asthma and poor lung function is one method that may have altered the destiny of the children with lower lung function, if it had been used, Eric Gartman, MD, FCCP, said in an interview.

Using inhaled corticosteroids and other medications for maintenance control, reducing and monitoring impairment, educating patients and patients’ guardians on triggers, avoiding triggers, and having an action plan for changing therapy based on symptoms or measured flows are ways to aggressively treat such conditions, said Dr. Gartman, assistant professor of medicine at Brown University, Providence, R.I*. He cited avoiding exposure to smoke, environmental pollutants, and living near highways, for those with low childhood function, as interventions that might prevent people with low lung function from later developing COPD.

Dr. Gartman added that differences between the availability of medication for children with asthma today and at the time of the study may mean there are differences between the children with low lung function in the study and those children who have low function today. A population of children with low lung function now may be experiencing relatively less asthma and more chronic lung disorders brought on by prematurity or cystic fibrosis, he noted. “As such, identification of poor function in today’s young children may carry with it a significantly different set of interventions and challenges,” Dr. Gartman said.

While asthma in children is better controlled now than it was at the time of the study, because the researchers did not provide any information about the asthma control of the study participants, “it [is] hard for me to say if better asthma drugs in those children would have made a difference in long-term outcomes of COPD and ACOS as an adult,” Dr. Swaminathan noted.

“The best thing we currently can do for children with low lung function is try and determine the underlying cause and treat any active diseases [such as asthma] that we can. This study reminds us of the need to keep searching for causes of low lung function that may be reversible,” she said.

The investigators recommended future research to understand the risk factors for lower lung function in children. They called for studies that address “the risk factors over adulthood that interact with lower lung function to increase the risk of rapid lung function decline.”

 

 

The study was supported by a National Health and Medical Research Council of Australia research grant, the University of Melbourne, Clifford Craig Medical Research Trust of Tasmania, the Victorian, Queensland & Tasmanian Asthma Foundations, The Royal Hobart Hospital, Helen MacPherson Smith Trust, GlaxoSmithKline, and John L Hopper. Five authors were supported by the research grant; the others reported no conflicts. Dr. Swaminathan and Dr. Gartman had no disclosures.

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Children with poor lung function will be more likely to develop asthma-chronic obstructive pulmonary disease (COPD) overlap syndrome (ACOS), suggesting that prevention of this disease should be attempted in early life, a study shows.

While other research has found that patients with poor lung function in early life have poor lung function as adults, this was the first study to investigate the relationship between childhood lung function and ACOS in adult life, according to Dinh S. Bui of the University of Melbourne, and his colleagues.

The study, published in the American Journal of Respiratory and Critical Care Medicine, used multinomial regression models to investigate associations between childhood lung parameters at age 7 years and asthma, COPD, and ACOS at age 45 years (Am J Respir Crit Care Med. 2017 Feb 1. doi: 10.1164/rccm.201606-1272OC).

“We found that ACOS participants showed evidence of persistently lower FEV1 [forced expiratory volume in 1 second] and FEV1/FVC [forced vital capacity] from childhood. This suggests that poorer childhood lung function tracked to early adult life, leading to impaired maximally attained lung function,” the researchers said.

“The study highlights that low childhood lung function is a risk factor for COPD (and ACOS) independent of smoking,” they noted.

The 1,355 study participants who had postbronchodilator (post-BD) lung function available were categorized into the following four mutually exclusive groups at age 45 years based on their asthma and COPD status: having neither asthma nor COPD (unaffected) (n = 959); having asthma alone (n = 269); having COPD alone (n = 59); having ACOS (n = 68).

Once adjusted for the sampling weights, the prevalence of current asthma alone was 13.5%, COPD alone was 4.1%, and ACOS was 2.9%. The researchers defined COPD at age 45 years as post-BD FEV1/FVC less than the Global Lung Initiative lower limit of normal. Because the associations between childhood lung function and both ACOS and COPD alone were nonlinear, the patients were grouped into quartiles based on their characteristics, such as their percent predicted FEV1 and percent predicted FEV1/FVC at 7 years, the investigators said.

Patients in the lowest quartile for FEV1 percent predicted at 7 years were 2.93 times more likely to have ACOS, compared with patients in the other quartiles for FEV1 percent predicted. Patients in the lowest quartile for FEV1/FVC percent predicted at 7 years were 16.3 times more likely to have ACOS and 5.76 times more likely to have COPD alone, compared with patients in the higher quartiles.

The researchers found large variation in childhood lung function among patients in the lowest quartiles for FEV1 and FEV1/FVC. To account for this, they conducted a sensitivity analysis, which excluded those with less than 80% predicted FEV1 and FEV1/FVC (n = 76 and 13, respectively).The associations between lung function measures and diseases in adulthood for patients in the lowest quartiles differed slightly following this adjustment. The sensitivity analysis showed that patients in the lowest quartile for FEV1 had an odds ratio of 2.4 for ACOS and that those patients in the lowest quartile for FEV1/FVC had an odds ratio of 5.2 for COPD alone and 15.1 for ACOS.

A sensitivity analysis that excluded patients with remitted asthma from the unaffected group showed childhood FEV1 was more strongly associated with ACOS for patients in the lowest quartile, compared with patients in the highest quartile (OR: 7.0, 95% CI: 2.7-18.3). This same analysis found that patients from the lowest quartile and second quartile for childhood FEV1/FVC were 6.8 and 3.9 times more likely to have COPD, respectively, compared with patients in the other quartiles. This sensitivity analysis also found that patients in the first quartile for FEV1/FVC were 19.1 times more likely to have ACOS, and patients in the second quartile for FEV1/FVC were 5.3 times more likely to have ACOS.

The researchers analyzed data from the Tasmanian Longitudinal Health Study, which began in 1968 when Tasmanian children born in 1961 and attending school in Tasmania were studied with respiratory health surveys and prebronchodilator (pre-BD) spirometry measurements. The most recent survey started in 2002. Survey respondents who had participated in past follow-up studies and/or reported symptoms of asthma or cough were invited to participate in a more detailed laboratory study from 2006 to 2008. That study included completing a questionnaire, pre-BD and post-BD spirometry, and skin prick testing. The predicted and percent predicted values for spirometry were derived from the Global Lung Initiative reference equations.

The final multinomial model was adjusted for various factors including childhood asthma, maternal smoking, and paternal smoking during childhood.

History of active smoking was significantly more frequent in patients with ACOS (73.5%) and COPD alone (73%) than in the unaffected (57%) groups. Childhood asthma, maternal asthma and atopy were more prevalent in the ACOS and asthma alone groups. ACOS and COPD participants had a higher prevalence of maternal smoking during childhood.

Individuals with ACOS had the lowest pre-BD FEV1 (percent predicted values) over time. Those with COPD alone or ACOS had significantly lower pre-BD FEV1/FVC (percent predicted values) at all time points, when patients were assessed, compared with unaffected participants. “Participants with COPD alone had significantly higher FVC at 7 and 13 years, while ACOS participants had significantly lower FVC at 45 years,” the researchers said.

“There was no evidence of effect modification by childhood lung infections, childhood asthma, maternal asthma, maternal smoking, or paternal smoking during childhood on the associations between childhood lung and the disease groups,” they noted.

The study was limited by its “relatively small sample sizes for the ACOS and COPD alone groups” and the absence of post-BD spirometry at 7 years, they added.

The researchers concluded that “screening of lung function in school-aged children may provide an opportunity to detect children likely to have ongoing poorer lung health, such as those with lung function below the lower limit of normal,” and that “[multifaceted] intervention strategies could then be implemented to reduce the burden of COPD and ACOS in adulthood.”

Dr. Aparna Swaminathan
Asked to comment on the study, Aparna Swaminathan, MD, a pulmonary/critical care fellow at Duke University, Durham, N.C., and an incoming Duke Clinical Research Institute fellow, said she would want to know “what is driving the effects in the study” before designing an intervention.

“I suspect that genetics may play a big role in the results, and there is increasing interest in learning how genetics are involved in COPD. A better understanding of the risk factors for lower lung function in children may also provide targets of intervention. The groups with ACOS and COPD have higher rates of maternal smoking, and while this study determined that the association between childhood low lung function and development of COPD and ACOS is independent of maternal smoking, maternal smoking still seems like a good area to target,” she said in an interview.

It would also be interesting to further study the first quartile of patients, she added. “The clinical disease for this quartile of patients covers a wide range of severities. I would be interested in dividing this group up further and learning the outcomes of their lung function and development of COPD and ACOS.”

Dr. Eric J. Gartman
Dr. Eric J. Gartman
Aggressively treating childhood asthma and poor lung function is one method that may have altered the destiny of the children with lower lung function, if it had been used, Eric Gartman, MD, FCCP, said in an interview.

Using inhaled corticosteroids and other medications for maintenance control, reducing and monitoring impairment, educating patients and patients’ guardians on triggers, avoiding triggers, and having an action plan for changing therapy based on symptoms or measured flows are ways to aggressively treat such conditions, said Dr. Gartman, assistant professor of medicine at Brown University, Providence, R.I*. He cited avoiding exposure to smoke, environmental pollutants, and living near highways, for those with low childhood function, as interventions that might prevent people with low lung function from later developing COPD.

Dr. Gartman added that differences between the availability of medication for children with asthma today and at the time of the study may mean there are differences between the children with low lung function in the study and those children who have low function today. A population of children with low lung function now may be experiencing relatively less asthma and more chronic lung disorders brought on by prematurity or cystic fibrosis, he noted. “As such, identification of poor function in today’s young children may carry with it a significantly different set of interventions and challenges,” Dr. Gartman said.

While asthma in children is better controlled now than it was at the time of the study, because the researchers did not provide any information about the asthma control of the study participants, “it [is] hard for me to say if better asthma drugs in those children would have made a difference in long-term outcomes of COPD and ACOS as an adult,” Dr. Swaminathan noted.

“The best thing we currently can do for children with low lung function is try and determine the underlying cause and treat any active diseases [such as asthma] that we can. This study reminds us of the need to keep searching for causes of low lung function that may be reversible,” she said.

The investigators recommended future research to understand the risk factors for lower lung function in children. They called for studies that address “the risk factors over adulthood that interact with lower lung function to increase the risk of rapid lung function decline.”

 

 

The study was supported by a National Health and Medical Research Council of Australia research grant, the University of Melbourne, Clifford Craig Medical Research Trust of Tasmania, the Victorian, Queensland & Tasmanian Asthma Foundations, The Royal Hobart Hospital, Helen MacPherson Smith Trust, GlaxoSmithKline, and John L Hopper. Five authors were supported by the research grant; the others reported no conflicts. Dr. Swaminathan and Dr. Gartman had no disclosures.

 

Children with poor lung function will be more likely to develop asthma-chronic obstructive pulmonary disease (COPD) overlap syndrome (ACOS), suggesting that prevention of this disease should be attempted in early life, a study shows.

While other research has found that patients with poor lung function in early life have poor lung function as adults, this was the first study to investigate the relationship between childhood lung function and ACOS in adult life, according to Dinh S. Bui of the University of Melbourne, and his colleagues.

The study, published in the American Journal of Respiratory and Critical Care Medicine, used multinomial regression models to investigate associations between childhood lung parameters at age 7 years and asthma, COPD, and ACOS at age 45 years (Am J Respir Crit Care Med. 2017 Feb 1. doi: 10.1164/rccm.201606-1272OC).

“We found that ACOS participants showed evidence of persistently lower FEV1 [forced expiratory volume in 1 second] and FEV1/FVC [forced vital capacity] from childhood. This suggests that poorer childhood lung function tracked to early adult life, leading to impaired maximally attained lung function,” the researchers said.

“The study highlights that low childhood lung function is a risk factor for COPD (and ACOS) independent of smoking,” they noted.

The 1,355 study participants who had postbronchodilator (post-BD) lung function available were categorized into the following four mutually exclusive groups at age 45 years based on their asthma and COPD status: having neither asthma nor COPD (unaffected) (n = 959); having asthma alone (n = 269); having COPD alone (n = 59); having ACOS (n = 68).

Once adjusted for the sampling weights, the prevalence of current asthma alone was 13.5%, COPD alone was 4.1%, and ACOS was 2.9%. The researchers defined COPD at age 45 years as post-BD FEV1/FVC less than the Global Lung Initiative lower limit of normal. Because the associations between childhood lung function and both ACOS and COPD alone were nonlinear, the patients were grouped into quartiles based on their characteristics, such as their percent predicted FEV1 and percent predicted FEV1/FVC at 7 years, the investigators said.

Patients in the lowest quartile for FEV1 percent predicted at 7 years were 2.93 times more likely to have ACOS, compared with patients in the other quartiles for FEV1 percent predicted. Patients in the lowest quartile for FEV1/FVC percent predicted at 7 years were 16.3 times more likely to have ACOS and 5.76 times more likely to have COPD alone, compared with patients in the higher quartiles.

The researchers found large variation in childhood lung function among patients in the lowest quartiles for FEV1 and FEV1/FVC. To account for this, they conducted a sensitivity analysis, which excluded those with less than 80% predicted FEV1 and FEV1/FVC (n = 76 and 13, respectively).The associations between lung function measures and diseases in adulthood for patients in the lowest quartiles differed slightly following this adjustment. The sensitivity analysis showed that patients in the lowest quartile for FEV1 had an odds ratio of 2.4 for ACOS and that those patients in the lowest quartile for FEV1/FVC had an odds ratio of 5.2 for COPD alone and 15.1 for ACOS.

A sensitivity analysis that excluded patients with remitted asthma from the unaffected group showed childhood FEV1 was more strongly associated with ACOS for patients in the lowest quartile, compared with patients in the highest quartile (OR: 7.0, 95% CI: 2.7-18.3). This same analysis found that patients from the lowest quartile and second quartile for childhood FEV1/FVC were 6.8 and 3.9 times more likely to have COPD, respectively, compared with patients in the other quartiles. This sensitivity analysis also found that patients in the first quartile for FEV1/FVC were 19.1 times more likely to have ACOS, and patients in the second quartile for FEV1/FVC were 5.3 times more likely to have ACOS.

The researchers analyzed data from the Tasmanian Longitudinal Health Study, which began in 1968 when Tasmanian children born in 1961 and attending school in Tasmania were studied with respiratory health surveys and prebronchodilator (pre-BD) spirometry measurements. The most recent survey started in 2002. Survey respondents who had participated in past follow-up studies and/or reported symptoms of asthma or cough were invited to participate in a more detailed laboratory study from 2006 to 2008. That study included completing a questionnaire, pre-BD and post-BD spirometry, and skin prick testing. The predicted and percent predicted values for spirometry were derived from the Global Lung Initiative reference equations.

The final multinomial model was adjusted for various factors including childhood asthma, maternal smoking, and paternal smoking during childhood.

History of active smoking was significantly more frequent in patients with ACOS (73.5%) and COPD alone (73%) than in the unaffected (57%) groups. Childhood asthma, maternal asthma and atopy were more prevalent in the ACOS and asthma alone groups. ACOS and COPD participants had a higher prevalence of maternal smoking during childhood.

Individuals with ACOS had the lowest pre-BD FEV1 (percent predicted values) over time. Those with COPD alone or ACOS had significantly lower pre-BD FEV1/FVC (percent predicted values) at all time points, when patients were assessed, compared with unaffected participants. “Participants with COPD alone had significantly higher FVC at 7 and 13 years, while ACOS participants had significantly lower FVC at 45 years,” the researchers said.

“There was no evidence of effect modification by childhood lung infections, childhood asthma, maternal asthma, maternal smoking, or paternal smoking during childhood on the associations between childhood lung and the disease groups,” they noted.

The study was limited by its “relatively small sample sizes for the ACOS and COPD alone groups” and the absence of post-BD spirometry at 7 years, they added.

The researchers concluded that “screening of lung function in school-aged children may provide an opportunity to detect children likely to have ongoing poorer lung health, such as those with lung function below the lower limit of normal,” and that “[multifaceted] intervention strategies could then be implemented to reduce the burden of COPD and ACOS in adulthood.”

Dr. Aparna Swaminathan
Asked to comment on the study, Aparna Swaminathan, MD, a pulmonary/critical care fellow at Duke University, Durham, N.C., and an incoming Duke Clinical Research Institute fellow, said she would want to know “what is driving the effects in the study” before designing an intervention.

“I suspect that genetics may play a big role in the results, and there is increasing interest in learning how genetics are involved in COPD. A better understanding of the risk factors for lower lung function in children may also provide targets of intervention. The groups with ACOS and COPD have higher rates of maternal smoking, and while this study determined that the association between childhood low lung function and development of COPD and ACOS is independent of maternal smoking, maternal smoking still seems like a good area to target,” she said in an interview.

It would also be interesting to further study the first quartile of patients, she added. “The clinical disease for this quartile of patients covers a wide range of severities. I would be interested in dividing this group up further and learning the outcomes of their lung function and development of COPD and ACOS.”

Dr. Eric J. Gartman
Dr. Eric J. Gartman
Aggressively treating childhood asthma and poor lung function is one method that may have altered the destiny of the children with lower lung function, if it had been used, Eric Gartman, MD, FCCP, said in an interview.

Using inhaled corticosteroids and other medications for maintenance control, reducing and monitoring impairment, educating patients and patients’ guardians on triggers, avoiding triggers, and having an action plan for changing therapy based on symptoms or measured flows are ways to aggressively treat such conditions, said Dr. Gartman, assistant professor of medicine at Brown University, Providence, R.I*. He cited avoiding exposure to smoke, environmental pollutants, and living near highways, for those with low childhood function, as interventions that might prevent people with low lung function from later developing COPD.

Dr. Gartman added that differences between the availability of medication for children with asthma today and at the time of the study may mean there are differences between the children with low lung function in the study and those children who have low function today. A population of children with low lung function now may be experiencing relatively less asthma and more chronic lung disorders brought on by prematurity or cystic fibrosis, he noted. “As such, identification of poor function in today’s young children may carry with it a significantly different set of interventions and challenges,” Dr. Gartman said.

While asthma in children is better controlled now than it was at the time of the study, because the researchers did not provide any information about the asthma control of the study participants, “it [is] hard for me to say if better asthma drugs in those children would have made a difference in long-term outcomes of COPD and ACOS as an adult,” Dr. Swaminathan noted.

“The best thing we currently can do for children with low lung function is try and determine the underlying cause and treat any active diseases [such as asthma] that we can. This study reminds us of the need to keep searching for causes of low lung function that may be reversible,” she said.

The investigators recommended future research to understand the risk factors for lower lung function in children. They called for studies that address “the risk factors over adulthood that interact with lower lung function to increase the risk of rapid lung function decline.”

 

 

The study was supported by a National Health and Medical Research Council of Australia research grant, the University of Melbourne, Clifford Craig Medical Research Trust of Tasmania, the Victorian, Queensland & Tasmanian Asthma Foundations, The Royal Hobart Hospital, Helen MacPherson Smith Trust, GlaxoSmithKline, and John L Hopper. Five authors were supported by the research grant; the others reported no conflicts. Dr. Swaminathan and Dr. Gartman had no disclosures.

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Pulmonary rehabilitation helps wide range of COPD patients

Rehab may help COPD patients
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Participation in at least 20 days of pulmonary rehabilitation by patients with chronic obstructive pulmonary disease (COPD) resulted in statistically significant improvements in quality of life, perception of health status, functional capacity, dyspnea, and depression, in a retrospective analysis.

Furthermore, improvements were seen regardless of the degree of exercise function, dyspnea, or lung function at baseline, reported lead investigator Praful Schroff.

Current American Thoracic Society and European Respiratory Society guidelines recommend the consideration of pulmonary rehabilitation for patients who have persistent symptoms and activity limitations and for those who are unable to adjust to their illness despite optimal medical management (Am J Respir Critical Care Med. 2013 Oct 15;188[8]:e13-64). Recent research had shown that pulmonary rehabilitation benefits patients with COPD without regard to their level of baseline dyspnea, but the influence of the level of baseline exercise capacity on the benefits of pulmonary rehabilitation had not been systematically studied, wrote Mr. Schroff, the designer of the analysis and a student in the division of pulmonary, allergy, and critical care medicine at the University of Alabama, Birmingham (UAB).

The analysis focused on 229 COPD patients enrolled in the pulmonary rehabilitation program at UAB during 1996-2013, all of whom completed questionnaires both at enrollment and after completion of their respective exercise programs. The mean forced expiratory volume in 1 second (FEV1) percent predicted for the cohort was 46.3%.The researchers used pulmonary function data from tests performed within 2 years of enrollment. Change in quality of life and perception of health status were measured using the 36-item Short Form Health Survey (SF-36), dyspnea was assessed using the San Diego Shortness of Breath Questionnaire (SOBQ), depression was assessed using the Beck Depression Inventory (BDI)-II, and functional capacity was assessed using the 6-minute-walk-distance (6MWD) test. On average, the patients reported clinically significant improvements in most components of the SF-36, including an 11.5-unit, a 16.4-U, and a 12.4-U increase in physical function, social function, and vitality, respectively (P less than .001 for all three). The patients also experienced clinically important improvements in the 6MWD test (increase of 52.4 m; P less than .001) and dyspnea (decrease of 9.1 U in the SOBQ; P less than .001). On average, patients’ depression decreased by 3 U, using the BDI II (P less than .001).

When patients in this study were divided into groups based on various aspects of their health at baseline, the levels of improvements seen by each group in most components of the SF-36, the 6MWD, the SOBQ, and the BDI-II were almost always similar.

“We add to the literature by comparing outcomes across quartiles of baseline exercise capacity and showing that patients benefit independent of underlying functional capacity,” said Mr. Schroff and his colleagues.

A few differences in the outcomes following pulmonary rehabilitation were observed between these baseline characteristics–based groups. When patients were grouped by exercise capacity, for example, those with the lowest baseline exercise capacity (as measured by the 6MWD) experienced the largest incremental improvement in the 6MWD. Additionally, when patients were grouped by dyspnea score, those with the worst baseline dyspnea experienced the greatest reduction in dyspnea. However, those with the lowest lung function made the smallest improvement in the 6MWD. Another of these differences was observed between the patients with the lowest baseline lung function and the patients in the other lung function-based quartiles. Those with the worst lung function made the smallest improvement in the 6MWD, which was 39.0 m, on average. All of these subgroups achieved clinically significant improvements in the 6MWD and SOBQ (Ann Am Thorac Soc. 2017 Jan 1;14[1]:26-32).

Each exercise session included aerobic exercises, resistance training, and breathing techniques. Cardiovascular exercise was prescribed starting at 20-30 minutes of continuous or interval bouts and was gradually increasing until 30-45 minutes of exercise was achieved. Patients also received education sessions lasting 40-60 minutes on understanding their disease, smoking cessation counseling, appropriate use of inhalers, diet and nutrition, and stress management. Subjects with other concurrent chronic respiratory diseases were excluded from the analysis.

The researchers noted that their findings may not be generalizable to patients with disease burdens causing them to drop out of the study. “Although we have previously shown that baseline levels of dyspnea, FEV1, and exercise capacity did not influence dropout rates, this could be a source of bias,” they noted.

“Patients with COPD experienced meaningful improvements in quality of life, dyspnea, exercise capacity, and depression, regardless of baseline lung function, dyspnea, and exercise capacity. Current guidelines should be amended to recommend pulmonary rehabilitation to all patients with COPD, regardless of their baseline level of disease burden,” the analysis’ authors said.

 

 

Three of the study’s authors reported receiving grants and other fees or a single grant from various sources. The other authors, including Mr. Schroff, said they had nothing to disclose.

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Dr. Vera De Palo
Vera A. De Palo, MD, FCCP, comments: The care goals for COPD patients often include efforts to improve functionality. The authors of this retrospective analysis of pulmonary rehabilitation for patients with persistent symptoms and activity limitations report significant patient-reported improvements in physical function, social function, and vitality. Dyspnea and the patients’ reported level of depression also improved. Participation in pulmonary rehab may help our COPD patients better modulate the quality of life impact of their disease.

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Dr. Vera De Palo
Vera A. De Palo, MD, FCCP, comments: The care goals for COPD patients often include efforts to improve functionality. The authors of this retrospective analysis of pulmonary rehabilitation for patients with persistent symptoms and activity limitations report significant patient-reported improvements in physical function, social function, and vitality. Dyspnea and the patients’ reported level of depression also improved. Participation in pulmonary rehab may help our COPD patients better modulate the quality of life impact of their disease.

Body

Dr. Vera De Palo
Vera A. De Palo, MD, FCCP, comments: The care goals for COPD patients often include efforts to improve functionality. The authors of this retrospective analysis of pulmonary rehabilitation for patients with persistent symptoms and activity limitations report significant patient-reported improvements in physical function, social function, and vitality. Dyspnea and the patients’ reported level of depression also improved. Participation in pulmonary rehab may help our COPD patients better modulate the quality of life impact of their disease.

Title
Rehab may help COPD patients
Rehab may help COPD patients

Participation in at least 20 days of pulmonary rehabilitation by patients with chronic obstructive pulmonary disease (COPD) resulted in statistically significant improvements in quality of life, perception of health status, functional capacity, dyspnea, and depression, in a retrospective analysis.

Furthermore, improvements were seen regardless of the degree of exercise function, dyspnea, or lung function at baseline, reported lead investigator Praful Schroff.

Current American Thoracic Society and European Respiratory Society guidelines recommend the consideration of pulmonary rehabilitation for patients who have persistent symptoms and activity limitations and for those who are unable to adjust to their illness despite optimal medical management (Am J Respir Critical Care Med. 2013 Oct 15;188[8]:e13-64). Recent research had shown that pulmonary rehabilitation benefits patients with COPD without regard to their level of baseline dyspnea, but the influence of the level of baseline exercise capacity on the benefits of pulmonary rehabilitation had not been systematically studied, wrote Mr. Schroff, the designer of the analysis and a student in the division of pulmonary, allergy, and critical care medicine at the University of Alabama, Birmingham (UAB).

The analysis focused on 229 COPD patients enrolled in the pulmonary rehabilitation program at UAB during 1996-2013, all of whom completed questionnaires both at enrollment and after completion of their respective exercise programs. The mean forced expiratory volume in 1 second (FEV1) percent predicted for the cohort was 46.3%.The researchers used pulmonary function data from tests performed within 2 years of enrollment. Change in quality of life and perception of health status were measured using the 36-item Short Form Health Survey (SF-36), dyspnea was assessed using the San Diego Shortness of Breath Questionnaire (SOBQ), depression was assessed using the Beck Depression Inventory (BDI)-II, and functional capacity was assessed using the 6-minute-walk-distance (6MWD) test. On average, the patients reported clinically significant improvements in most components of the SF-36, including an 11.5-unit, a 16.4-U, and a 12.4-U increase in physical function, social function, and vitality, respectively (P less than .001 for all three). The patients also experienced clinically important improvements in the 6MWD test (increase of 52.4 m; P less than .001) and dyspnea (decrease of 9.1 U in the SOBQ; P less than .001). On average, patients’ depression decreased by 3 U, using the BDI II (P less than .001).

When patients in this study were divided into groups based on various aspects of their health at baseline, the levels of improvements seen by each group in most components of the SF-36, the 6MWD, the SOBQ, and the BDI-II were almost always similar.

“We add to the literature by comparing outcomes across quartiles of baseline exercise capacity and showing that patients benefit independent of underlying functional capacity,” said Mr. Schroff and his colleagues.

A few differences in the outcomes following pulmonary rehabilitation were observed between these baseline characteristics–based groups. When patients were grouped by exercise capacity, for example, those with the lowest baseline exercise capacity (as measured by the 6MWD) experienced the largest incremental improvement in the 6MWD. Additionally, when patients were grouped by dyspnea score, those with the worst baseline dyspnea experienced the greatest reduction in dyspnea. However, those with the lowest lung function made the smallest improvement in the 6MWD. Another of these differences was observed between the patients with the lowest baseline lung function and the patients in the other lung function-based quartiles. Those with the worst lung function made the smallest improvement in the 6MWD, which was 39.0 m, on average. All of these subgroups achieved clinically significant improvements in the 6MWD and SOBQ (Ann Am Thorac Soc. 2017 Jan 1;14[1]:26-32).

Each exercise session included aerobic exercises, resistance training, and breathing techniques. Cardiovascular exercise was prescribed starting at 20-30 minutes of continuous or interval bouts and was gradually increasing until 30-45 minutes of exercise was achieved. Patients also received education sessions lasting 40-60 minutes on understanding their disease, smoking cessation counseling, appropriate use of inhalers, diet and nutrition, and stress management. Subjects with other concurrent chronic respiratory diseases were excluded from the analysis.

The researchers noted that their findings may not be generalizable to patients with disease burdens causing them to drop out of the study. “Although we have previously shown that baseline levels of dyspnea, FEV1, and exercise capacity did not influence dropout rates, this could be a source of bias,” they noted.

“Patients with COPD experienced meaningful improvements in quality of life, dyspnea, exercise capacity, and depression, regardless of baseline lung function, dyspnea, and exercise capacity. Current guidelines should be amended to recommend pulmonary rehabilitation to all patients with COPD, regardless of their baseline level of disease burden,” the analysis’ authors said.

 

 

Three of the study’s authors reported receiving grants and other fees or a single grant from various sources. The other authors, including Mr. Schroff, said they had nothing to disclose.

Participation in at least 20 days of pulmonary rehabilitation by patients with chronic obstructive pulmonary disease (COPD) resulted in statistically significant improvements in quality of life, perception of health status, functional capacity, dyspnea, and depression, in a retrospective analysis.

Furthermore, improvements were seen regardless of the degree of exercise function, dyspnea, or lung function at baseline, reported lead investigator Praful Schroff.

Current American Thoracic Society and European Respiratory Society guidelines recommend the consideration of pulmonary rehabilitation for patients who have persistent symptoms and activity limitations and for those who are unable to adjust to their illness despite optimal medical management (Am J Respir Critical Care Med. 2013 Oct 15;188[8]:e13-64). Recent research had shown that pulmonary rehabilitation benefits patients with COPD without regard to their level of baseline dyspnea, but the influence of the level of baseline exercise capacity on the benefits of pulmonary rehabilitation had not been systematically studied, wrote Mr. Schroff, the designer of the analysis and a student in the division of pulmonary, allergy, and critical care medicine at the University of Alabama, Birmingham (UAB).

The analysis focused on 229 COPD patients enrolled in the pulmonary rehabilitation program at UAB during 1996-2013, all of whom completed questionnaires both at enrollment and after completion of their respective exercise programs. The mean forced expiratory volume in 1 second (FEV1) percent predicted for the cohort was 46.3%.The researchers used pulmonary function data from tests performed within 2 years of enrollment. Change in quality of life and perception of health status were measured using the 36-item Short Form Health Survey (SF-36), dyspnea was assessed using the San Diego Shortness of Breath Questionnaire (SOBQ), depression was assessed using the Beck Depression Inventory (BDI)-II, and functional capacity was assessed using the 6-minute-walk-distance (6MWD) test. On average, the patients reported clinically significant improvements in most components of the SF-36, including an 11.5-unit, a 16.4-U, and a 12.4-U increase in physical function, social function, and vitality, respectively (P less than .001 for all three). The patients also experienced clinically important improvements in the 6MWD test (increase of 52.4 m; P less than .001) and dyspnea (decrease of 9.1 U in the SOBQ; P less than .001). On average, patients’ depression decreased by 3 U, using the BDI II (P less than .001).

When patients in this study were divided into groups based on various aspects of their health at baseline, the levels of improvements seen by each group in most components of the SF-36, the 6MWD, the SOBQ, and the BDI-II were almost always similar.

“We add to the literature by comparing outcomes across quartiles of baseline exercise capacity and showing that patients benefit independent of underlying functional capacity,” said Mr. Schroff and his colleagues.

A few differences in the outcomes following pulmonary rehabilitation were observed between these baseline characteristics–based groups. When patients were grouped by exercise capacity, for example, those with the lowest baseline exercise capacity (as measured by the 6MWD) experienced the largest incremental improvement in the 6MWD. Additionally, when patients were grouped by dyspnea score, those with the worst baseline dyspnea experienced the greatest reduction in dyspnea. However, those with the lowest lung function made the smallest improvement in the 6MWD. Another of these differences was observed between the patients with the lowest baseline lung function and the patients in the other lung function-based quartiles. Those with the worst lung function made the smallest improvement in the 6MWD, which was 39.0 m, on average. All of these subgroups achieved clinically significant improvements in the 6MWD and SOBQ (Ann Am Thorac Soc. 2017 Jan 1;14[1]:26-32).

Each exercise session included aerobic exercises, resistance training, and breathing techniques. Cardiovascular exercise was prescribed starting at 20-30 minutes of continuous or interval bouts and was gradually increasing until 30-45 minutes of exercise was achieved. Patients also received education sessions lasting 40-60 minutes on understanding their disease, smoking cessation counseling, appropriate use of inhalers, diet and nutrition, and stress management. Subjects with other concurrent chronic respiratory diseases were excluded from the analysis.

The researchers noted that their findings may not be generalizable to patients with disease burdens causing them to drop out of the study. “Although we have previously shown that baseline levels of dyspnea, FEV1, and exercise capacity did not influence dropout rates, this could be a source of bias,” they noted.

“Patients with COPD experienced meaningful improvements in quality of life, dyspnea, exercise capacity, and depression, regardless of baseline lung function, dyspnea, and exercise capacity. Current guidelines should be amended to recommend pulmonary rehabilitation to all patients with COPD, regardless of their baseline level of disease burden,” the analysis’ authors said.

 

 

Three of the study’s authors reported receiving grants and other fees or a single grant from various sources. The other authors, including Mr. Schroff, said they had nothing to disclose.

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Key clinical point: COPD patients with a variety of baseline health characteristics experienced clinically significant improvements in quality of life, functional capacity, and dyspnea following at least 20 days of pulmonary rehabilitation.

Major finding: The patients experienced clinically important improvements in the 6-minute-walk-distance test (an average increase of 52.4 m; P less than .001) and dyspnea (an average decrease of 9.1 U in the San Diego Shortness of Breath Questionnaire, P less than .001).

Data source: A retrospective analysis of 229 COPD patients from a prospectively maintained database.

Disclosures: Three of the study’s authors reported receiving grants and other fees or a single grant from various sources. The other authors, including Mr. Schroff, said they had nothing to disclose.

Rhinovirus most often caused HA-VRIs in two hospitals

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Health care–associated viral respiratory infections (HA-VRIs) were common in two pediatric hospitals, with rhinovirus the most frequent cause of the infections in a 3-year analysis.

The incidence rate of laboratory-confirmed HA-VRIs was 1.29/1,000 patient-days in an examination of the hospitals’ patient data. Forty-eight percent of all 323 HA-VRI cases were caused by rhinovirus, with an overall incidence rate of 0.72/1,000 patient-days. Additionally, rhinovirus was the most frequently identified virus in cases of HA-VRI in all units of both hospitals, followed by parainfluenza virus and respiratory syncytial virus. An exception was the medical/surgical ward of Steven and Alexandra Cohen Children’s Medical Center (CCMC) of New York; in this unit of the CCMC, the incidence rate of parainfluenza virus was higher than that of rhinovirus (0.21/1,000 patient-days vs. 0.15/1,000 patient-days) (J Ped Inf Dis. 2016. doi: 10.1093/jpids/piw072).

The researchers used infection prevention and control surveillance databases from Montreal Children’s Hospital (MCH) in Quebec and the CCMC to identify HA-VRIs that occurred between April 1, 2010, and March 31, 2013, In both hospitals, HAIs were attributed to the unit to which the patient was admitted at the time of transmission. Both hospitals used a multiplex nucleic acid amplification test for respiratory virus detection on nasopharyngeal swabs or aspirates.

“An HA-VRI with an onset of symptoms after hospital discharge would be detected and included only for patients who presented to the emergency department or were readmitted for VRI and tested,” according to Caroline Quach, MD, of the Montreal Children’s Hospital, McGill University Health Centre, Quebec, and her colleagues.

The HA-VRI rate was 1.91/1,000 patient-days at Montreal Children’s Hospital, compared with 0.80/1,000 patient-days at the CCMC (P less than .0001). At the CCMC, the HA-VRI incidence rate was lowest in the neonatal ICU, but at Montgomery Children’s Hospital, the hematology/oncology ward had the lowest rate of HA-VRI.

Having less than 50% single rooms in a given unit was associated with a statistically significantly higher rate of HA-VRI, after the investigators adjusted for unit type and took the correlation of HA-VRI rates within a hospital into consideration. The study authors’ model predicted that units with less than 50% single rooms have 1.33 times higher HA-VRI rates than units with at least 50% single rooms, regardless of unit type.

Dr. Quach has received funding from GlaxoSmithKline, Pfizer, Sage, and AbbVie for an unrelated research project, while the other authors disclosed no financial relationships.

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Health care–associated viral respiratory infections (HA-VRIs) were common in two pediatric hospitals, with rhinovirus the most frequent cause of the infections in a 3-year analysis.

The incidence rate of laboratory-confirmed HA-VRIs was 1.29/1,000 patient-days in an examination of the hospitals’ patient data. Forty-eight percent of all 323 HA-VRI cases were caused by rhinovirus, with an overall incidence rate of 0.72/1,000 patient-days. Additionally, rhinovirus was the most frequently identified virus in cases of HA-VRI in all units of both hospitals, followed by parainfluenza virus and respiratory syncytial virus. An exception was the medical/surgical ward of Steven and Alexandra Cohen Children’s Medical Center (CCMC) of New York; in this unit of the CCMC, the incidence rate of parainfluenza virus was higher than that of rhinovirus (0.21/1,000 patient-days vs. 0.15/1,000 patient-days) (J Ped Inf Dis. 2016. doi: 10.1093/jpids/piw072).

The researchers used infection prevention and control surveillance databases from Montreal Children’s Hospital (MCH) in Quebec and the CCMC to identify HA-VRIs that occurred between April 1, 2010, and March 31, 2013, In both hospitals, HAIs were attributed to the unit to which the patient was admitted at the time of transmission. Both hospitals used a multiplex nucleic acid amplification test for respiratory virus detection on nasopharyngeal swabs or aspirates.

“An HA-VRI with an onset of symptoms after hospital discharge would be detected and included only for patients who presented to the emergency department or were readmitted for VRI and tested,” according to Caroline Quach, MD, of the Montreal Children’s Hospital, McGill University Health Centre, Quebec, and her colleagues.

The HA-VRI rate was 1.91/1,000 patient-days at Montreal Children’s Hospital, compared with 0.80/1,000 patient-days at the CCMC (P less than .0001). At the CCMC, the HA-VRI incidence rate was lowest in the neonatal ICU, but at Montgomery Children’s Hospital, the hematology/oncology ward had the lowest rate of HA-VRI.

Having less than 50% single rooms in a given unit was associated with a statistically significantly higher rate of HA-VRI, after the investigators adjusted for unit type and took the correlation of HA-VRI rates within a hospital into consideration. The study authors’ model predicted that units with less than 50% single rooms have 1.33 times higher HA-VRI rates than units with at least 50% single rooms, regardless of unit type.

Dr. Quach has received funding from GlaxoSmithKline, Pfizer, Sage, and AbbVie for an unrelated research project, while the other authors disclosed no financial relationships.

 

Health care–associated viral respiratory infections (HA-VRIs) were common in two pediatric hospitals, with rhinovirus the most frequent cause of the infections in a 3-year analysis.

The incidence rate of laboratory-confirmed HA-VRIs was 1.29/1,000 patient-days in an examination of the hospitals’ patient data. Forty-eight percent of all 323 HA-VRI cases were caused by rhinovirus, with an overall incidence rate of 0.72/1,000 patient-days. Additionally, rhinovirus was the most frequently identified virus in cases of HA-VRI in all units of both hospitals, followed by parainfluenza virus and respiratory syncytial virus. An exception was the medical/surgical ward of Steven and Alexandra Cohen Children’s Medical Center (CCMC) of New York; in this unit of the CCMC, the incidence rate of parainfluenza virus was higher than that of rhinovirus (0.21/1,000 patient-days vs. 0.15/1,000 patient-days) (J Ped Inf Dis. 2016. doi: 10.1093/jpids/piw072).

The researchers used infection prevention and control surveillance databases from Montreal Children’s Hospital (MCH) in Quebec and the CCMC to identify HA-VRIs that occurred between April 1, 2010, and March 31, 2013, In both hospitals, HAIs were attributed to the unit to which the patient was admitted at the time of transmission. Both hospitals used a multiplex nucleic acid amplification test for respiratory virus detection on nasopharyngeal swabs or aspirates.

“An HA-VRI with an onset of symptoms after hospital discharge would be detected and included only for patients who presented to the emergency department or were readmitted for VRI and tested,” according to Caroline Quach, MD, of the Montreal Children’s Hospital, McGill University Health Centre, Quebec, and her colleagues.

The HA-VRI rate was 1.91/1,000 patient-days at Montreal Children’s Hospital, compared with 0.80/1,000 patient-days at the CCMC (P less than .0001). At the CCMC, the HA-VRI incidence rate was lowest in the neonatal ICU, but at Montgomery Children’s Hospital, the hematology/oncology ward had the lowest rate of HA-VRI.

Having less than 50% single rooms in a given unit was associated with a statistically significantly higher rate of HA-VRI, after the investigators adjusted for unit type and took the correlation of HA-VRI rates within a hospital into consideration. The study authors’ model predicted that units with less than 50% single rooms have 1.33 times higher HA-VRI rates than units with at least 50% single rooms, regardless of unit type.

Dr. Quach has received funding from GlaxoSmithKline, Pfizer, Sage, and AbbVie for an unrelated research project, while the other authors disclosed no financial relationships.

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FROM THE JOURNAL OF THE PEDIATRIC INFECTIOUS DISEASES SOCIETY

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Key clinical point: Health care–associated viral respiratory infections were common in two pediatric hospitals, with rhinovirus the most frequent cause of the infections.

Major finding: The incidence rate of HA-VRIs was 1.29/1,000 patient-days in an examination of two pediatric hospitals’ patient data between April 1, 2010, and March 31, 2013.

Data source: A retrospective comparison of two hospitals’ 3 years of infection prevention and control surveillance data.

Disclosures: Dr. Quach has received funding from GlaxoSmithKline, Pfizer, Sage, and AbbVie for an unrelated research project, while the other authors disclosed no relevant financial relationships.

Streptococcal pneumonia’s resistance to macrolides increasing

Comment by Dr. Daniel Ouellette
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The incidence of resistance of Streptococcus pneumoniae to the macrolide azithromycin – one of the most commonly prescribed antibiotics for treating pneumonia – was almost 50% in 2014, according to a report by Kara Keedy, PhD, executive director of microbiology at Cempra Pharmaceuticals, and her colleagues.

The researchers prospectively collected and investigated 4,567 nonreplicative community-acquired bacterial pneumonia (CABP) S. pneumoniae isolates between 2008 and 2014 in the United States, according to the report presented as a poster at IDWeek 2016. The isolates were tested for susceptibility by broth microdilution methods, according to Clinical and Laboratory Standards Institute breakpoint criteria. Macrolide resistance rates were based on azithromycin and/or clarithromycin minimal inhibitory concentrations as available, with only data on azithromycin having been collected in 2014.

CDC/Dr. Mike Miller
On average in 2014, 48.4% of isolates were resistant to azithromycin and 31.3% of isolates exhibited high-level resistance to the macrolide, while 12.6% of isolates were co-resistant to macrolide and penicillin.

The overall resistance of S. pneumoniae to azithromycin exceeded 30% in all of the nine geographical divisions of the Centers for Disease Control and Prevention (CDC), with the high-level resistance of this bacterial cause of CABP to azithromycin having been greater than 25% in eight of the CDC divisions.

The co-resistance of S. pneumoniae to azithromycin and penicillin was highest in the CDC’s East South Central division in 2014. The regions with the largest percentages of isolates with high-level macrolide resistance were the East South Central (43.2%), the West South Central (38.1%), and the Mid-Atlantic (35.0%). The regions with the largest percentages of overall macrolide resistance were the West South Central (62.9%), the East South Central (56.8%), and the South Atlantic (53.2%).

The analysis also determined that the 2014 overall rate of macrolide resistance in S. pneumoniae in the United States of 48.4% is higher than it was for any of the four earlier years examined. In 2008, 2009, 2010, and 2011, those macrolide resistance rates were 39.7%, 40.2%, 37.1%, and 44.3%, respectively.

The researchers concluded that S. pneumoniae is the most common bacterial cause of CABP and that antibiotic resistance to it is “a significant clinical challenge as highlighted by” the CDC having listed it as a threatening pathogen in the urgent category. Dr. Keedy and her associates noted that in the United States, macrolides, amoxicillin/clavulanate, and respiratory fluoroquinolones are the most frequent agents prescribed to treat almost all community-acquired respiratory infections.

“Macrolide resistance in S. pneumoniae is continuing to increase in the U.S.,” the researchers reported in the poster. “Both low- and high-level macrolide resistance have been reported to cause clinical failures and other negative outcomes including longer hospital stays and higher costs.”

The study also examined the abilities of several other drugs, including the fourth-generation macrolide solithromycin, to inhibit S. pneumoniae isolates. Solithromycin does not yet have approved Clinical and Laboratory Standards Institute breakpoints, so only minimum inhibitory concentrations (MICs) were presented.

According to the study, more than 50% of S. pneumoniae isolates were inhibited by 0.008 mcg/mL solithromycin. Additionally, solithromycin had one of the lowest MICs against S. pneumoniae of all of the drugs tested in the study. The higher end of the MICs against S. pneumoniae for solithromycin and moxifloxacin was 0.25, which was lower than the higher end of the MICs for any of the other drugs tested against S. pneumoniae isolates.

Solithromycin is the first fluoroketolide in Phase III clinical development. It “shows activity against all macrolide-resistant strains of S. pneumoniae isolates, irrespective of the location in the U.S.,” according to the poster.

The data included in the poster was extracted from a global study by JMI Laboratories. Cempra funded this study. Dr. Keedy and the other authors of the poster are employees of Cempra.

Body

Dr. Daniel Ouellette
Dr. Daniel Ouellette
Daniel Ouellette, MD, FCCP, comments: “Mrs. Jones told me over the phone that she was having another COPD exacerbation. I called her pharmacy and ordered five days of azithromycin,” the fellow said.
How many of us have heard that line? How many of us have done that ourselves? Did you do that today? Dr. Keedy and her colleagues report that in all geographic areas in the US, resistance to azithromycin for S pneumoniae now exceeds 30%. On average, 48.4% of S pneumoniae isolates display resistance in the US. Without antibiotic stewardship by all of us, azithromycin, along with other antibiotics, will become an expensive placebo.

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Dr. Daniel Ouellette
Dr. Daniel Ouellette
Daniel Ouellette, MD, FCCP, comments: “Mrs. Jones told me over the phone that she was having another COPD exacerbation. I called her pharmacy and ordered five days of azithromycin,” the fellow said.
How many of us have heard that line? How many of us have done that ourselves? Did you do that today? Dr. Keedy and her colleagues report that in all geographic areas in the US, resistance to azithromycin for S pneumoniae now exceeds 30%. On average, 48.4% of S pneumoniae isolates display resistance in the US. Without antibiotic stewardship by all of us, azithromycin, along with other antibiotics, will become an expensive placebo.

Body

Dr. Daniel Ouellette
Dr. Daniel Ouellette
Daniel Ouellette, MD, FCCP, comments: “Mrs. Jones told me over the phone that she was having another COPD exacerbation. I called her pharmacy and ordered five days of azithromycin,” the fellow said.
How many of us have heard that line? How many of us have done that ourselves? Did you do that today? Dr. Keedy and her colleagues report that in all geographic areas in the US, resistance to azithromycin for S pneumoniae now exceeds 30%. On average, 48.4% of S pneumoniae isolates display resistance in the US. Without antibiotic stewardship by all of us, azithromycin, along with other antibiotics, will become an expensive placebo.

Title
Comment by Dr. Daniel Ouellette
Comment by Dr. Daniel Ouellette

 

The incidence of resistance of Streptococcus pneumoniae to the macrolide azithromycin – one of the most commonly prescribed antibiotics for treating pneumonia – was almost 50% in 2014, according to a report by Kara Keedy, PhD, executive director of microbiology at Cempra Pharmaceuticals, and her colleagues.

The researchers prospectively collected and investigated 4,567 nonreplicative community-acquired bacterial pneumonia (CABP) S. pneumoniae isolates between 2008 and 2014 in the United States, according to the report presented as a poster at IDWeek 2016. The isolates were tested for susceptibility by broth microdilution methods, according to Clinical and Laboratory Standards Institute breakpoint criteria. Macrolide resistance rates were based on azithromycin and/or clarithromycin minimal inhibitory concentrations as available, with only data on azithromycin having been collected in 2014.

CDC/Dr. Mike Miller
On average in 2014, 48.4% of isolates were resistant to azithromycin and 31.3% of isolates exhibited high-level resistance to the macrolide, while 12.6% of isolates were co-resistant to macrolide and penicillin.

The overall resistance of S. pneumoniae to azithromycin exceeded 30% in all of the nine geographical divisions of the Centers for Disease Control and Prevention (CDC), with the high-level resistance of this bacterial cause of CABP to azithromycin having been greater than 25% in eight of the CDC divisions.

The co-resistance of S. pneumoniae to azithromycin and penicillin was highest in the CDC’s East South Central division in 2014. The regions with the largest percentages of isolates with high-level macrolide resistance were the East South Central (43.2%), the West South Central (38.1%), and the Mid-Atlantic (35.0%). The regions with the largest percentages of overall macrolide resistance were the West South Central (62.9%), the East South Central (56.8%), and the South Atlantic (53.2%).

The analysis also determined that the 2014 overall rate of macrolide resistance in S. pneumoniae in the United States of 48.4% is higher than it was for any of the four earlier years examined. In 2008, 2009, 2010, and 2011, those macrolide resistance rates were 39.7%, 40.2%, 37.1%, and 44.3%, respectively.

The researchers concluded that S. pneumoniae is the most common bacterial cause of CABP and that antibiotic resistance to it is “a significant clinical challenge as highlighted by” the CDC having listed it as a threatening pathogen in the urgent category. Dr. Keedy and her associates noted that in the United States, macrolides, amoxicillin/clavulanate, and respiratory fluoroquinolones are the most frequent agents prescribed to treat almost all community-acquired respiratory infections.

“Macrolide resistance in S. pneumoniae is continuing to increase in the U.S.,” the researchers reported in the poster. “Both low- and high-level macrolide resistance have been reported to cause clinical failures and other negative outcomes including longer hospital stays and higher costs.”

The study also examined the abilities of several other drugs, including the fourth-generation macrolide solithromycin, to inhibit S. pneumoniae isolates. Solithromycin does not yet have approved Clinical and Laboratory Standards Institute breakpoints, so only minimum inhibitory concentrations (MICs) were presented.

According to the study, more than 50% of S. pneumoniae isolates were inhibited by 0.008 mcg/mL solithromycin. Additionally, solithromycin had one of the lowest MICs against S. pneumoniae of all of the drugs tested in the study. The higher end of the MICs against S. pneumoniae for solithromycin and moxifloxacin was 0.25, which was lower than the higher end of the MICs for any of the other drugs tested against S. pneumoniae isolates.

Solithromycin is the first fluoroketolide in Phase III clinical development. It “shows activity against all macrolide-resistant strains of S. pneumoniae isolates, irrespective of the location in the U.S.,” according to the poster.

The data included in the poster was extracted from a global study by JMI Laboratories. Cempra funded this study. Dr. Keedy and the other authors of the poster are employees of Cempra.

 

The incidence of resistance of Streptococcus pneumoniae to the macrolide azithromycin – one of the most commonly prescribed antibiotics for treating pneumonia – was almost 50% in 2014, according to a report by Kara Keedy, PhD, executive director of microbiology at Cempra Pharmaceuticals, and her colleagues.

The researchers prospectively collected and investigated 4,567 nonreplicative community-acquired bacterial pneumonia (CABP) S. pneumoniae isolates between 2008 and 2014 in the United States, according to the report presented as a poster at IDWeek 2016. The isolates were tested for susceptibility by broth microdilution methods, according to Clinical and Laboratory Standards Institute breakpoint criteria. Macrolide resistance rates were based on azithromycin and/or clarithromycin minimal inhibitory concentrations as available, with only data on azithromycin having been collected in 2014.

CDC/Dr. Mike Miller
On average in 2014, 48.4% of isolates were resistant to azithromycin and 31.3% of isolates exhibited high-level resistance to the macrolide, while 12.6% of isolates were co-resistant to macrolide and penicillin.

The overall resistance of S. pneumoniae to azithromycin exceeded 30% in all of the nine geographical divisions of the Centers for Disease Control and Prevention (CDC), with the high-level resistance of this bacterial cause of CABP to azithromycin having been greater than 25% in eight of the CDC divisions.

The co-resistance of S. pneumoniae to azithromycin and penicillin was highest in the CDC’s East South Central division in 2014. The regions with the largest percentages of isolates with high-level macrolide resistance were the East South Central (43.2%), the West South Central (38.1%), and the Mid-Atlantic (35.0%). The regions with the largest percentages of overall macrolide resistance were the West South Central (62.9%), the East South Central (56.8%), and the South Atlantic (53.2%).

The analysis also determined that the 2014 overall rate of macrolide resistance in S. pneumoniae in the United States of 48.4% is higher than it was for any of the four earlier years examined. In 2008, 2009, 2010, and 2011, those macrolide resistance rates were 39.7%, 40.2%, 37.1%, and 44.3%, respectively.

The researchers concluded that S. pneumoniae is the most common bacterial cause of CABP and that antibiotic resistance to it is “a significant clinical challenge as highlighted by” the CDC having listed it as a threatening pathogen in the urgent category. Dr. Keedy and her associates noted that in the United States, macrolides, amoxicillin/clavulanate, and respiratory fluoroquinolones are the most frequent agents prescribed to treat almost all community-acquired respiratory infections.

“Macrolide resistance in S. pneumoniae is continuing to increase in the U.S.,” the researchers reported in the poster. “Both low- and high-level macrolide resistance have been reported to cause clinical failures and other negative outcomes including longer hospital stays and higher costs.”

The study also examined the abilities of several other drugs, including the fourth-generation macrolide solithromycin, to inhibit S. pneumoniae isolates. Solithromycin does not yet have approved Clinical and Laboratory Standards Institute breakpoints, so only minimum inhibitory concentrations (MICs) were presented.

According to the study, more than 50% of S. pneumoniae isolates were inhibited by 0.008 mcg/mL solithromycin. Additionally, solithromycin had one of the lowest MICs against S. pneumoniae of all of the drugs tested in the study. The higher end of the MICs against S. pneumoniae for solithromycin and moxifloxacin was 0.25, which was lower than the higher end of the MICs for any of the other drugs tested against S. pneumoniae isolates.

Solithromycin is the first fluoroketolide in Phase III clinical development. It “shows activity against all macrolide-resistant strains of S. pneumoniae isolates, irrespective of the location in the U.S.,” according to the poster.

The data included in the poster was extracted from a global study by JMI Laboratories. Cempra funded this study. Dr. Keedy and the other authors of the poster are employees of Cempra.

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Key clinical point: Macrolide resistance in S. pneumoniae has been rising in the United States.

Major finding: S. pneumoniae isolatesaverage resistance to the macrolide azithromycin was 48.4% in 2014.

Data source: A prospective collection and investigation of 4,567 non-replicative community-acquired bacterial pneumonia isolates.

Disclosures: The data included in the poster was extracted from a global study by JMI Laboratories. Cempra funded this study. Dr. Keedy and the other authors of the poster are employees of Cempra.

Initial outcomes of PERT at Cleveland Clinic

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– Initial outcomes measures are beginning to emerge from Pulmonary Embolism Response Teams.

Members of the Cleveland Clinic’s PERT, which was established in 2014, presented some of their preliminary data during a presentation at the CHEST annual meeting.

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Dr. Jamal Mahar
Their findings indicate that “our residents, staff, and clinicians [understand] the utility of the PERT team and when and how to activate it. We have [documented that our approaches have] been associated with overall low bleeding risks,” study presenter Jamal Mahar, MD, said in an interview.

The concept behind the PERT is to rapidly mobilize a team with varied expertise helpful for treating patients with pulmonary embolisms (PEs). While the PERT “can be activated by any (clinician) for any patient, even low-risk patients ... those with submassive and massive PEs [intermediate- and high-risk patients]” are the target patients, said Dr. Mahar of the Cleveland Clinic.

The first PERT was created at Massachusetts General Hospital in Boston in 2012, according to the National Consortium of Pulmonary Embolism Response Team’s website. As of May 2015, the PERT model has been adopted by physicians and health care professionals from more than 40 institutions.

Dr. Mahar reported that the Cleveland Clinic’s PERT is activated through a single pager that resides with a vascular medicine fellow during the day and a critical care fellow at night. When paged, the fellow promptly evaluates the patient and ensures a complete basic work-up, which includes an ECG, cardiac enzymes, N-terminal pro b-type natriuretic peptide, lower-extremity deep vein thrombosis scans, transthoracic echocardiogram, and confirmatory CT/PE protocol or ventilation/perfusion scan.

Based on the simplified Pulmonary Embolism Severity Index and Bova scores, the patient is risk stratified and the patient’s indications, and relative and absolute contraindications to advanced therapies are reviewed. The fellow next sends a group notification to the PERT via email and text message. The team then convenes online for a virtual meeting and case presentation that includes sharing of lab and test results and images.

The process sounds complex, but the surgeon, interventional radiologist, vascular medicine specialist, and cardiologist are on call and simultaneously get the message and respond, Dr. Mahar said. With a team approach, the decision to use advanced therapies – systemic lytics, surgery, catheter-directed lysis and extracorporeal membrane oxygenation – is expedited. “For example, over the last 2 years, four out of four patients who underwent surgical embolectomies had good outcomes without any deaths,” he said.

Based on a retrospective chart review from October 2014 through August 2016, Cleveland Clinic’s PERT had been activated for 134 patients, 112 of whom were found to have PEs, Dr. Mahar said during his presentation at the annual meeting of the American College of Chest Physicians (CHEST).

The number of low risk, submassive, and massive PEs were 14 (12%), 76 (68%), and 22 (20%), respectively. Just over half of the PE patients, 55% (60 patients), were treated with anticoagulation therapy alone. Inferior vena cava filters were placed in 32 patients (29%); 14 patients received catheter-directed thrombolysis, 3 received a suction thrombectomy, and 4 received a surgical embolectomy.

The 30-day all-cause mortality rate was 9%; the deaths occurred in six patients who had massive PEs, three patients with submassive PEs, and one patient with a low-risk PE. Six of the patients who died had been treated with anticoagulation, two had received catheter-directed thrombolysis, and one had received a full dose of systemic thrombolysis.

Bleeding complications occurred in 10 patients, 6 of whom were treated with anticoagulation alone and 4 of whom underwent catheter-directed thrombolysis.

Cleveland Clinic is a large entity with multiple resources, but the principles of PERT can be applied in smaller facilities, as well, according to Gustavo A. Heresi-Davila, MD, medical director of the Cleveland Clinic’s pulmonary thromboendarterectomy program and the lead researcher for the PERT project at the clinic. “I would emphasize the notion that a PERT has to be multidisciplinary, as people with different backgrounds and expertise bring complementary talent to the discussion of each case. I would not minimize the challenges of assembling such a team,” he said during an interview following the meeting.

The moderator of the meeting session, Robert Schilz, DO, PhD, noted, that the goal of PERT is to determine the best approach for an individual patient based on available resources. To establish a PERT, “you don’t have to be able to put a patient on ECMO [extracorporeal membrane oxygenation] in 15 minutes, and you don’t have to be able to do endarterectomies, embolectomies, and all the catheter-drive techniques emergently. But you do need to have the disposition to have efficient and standardized care, and the solutions may need to be very geographic. What hospital A may do may be very different from hospital B.”

Small hospitals can draw on their available resources, added Dr. Schilz, director of pulmonary vascular disease and lung transplantation at Case Western Reserve University, Cleveland. “Most hospitals have cardiologists on call 24/7, and many have some flavor of interventional radiology; others have clear referral and transfer schemes. Emergency department personnel at small rural hospitals can rapidly identify patients appropriate for transfer.”

Dr. Mahar added that PERTs are already being utilized in smaller hospitals and that he thinks that, in the next 5 years, having a PERT will be the standard protocol.

Dr. Mahar reported no disclosures.

Mary Jo Dales contributed to this report.

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– Initial outcomes measures are beginning to emerge from Pulmonary Embolism Response Teams.

Members of the Cleveland Clinic’s PERT, which was established in 2014, presented some of their preliminary data during a presentation at the CHEST annual meeting.

Frontline Medical News
Dr. Jamal Mahar
Their findings indicate that “our residents, staff, and clinicians [understand] the utility of the PERT team and when and how to activate it. We have [documented that our approaches have] been associated with overall low bleeding risks,” study presenter Jamal Mahar, MD, said in an interview.

The concept behind the PERT is to rapidly mobilize a team with varied expertise helpful for treating patients with pulmonary embolisms (PEs). While the PERT “can be activated by any (clinician) for any patient, even low-risk patients ... those with submassive and massive PEs [intermediate- and high-risk patients]” are the target patients, said Dr. Mahar of the Cleveland Clinic.

The first PERT was created at Massachusetts General Hospital in Boston in 2012, according to the National Consortium of Pulmonary Embolism Response Team’s website. As of May 2015, the PERT model has been adopted by physicians and health care professionals from more than 40 institutions.

Dr. Mahar reported that the Cleveland Clinic’s PERT is activated through a single pager that resides with a vascular medicine fellow during the day and a critical care fellow at night. When paged, the fellow promptly evaluates the patient and ensures a complete basic work-up, which includes an ECG, cardiac enzymes, N-terminal pro b-type natriuretic peptide, lower-extremity deep vein thrombosis scans, transthoracic echocardiogram, and confirmatory CT/PE protocol or ventilation/perfusion scan.

Based on the simplified Pulmonary Embolism Severity Index and Bova scores, the patient is risk stratified and the patient’s indications, and relative and absolute contraindications to advanced therapies are reviewed. The fellow next sends a group notification to the PERT via email and text message. The team then convenes online for a virtual meeting and case presentation that includes sharing of lab and test results and images.

The process sounds complex, but the surgeon, interventional radiologist, vascular medicine specialist, and cardiologist are on call and simultaneously get the message and respond, Dr. Mahar said. With a team approach, the decision to use advanced therapies – systemic lytics, surgery, catheter-directed lysis and extracorporeal membrane oxygenation – is expedited. “For example, over the last 2 years, four out of four patients who underwent surgical embolectomies had good outcomes without any deaths,” he said.

Based on a retrospective chart review from October 2014 through August 2016, Cleveland Clinic’s PERT had been activated for 134 patients, 112 of whom were found to have PEs, Dr. Mahar said during his presentation at the annual meeting of the American College of Chest Physicians (CHEST).

The number of low risk, submassive, and massive PEs were 14 (12%), 76 (68%), and 22 (20%), respectively. Just over half of the PE patients, 55% (60 patients), were treated with anticoagulation therapy alone. Inferior vena cava filters were placed in 32 patients (29%); 14 patients received catheter-directed thrombolysis, 3 received a suction thrombectomy, and 4 received a surgical embolectomy.

The 30-day all-cause mortality rate was 9%; the deaths occurred in six patients who had massive PEs, three patients with submassive PEs, and one patient with a low-risk PE. Six of the patients who died had been treated with anticoagulation, two had received catheter-directed thrombolysis, and one had received a full dose of systemic thrombolysis.

Bleeding complications occurred in 10 patients, 6 of whom were treated with anticoagulation alone and 4 of whom underwent catheter-directed thrombolysis.

Cleveland Clinic is a large entity with multiple resources, but the principles of PERT can be applied in smaller facilities, as well, according to Gustavo A. Heresi-Davila, MD, medical director of the Cleveland Clinic’s pulmonary thromboendarterectomy program and the lead researcher for the PERT project at the clinic. “I would emphasize the notion that a PERT has to be multidisciplinary, as people with different backgrounds and expertise bring complementary talent to the discussion of each case. I would not minimize the challenges of assembling such a team,” he said during an interview following the meeting.

The moderator of the meeting session, Robert Schilz, DO, PhD, noted, that the goal of PERT is to determine the best approach for an individual patient based on available resources. To establish a PERT, “you don’t have to be able to put a patient on ECMO [extracorporeal membrane oxygenation] in 15 minutes, and you don’t have to be able to do endarterectomies, embolectomies, and all the catheter-drive techniques emergently. But you do need to have the disposition to have efficient and standardized care, and the solutions may need to be very geographic. What hospital A may do may be very different from hospital B.”

Small hospitals can draw on their available resources, added Dr. Schilz, director of pulmonary vascular disease and lung transplantation at Case Western Reserve University, Cleveland. “Most hospitals have cardiologists on call 24/7, and many have some flavor of interventional radiology; others have clear referral and transfer schemes. Emergency department personnel at small rural hospitals can rapidly identify patients appropriate for transfer.”

Dr. Mahar added that PERTs are already being utilized in smaller hospitals and that he thinks that, in the next 5 years, having a PERT will be the standard protocol.

Dr. Mahar reported no disclosures.

Mary Jo Dales contributed to this report.

– Initial outcomes measures are beginning to emerge from Pulmonary Embolism Response Teams.

Members of the Cleveland Clinic’s PERT, which was established in 2014, presented some of their preliminary data during a presentation at the CHEST annual meeting.

Frontline Medical News
Dr. Jamal Mahar
Their findings indicate that “our residents, staff, and clinicians [understand] the utility of the PERT team and when and how to activate it. We have [documented that our approaches have] been associated with overall low bleeding risks,” study presenter Jamal Mahar, MD, said in an interview.

The concept behind the PERT is to rapidly mobilize a team with varied expertise helpful for treating patients with pulmonary embolisms (PEs). While the PERT “can be activated by any (clinician) for any patient, even low-risk patients ... those with submassive and massive PEs [intermediate- and high-risk patients]” are the target patients, said Dr. Mahar of the Cleveland Clinic.

The first PERT was created at Massachusetts General Hospital in Boston in 2012, according to the National Consortium of Pulmonary Embolism Response Team’s website. As of May 2015, the PERT model has been adopted by physicians and health care professionals from more than 40 institutions.

Dr. Mahar reported that the Cleveland Clinic’s PERT is activated through a single pager that resides with a vascular medicine fellow during the day and a critical care fellow at night. When paged, the fellow promptly evaluates the patient and ensures a complete basic work-up, which includes an ECG, cardiac enzymes, N-terminal pro b-type natriuretic peptide, lower-extremity deep vein thrombosis scans, transthoracic echocardiogram, and confirmatory CT/PE protocol or ventilation/perfusion scan.

Based on the simplified Pulmonary Embolism Severity Index and Bova scores, the patient is risk stratified and the patient’s indications, and relative and absolute contraindications to advanced therapies are reviewed. The fellow next sends a group notification to the PERT via email and text message. The team then convenes online for a virtual meeting and case presentation that includes sharing of lab and test results and images.

The process sounds complex, but the surgeon, interventional radiologist, vascular medicine specialist, and cardiologist are on call and simultaneously get the message and respond, Dr. Mahar said. With a team approach, the decision to use advanced therapies – systemic lytics, surgery, catheter-directed lysis and extracorporeal membrane oxygenation – is expedited. “For example, over the last 2 years, four out of four patients who underwent surgical embolectomies had good outcomes without any deaths,” he said.

Based on a retrospective chart review from October 2014 through August 2016, Cleveland Clinic’s PERT had been activated for 134 patients, 112 of whom were found to have PEs, Dr. Mahar said during his presentation at the annual meeting of the American College of Chest Physicians (CHEST).

The number of low risk, submassive, and massive PEs were 14 (12%), 76 (68%), and 22 (20%), respectively. Just over half of the PE patients, 55% (60 patients), were treated with anticoagulation therapy alone. Inferior vena cava filters were placed in 32 patients (29%); 14 patients received catheter-directed thrombolysis, 3 received a suction thrombectomy, and 4 received a surgical embolectomy.

The 30-day all-cause mortality rate was 9%; the deaths occurred in six patients who had massive PEs, three patients with submassive PEs, and one patient with a low-risk PE. Six of the patients who died had been treated with anticoagulation, two had received catheter-directed thrombolysis, and one had received a full dose of systemic thrombolysis.

Bleeding complications occurred in 10 patients, 6 of whom were treated with anticoagulation alone and 4 of whom underwent catheter-directed thrombolysis.

Cleveland Clinic is a large entity with multiple resources, but the principles of PERT can be applied in smaller facilities, as well, according to Gustavo A. Heresi-Davila, MD, medical director of the Cleveland Clinic’s pulmonary thromboendarterectomy program and the lead researcher for the PERT project at the clinic. “I would emphasize the notion that a PERT has to be multidisciplinary, as people with different backgrounds and expertise bring complementary talent to the discussion of each case. I would not minimize the challenges of assembling such a team,” he said during an interview following the meeting.

The moderator of the meeting session, Robert Schilz, DO, PhD, noted, that the goal of PERT is to determine the best approach for an individual patient based on available resources. To establish a PERT, “you don’t have to be able to put a patient on ECMO [extracorporeal membrane oxygenation] in 15 minutes, and you don’t have to be able to do endarterectomies, embolectomies, and all the catheter-drive techniques emergently. But you do need to have the disposition to have efficient and standardized care, and the solutions may need to be very geographic. What hospital A may do may be very different from hospital B.”

Small hospitals can draw on their available resources, added Dr. Schilz, director of pulmonary vascular disease and lung transplantation at Case Western Reserve University, Cleveland. “Most hospitals have cardiologists on call 24/7, and many have some flavor of interventional radiology; others have clear referral and transfer schemes. Emergency department personnel at small rural hospitals can rapidly identify patients appropriate for transfer.”

Dr. Mahar added that PERTs are already being utilized in smaller hospitals and that he thinks that, in the next 5 years, having a PERT will be the standard protocol.

Dr. Mahar reported no disclosures.

Mary Jo Dales contributed to this report.

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FROM CHEST 2016

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Home oxygen upped survival in PAH with severely impaired DLCO

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– Pulmonary arterial hypertension (PAH) patients with severely impaired diffusing capacity of the lung for carbon monoxide (DLCO) were much more likely to survive when they received home oxygen therapy, according to a disease registry analysis.

“We all know that supplemental oxygen is widely used with PAH,” said Harrison W. Farber, MD, director of the pulmonary hypertension center at Boston University. But there are practically no data showing that it is successful, and there are even fewer data for patients with PAH who have very low diffusion capacity, he added.

That knowledge gap prompted Dr. Farber and his colleagues to analyze data from the Registry to Evaluate Early and Long-Term PAH Disease Management (REVEAL), the largest disease registry in the world of patients with PAH.

“Patients in that group – the severe DLCO group – who got oxygen had poorer prognostic features but improved overall survival relative to those who didn’t,” Dr. Farber explained during a presentation at the annual meeting of the American College of Chest Physicians. “Based on this, it makes us think that home oxygen, supplemental oxygen treatment, is associated with improved survival in patients, especially those with severe DLCO and PAH.”

The 3,046 patients analyzed by Dr. Farber and his colleagues had World Health Organization Group 1 PAH with right heart catheterization hemodynamic criteria: a mean pulmonary artery pressure greater than 25 mm Hg, a pulmonary capillary wedge pressure less than or equal to 15 mm Hg, and a pulmonary vascular resistance of at least 3 Wood units (WU). Patients were at least 18 years of age and grouped by oxygen use, which was defined as any use at any time from study enrollment to the end of follow-up, and by DLCO group.

A total of 57% of the patients (1,734) received oxygen, and the remaining 43% of the patients (1,312) did not receive oxygen. Among the patients who received oxygen, 71% (1,227) received the therapy continuously, and 24% (408) received oxygen at night only.

The 424 patients with a DLCO of less than 40% were considered to have a severe DLCO impairment. The other two groups comprised 505 patients with a moderate DLCO impairment (at least 40%, but less than 60%) and 844 patients with a mild to normal DLCO (at least 60%). The DLCOs of 1,273 patients analyzed were unknown.

Among those patients with severe DLCO impairment, the risk of death was significantly lower in those who received oxygen, compared with those who did not receive oxygen (hazard ratio, 0.56; P = .0033). Oxygen use was associated with significant improvements in overall survival in both the newly diagnosed (HR, 0.47; P = .029) and previously diagnosed (HR, 0.59; P = .026) severe DLCO cohorts, Dr. Farber said.

Patients receiving oxygen were more likely to be treated with PAH-specific medications, regardless of their DLCO group.

Among the analysis’s limitations was that the lengths of time patients had been undergoing oxygen treatment were unknown. That prevented adjustments for duration of oxygen treatment, according to Dr. Farber.

Dr. Farber disclosed serving on the steering committees or advisory boards for Actelion, Bayer, Bellerophon, Gilead, and United Therapeutics. He has received research support from Actelion, Gilead, and United Therapeutics, and has been a speaker for Actelion, Bayer, and Gilead.

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– Pulmonary arterial hypertension (PAH) patients with severely impaired diffusing capacity of the lung for carbon monoxide (DLCO) were much more likely to survive when they received home oxygen therapy, according to a disease registry analysis.

“We all know that supplemental oxygen is widely used with PAH,” said Harrison W. Farber, MD, director of the pulmonary hypertension center at Boston University. But there are practically no data showing that it is successful, and there are even fewer data for patients with PAH who have very low diffusion capacity, he added.

That knowledge gap prompted Dr. Farber and his colleagues to analyze data from the Registry to Evaluate Early and Long-Term PAH Disease Management (REVEAL), the largest disease registry in the world of patients with PAH.

“Patients in that group – the severe DLCO group – who got oxygen had poorer prognostic features but improved overall survival relative to those who didn’t,” Dr. Farber explained during a presentation at the annual meeting of the American College of Chest Physicians. “Based on this, it makes us think that home oxygen, supplemental oxygen treatment, is associated with improved survival in patients, especially those with severe DLCO and PAH.”

The 3,046 patients analyzed by Dr. Farber and his colleagues had World Health Organization Group 1 PAH with right heart catheterization hemodynamic criteria: a mean pulmonary artery pressure greater than 25 mm Hg, a pulmonary capillary wedge pressure less than or equal to 15 mm Hg, and a pulmonary vascular resistance of at least 3 Wood units (WU). Patients were at least 18 years of age and grouped by oxygen use, which was defined as any use at any time from study enrollment to the end of follow-up, and by DLCO group.

A total of 57% of the patients (1,734) received oxygen, and the remaining 43% of the patients (1,312) did not receive oxygen. Among the patients who received oxygen, 71% (1,227) received the therapy continuously, and 24% (408) received oxygen at night only.

The 424 patients with a DLCO of less than 40% were considered to have a severe DLCO impairment. The other two groups comprised 505 patients with a moderate DLCO impairment (at least 40%, but less than 60%) and 844 patients with a mild to normal DLCO (at least 60%). The DLCOs of 1,273 patients analyzed were unknown.

Among those patients with severe DLCO impairment, the risk of death was significantly lower in those who received oxygen, compared with those who did not receive oxygen (hazard ratio, 0.56; P = .0033). Oxygen use was associated with significant improvements in overall survival in both the newly diagnosed (HR, 0.47; P = .029) and previously diagnosed (HR, 0.59; P = .026) severe DLCO cohorts, Dr. Farber said.

Patients receiving oxygen were more likely to be treated with PAH-specific medications, regardless of their DLCO group.

Among the analysis’s limitations was that the lengths of time patients had been undergoing oxygen treatment were unknown. That prevented adjustments for duration of oxygen treatment, according to Dr. Farber.

Dr. Farber disclosed serving on the steering committees or advisory boards for Actelion, Bayer, Bellerophon, Gilead, and United Therapeutics. He has received research support from Actelion, Gilead, and United Therapeutics, and has been a speaker for Actelion, Bayer, and Gilead.

 

– Pulmonary arterial hypertension (PAH) patients with severely impaired diffusing capacity of the lung for carbon monoxide (DLCO) were much more likely to survive when they received home oxygen therapy, according to a disease registry analysis.

“We all know that supplemental oxygen is widely used with PAH,” said Harrison W. Farber, MD, director of the pulmonary hypertension center at Boston University. But there are practically no data showing that it is successful, and there are even fewer data for patients with PAH who have very low diffusion capacity, he added.

That knowledge gap prompted Dr. Farber and his colleagues to analyze data from the Registry to Evaluate Early and Long-Term PAH Disease Management (REVEAL), the largest disease registry in the world of patients with PAH.

“Patients in that group – the severe DLCO group – who got oxygen had poorer prognostic features but improved overall survival relative to those who didn’t,” Dr. Farber explained during a presentation at the annual meeting of the American College of Chest Physicians. “Based on this, it makes us think that home oxygen, supplemental oxygen treatment, is associated with improved survival in patients, especially those with severe DLCO and PAH.”

The 3,046 patients analyzed by Dr. Farber and his colleagues had World Health Organization Group 1 PAH with right heart catheterization hemodynamic criteria: a mean pulmonary artery pressure greater than 25 mm Hg, a pulmonary capillary wedge pressure less than or equal to 15 mm Hg, and a pulmonary vascular resistance of at least 3 Wood units (WU). Patients were at least 18 years of age and grouped by oxygen use, which was defined as any use at any time from study enrollment to the end of follow-up, and by DLCO group.

A total of 57% of the patients (1,734) received oxygen, and the remaining 43% of the patients (1,312) did not receive oxygen. Among the patients who received oxygen, 71% (1,227) received the therapy continuously, and 24% (408) received oxygen at night only.

The 424 patients with a DLCO of less than 40% were considered to have a severe DLCO impairment. The other two groups comprised 505 patients with a moderate DLCO impairment (at least 40%, but less than 60%) and 844 patients with a mild to normal DLCO (at least 60%). The DLCOs of 1,273 patients analyzed were unknown.

Among those patients with severe DLCO impairment, the risk of death was significantly lower in those who received oxygen, compared with those who did not receive oxygen (hazard ratio, 0.56; P = .0033). Oxygen use was associated with significant improvements in overall survival in both the newly diagnosed (HR, 0.47; P = .029) and previously diagnosed (HR, 0.59; P = .026) severe DLCO cohorts, Dr. Farber said.

Patients receiving oxygen were more likely to be treated with PAH-specific medications, regardless of their DLCO group.

Among the analysis’s limitations was that the lengths of time patients had been undergoing oxygen treatment were unknown. That prevented adjustments for duration of oxygen treatment, according to Dr. Farber.

Dr. Farber disclosed serving on the steering committees or advisory boards for Actelion, Bayer, Bellerophon, Gilead, and United Therapeutics. He has received research support from Actelion, Gilead, and United Therapeutics, and has been a speaker for Actelion, Bayer, and Gilead.

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Key clinical point: PAH patients with severely impaired DLCO were much more likely to survive when they received home oxygen therapy.

Major finding: PAH patients with severe DLCO impairment who received oxygen had a significantly higher probability of survival than those who didn’t receive oxygen (HR, 0.56; P = .0033).

Data source: An analysis of 3,046 patients in the U.S. multicenter, observational REVEAL disease registry.

Disclosures: Dr. Farber disclosed serving on the steering committees or advisory boards for Actelion, Bayer, Bellerophon, Gilead, and United Therapeutics. He has received research support from Actelion, Gilead, and United Therapeutics, and has been a speaker for Actelion, Bayer, and Gilead.

Pediatric OSA improved with oral montelukast

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Tue, 02/14/2023 - 13:06

 

The majority of children with obstructive sleep apnea (OSA) who took oral montelukast showed reductions in their apnea-hypopnea index (AHI) scores, in a randomized, double-blind placebo-controlled study.

Typically, OSA in children is treated by adenotonsillectomy, according to Leila Kheirandish-Gozal, MD, director of clinical sleep research at the University of Chicago, and her colleagues. Prior to this study, only one randomized controlled trial had showed that children with mild OSA “responded favorably” to the leukotriene modifier montelukast (Pediatrics. 2012 Aug 31. doi: 10.1542/peds.2012-0310).

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Dr. Kheirandish-Gozal’s new study was conducted over a 16-week period in 57 children with OSA, who were 2-10 years old (Ann Am Thorac Soc. 2016 Oct;13[10]:1736-41). Participants received either montelukast, which was given in 4-mg/day doses to children less than 6 years and in 5-mg/day doses to children at least 6 years of age, or a placebo. At the end of the trial, all remaining subjects, including those 15 who failed to use their assigned medication more than once a week (of which 7 received oral montelukast and 8 got the placebo), participated in an overnight polysomnographic study.

Twenty (71%) of the children who received montelukast had fewer AHI events per hour of total sleep time at the end of the study. The average number of such events for these patients was 4.2 plus or minus 2.8 after taking the drug, compared with 9.2 plus or minus 4.1 at the beginning of the study (P less than .0001). Only two (6.9%) of the patients who took the placebo had lower AHI scores at the end of the study, with the average AHI score for the placebo group having been 8.7 plus or minus 4.9 events per hour of total sleep time. At baseline, the average score for patients in the placebo group was 8.2 plus or minus 5.0 AHI events per hour of total sleep time at baseline.

Another improvement seen by patients who received the drug was a decrease in the number of 3% reductions in arterial oxygen saturation per hour of sleep. At the beginning of the study, these patients had 7.2 plus or minus 3.1 of these events; by the end of the study, the number of these events was down to 2.8 plus or minus 1.8 (P less than .001). No significant decrease in the number of these events was seen among patients in the placebo group.

In this study, “montelukast emerges as favorably reducing the severity of OSA short term in children 2-10 years of age. These findings add to the existing evidence supporting a therapeutic role for anti-inflammatory approaches in the management of this highly prevalent condition in children, and clearly justify future studies targeting the long-term benefits of these approaches in children with OSA,” the researchers wrote.

All patients participated in overnight sleep studies following a referral to one of two sleep clinics by their primary care pediatrician or pediatric otolaryngologist, at the beginning of the study. Children who had been diagnosed with symptomatic snoring and had an AHI score of greater than 2 events per hour of total sleep time, and for whom adenotonsillectomy was contemplated, were included in the study.

Central, obstructive, mixed apneic events were counted and hypopneas were assessed. OSA was defined “as the absence of airflow with continued chest wall and abdominal movement for a duration of at least two breaths,” the investigators said. Hypopneas were defined “as a decrease in oronasal flow greater than 50% on either the thermistor or nasal pressure transducer signal. with a corresponding decrease in arterial oxygen saturation greater than 3% or arousal,” Dr. Kheirandish-Gozal and her coauthors said.

Patients were excluded from the study for a variety of reasons, including having severe OSA requiring early surgical intervention.

Adverse events included headache in two children, one from the experimental group and one from the placebo group, and nausea in two subjects from the placebo group and in one from the montelukast group.

Merck provided tablets used in this study. Dr. Kheirandish-Gozal reported grants from Merck and the National Institutes of Health during the conduct of the study. David Gozal, MD, is supported by the Herbert T. Abelson Chair in Pediatrics at the University of Chicago.

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The majority of children with obstructive sleep apnea (OSA) who took oral montelukast showed reductions in their apnea-hypopnea index (AHI) scores, in a randomized, double-blind placebo-controlled study.

Typically, OSA in children is treated by adenotonsillectomy, according to Leila Kheirandish-Gozal, MD, director of clinical sleep research at the University of Chicago, and her colleagues. Prior to this study, only one randomized controlled trial had showed that children with mild OSA “responded favorably” to the leukotriene modifier montelukast (Pediatrics. 2012 Aug 31. doi: 10.1542/peds.2012-0310).

Thinkstock
Dr. Kheirandish-Gozal’s new study was conducted over a 16-week period in 57 children with OSA, who were 2-10 years old (Ann Am Thorac Soc. 2016 Oct;13[10]:1736-41). Participants received either montelukast, which was given in 4-mg/day doses to children less than 6 years and in 5-mg/day doses to children at least 6 years of age, or a placebo. At the end of the trial, all remaining subjects, including those 15 who failed to use their assigned medication more than once a week (of which 7 received oral montelukast and 8 got the placebo), participated in an overnight polysomnographic study.

Twenty (71%) of the children who received montelukast had fewer AHI events per hour of total sleep time at the end of the study. The average number of such events for these patients was 4.2 plus or minus 2.8 after taking the drug, compared with 9.2 plus or minus 4.1 at the beginning of the study (P less than .0001). Only two (6.9%) of the patients who took the placebo had lower AHI scores at the end of the study, with the average AHI score for the placebo group having been 8.7 plus or minus 4.9 events per hour of total sleep time. At baseline, the average score for patients in the placebo group was 8.2 plus or minus 5.0 AHI events per hour of total sleep time at baseline.

Another improvement seen by patients who received the drug was a decrease in the number of 3% reductions in arterial oxygen saturation per hour of sleep. At the beginning of the study, these patients had 7.2 plus or minus 3.1 of these events; by the end of the study, the number of these events was down to 2.8 plus or minus 1.8 (P less than .001). No significant decrease in the number of these events was seen among patients in the placebo group.

In this study, “montelukast emerges as favorably reducing the severity of OSA short term in children 2-10 years of age. These findings add to the existing evidence supporting a therapeutic role for anti-inflammatory approaches in the management of this highly prevalent condition in children, and clearly justify future studies targeting the long-term benefits of these approaches in children with OSA,” the researchers wrote.

All patients participated in overnight sleep studies following a referral to one of two sleep clinics by their primary care pediatrician or pediatric otolaryngologist, at the beginning of the study. Children who had been diagnosed with symptomatic snoring and had an AHI score of greater than 2 events per hour of total sleep time, and for whom adenotonsillectomy was contemplated, were included in the study.

Central, obstructive, mixed apneic events were counted and hypopneas were assessed. OSA was defined “as the absence of airflow with continued chest wall and abdominal movement for a duration of at least two breaths,” the investigators said. Hypopneas were defined “as a decrease in oronasal flow greater than 50% on either the thermistor or nasal pressure transducer signal. with a corresponding decrease in arterial oxygen saturation greater than 3% or arousal,” Dr. Kheirandish-Gozal and her coauthors said.

Patients were excluded from the study for a variety of reasons, including having severe OSA requiring early surgical intervention.

Adverse events included headache in two children, one from the experimental group and one from the placebo group, and nausea in two subjects from the placebo group and in one from the montelukast group.

Merck provided tablets used in this study. Dr. Kheirandish-Gozal reported grants from Merck and the National Institutes of Health during the conduct of the study. David Gozal, MD, is supported by the Herbert T. Abelson Chair in Pediatrics at the University of Chicago.

 

The majority of children with obstructive sleep apnea (OSA) who took oral montelukast showed reductions in their apnea-hypopnea index (AHI) scores, in a randomized, double-blind placebo-controlled study.

Typically, OSA in children is treated by adenotonsillectomy, according to Leila Kheirandish-Gozal, MD, director of clinical sleep research at the University of Chicago, and her colleagues. Prior to this study, only one randomized controlled trial had showed that children with mild OSA “responded favorably” to the leukotriene modifier montelukast (Pediatrics. 2012 Aug 31. doi: 10.1542/peds.2012-0310).

Thinkstock
Dr. Kheirandish-Gozal’s new study was conducted over a 16-week period in 57 children with OSA, who were 2-10 years old (Ann Am Thorac Soc. 2016 Oct;13[10]:1736-41). Participants received either montelukast, which was given in 4-mg/day doses to children less than 6 years and in 5-mg/day doses to children at least 6 years of age, or a placebo. At the end of the trial, all remaining subjects, including those 15 who failed to use their assigned medication more than once a week (of which 7 received oral montelukast and 8 got the placebo), participated in an overnight polysomnographic study.

Twenty (71%) of the children who received montelukast had fewer AHI events per hour of total sleep time at the end of the study. The average number of such events for these patients was 4.2 plus or minus 2.8 after taking the drug, compared with 9.2 plus or minus 4.1 at the beginning of the study (P less than .0001). Only two (6.9%) of the patients who took the placebo had lower AHI scores at the end of the study, with the average AHI score for the placebo group having been 8.7 plus or minus 4.9 events per hour of total sleep time. At baseline, the average score for patients in the placebo group was 8.2 plus or minus 5.0 AHI events per hour of total sleep time at baseline.

Another improvement seen by patients who received the drug was a decrease in the number of 3% reductions in arterial oxygen saturation per hour of sleep. At the beginning of the study, these patients had 7.2 plus or minus 3.1 of these events; by the end of the study, the number of these events was down to 2.8 plus or minus 1.8 (P less than .001). No significant decrease in the number of these events was seen among patients in the placebo group.

In this study, “montelukast emerges as favorably reducing the severity of OSA short term in children 2-10 years of age. These findings add to the existing evidence supporting a therapeutic role for anti-inflammatory approaches in the management of this highly prevalent condition in children, and clearly justify future studies targeting the long-term benefits of these approaches in children with OSA,” the researchers wrote.

All patients participated in overnight sleep studies following a referral to one of two sleep clinics by their primary care pediatrician or pediatric otolaryngologist, at the beginning of the study. Children who had been diagnosed with symptomatic snoring and had an AHI score of greater than 2 events per hour of total sleep time, and for whom adenotonsillectomy was contemplated, were included in the study.

Central, obstructive, mixed apneic events were counted and hypopneas were assessed. OSA was defined “as the absence of airflow with continued chest wall and abdominal movement for a duration of at least two breaths,” the investigators said. Hypopneas were defined “as a decrease in oronasal flow greater than 50% on either the thermistor or nasal pressure transducer signal. with a corresponding decrease in arterial oxygen saturation greater than 3% or arousal,” Dr. Kheirandish-Gozal and her coauthors said.

Patients were excluded from the study for a variety of reasons, including having severe OSA requiring early surgical intervention.

Adverse events included headache in two children, one from the experimental group and one from the placebo group, and nausea in two subjects from the placebo group and in one from the montelukast group.

Merck provided tablets used in this study. Dr. Kheirandish-Gozal reported grants from Merck and the National Institutes of Health during the conduct of the study. David Gozal, MD, is supported by the Herbert T. Abelson Chair in Pediatrics at the University of Chicago.

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Key clinical point: The majority of children with obstructive sleep apnea who took montelukast showed reductions in their apnea-hypopnea index scores.

Major finding: 71% of patients who took montelukast had a significant reduction in AHI events per hour of total sleep time (P less than .0001).

Data source: A prospective, randomized, double-blind placebo-controlled study of 57 children with obstructive sleep apnea.

Disclosures: Merck provided tablets used in this study. Dr. Kheirandish-Gozal reported grants from Merck and the National Institutes of Health during the conduct of the study. David Gozal, MD, is supported by the Herbert T. Abelson Chair in Pediatrics at the University of Chicago.