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Trump administration finalizing ban on flavored e-cigarettes
The Food and Drug Administration is finalizing a compliance policy that will target flavored e-cigarettes and aim to clear the market of unauthorized, non–tobacco-flavored e-cigarette products, U.S. Department of Health & Human Services Secretary Alex M. Azar II announced Sept. 11.
“The Trump administration is making it clear that we intend to clear the market of flavored e-cigarettes to reverse the deeply concerning epidemic of youth e-cigarette use that is impacting children, families, schools, and communities,” Mr. Azar said in a statement. “We will not stand idly by as these products become an on-ramp to combustible cigarettes or nicotine addiction for a generation of youth.”
The announcement comes as the Centers for Disease Control and Prevention and state health departments track hundreds of lung-related illnesses that are linked to the use of e-cigarettes. At least 450 cases have been reported in 33 states and one jurisdiction. Diagnoses include lipoid pneumonia, alveolar hemorrhage, and cryptogenic organizing pneumonia, according to a Sept. 6 press briefing by Ileana Arias, PhD, CDC acting deputy director for non-infectious diseases. Six deaths associated with the illnesses have been reported thus far.
Details of new regulatory action will be forthcoming and will outline enforcement policy for non–tobacco-flavored e-cigarette products that lack premarket authorization, HHS officials said. According to federal rules, all electronic nicotine delivery system (ENDS) products must file premarket tobacco product applications with the FDA within 2 years. Many ENDS products currently on the market are not being legally marketed and are subject to government action, according to the Trump administration.
“Once finalized, this compliance policy will serve as a powerful tool that the FDA can use to combat the troubling trend of youth e-cigarette use,” Ned Sharpless, MD, acting FDA commissioner, said in the statement. “We must act swiftly against flavored e-cigarette products that are especially attractive to children. Moreover, if we see a migration to tobacco-flavored products by kids, we will take additional steps to address youth use of these products.”
Federal officials noted that preliminary numbers from the National Youth Tobacco Survey show a continued rise in youth e-cigarette use, with more than a quarter of high school students current e-cigarette users in 2019. The overwhelming majority of youth e-cigarette users cited the use of fruit, menthol, or mint flavors, according to the preliminary data, which have not yet been published.
According to 2018 survey data, e-cigarette use increased from 12% to 21% among high school students and from 3% to 5% among middle school students from 2017 to 2018. There were 1.5 million more youth e-cigarette users in 2018 than in 2017, and youth who were using e-cigarettes were using them more often, according to the survey.
The Food and Drug Administration is finalizing a compliance policy that will target flavored e-cigarettes and aim to clear the market of unauthorized, non–tobacco-flavored e-cigarette products, U.S. Department of Health & Human Services Secretary Alex M. Azar II announced Sept. 11.
“The Trump administration is making it clear that we intend to clear the market of flavored e-cigarettes to reverse the deeply concerning epidemic of youth e-cigarette use that is impacting children, families, schools, and communities,” Mr. Azar said in a statement. “We will not stand idly by as these products become an on-ramp to combustible cigarettes or nicotine addiction for a generation of youth.”
The announcement comes as the Centers for Disease Control and Prevention and state health departments track hundreds of lung-related illnesses that are linked to the use of e-cigarettes. At least 450 cases have been reported in 33 states and one jurisdiction. Diagnoses include lipoid pneumonia, alveolar hemorrhage, and cryptogenic organizing pneumonia, according to a Sept. 6 press briefing by Ileana Arias, PhD, CDC acting deputy director for non-infectious diseases. Six deaths associated with the illnesses have been reported thus far.
Details of new regulatory action will be forthcoming and will outline enforcement policy for non–tobacco-flavored e-cigarette products that lack premarket authorization, HHS officials said. According to federal rules, all electronic nicotine delivery system (ENDS) products must file premarket tobacco product applications with the FDA within 2 years. Many ENDS products currently on the market are not being legally marketed and are subject to government action, according to the Trump administration.
“Once finalized, this compliance policy will serve as a powerful tool that the FDA can use to combat the troubling trend of youth e-cigarette use,” Ned Sharpless, MD, acting FDA commissioner, said in the statement. “We must act swiftly against flavored e-cigarette products that are especially attractive to children. Moreover, if we see a migration to tobacco-flavored products by kids, we will take additional steps to address youth use of these products.”
Federal officials noted that preliminary numbers from the National Youth Tobacco Survey show a continued rise in youth e-cigarette use, with more than a quarter of high school students current e-cigarette users in 2019. The overwhelming majority of youth e-cigarette users cited the use of fruit, menthol, or mint flavors, according to the preliminary data, which have not yet been published.
According to 2018 survey data, e-cigarette use increased from 12% to 21% among high school students and from 3% to 5% among middle school students from 2017 to 2018. There were 1.5 million more youth e-cigarette users in 2018 than in 2017, and youth who were using e-cigarettes were using them more often, according to the survey.
The Food and Drug Administration is finalizing a compliance policy that will target flavored e-cigarettes and aim to clear the market of unauthorized, non–tobacco-flavored e-cigarette products, U.S. Department of Health & Human Services Secretary Alex M. Azar II announced Sept. 11.
“The Trump administration is making it clear that we intend to clear the market of flavored e-cigarettes to reverse the deeply concerning epidemic of youth e-cigarette use that is impacting children, families, schools, and communities,” Mr. Azar said in a statement. “We will not stand idly by as these products become an on-ramp to combustible cigarettes or nicotine addiction for a generation of youth.”
The announcement comes as the Centers for Disease Control and Prevention and state health departments track hundreds of lung-related illnesses that are linked to the use of e-cigarettes. At least 450 cases have been reported in 33 states and one jurisdiction. Diagnoses include lipoid pneumonia, alveolar hemorrhage, and cryptogenic organizing pneumonia, according to a Sept. 6 press briefing by Ileana Arias, PhD, CDC acting deputy director for non-infectious diseases. Six deaths associated with the illnesses have been reported thus far.
Details of new regulatory action will be forthcoming and will outline enforcement policy for non–tobacco-flavored e-cigarette products that lack premarket authorization, HHS officials said. According to federal rules, all electronic nicotine delivery system (ENDS) products must file premarket tobacco product applications with the FDA within 2 years. Many ENDS products currently on the market are not being legally marketed and are subject to government action, according to the Trump administration.
“Once finalized, this compliance policy will serve as a powerful tool that the FDA can use to combat the troubling trend of youth e-cigarette use,” Ned Sharpless, MD, acting FDA commissioner, said in the statement. “We must act swiftly against flavored e-cigarette products that are especially attractive to children. Moreover, if we see a migration to tobacco-flavored products by kids, we will take additional steps to address youth use of these products.”
Federal officials noted that preliminary numbers from the National Youth Tobacco Survey show a continued rise in youth e-cigarette use, with more than a quarter of high school students current e-cigarette users in 2019. The overwhelming majority of youth e-cigarette users cited the use of fruit, menthol, or mint flavors, according to the preliminary data, which have not yet been published.
According to 2018 survey data, e-cigarette use increased from 12% to 21% among high school students and from 3% to 5% among middle school students from 2017 to 2018. There were 1.5 million more youth e-cigarette users in 2018 than in 2017, and youth who were using e-cigarettes were using them more often, according to the survey.
Consider triple therapy for the management of COPD
Background: The Global Initiative for Obstructive Lung Disease (GOLD) recommends triple therapy with inhaled corticosteroids, long-acting beta2-adrenoceptor agonists (LABA), and long-acting muscarinic receptor antagonists (LAMA) for patients with severe COPD who have frequent exacerbations despite treatment with a LABA and LAMA. Triple therapy has been shown to improve forced expiratory volume in 1 second (FEV1), but its effect on preventing exacerbations has not been well documented in previous meta-analyses.
Study design: Meta-analysis.
Setting: Studies published on PubMed, Embase, Cochrane Library website, Cochrane Central Register of Controlled Trials (CENTRAL), and ClinicalTrials.gov databases.
Synopsis: 21 randomized, controlled trials of triple therapy in stable cases of moderate to very severe COPD were included in this meta-analysis. Triple therapy was associated with a significantly greater reduction in the rate of COPD exacerbations, compared with dual therapy of LAMA and LABA (rate ratio, 0.78; 95% confidence interval, 0.70-0.88), inhaled corticosteroid and LABA (rate ratio, 0.77; 95% CI, 0.66-0.91), or LAMA monotherapy (rate ratio, 0.71; 95% CI, 0.60-0.85). Triple therapy was also associated with greater improvement in FEV1.
There was a significantly higher incidence of pneumonia in patients using triple therapy, compared with those using dual therapy (LAMA and LABA), and there also was a trend toward increased pneumonia incidence with triple therapy, compared with LAMA monotherapy. Triple therapy was not shown to improve survival; however, most trials lasted less than 6 months, which limits their analysis of survival outcomes.
Bottom line: In patients with advanced COPD, triple therapy is associated with lower rates of COPD exacerbations and improved lung function, compared with dual therapy or monotherapy.
Citation: Zheng Y et al. Triple therapy in the management of chronic obstructive pulmonary disease: Systemic review and meta-analysis. BMJ. 2018;363:k4388.
Dr. Chace is an associate physician in the division of hospital medicine at the University of California, San Diego.
Background: The Global Initiative for Obstructive Lung Disease (GOLD) recommends triple therapy with inhaled corticosteroids, long-acting beta2-adrenoceptor agonists (LABA), and long-acting muscarinic receptor antagonists (LAMA) for patients with severe COPD who have frequent exacerbations despite treatment with a LABA and LAMA. Triple therapy has been shown to improve forced expiratory volume in 1 second (FEV1), but its effect on preventing exacerbations has not been well documented in previous meta-analyses.
Study design: Meta-analysis.
Setting: Studies published on PubMed, Embase, Cochrane Library website, Cochrane Central Register of Controlled Trials (CENTRAL), and ClinicalTrials.gov databases.
Synopsis: 21 randomized, controlled trials of triple therapy in stable cases of moderate to very severe COPD were included in this meta-analysis. Triple therapy was associated with a significantly greater reduction in the rate of COPD exacerbations, compared with dual therapy of LAMA and LABA (rate ratio, 0.78; 95% confidence interval, 0.70-0.88), inhaled corticosteroid and LABA (rate ratio, 0.77; 95% CI, 0.66-0.91), or LAMA monotherapy (rate ratio, 0.71; 95% CI, 0.60-0.85). Triple therapy was also associated with greater improvement in FEV1.
There was a significantly higher incidence of pneumonia in patients using triple therapy, compared with those using dual therapy (LAMA and LABA), and there also was a trend toward increased pneumonia incidence with triple therapy, compared with LAMA monotherapy. Triple therapy was not shown to improve survival; however, most trials lasted less than 6 months, which limits their analysis of survival outcomes.
Bottom line: In patients with advanced COPD, triple therapy is associated with lower rates of COPD exacerbations and improved lung function, compared with dual therapy or monotherapy.
Citation: Zheng Y et al. Triple therapy in the management of chronic obstructive pulmonary disease: Systemic review and meta-analysis. BMJ. 2018;363:k4388.
Dr. Chace is an associate physician in the division of hospital medicine at the University of California, San Diego.
Background: The Global Initiative for Obstructive Lung Disease (GOLD) recommends triple therapy with inhaled corticosteroids, long-acting beta2-adrenoceptor agonists (LABA), and long-acting muscarinic receptor antagonists (LAMA) for patients with severe COPD who have frequent exacerbations despite treatment with a LABA and LAMA. Triple therapy has been shown to improve forced expiratory volume in 1 second (FEV1), but its effect on preventing exacerbations has not been well documented in previous meta-analyses.
Study design: Meta-analysis.
Setting: Studies published on PubMed, Embase, Cochrane Library website, Cochrane Central Register of Controlled Trials (CENTRAL), and ClinicalTrials.gov databases.
Synopsis: 21 randomized, controlled trials of triple therapy in stable cases of moderate to very severe COPD were included in this meta-analysis. Triple therapy was associated with a significantly greater reduction in the rate of COPD exacerbations, compared with dual therapy of LAMA and LABA (rate ratio, 0.78; 95% confidence interval, 0.70-0.88), inhaled corticosteroid and LABA (rate ratio, 0.77; 95% CI, 0.66-0.91), or LAMA monotherapy (rate ratio, 0.71; 95% CI, 0.60-0.85). Triple therapy was also associated with greater improvement in FEV1.
There was a significantly higher incidence of pneumonia in patients using triple therapy, compared with those using dual therapy (LAMA and LABA), and there also was a trend toward increased pneumonia incidence with triple therapy, compared with LAMA monotherapy. Triple therapy was not shown to improve survival; however, most trials lasted less than 6 months, which limits their analysis of survival outcomes.
Bottom line: In patients with advanced COPD, triple therapy is associated with lower rates of COPD exacerbations and improved lung function, compared with dual therapy or monotherapy.
Citation: Zheng Y et al. Triple therapy in the management of chronic obstructive pulmonary disease: Systemic review and meta-analysis. BMJ. 2018;363:k4388.
Dr. Chace is an associate physician in the division of hospital medicine at the University of California, San Diego.
FDA issues warning to JUUL on illegal marketing of e-cigarettes
, citing violation of the Federal Food, Drug, and Cosmetic Act.
According to the letter, JUUL has marketed its e-cigarettes and e-liquids as modified-risk tobacco products without receiving FDA authorization to do so. JUUL’s labeling, advertising, and other consumer-oriented activities to this effect could reasonably lead consumers to believe that JUUL products represent a lower risk of tobacco-related disease, compared with other tobacco products; that they contain a reduced level of a substance; and that they are free of a particular substance or substances.
As evidence, the letter cited testimony given at a July 2019 hearing held by the Subcommittee on Economic and Consumer Policy of the Committee on Oversight and Reform of the House of Representatives, in which a representative from JUUL, speaking to students at a school presentation, said that JUUL products were “much safer than cigarettes” and that the “FDA would approve it any day,” that JUUL products were “totally safe,” that a student “should mention JUUL to his [nicotine-addicted] friend ... because that’s a safer alternative than smoking cigarettes, and it would be better for the kid to use,” and that the FDA “was about to come out and say it [JUUL] was 99% safer than cigarettes ... and that ... would happen very soon.”
In addition, a “Letter from the CEO” that appeared on the JUUL website and was emailed to a parent in response to her complaint that the company sold JUUL products to her child stated that “[JUUL’s] simple and convenient system incorporates temperature regulation to heat nicotine liquid and deliver smokers the satisfaction that they want without the combustion and the harm associated with it.”
In a related press release, acting FDA Commissioner Ned Sharpless, MD, said that “regardless of where products like e-cigarettes fall on the continuum of tobacco product risk, the law is clear that, before marketing tobacco products for reduced risk, companies must demonstrate with scientific evidence that their specific product does in fact pose less risk or is less harmful. JUUL has ignored the law, and very concerningly, has made some of these statements in school to our nation’s youth.”
The FDA has requested a response from JUUL within 15 working days of the letter’s issue. Failure to comply with the Federal Food, Drug, and Cosmetic Act could result in the FDA’s initiating further actions such as civil money penalties, seizure, and/or injunction.
, citing violation of the Federal Food, Drug, and Cosmetic Act.
According to the letter, JUUL has marketed its e-cigarettes and e-liquids as modified-risk tobacco products without receiving FDA authorization to do so. JUUL’s labeling, advertising, and other consumer-oriented activities to this effect could reasonably lead consumers to believe that JUUL products represent a lower risk of tobacco-related disease, compared with other tobacco products; that they contain a reduced level of a substance; and that they are free of a particular substance or substances.
As evidence, the letter cited testimony given at a July 2019 hearing held by the Subcommittee on Economic and Consumer Policy of the Committee on Oversight and Reform of the House of Representatives, in which a representative from JUUL, speaking to students at a school presentation, said that JUUL products were “much safer than cigarettes” and that the “FDA would approve it any day,” that JUUL products were “totally safe,” that a student “should mention JUUL to his [nicotine-addicted] friend ... because that’s a safer alternative than smoking cigarettes, and it would be better for the kid to use,” and that the FDA “was about to come out and say it [JUUL] was 99% safer than cigarettes ... and that ... would happen very soon.”
In addition, a “Letter from the CEO” that appeared on the JUUL website and was emailed to a parent in response to her complaint that the company sold JUUL products to her child stated that “[JUUL’s] simple and convenient system incorporates temperature regulation to heat nicotine liquid and deliver smokers the satisfaction that they want without the combustion and the harm associated with it.”
In a related press release, acting FDA Commissioner Ned Sharpless, MD, said that “regardless of where products like e-cigarettes fall on the continuum of tobacco product risk, the law is clear that, before marketing tobacco products for reduced risk, companies must demonstrate with scientific evidence that their specific product does in fact pose less risk or is less harmful. JUUL has ignored the law, and very concerningly, has made some of these statements in school to our nation’s youth.”
The FDA has requested a response from JUUL within 15 working days of the letter’s issue. Failure to comply with the Federal Food, Drug, and Cosmetic Act could result in the FDA’s initiating further actions such as civil money penalties, seizure, and/or injunction.
, citing violation of the Federal Food, Drug, and Cosmetic Act.
According to the letter, JUUL has marketed its e-cigarettes and e-liquids as modified-risk tobacco products without receiving FDA authorization to do so. JUUL’s labeling, advertising, and other consumer-oriented activities to this effect could reasonably lead consumers to believe that JUUL products represent a lower risk of tobacco-related disease, compared with other tobacco products; that they contain a reduced level of a substance; and that they are free of a particular substance or substances.
As evidence, the letter cited testimony given at a July 2019 hearing held by the Subcommittee on Economic and Consumer Policy of the Committee on Oversight and Reform of the House of Representatives, in which a representative from JUUL, speaking to students at a school presentation, said that JUUL products were “much safer than cigarettes” and that the “FDA would approve it any day,” that JUUL products were “totally safe,” that a student “should mention JUUL to his [nicotine-addicted] friend ... because that’s a safer alternative than smoking cigarettes, and it would be better for the kid to use,” and that the FDA “was about to come out and say it [JUUL] was 99% safer than cigarettes ... and that ... would happen very soon.”
In addition, a “Letter from the CEO” that appeared on the JUUL website and was emailed to a parent in response to her complaint that the company sold JUUL products to her child stated that “[JUUL’s] simple and convenient system incorporates temperature regulation to heat nicotine liquid and deliver smokers the satisfaction that they want without the combustion and the harm associated with it.”
In a related press release, acting FDA Commissioner Ned Sharpless, MD, said that “regardless of where products like e-cigarettes fall on the continuum of tobacco product risk, the law is clear that, before marketing tobacco products for reduced risk, companies must demonstrate with scientific evidence that their specific product does in fact pose less risk or is less harmful. JUUL has ignored the law, and very concerningly, has made some of these statements in school to our nation’s youth.”
The FDA has requested a response from JUUL within 15 working days of the letter’s issue. Failure to comply with the Federal Food, Drug, and Cosmetic Act could result in the FDA’s initiating further actions such as civil money penalties, seizure, and/or injunction.
Can Vitamin D Prevent Acute Respiratory Infections?
Ms. M, a generally healthy 55-year-old woman, was diagnosed recently with severe vitamin D deficiency (serum 25-hydroxyvitamin D [25(OH)D] level of 8 ng/mL). She presents with her second episode of acute viral bronchitis in the past 6 months. She has no history of significant smoking or exposure or history of asthma and does not take respiratory medications. Standard treatment for her level of vitamin D deficiency is 50,000 IU/wk in bolus dosing—but is that your best option for the patient?
ARTIs include nonspecific upper respiratory illnesses, otitis media, sinusitis (~70% viral), pharyngitis, acute bronchitis (also ~70% viral), influenza, respiratory syncytial virus, and pneumonia.1,2 In the United States, ARTIs strain the health care system and are the most common reason for ambulatory care visits, accounting for almost 120 million (about 10% of all) visits per year.3 In addition, ARTIs account for almost 50% of antibiotic prescriptions for adults and almost 75% of antibiotic prescriptions for children—many of which are unnecessary.2,4
While patient and parent education, antibiotic stewardship programs, and demand management may reduce inappropriate antibiotic use and the overall burden of ARTIs on the health care system, prevention of infections is a powerful tool within the overall approach to managing ARTIs.
STUDY SUMMARY
Vitamin D is protective in smaller doses
This 2017 systematic review and meta-analysis of 25 trials (N = 10,933) evaluated vitamin D supplementation for the prevention of ARTIs in the primary care setting. Individual participant data were reevaluated to reduce risk for bias. The Cochrane risk-for-bias tool was used to address threats to validity.
The study included institutional review board–approved, randomized, double-blind, placebo-controlled trials of vitamin D3 or D2 supplementation of any duration and in any language. The incidence of ARTI was a prespecified efficacy outcome. Duration of the included randomized controlled trials (RCTs) ranged from 7 weeks to 1.5 years.
Outcomes. The primary outcome was an incidence of at least 1 ARTI. Secondary outcomes included incidence of upper and lower ARTIs; incidence of adverse reactions to vitamin D; incidence of emergency department visits or hospital admission or both for ARTI; use of antimicrobials for ARTI; absence from work or school due to ARTI; and mortality (ARTI-related and all-cause).
Findings. Daily or weekly vitamin D supplementation (in doses ranging from < 20 to ≥ 50 µg/d) reduced the risk for ARTI (adjusted odds ratio [AOR], 0.88; number needed to treat [NNT], 33). In subgroup analysis, daily or weekly vitamin D was protective (AOR, 0.81), but bolus dosing (≥ 30,000 IU) was not (AOR, 0.97).
In 2-step analysis, patients benefited if they had baseline circulating 25(OH)D concentrations < 10 ng/mL (AOR, 0.30; NNT, 4); had baseline circulating 25(OH)D levels of 10 to 28 ng/mL (AOR, 0.75; NNT, 15); were ages 1.1 to 15.9 (AOR, 0.59); were ages 16 to 65 (AOR, 0.79); or had a BMI < 25 (AOR, 0.82).
Higher D levels are a different story. Vitamin D supplementation in people with circulating levels of 25(OH)D ≥ 30 ng/mL did not appear to provide benefit (AOR, 0.96). Supplementation in this population did not influence any of the secondary outcomes, including risk for all-cause serious adverse events (AOR, 0.98).
WHAT’S NEW
A more accurate snapshot
Previous studies of vitamin D and respiratory tract infections were mostly observational in nature. Those that were RCTs used variable doses of vitamin D, had variable baseline 25(OH)D levels, and employed various methods to monitor ARTI symptoms/incidence.5-8 This is the first systematic review and meta-analysis of randomized, double-blind, placebo-controlled trials with supplementation using vitamin D3 or D2 that used individual participant-level data, which gives a more accurate estimate of outcomes when compared with traditional meta-analyses.
CAVEATS
Only the most deficient benefit?
Vitamin D supplementation was safe and protected against ARTIs overall, but the greatest effect was noted in those who were most severely vitamin D deficient (those with circulating 25(OH)D levels < 10 ng/mL [NNT, 4] and those with circulating 25(OH)D levels 10-28 ng/mL [NNT, 15]). There was no demonstrable effect once circulating 25(OH)D levels reached 30 ng/mL.
CHALLENGES TO IMPLEMENTATION
Breaking tradition
The study found that both daily and weekly doses of vitamin D were effective in reducing the incidence of ARTIs. However, the doses studied were much lower than those commonly used (10,000 to 50,000 IU bolus), which were ineffective in reducing ARTIs in this meta-analysis. Changing from bolus dosing may prove challenging, a
In addition, the authors of the study suggest that one way to provide this level of vitamin D is through food fortification. But this method is often complicated by emotional and/or political issues that could thwart implementation.
ACKNOWLEDGEMENT
The PURLs Surveillance System was supported in part by Grant Number UL1RR024999 from the National Center For Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center For Research Resources or the National Institutes of Health.
Copyright © 2019. The Family Physicians Inquiries Network. All rights reserved.
Reprinted with permission from the Family Physicians Inquiries Network and The Journal of Family Practice (2019;68[4]:230-231).
1. Martineau AR, Jolliffe DA, Hooper RL, et al. Vitamin D supplementation to prevent acute respiratory tract infections: systematic review and meta-analysis of individual participant data. BMJ. 2017;356:i6583.
2. Renati S, Linder JA. Necessity of office visits for acute respiratory infections in primary care. Fam Pract. 2016,33:312-317.
3. CDC National Center for Health Statistics. National Health Care Surveys. www.cdc.gov/nchs/dhcs.htm. Accessed September 5, 2019.
4. Grijalva CG, Nuorti JP, Griffin MR. Antibiotic prescription rates for acute respiratory tract infections in US ambulatory settings. JAMA. 2009;302:758-766.
5. Rees JR, Hendricks K, Barry EL, et al. Vitamin D3 supplementation and upper respiratory tract infections in a randomized, controlled trial. Clin Infect Dis. 2013;57:1384-1392.
6. Murdoch DR, Slow S, Chambers ST, et al. Effect of vitamin D3 supplementation on upper respiratory tract infections in healthy adults: the VIDARIS randomized controlled trial. JAMA. 2012;308:1333-1339.
7. Laaksi I, Ruohola J-P, Mattila V, et al. Vitamin D supplementation for the prevention of acute respiratory tract infection: a randomized, double-blinded trial among young Finnish men. Infect Dis. 2010;202:809-814.
8. Bergman P, Norlin A-C, Hansen S, et al. Vitamin D3 supplementation in patients with frequent respiratory tract infections: a randomised and double-blind intervention study. BMJ Open. 2012;2:e001663.
Ms. M, a generally healthy 55-year-old woman, was diagnosed recently with severe vitamin D deficiency (serum 25-hydroxyvitamin D [25(OH)D] level of 8 ng/mL). She presents with her second episode of acute viral bronchitis in the past 6 months. She has no history of significant smoking or exposure or history of asthma and does not take respiratory medications. Standard treatment for her level of vitamin D deficiency is 50,000 IU/wk in bolus dosing—but is that your best option for the patient?
ARTIs include nonspecific upper respiratory illnesses, otitis media, sinusitis (~70% viral), pharyngitis, acute bronchitis (also ~70% viral), influenza, respiratory syncytial virus, and pneumonia.1,2 In the United States, ARTIs strain the health care system and are the most common reason for ambulatory care visits, accounting for almost 120 million (about 10% of all) visits per year.3 In addition, ARTIs account for almost 50% of antibiotic prescriptions for adults and almost 75% of antibiotic prescriptions for children—many of which are unnecessary.2,4
While patient and parent education, antibiotic stewardship programs, and demand management may reduce inappropriate antibiotic use and the overall burden of ARTIs on the health care system, prevention of infections is a powerful tool within the overall approach to managing ARTIs.
STUDY SUMMARY
Vitamin D is protective in smaller doses
This 2017 systematic review and meta-analysis of 25 trials (N = 10,933) evaluated vitamin D supplementation for the prevention of ARTIs in the primary care setting. Individual participant data were reevaluated to reduce risk for bias. The Cochrane risk-for-bias tool was used to address threats to validity.
The study included institutional review board–approved, randomized, double-blind, placebo-controlled trials of vitamin D3 or D2 supplementation of any duration and in any language. The incidence of ARTI was a prespecified efficacy outcome. Duration of the included randomized controlled trials (RCTs) ranged from 7 weeks to 1.5 years.
Outcomes. The primary outcome was an incidence of at least 1 ARTI. Secondary outcomes included incidence of upper and lower ARTIs; incidence of adverse reactions to vitamin D; incidence of emergency department visits or hospital admission or both for ARTI; use of antimicrobials for ARTI; absence from work or school due to ARTI; and mortality (ARTI-related and all-cause).
Findings. Daily or weekly vitamin D supplementation (in doses ranging from < 20 to ≥ 50 µg/d) reduced the risk for ARTI (adjusted odds ratio [AOR], 0.88; number needed to treat [NNT], 33). In subgroup analysis, daily or weekly vitamin D was protective (AOR, 0.81), but bolus dosing (≥ 30,000 IU) was not (AOR, 0.97).
In 2-step analysis, patients benefited if they had baseline circulating 25(OH)D concentrations < 10 ng/mL (AOR, 0.30; NNT, 4); had baseline circulating 25(OH)D levels of 10 to 28 ng/mL (AOR, 0.75; NNT, 15); were ages 1.1 to 15.9 (AOR, 0.59); were ages 16 to 65 (AOR, 0.79); or had a BMI < 25 (AOR, 0.82).
Higher D levels are a different story. Vitamin D supplementation in people with circulating levels of 25(OH)D ≥ 30 ng/mL did not appear to provide benefit (AOR, 0.96). Supplementation in this population did not influence any of the secondary outcomes, including risk for all-cause serious adverse events (AOR, 0.98).
WHAT’S NEW
A more accurate snapshot
Previous studies of vitamin D and respiratory tract infections were mostly observational in nature. Those that were RCTs used variable doses of vitamin D, had variable baseline 25(OH)D levels, and employed various methods to monitor ARTI symptoms/incidence.5-8 This is the first systematic review and meta-analysis of randomized, double-blind, placebo-controlled trials with supplementation using vitamin D3 or D2 that used individual participant-level data, which gives a more accurate estimate of outcomes when compared with traditional meta-analyses.
CAVEATS
Only the most deficient benefit?
Vitamin D supplementation was safe and protected against ARTIs overall, but the greatest effect was noted in those who were most severely vitamin D deficient (those with circulating 25(OH)D levels < 10 ng/mL [NNT, 4] and those with circulating 25(OH)D levels 10-28 ng/mL [NNT, 15]). There was no demonstrable effect once circulating 25(OH)D levels reached 30 ng/mL.
CHALLENGES TO IMPLEMENTATION
Breaking tradition
The study found that both daily and weekly doses of vitamin D were effective in reducing the incidence of ARTIs. However, the doses studied were much lower than those commonly used (10,000 to 50,000 IU bolus), which were ineffective in reducing ARTIs in this meta-analysis. Changing from bolus dosing may prove challenging, a
In addition, the authors of the study suggest that one way to provide this level of vitamin D is through food fortification. But this method is often complicated by emotional and/or political issues that could thwart implementation.
ACKNOWLEDGEMENT
The PURLs Surveillance System was supported in part by Grant Number UL1RR024999 from the National Center For Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center For Research Resources or the National Institutes of Health.
Copyright © 2019. The Family Physicians Inquiries Network. All rights reserved.
Reprinted with permission from the Family Physicians Inquiries Network and The Journal of Family Practice (2019;68[4]:230-231).
Ms. M, a generally healthy 55-year-old woman, was diagnosed recently with severe vitamin D deficiency (serum 25-hydroxyvitamin D [25(OH)D] level of 8 ng/mL). She presents with her second episode of acute viral bronchitis in the past 6 months. She has no history of significant smoking or exposure or history of asthma and does not take respiratory medications. Standard treatment for her level of vitamin D deficiency is 50,000 IU/wk in bolus dosing—but is that your best option for the patient?
ARTIs include nonspecific upper respiratory illnesses, otitis media, sinusitis (~70% viral), pharyngitis, acute bronchitis (also ~70% viral), influenza, respiratory syncytial virus, and pneumonia.1,2 In the United States, ARTIs strain the health care system and are the most common reason for ambulatory care visits, accounting for almost 120 million (about 10% of all) visits per year.3 In addition, ARTIs account for almost 50% of antibiotic prescriptions for adults and almost 75% of antibiotic prescriptions for children—many of which are unnecessary.2,4
While patient and parent education, antibiotic stewardship programs, and demand management may reduce inappropriate antibiotic use and the overall burden of ARTIs on the health care system, prevention of infections is a powerful tool within the overall approach to managing ARTIs.
STUDY SUMMARY
Vitamin D is protective in smaller doses
This 2017 systematic review and meta-analysis of 25 trials (N = 10,933) evaluated vitamin D supplementation for the prevention of ARTIs in the primary care setting. Individual participant data were reevaluated to reduce risk for bias. The Cochrane risk-for-bias tool was used to address threats to validity.
The study included institutional review board–approved, randomized, double-blind, placebo-controlled trials of vitamin D3 or D2 supplementation of any duration and in any language. The incidence of ARTI was a prespecified efficacy outcome. Duration of the included randomized controlled trials (RCTs) ranged from 7 weeks to 1.5 years.
Outcomes. The primary outcome was an incidence of at least 1 ARTI. Secondary outcomes included incidence of upper and lower ARTIs; incidence of adverse reactions to vitamin D; incidence of emergency department visits or hospital admission or both for ARTI; use of antimicrobials for ARTI; absence from work or school due to ARTI; and mortality (ARTI-related and all-cause).
Findings. Daily or weekly vitamin D supplementation (in doses ranging from < 20 to ≥ 50 µg/d) reduced the risk for ARTI (adjusted odds ratio [AOR], 0.88; number needed to treat [NNT], 33). In subgroup analysis, daily or weekly vitamin D was protective (AOR, 0.81), but bolus dosing (≥ 30,000 IU) was not (AOR, 0.97).
In 2-step analysis, patients benefited if they had baseline circulating 25(OH)D concentrations < 10 ng/mL (AOR, 0.30; NNT, 4); had baseline circulating 25(OH)D levels of 10 to 28 ng/mL (AOR, 0.75; NNT, 15); were ages 1.1 to 15.9 (AOR, 0.59); were ages 16 to 65 (AOR, 0.79); or had a BMI < 25 (AOR, 0.82).
Higher D levels are a different story. Vitamin D supplementation in people with circulating levels of 25(OH)D ≥ 30 ng/mL did not appear to provide benefit (AOR, 0.96). Supplementation in this population did not influence any of the secondary outcomes, including risk for all-cause serious adverse events (AOR, 0.98).
WHAT’S NEW
A more accurate snapshot
Previous studies of vitamin D and respiratory tract infections were mostly observational in nature. Those that were RCTs used variable doses of vitamin D, had variable baseline 25(OH)D levels, and employed various methods to monitor ARTI symptoms/incidence.5-8 This is the first systematic review and meta-analysis of randomized, double-blind, placebo-controlled trials with supplementation using vitamin D3 or D2 that used individual participant-level data, which gives a more accurate estimate of outcomes when compared with traditional meta-analyses.
CAVEATS
Only the most deficient benefit?
Vitamin D supplementation was safe and protected against ARTIs overall, but the greatest effect was noted in those who were most severely vitamin D deficient (those with circulating 25(OH)D levels < 10 ng/mL [NNT, 4] and those with circulating 25(OH)D levels 10-28 ng/mL [NNT, 15]). There was no demonstrable effect once circulating 25(OH)D levels reached 30 ng/mL.
CHALLENGES TO IMPLEMENTATION
Breaking tradition
The study found that both daily and weekly doses of vitamin D were effective in reducing the incidence of ARTIs. However, the doses studied were much lower than those commonly used (10,000 to 50,000 IU bolus), which were ineffective in reducing ARTIs in this meta-analysis. Changing from bolus dosing may prove challenging, a
In addition, the authors of the study suggest that one way to provide this level of vitamin D is through food fortification. But this method is often complicated by emotional and/or political issues that could thwart implementation.
ACKNOWLEDGEMENT
The PURLs Surveillance System was supported in part by Grant Number UL1RR024999 from the National Center For Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center For Research Resources or the National Institutes of Health.
Copyright © 2019. The Family Physicians Inquiries Network. All rights reserved.
Reprinted with permission from the Family Physicians Inquiries Network and The Journal of Family Practice (2019;68[4]:230-231).
1. Martineau AR, Jolliffe DA, Hooper RL, et al. Vitamin D supplementation to prevent acute respiratory tract infections: systematic review and meta-analysis of individual participant data. BMJ. 2017;356:i6583.
2. Renati S, Linder JA. Necessity of office visits for acute respiratory infections in primary care. Fam Pract. 2016,33:312-317.
3. CDC National Center for Health Statistics. National Health Care Surveys. www.cdc.gov/nchs/dhcs.htm. Accessed September 5, 2019.
4. Grijalva CG, Nuorti JP, Griffin MR. Antibiotic prescription rates for acute respiratory tract infections in US ambulatory settings. JAMA. 2009;302:758-766.
5. Rees JR, Hendricks K, Barry EL, et al. Vitamin D3 supplementation and upper respiratory tract infections in a randomized, controlled trial. Clin Infect Dis. 2013;57:1384-1392.
6. Murdoch DR, Slow S, Chambers ST, et al. Effect of vitamin D3 supplementation on upper respiratory tract infections in healthy adults: the VIDARIS randomized controlled trial. JAMA. 2012;308:1333-1339.
7. Laaksi I, Ruohola J-P, Mattila V, et al. Vitamin D supplementation for the prevention of acute respiratory tract infection: a randomized, double-blinded trial among young Finnish men. Infect Dis. 2010;202:809-814.
8. Bergman P, Norlin A-C, Hansen S, et al. Vitamin D3 supplementation in patients with frequent respiratory tract infections: a randomised and double-blind intervention study. BMJ Open. 2012;2:e001663.
1. Martineau AR, Jolliffe DA, Hooper RL, et al. Vitamin D supplementation to prevent acute respiratory tract infections: systematic review and meta-analysis of individual participant data. BMJ. 2017;356:i6583.
2. Renati S, Linder JA. Necessity of office visits for acute respiratory infections in primary care. Fam Pract. 2016,33:312-317.
3. CDC National Center for Health Statistics. National Health Care Surveys. www.cdc.gov/nchs/dhcs.htm. Accessed September 5, 2019.
4. Grijalva CG, Nuorti JP, Griffin MR. Antibiotic prescription rates for acute respiratory tract infections in US ambulatory settings. JAMA. 2009;302:758-766.
5. Rees JR, Hendricks K, Barry EL, et al. Vitamin D3 supplementation and upper respiratory tract infections in a randomized, controlled trial. Clin Infect Dis. 2013;57:1384-1392.
6. Murdoch DR, Slow S, Chambers ST, et al. Effect of vitamin D3 supplementation on upper respiratory tract infections in healthy adults: the VIDARIS randomized controlled trial. JAMA. 2012;308:1333-1339.
7. Laaksi I, Ruohola J-P, Mattila V, et al. Vitamin D supplementation for the prevention of acute respiratory tract infection: a randomized, double-blinded trial among young Finnish men. Infect Dis. 2010;202:809-814.
8. Bergman P, Norlin A-C, Hansen S, et al. Vitamin D3 supplementation in patients with frequent respiratory tract infections: a randomised and double-blind intervention study. BMJ Open. 2012;2:e001663.
FDA approves nintedanib for scleroderma interstitial lung disease
The Food and Drug Administration has approved nintedanib (Ofev) for the rare but sometimes deadly form of interstitial lung disease that’s caused by systemic sclerosis, or scleroderma.
Although scleroderma itself is rare, half of those patients present with scleroderma-related interstitial lung disease (SSc-ILD), and it remains the leading cause of death in scleroderma patients because it can lead to loss of pulmonary function. Nintedanib appears to slow the progress of SSc-ILD and is the first treatment approved for it, according to a news release from the FDA.
The approval is based on a randomized, double-blind, placebo-controlled trial of 576 patients aged 20-79 years with SSc-ILD. The primary efficacy endpoint was forced vital capacity, and patients on nintedanib showed less decline than did those on placebo.
The most frequent serious adverse event reported in this trial was pneumonia (2.8% with nintedanib vs. 0.3% with placebo). Adverse reactions that led to permanent dose reductions occurred in 34% of nintedanib patients and 4% of placebo-treated patients; the most common of these was diarrhea.
The full prescribing information, which is available on the FDA website, includes warnings for patients with moderate to severe hepatic impairment, elevated liver enzymes, and drug-induced liver injury, as well as those with gastrointestinal disorders. Nintedanib may cause embryo-fetal toxicity, so women of childbearing age should be counseled to avoid pregnancy while taking this drug.
Nintedanib received both Priority Review and Orphan Drug designation. The former meant the FDA intends to take action on the application within 6 months because the agency has determined that, if approved, it would have important effects on treatment of a serious condition. The latter provides incentives to assist and encourage development of drugs for rare diseases. The drug was approved in 2014 for adult patients with idiopathic pulmonary fibrosis, another interstitial lung disease.
The full release is available on the FDA website.
The Food and Drug Administration has approved nintedanib (Ofev) for the rare but sometimes deadly form of interstitial lung disease that’s caused by systemic sclerosis, or scleroderma.
Although scleroderma itself is rare, half of those patients present with scleroderma-related interstitial lung disease (SSc-ILD), and it remains the leading cause of death in scleroderma patients because it can lead to loss of pulmonary function. Nintedanib appears to slow the progress of SSc-ILD and is the first treatment approved for it, according to a news release from the FDA.
The approval is based on a randomized, double-blind, placebo-controlled trial of 576 patients aged 20-79 years with SSc-ILD. The primary efficacy endpoint was forced vital capacity, and patients on nintedanib showed less decline than did those on placebo.
The most frequent serious adverse event reported in this trial was pneumonia (2.8% with nintedanib vs. 0.3% with placebo). Adverse reactions that led to permanent dose reductions occurred in 34% of nintedanib patients and 4% of placebo-treated patients; the most common of these was diarrhea.
The full prescribing information, which is available on the FDA website, includes warnings for patients with moderate to severe hepatic impairment, elevated liver enzymes, and drug-induced liver injury, as well as those with gastrointestinal disorders. Nintedanib may cause embryo-fetal toxicity, so women of childbearing age should be counseled to avoid pregnancy while taking this drug.
Nintedanib received both Priority Review and Orphan Drug designation. The former meant the FDA intends to take action on the application within 6 months because the agency has determined that, if approved, it would have important effects on treatment of a serious condition. The latter provides incentives to assist and encourage development of drugs for rare diseases. The drug was approved in 2014 for adult patients with idiopathic pulmonary fibrosis, another interstitial lung disease.
The full release is available on the FDA website.
The Food and Drug Administration has approved nintedanib (Ofev) for the rare but sometimes deadly form of interstitial lung disease that’s caused by systemic sclerosis, or scleroderma.
Although scleroderma itself is rare, half of those patients present with scleroderma-related interstitial lung disease (SSc-ILD), and it remains the leading cause of death in scleroderma patients because it can lead to loss of pulmonary function. Nintedanib appears to slow the progress of SSc-ILD and is the first treatment approved for it, according to a news release from the FDA.
The approval is based on a randomized, double-blind, placebo-controlled trial of 576 patients aged 20-79 years with SSc-ILD. The primary efficacy endpoint was forced vital capacity, and patients on nintedanib showed less decline than did those on placebo.
The most frequent serious adverse event reported in this trial was pneumonia (2.8% with nintedanib vs. 0.3% with placebo). Adverse reactions that led to permanent dose reductions occurred in 34% of nintedanib patients and 4% of placebo-treated patients; the most common of these was diarrhea.
The full prescribing information, which is available on the FDA website, includes warnings for patients with moderate to severe hepatic impairment, elevated liver enzymes, and drug-induced liver injury, as well as those with gastrointestinal disorders. Nintedanib may cause embryo-fetal toxicity, so women of childbearing age should be counseled to avoid pregnancy while taking this drug.
Nintedanib received both Priority Review and Orphan Drug designation. The former meant the FDA intends to take action on the application within 6 months because the agency has determined that, if approved, it would have important effects on treatment of a serious condition. The latter provides incentives to assist and encourage development of drugs for rare diseases. The drug was approved in 2014 for adult patients with idiopathic pulmonary fibrosis, another interstitial lung disease.
The full release is available on the FDA website.
Less CPAP time linked to exacerbation in COPD/OSA overlap syndrome
and all‐cause mortality, according to a retrospective cohort study.
“These factors should be taken into account when considering the management and prognosis of these patients,” the researchers said in the Clinical Respiratory Journal.
Prior studies have found that patients with COPD and OSA – that is, with overlap syndrome – “have a substantially greater risk of morbidity and mortality, compared to those with either COPD or OSA alone,” said Philippe E. Jaoude, MD, and Ali A. El Solh, MD, both of the Veterans Affairs Western New York Healthcare System in Buffalo and the University at Buffalo.
To identify factors associated with COPD exacerbation and all‐cause mortality in patients with overlap syndrome, Dr. Jaoude and Dr. El Solh reviewed the electronic health records of patients with simultaneous COPD and OSA. They compared patients with overlap syndrome who had an acute exacerbation of COPD during a 42-month period with a control group of patients with overlap syndrome who did not have exacerbations during that time. Patients with exacerbations and controls were matched 1:1 by age and body mass index.
Eligible patients were aged 42-90 years, had objectively confirmed COPD, and had documented OSA by in-laboratory polysomnography (that is, at least five obstructive apneas and hypopneas per hour). The investigators defined a COPD exacerbation as a sustained worsening of a patient’s respiratory condition that warranted additional treatment.
Of 225 eligible patients, 92 had at least one COPD exacerbation between March 2014 and September 2017. Patients with COPD exacerbation and controls had a mean age of about 68 years. The group of patients with exacerbation had a higher percentage of active smokers (21% vs. 9%) and had poorer lung function (mean forced expiratory volume in 1 second percent predicted: 55.2% vs. 64.5%).
“Although the rate of CPAP adherence between the two groups was not significantly different, the average time of CPAP use was significantly higher in patients with no recorded exacerbation,” the researchers reported – 285.4 min/night versus 238.2 min/night.
In all, 146 patients (79.4%) survived, and 38 patients (20.6%) died during the study period. The crude mortality rate was significantly higher in the group with COPD exacerbations (14% vs. 7%).
“Multivariate logistic regression analysis identified the independent risk factors associated with COPD exacerbations as active smoking, worse airflow limitation, and lower CPAP utilization,” they said. “As for all-cause mortality, a higher burden of comorbidities, worse airflow limitation, and lower time of CPAP use were independently associated with poor outcome.”
The researchers noted that they cannot rule out the possibility that patients who were adherent to CPAP were systematically different from those who were not.
The authors had no conflicts of interest.
SOURCE: Jaoude P et al. Clin Respir J. 2019 Aug 22. doi: 10.1111/crj.13079.
and all‐cause mortality, according to a retrospective cohort study.
“These factors should be taken into account when considering the management and prognosis of these patients,” the researchers said in the Clinical Respiratory Journal.
Prior studies have found that patients with COPD and OSA – that is, with overlap syndrome – “have a substantially greater risk of morbidity and mortality, compared to those with either COPD or OSA alone,” said Philippe E. Jaoude, MD, and Ali A. El Solh, MD, both of the Veterans Affairs Western New York Healthcare System in Buffalo and the University at Buffalo.
To identify factors associated with COPD exacerbation and all‐cause mortality in patients with overlap syndrome, Dr. Jaoude and Dr. El Solh reviewed the electronic health records of patients with simultaneous COPD and OSA. They compared patients with overlap syndrome who had an acute exacerbation of COPD during a 42-month period with a control group of patients with overlap syndrome who did not have exacerbations during that time. Patients with exacerbations and controls were matched 1:1 by age and body mass index.
Eligible patients were aged 42-90 years, had objectively confirmed COPD, and had documented OSA by in-laboratory polysomnography (that is, at least five obstructive apneas and hypopneas per hour). The investigators defined a COPD exacerbation as a sustained worsening of a patient’s respiratory condition that warranted additional treatment.
Of 225 eligible patients, 92 had at least one COPD exacerbation between March 2014 and September 2017. Patients with COPD exacerbation and controls had a mean age of about 68 years. The group of patients with exacerbation had a higher percentage of active smokers (21% vs. 9%) and had poorer lung function (mean forced expiratory volume in 1 second percent predicted: 55.2% vs. 64.5%).
“Although the rate of CPAP adherence between the two groups was not significantly different, the average time of CPAP use was significantly higher in patients with no recorded exacerbation,” the researchers reported – 285.4 min/night versus 238.2 min/night.
In all, 146 patients (79.4%) survived, and 38 patients (20.6%) died during the study period. The crude mortality rate was significantly higher in the group with COPD exacerbations (14% vs. 7%).
“Multivariate logistic regression analysis identified the independent risk factors associated with COPD exacerbations as active smoking, worse airflow limitation, and lower CPAP utilization,” they said. “As for all-cause mortality, a higher burden of comorbidities, worse airflow limitation, and lower time of CPAP use were independently associated with poor outcome.”
The researchers noted that they cannot rule out the possibility that patients who were adherent to CPAP were systematically different from those who were not.
The authors had no conflicts of interest.
SOURCE: Jaoude P et al. Clin Respir J. 2019 Aug 22. doi: 10.1111/crj.13079.
and all‐cause mortality, according to a retrospective cohort study.
“These factors should be taken into account when considering the management and prognosis of these patients,” the researchers said in the Clinical Respiratory Journal.
Prior studies have found that patients with COPD and OSA – that is, with overlap syndrome – “have a substantially greater risk of morbidity and mortality, compared to those with either COPD or OSA alone,” said Philippe E. Jaoude, MD, and Ali A. El Solh, MD, both of the Veterans Affairs Western New York Healthcare System in Buffalo and the University at Buffalo.
To identify factors associated with COPD exacerbation and all‐cause mortality in patients with overlap syndrome, Dr. Jaoude and Dr. El Solh reviewed the electronic health records of patients with simultaneous COPD and OSA. They compared patients with overlap syndrome who had an acute exacerbation of COPD during a 42-month period with a control group of patients with overlap syndrome who did not have exacerbations during that time. Patients with exacerbations and controls were matched 1:1 by age and body mass index.
Eligible patients were aged 42-90 years, had objectively confirmed COPD, and had documented OSA by in-laboratory polysomnography (that is, at least five obstructive apneas and hypopneas per hour). The investigators defined a COPD exacerbation as a sustained worsening of a patient’s respiratory condition that warranted additional treatment.
Of 225 eligible patients, 92 had at least one COPD exacerbation between March 2014 and September 2017. Patients with COPD exacerbation and controls had a mean age of about 68 years. The group of patients with exacerbation had a higher percentage of active smokers (21% vs. 9%) and had poorer lung function (mean forced expiratory volume in 1 second percent predicted: 55.2% vs. 64.5%).
“Although the rate of CPAP adherence between the two groups was not significantly different, the average time of CPAP use was significantly higher in patients with no recorded exacerbation,” the researchers reported – 285.4 min/night versus 238.2 min/night.
In all, 146 patients (79.4%) survived, and 38 patients (20.6%) died during the study period. The crude mortality rate was significantly higher in the group with COPD exacerbations (14% vs. 7%).
“Multivariate logistic regression analysis identified the independent risk factors associated with COPD exacerbations as active smoking, worse airflow limitation, and lower CPAP utilization,” they said. “As for all-cause mortality, a higher burden of comorbidities, worse airflow limitation, and lower time of CPAP use were independently associated with poor outcome.”
The researchers noted that they cannot rule out the possibility that patients who were adherent to CPAP were systematically different from those who were not.
The authors had no conflicts of interest.
SOURCE: Jaoude P et al. Clin Respir J. 2019 Aug 22. doi: 10.1111/crj.13079.
FROM CLINICAL RESPIRATORY JOURNAL
Guideline: Blood CO2 can be used to screen for OHS
A blood test for elevated carbon dioxide may be used in screening adults for obesity hypoventilation syndrome, according to new guidelines.
Obese adults with sleep-disordered breathing and increased blood carbon dioxide levels during the day are likely to have obesity hypoventilation syndrome (OHS), a result of shallow or slow breathing that can lead to respiratory failure, heart failure, pulmonary hypertension, and death. Pulmonologists and sleep specialists may be the first to see and diagnose patients with OHS in the outpatient setting, while other cases are diagnosed in the hospital when patients present with hypercapnic respiratory failure.
Screening for OHS usually involves measuring arterial blood gases, which is not standard practice in outpatient clinics. Patients often remain undiagnosed and untreated until late in the course of the disease, according to the American Thoracic Society, which in August published a new diagnosis and management guideline aiming to boost early diagnosis and reduce variability in treatment (Am J Respir Crit Care Med. 2019;200:3,e6–e24).
The guideline authors, led by Babak Mokhlesi, MD, of the University of Chicago, recommend a simpler screening method – measuring serum bicarbonate only – to rule out OHS in obese patients with nighttime breathing problems.
Serum bicarbonate should be measured in obese patients with sleep-disordered breathing and a low likelihood of OHS, Dr. Mokhlesi and colleagues recommend in the guideline. If serum bicarbonate is below 27 mmol/L, it is not necessary to conduct further testing as the patient is unlikely to have OHS.
In patients whose serum bicarbonate is higher than 27 mmol/L, or who are strongly suspected of having OHS at presentation because of severe obesity or other symptoms, arterial blood gases should be measured and a sleep study conducted. The guideline authors said that there is insufficient evidence to recommend that pulse oximetry be used in the diagnostic pathway for OHS.
First-line treatment for stable, ambulatory patients with OHS should be positive airway pressure during sleep, rather than noninvasive ventilation, Dr. Mokhlesi and colleagues concluded. For patients with comorbid obstructive sleep apnea – as many as 70% of OHS patients also have OSA – the first-line treatment should be continuous positive airway pressure (CPAP) at night, the guideline states.
Patients hospitalized with respiratory failure and suspected of having OHS should be discharged with noninvasive ventilation until diagnostic procedures can be performed, along with PAP titration in a sleep lab.
In patients initially treated with CPAP who remain symptomatic or whose blood carbon dioxide does not improve, noninvasive ventilation can be tried, the guidelines say. Finally, patients diagnosed with OHS should be guided to weight loss interventions with the aim of reducing body weight by 25%-30%. This can include referral for bariatric surgery in patients without contraindications.
Dr. Mokhlesi and colleagues acknowledged that all of the recommendations contained in the guideline are classed as “conditional,” based on the quality of evidence assessed.
The American Thoracic Society funded the study. Dr. Mokhlesi and 7 coauthors disclosed financial conflicts of interest, while an additional 13 coauthors had none. Disclosures can be found on the AJRCCM website.
SOURCE: Mokhlesi B et al. Am J Respir Crit Care Med. 2019;200:3,e6-e24
A blood test for elevated carbon dioxide may be used in screening adults for obesity hypoventilation syndrome, according to new guidelines.
Obese adults with sleep-disordered breathing and increased blood carbon dioxide levels during the day are likely to have obesity hypoventilation syndrome (OHS), a result of shallow or slow breathing that can lead to respiratory failure, heart failure, pulmonary hypertension, and death. Pulmonologists and sleep specialists may be the first to see and diagnose patients with OHS in the outpatient setting, while other cases are diagnosed in the hospital when patients present with hypercapnic respiratory failure.
Screening for OHS usually involves measuring arterial blood gases, which is not standard practice in outpatient clinics. Patients often remain undiagnosed and untreated until late in the course of the disease, according to the American Thoracic Society, which in August published a new diagnosis and management guideline aiming to boost early diagnosis and reduce variability in treatment (Am J Respir Crit Care Med. 2019;200:3,e6–e24).
The guideline authors, led by Babak Mokhlesi, MD, of the University of Chicago, recommend a simpler screening method – measuring serum bicarbonate only – to rule out OHS in obese patients with nighttime breathing problems.
Serum bicarbonate should be measured in obese patients with sleep-disordered breathing and a low likelihood of OHS, Dr. Mokhlesi and colleagues recommend in the guideline. If serum bicarbonate is below 27 mmol/L, it is not necessary to conduct further testing as the patient is unlikely to have OHS.
In patients whose serum bicarbonate is higher than 27 mmol/L, or who are strongly suspected of having OHS at presentation because of severe obesity or other symptoms, arterial blood gases should be measured and a sleep study conducted. The guideline authors said that there is insufficient evidence to recommend that pulse oximetry be used in the diagnostic pathway for OHS.
First-line treatment for stable, ambulatory patients with OHS should be positive airway pressure during sleep, rather than noninvasive ventilation, Dr. Mokhlesi and colleagues concluded. For patients with comorbid obstructive sleep apnea – as many as 70% of OHS patients also have OSA – the first-line treatment should be continuous positive airway pressure (CPAP) at night, the guideline states.
Patients hospitalized with respiratory failure and suspected of having OHS should be discharged with noninvasive ventilation until diagnostic procedures can be performed, along with PAP titration in a sleep lab.
In patients initially treated with CPAP who remain symptomatic or whose blood carbon dioxide does not improve, noninvasive ventilation can be tried, the guidelines say. Finally, patients diagnosed with OHS should be guided to weight loss interventions with the aim of reducing body weight by 25%-30%. This can include referral for bariatric surgery in patients without contraindications.
Dr. Mokhlesi and colleagues acknowledged that all of the recommendations contained in the guideline are classed as “conditional,” based on the quality of evidence assessed.
The American Thoracic Society funded the study. Dr. Mokhlesi and 7 coauthors disclosed financial conflicts of interest, while an additional 13 coauthors had none. Disclosures can be found on the AJRCCM website.
SOURCE: Mokhlesi B et al. Am J Respir Crit Care Med. 2019;200:3,e6-e24
A blood test for elevated carbon dioxide may be used in screening adults for obesity hypoventilation syndrome, according to new guidelines.
Obese adults with sleep-disordered breathing and increased blood carbon dioxide levels during the day are likely to have obesity hypoventilation syndrome (OHS), a result of shallow or slow breathing that can lead to respiratory failure, heart failure, pulmonary hypertension, and death. Pulmonologists and sleep specialists may be the first to see and diagnose patients with OHS in the outpatient setting, while other cases are diagnosed in the hospital when patients present with hypercapnic respiratory failure.
Screening for OHS usually involves measuring arterial blood gases, which is not standard practice in outpatient clinics. Patients often remain undiagnosed and untreated until late in the course of the disease, according to the American Thoracic Society, which in August published a new diagnosis and management guideline aiming to boost early diagnosis and reduce variability in treatment (Am J Respir Crit Care Med. 2019;200:3,e6–e24).
The guideline authors, led by Babak Mokhlesi, MD, of the University of Chicago, recommend a simpler screening method – measuring serum bicarbonate only – to rule out OHS in obese patients with nighttime breathing problems.
Serum bicarbonate should be measured in obese patients with sleep-disordered breathing and a low likelihood of OHS, Dr. Mokhlesi and colleagues recommend in the guideline. If serum bicarbonate is below 27 mmol/L, it is not necessary to conduct further testing as the patient is unlikely to have OHS.
In patients whose serum bicarbonate is higher than 27 mmol/L, or who are strongly suspected of having OHS at presentation because of severe obesity or other symptoms, arterial blood gases should be measured and a sleep study conducted. The guideline authors said that there is insufficient evidence to recommend that pulse oximetry be used in the diagnostic pathway for OHS.
First-line treatment for stable, ambulatory patients with OHS should be positive airway pressure during sleep, rather than noninvasive ventilation, Dr. Mokhlesi and colleagues concluded. For patients with comorbid obstructive sleep apnea – as many as 70% of OHS patients also have OSA – the first-line treatment should be continuous positive airway pressure (CPAP) at night, the guideline states.
Patients hospitalized with respiratory failure and suspected of having OHS should be discharged with noninvasive ventilation until diagnostic procedures can be performed, along with PAP titration in a sleep lab.
In patients initially treated with CPAP who remain symptomatic or whose blood carbon dioxide does not improve, noninvasive ventilation can be tried, the guidelines say. Finally, patients diagnosed with OHS should be guided to weight loss interventions with the aim of reducing body weight by 25%-30%. This can include referral for bariatric surgery in patients without contraindications.
Dr. Mokhlesi and colleagues acknowledged that all of the recommendations contained in the guideline are classed as “conditional,” based on the quality of evidence assessed.
The American Thoracic Society funded the study. Dr. Mokhlesi and 7 coauthors disclosed financial conflicts of interest, while an additional 13 coauthors had none. Disclosures can be found on the AJRCCM website.
SOURCE: Mokhlesi B et al. Am J Respir Crit Care Med. 2019;200:3,e6-e24
FROM THE AMERICAN JOURNAL OF RESPIRATORY AND CRITICAL CARE MEDICINE
Vape lung disease cases exceed 400, 3 dead
Vitamin E acetate is one possible culprit in the mysterious vaping-associated lung disease that has killed three patients, sickened 450, and baffled clinicians and investigators all summer.
Another death may be linked to the disorder, officials said during a joint press briefing held by the Centers for Disease Control and Prevention and the Food and Drug Administration. In all, 450 potential cases have been reported and e-cigarette use confirmed in 215. Cases have occurred in 33 states and one territory. A total of 84% of the patients reported having used tetrahydrocannabinol (THC) products in e-cigarette devices.
A preliminary report on the situation by Jennifer Layden, MD, of the department of public health in Illinois and colleagues – including a preliminary case definition – was simultaneously released in the New England Journal of Medicine (2019 Sep 6. doi: 10.1056/NEJMoa1911614).
No single device or substance was common to all the cases, leading officials to issue a blanket warning against e-cigarettes, especially those containing THC.
“We believe a chemical exposure is likely related, but more information is needed to determine what substances. Some labs have identified vitamin E acetate in some samples,” said Dana Meaney-Delman, MD, MPH, incident manager, CDC 2019 Lung Injury Response. “Continued investigation is needed to identify the risk associated with a specific product or substance.”
Besides vitamin E acetate, federal labs are looking at other cannabinoids, cutting agents, diluting agents, pesticides, opioids, and toxins.
Officials also issued a general warning about the products. Youths, young people, and pregnant women should never use e-cigarettes, they cautioned, and no one should buy them from a noncertified source, a street vendor, or a social contact. Even cartridges originally obtained from a certified source should never have been altered in any way.
Dr. Layden and colleagues reported that bilateral lung infiltrates was characterized in 98% of the 53 patients hospitalized with the recently reported e-cigarette–induced lung injury. Nonspecific constitutional symptoms, including fever, chills, weight loss, and fatigue, were present in all of the patients.
Patients may show some symptoms days or even weeks before acute respiratory failure develops, and many had sought medical help before that. All presented with bilateral lung infiltrates, part of an evolving case definition. Many complained of nonspecific constitutional symptoms, including fever, chills, gastrointestinal symptoms, and weight loss. Of the patients who underwent bronchoscopy, many were diagnosed as having lipoid pneumonia, a rare condition characterized by lipid-laden macrophages.
“We don’t know the significance of the lipid-containing macrophages, and we don’t know if the lipids are endogenous or exogenous,” Dr. Meaney-Delman said.
The incidence of such cases appears to be rising rapidly, Dr. Layden noted. An epidemiologic review of cases in Illinois found that the mean monthly rate of visits related to severe respiratory illness in June-August was twice that observed during the same months last year.
SOURCE: Layden JE et al. N Engl J Med. 2019 Sep 6. doi: 1 0.1056/NEJMoa1911614.
Vitamin E acetate is one possible culprit in the mysterious vaping-associated lung disease that has killed three patients, sickened 450, and baffled clinicians and investigators all summer.
Another death may be linked to the disorder, officials said during a joint press briefing held by the Centers for Disease Control and Prevention and the Food and Drug Administration. In all, 450 potential cases have been reported and e-cigarette use confirmed in 215. Cases have occurred in 33 states and one territory. A total of 84% of the patients reported having used tetrahydrocannabinol (THC) products in e-cigarette devices.
A preliminary report on the situation by Jennifer Layden, MD, of the department of public health in Illinois and colleagues – including a preliminary case definition – was simultaneously released in the New England Journal of Medicine (2019 Sep 6. doi: 10.1056/NEJMoa1911614).
No single device or substance was common to all the cases, leading officials to issue a blanket warning against e-cigarettes, especially those containing THC.
“We believe a chemical exposure is likely related, but more information is needed to determine what substances. Some labs have identified vitamin E acetate in some samples,” said Dana Meaney-Delman, MD, MPH, incident manager, CDC 2019 Lung Injury Response. “Continued investigation is needed to identify the risk associated with a specific product or substance.”
Besides vitamin E acetate, federal labs are looking at other cannabinoids, cutting agents, diluting agents, pesticides, opioids, and toxins.
Officials also issued a general warning about the products. Youths, young people, and pregnant women should never use e-cigarettes, they cautioned, and no one should buy them from a noncertified source, a street vendor, or a social contact. Even cartridges originally obtained from a certified source should never have been altered in any way.
Dr. Layden and colleagues reported that bilateral lung infiltrates was characterized in 98% of the 53 patients hospitalized with the recently reported e-cigarette–induced lung injury. Nonspecific constitutional symptoms, including fever, chills, weight loss, and fatigue, were present in all of the patients.
Patients may show some symptoms days or even weeks before acute respiratory failure develops, and many had sought medical help before that. All presented with bilateral lung infiltrates, part of an evolving case definition. Many complained of nonspecific constitutional symptoms, including fever, chills, gastrointestinal symptoms, and weight loss. Of the patients who underwent bronchoscopy, many were diagnosed as having lipoid pneumonia, a rare condition characterized by lipid-laden macrophages.
“We don’t know the significance of the lipid-containing macrophages, and we don’t know if the lipids are endogenous or exogenous,” Dr. Meaney-Delman said.
The incidence of such cases appears to be rising rapidly, Dr. Layden noted. An epidemiologic review of cases in Illinois found that the mean monthly rate of visits related to severe respiratory illness in June-August was twice that observed during the same months last year.
SOURCE: Layden JE et al. N Engl J Med. 2019 Sep 6. doi: 1 0.1056/NEJMoa1911614.
Vitamin E acetate is one possible culprit in the mysterious vaping-associated lung disease that has killed three patients, sickened 450, and baffled clinicians and investigators all summer.
Another death may be linked to the disorder, officials said during a joint press briefing held by the Centers for Disease Control and Prevention and the Food and Drug Administration. In all, 450 potential cases have been reported and e-cigarette use confirmed in 215. Cases have occurred in 33 states and one territory. A total of 84% of the patients reported having used tetrahydrocannabinol (THC) products in e-cigarette devices.
A preliminary report on the situation by Jennifer Layden, MD, of the department of public health in Illinois and colleagues – including a preliminary case definition – was simultaneously released in the New England Journal of Medicine (2019 Sep 6. doi: 10.1056/NEJMoa1911614).
No single device or substance was common to all the cases, leading officials to issue a blanket warning against e-cigarettes, especially those containing THC.
“We believe a chemical exposure is likely related, but more information is needed to determine what substances. Some labs have identified vitamin E acetate in some samples,” said Dana Meaney-Delman, MD, MPH, incident manager, CDC 2019 Lung Injury Response. “Continued investigation is needed to identify the risk associated with a specific product or substance.”
Besides vitamin E acetate, federal labs are looking at other cannabinoids, cutting agents, diluting agents, pesticides, opioids, and toxins.
Officials also issued a general warning about the products. Youths, young people, and pregnant women should never use e-cigarettes, they cautioned, and no one should buy them from a noncertified source, a street vendor, or a social contact. Even cartridges originally obtained from a certified source should never have been altered in any way.
Dr. Layden and colleagues reported that bilateral lung infiltrates was characterized in 98% of the 53 patients hospitalized with the recently reported e-cigarette–induced lung injury. Nonspecific constitutional symptoms, including fever, chills, weight loss, and fatigue, were present in all of the patients.
Patients may show some symptoms days or even weeks before acute respiratory failure develops, and many had sought medical help before that. All presented with bilateral lung infiltrates, part of an evolving case definition. Many complained of nonspecific constitutional symptoms, including fever, chills, gastrointestinal symptoms, and weight loss. Of the patients who underwent bronchoscopy, many were diagnosed as having lipoid pneumonia, a rare condition characterized by lipid-laden macrophages.
“We don’t know the significance of the lipid-containing macrophages, and we don’t know if the lipids are endogenous or exogenous,” Dr. Meaney-Delman said.
The incidence of such cases appears to be rising rapidly, Dr. Layden noted. An epidemiologic review of cases in Illinois found that the mean monthly rate of visits related to severe respiratory illness in June-August was twice that observed during the same months last year.
SOURCE: Layden JE et al. N Engl J Med. 2019 Sep 6. doi: 1 0.1056/NEJMoa1911614.
FROM A CDC TELECONFERENCE AND NEJM
Michigan becomes first state to ban flavored e-cigarettes
The state health agency is expected to issue rules outlining the ban within the next 30 days. The emergency ban will be in effect for 6 months, with the possibility of a 6-month extension while state health regulators craft rules to set in place a permanent ban.
The ban will also prohibit “misleading marketing of vaping products, including the use of terms like ‘clean,’ ‘safe,’ and ‘healthy,’ that perpetuate beliefs that these products are harmless,” according to a statement issued by Gov. Whitmer.
Companies selling vaping products “are using candy flavors to hook children on nicotine and misleading claims to promote the belief that these products are safe,” she said in a statement. “That ends today. Our kids deserve leaders who are going to fight to protect them. These bold steps will finally put an end to these irresponsible and deceptive practices and protect Michiganders’ public health.”
The ban also will cover mint- and menthol-flavors in addition to sweet flavors but will not ban tobacco-flavored e-cigarette products.
The American Academy of Pediatrics, American Heart Association, American Lung Association, American Cancer Society Cancer Action Network and other organizations praised the action taken by the state, calling the steps “necessary and appropriate.”
“The need for action is even more urgent in light of the recent outbreak of severe lung illness associated with e-cigarette use and the failure of the U.S. Food and Drug Administration to take strong regulatory action such as prohibiting the sale of the flavored products nationwide that have attracted shocking numbers of our nation’s youth,” the organizations said in a statement.
The groups noted that “health authorities are investigating reports of severe respiratory illness associated with e-cigarette use in at least 215 people ... in 25 states,” adding that many are youth and young adults.
The U.S. Department of Health & Human Services Secretary Alex Azar said in an Aug. 30 statement that the federal government is “using every tool we have to get to the bottom of this deeply concerning outbreak of illness in Americans who use e-cigarettes. More broadly, we will continue using every regulatory and enforcement power we have to stop the epidemic of youth e-cigarette use.”
HHS noted that no single substance or e-cigarette product has been consistently associated with the reports of illness. The agency called upon clinicians to report any new cases as appropriate to their state and local health departments.
Gov. Whitmer earlier this year signed bills that clarify that it is illegal to sell nontraditional nicotine products to minors, but the governor’s statement notes her criticism that the bills did not go far enough to protect the state’s youth, necessitating this further action.
The state health agency is expected to issue rules outlining the ban within the next 30 days. The emergency ban will be in effect for 6 months, with the possibility of a 6-month extension while state health regulators craft rules to set in place a permanent ban.
The ban will also prohibit “misleading marketing of vaping products, including the use of terms like ‘clean,’ ‘safe,’ and ‘healthy,’ that perpetuate beliefs that these products are harmless,” according to a statement issued by Gov. Whitmer.
Companies selling vaping products “are using candy flavors to hook children on nicotine and misleading claims to promote the belief that these products are safe,” she said in a statement. “That ends today. Our kids deserve leaders who are going to fight to protect them. These bold steps will finally put an end to these irresponsible and deceptive practices and protect Michiganders’ public health.”
The ban also will cover mint- and menthol-flavors in addition to sweet flavors but will not ban tobacco-flavored e-cigarette products.
The American Academy of Pediatrics, American Heart Association, American Lung Association, American Cancer Society Cancer Action Network and other organizations praised the action taken by the state, calling the steps “necessary and appropriate.”
“The need for action is even more urgent in light of the recent outbreak of severe lung illness associated with e-cigarette use and the failure of the U.S. Food and Drug Administration to take strong regulatory action such as prohibiting the sale of the flavored products nationwide that have attracted shocking numbers of our nation’s youth,” the organizations said in a statement.
The groups noted that “health authorities are investigating reports of severe respiratory illness associated with e-cigarette use in at least 215 people ... in 25 states,” adding that many are youth and young adults.
The U.S. Department of Health & Human Services Secretary Alex Azar said in an Aug. 30 statement that the federal government is “using every tool we have to get to the bottom of this deeply concerning outbreak of illness in Americans who use e-cigarettes. More broadly, we will continue using every regulatory and enforcement power we have to stop the epidemic of youth e-cigarette use.”
HHS noted that no single substance or e-cigarette product has been consistently associated with the reports of illness. The agency called upon clinicians to report any new cases as appropriate to their state and local health departments.
Gov. Whitmer earlier this year signed bills that clarify that it is illegal to sell nontraditional nicotine products to minors, but the governor’s statement notes her criticism that the bills did not go far enough to protect the state’s youth, necessitating this further action.
The state health agency is expected to issue rules outlining the ban within the next 30 days. The emergency ban will be in effect for 6 months, with the possibility of a 6-month extension while state health regulators craft rules to set in place a permanent ban.
The ban will also prohibit “misleading marketing of vaping products, including the use of terms like ‘clean,’ ‘safe,’ and ‘healthy,’ that perpetuate beliefs that these products are harmless,” according to a statement issued by Gov. Whitmer.
Companies selling vaping products “are using candy flavors to hook children on nicotine and misleading claims to promote the belief that these products are safe,” she said in a statement. “That ends today. Our kids deserve leaders who are going to fight to protect them. These bold steps will finally put an end to these irresponsible and deceptive practices and protect Michiganders’ public health.”
The ban also will cover mint- and menthol-flavors in addition to sweet flavors but will not ban tobacco-flavored e-cigarette products.
The American Academy of Pediatrics, American Heart Association, American Lung Association, American Cancer Society Cancer Action Network and other organizations praised the action taken by the state, calling the steps “necessary and appropriate.”
“The need for action is even more urgent in light of the recent outbreak of severe lung illness associated with e-cigarette use and the failure of the U.S. Food and Drug Administration to take strong regulatory action such as prohibiting the sale of the flavored products nationwide that have attracted shocking numbers of our nation’s youth,” the organizations said in a statement.
The groups noted that “health authorities are investigating reports of severe respiratory illness associated with e-cigarette use in at least 215 people ... in 25 states,” adding that many are youth and young adults.
The U.S. Department of Health & Human Services Secretary Alex Azar said in an Aug. 30 statement that the federal government is “using every tool we have to get to the bottom of this deeply concerning outbreak of illness in Americans who use e-cigarettes. More broadly, we will continue using every regulatory and enforcement power we have to stop the epidemic of youth e-cigarette use.”
HHS noted that no single substance or e-cigarette product has been consistently associated with the reports of illness. The agency called upon clinicians to report any new cases as appropriate to their state and local health departments.
Gov. Whitmer earlier this year signed bills that clarify that it is illegal to sell nontraditional nicotine products to minors, but the governor’s statement notes her criticism that the bills did not go far enough to protect the state’s youth, necessitating this further action.
Telehealth Pulmonary Rehabilitation for Patients With Severe Chronic Obstructive Pulmonary Disease
According to World Health Organization estimates, 65 million people have moderate-to-severe chronic obstructive pulmonary disease (COPD) globally, and > 20 million patients with COPD are living in the US.1 COPD is a progressive respiratory disease with a poor prognosis and a significant cause of morbidity and mortality in the US, especially within the Veterans Health Administration (VHA).2 The prevalence of COPD is higher in veterans than it is in the general population. COPD prevalence in the adult US population has been estimated to be between 5% and 15%, whereas in veterans, prevalence estimates have ranged from about 5% to 43%.3-5
COPD is associated with disabling dyspnea, muscle weakness, exercise intolerance, morbidity, and mortality. These symptoms and complications gradually and progressively compromise mobility, ability to perform daily functions, and decrease quality of life (QOL). Dyspnea, fatigue, and discomfort are the principal symptoms that negatively impact exercise tolerance.6,7 Therefore, patients often intentionally limit their activities to avoid these uncomfortable feelings and adopt a more sedentary behavior. As the disease progresses, individuals with COPD will gradually need assistance in performing activities of daily living, which eventually leads to functional dependence.
Pulmonary rehabilitation (PR) is an essential component of the management of symptomatic patients with COPD. PR is an evidence-based, multidisciplinary, comprehensive intervention that includes exercise and education for patients with chronic respiratory disease.8 The key benefits of PR are clinical improvements in dyspnea, physical capacity, QOL, and reduced disability in patients with COPD and other respiratory diseases.9-11 PR was found to improve respiratory health in veterans with COPD and decrease respiratory-related health care utilization.12
Despite the known benefits of PR, many patients with chronic respiratory diseases are not referred or do not have access to rehabilitation. Also, uptake of PR is low due to patient frailty, transportation issues, and other health care access problems.13-15 Unfortunately, in the US health care system, access to PR and other nonpharmacologic treatments can be challenging due to a shortage of available PR programs, limited physician referral to existing programs, and lack of family and social support.16
There are only a few accredited PR programs in VHA facilities, and they tend to be located in urban areas.12,17 Many patients have limited access to the PR programs due to geographic distance to the programs and transportation challenges (eg, limited ability to drive, cost of transportation). Moreover, veterans with COPD are likely to have limited mobility or are homebound due to experiencing shortness of breath with minimal exertion. Given the clear benefits of PR and the increasing impact of COPD on morbidity and mortality of the patients with COPD, strategies to improve the access and capacity of PR are needed. VA telehealth services allow for distribution of health care services in different geographic locations by providing access for the veterans who live in rural and highly rural areas. The most recent implementation of VA Video Connect (VVC) by the VHA provides a new avenue for clinicians to deliver much needed medical care into the veterans’ home.
COPD Telehealth Program
In this article, we describe the processes for developing and delivering an in-home, interactive, supervised PR program for veterans with severe COPD through VA telehealth service. The program consists of 18 sessions delivered over 6 weeks by a licensed physical therapist (PT) and a respiratory therapist (RT). The aims of the telehealth PR are to improve exercise tolerance, reduce dyspnea and fatigue, improve QOL, improve accessibility, and decrease costs and transportation burdens for patients with COPD. The program was developed, implemented and delivered by an interdisciplinary team, including a pulmonologist, PT, RT, physiatrist, and nonclinical supporting staff.
Patient Assessment
To be eligible to participate in the program the patient must: (1) have a forced expiratory volume (FEV1) < 60%; ( 2) be medically stable and be receiving optimal medical management; (3) have no severe cognitive impairments; (4) be able to use a computer and e-mail; (5) be able to ambulate with or without a walking device; (6) be willing to enroll in a smoking cessation program or to stop smoking; (7) be willing to participate without prolonged interruption; and (8) have all visual and auditory impairments corrected with medical devices.
After referral and enrollment, patients receive medical and physical examinations by the PR team, including a pulmonologist, a PT, and a RT, to ensure that the patients are medically stable to undergo rehabilitation and to develop a tailored exercise program while being mindful of the comorbidities, limitations, and precautions, (eg, loss of balance, risk of fall, limited range of motion). The preprogram assessment includes a pulmonary function test, arterial blood gas test, Montreal Cognitive Assessment, Modified Medical Research Council Scale, St. George Respiratory Questionnaire, the COPD Assessment Test, Patient Health Questionnaire-9,Generalized Anxiety Disorder Assessment-7, Epworth Sleepiness Scale, Katz Index of Independence of Activities of Daily Living, medications and inhaler use, oxygen use, breathing pattern, coughing, 6-minute walk test, Modified Borg Dyspnea Scale, grip strength, 5 Times Sit to Stand Test, manual muscle test, gait measure, Timed Up & Go test, clinical balance tests, range of motion, flexibility, sensation, pain, and fall history.18-32 Educational needs (eg, respiratory hygiene, nutrition, infection control, sleep, disease/symptom management) also are evaluated.
This thorough assessment is performed in a face-to-face outpatient visit. During the program participation, a physiatrist may be consulted for additional needs (eg, wheelchair assessment, home safety evaluation/ modifications, and mobility/disability issues). After completing the 6-week program, patients are scheduled for the postprogram evaluation in a face-to-face outpatient visit with the clinicians.
Equipment
Both clinician and the patient are equipped with a computer with Wi-Fi connectivity, a webcam, and a microphone. Patients are provided an exercise pictorial booklet, an exercise compact disk (audio and video), small exercise apparatuses (eg, assorted colors of resistance bands, hand grip exerciser, hand putty, ergometer, harmonica, and pedometer), incentive spirometer, pulse oximeter, cough assistive device (as needed), blood pressure monitor, COPD information booklets, and a diary to use at home during the program.33
Technology Preparation
Prior to starting the telehealth program, the patient is contacted 1 or 2 days before the first session for technical preparation and familiarization of the VA telehealth connection process. Either the PT or RT provides step-by-step instructions for the patient to practice connecting through VVC during this preparatory phone call. The patient also practices using the computer webcam, speaker, and microphone; checks the telehealth scheduling e-mail; and learns how to solve possible common technical issues (eg, adjusting volume and position of webcam). The patient is asked to set up a table close to the computer and to place all exercise apparatuses and respiratory devices on the table surface.
Program Delivery
A secure online VVC is used for connection during the telehealth session. The patient received an e-mail from the telehealth scheduling system with a link for VVC before each session. During the 6-week program, each telehealth session is conducted by a PT and a RT concurrently for 120 minutes, 3 days per week. The PT provides exercises for the patient to attempt, and the RT provides breathing training and monitoring during the session. After a successful connection to VVC, the therapist verifies the patient’s identity and confirms patient consent for the telehealth session.
After this check-in process, the patient performs a self-measure of resting blood pressure (BP), heart rate, respiratory rate, and blood oxygen saturation and reports to the therapists. During the exercise session, fatigue/exertion, dyspnea (Modified Borg Dyspnea Scale; Borg CR10 Scale), BP, heart rate, oxygen saturation, and other clinical symptoms and responses to exercise are monitored by the therapists, using both patient-reported measures and clinical observation by the therapists.34,35 Any medical emergency during the session is reported immediately to the pulmonologist for further management.
Structure
Prior to each exercise session, exercise precautions, fall prevention, good posture, pursed-lip breathing, pacing, and coordinated breathing are discussed with the patient. The PT demonstrates stretching and warm-up exercises in front of the webcam for the patient to follow. Then the patient performs all exercises in view of the webcam during the session (Figure 1). A RT monitors breathing patterns and corrects with verbal instructions if not properly performed.
Loss of skeletal muscle mass and cachexia are highly prevalent comorbidities of COPD and have been associated with breathlessness, functional limitation, and poor prognosis.36 To address these comorbidities, our program consists of progressive strengthening, aerobic, balance, and flexibility exercises. Resistance bands and tubes are used for strengthening exercises. Callisthenic exercises (eg, chair squat, chair stand, knee marching, bridging, single limb stances, and lunge) are used for progressive strengthening and balance exercises. Progression of strengthening and balance exercises are done through increasing the volume of exercise (ie, numbers of sets and repetitions) and increased load and level of difficulty based on the patient’s progress and comorbidity. The exercise program focuses on strengthening muscles, especially large muscle groups, to improve overall muscle strength and performance of functional activities.37
Arm/pedal ergometer and daily walking are used for daily aerobic exercise. In a study of patients with COPD by the PAC-COPD Study Group, step counter use was found to increase physical activity and improve exercise capacity, which supports its use in COPD management.38 During program participation, the patient is asked to wear a pedometer to monitor the number of steps taken per day and to report step data to the therapists during the telehealth session. The pedometer stores the previous 41 calendar days of data and displays the most recent 7 calendar days of data.
The patient is encouraged to set a realistic daily step goal. The general program goal is to increase at least 1000 steps per day. However, this goal can be adjusted depending on the patient’s health status and comorbid conditions. The PAC-COPD Study Group found that for every additional 1000 daily steps at low intensity, COPD hospitalization risk decreased by 20%.39 A magnitude of 2000 steps or about 1 mile of walking per day was found to be associated with increased physical activity and health benefits in the general population.40
Respiratory muscle training and breathing exercise are provided by the RT, using breathing and incentive spirometer techniques (Figure 2). Huff coughing, diaphragmatic deep breathing, and pursed-lip breathing are instructed by the RT during the session. Effective coughing technique with a cough assistive device is also provided during breathing training if needed.
Patient Education
In patients with COPD, there are numerous positive health benefits associated with education, including assisting the patients to become active participants in the PR program leading to satisfying outcomes; assisting the patients to better understand the lung health, disease processes, physical and psychological changes that occur with COPD; assisting the patients to explore coping strategies for those changes; building lifelong behavioral changes; and developing the self-management skills for sustainability. Through the educational process, patients with COPD can become more skilled at collaborative self-management and improve adherence to their treatment plan, which in turn can result in a reduction in hospital admissions and reduced health care costs.8,41
Education is provided with every session after the patient completes the exercise. Patients are required to record their COPD symptoms, daily activity, home exercise program, sleep, food intake, and additional physical or social activity in their COPD diary and to report during the session (Figure 3). A COPD diary assists patients in self-monitoring their COPD symptoms and provides the therapists with information about clinical changes, behavioral changes, and/or specific unmet needs for education. Several topics related to COPD are included in the education session: lung or respiratory disease/condition and self-management; smoking cessation; physical activity; energy-conserving techniques; breathing and coughing techniques; smoking cessation; nutrition/healthy eating and weight counseling; sex and intimacy; psychological counseling and/or group support; emergency planning (eg, medical, travel, and inclement weather); correct use of inhaler and medications; home oxygen; sleep and sleep hygiene; palliative care and advanced directive; infection control; and sputum clearance.42,43
Program Maintenance
After successfully completing the 6-week program, patients are referred to the VA TeleMOVE! Program or MOVE! Weight Management Program for continuous, long-term management of weight, nutrition, physical activity/exercise, and social activity needs or goals. The patients are scheduled for monthly follow-up phone visits for 6 months with the telerehabilitation team for enforcing sustainability. The phone call visit consists of reviewing breathing techniques, exercise program, physical activity, education, encouragement, and addressing any issues that arise during the self-maintained period.
Limitations
There are several issues of concern and precautions when delivering PR through telehealth into the home. First, the patient performs exercises independently without being manually guarded by the therapists. Risk of falls are a major concern due to impaired balance, poor vision, and other possible unusual physiologic responses to exercise (eg, drop in BP, dizziness, loss of balance). The area in front of the computer needs to be cleared of fall hazards (ie, area rug, wires, objects on the floor). The patient also needs to be educated on self-measurements of BP and oxygen saturation and reports to the therapists. The therapists provide detailed instructions on how to obtain these measures correctly; otherwise, the values may not be valid for a clinical judgment during the exercise session or for other clinical management. In a home environment, there is a limited use of exercise apparatuses. For this program, we only used resistance bands/tubes, small arm/leg ergometer, hand grip, and hand putty for the exercise program. We feel that dumbbell and weight plates are not suitable due to a possible risk of injury if the patient accidently drops them.
Advanced balance training is not suitable due to an increased risk for falls. Without the presence of the PT, level of challenge/difficulty is somewhat limited for this telehealth supervision exercise program. In addition, visual and audio quality are necessary for the session. The patient and the therapists need to see each other clearly to ensure correct methods and forms of each exercise. Furthermore, rehearsal of technical skills with the therapists is very important because this population is older and often has limited computer skills. Any technical difficulty or failure can lead to undesirable situations (eg, anxiety episodes, worries, shortness of breath, upset), which compromise exercise performance during the session. Finally, a phone is needed as an alternative in case of a poor VVC connection.
Conclusion
COPD symptoms and complications greatly affect patients’ ability to perform daily activities, decrease QOL and functional ability, and result in extensive use of health services. Many patients have limited access to a PR program at hospitals or rehabilitation centers due to health conditions, lack of transportation, and/or family support. This home-based, interactive telehealth PR program can break down the geographic barriers, solve poor program accessibility, potentially increase the utilization of PR, and reduce the cost and travel required by the patients.
Acknowledgments
The Telehealth Pulmonary Rehabilitation Program was originally funded by the Veterans Health Administration VA ACCESS Program (AS, CL, HKH). We thank all the veterans for their time and effort in participating in this newly developed rehabilitation program.
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3. Doney B, Hnizdo E, Dillon CF, et al. Prevalence of airflow obstruction in U.S. adults aged 40-79 years: NHANES data 1988-1994 and 2007-2010. COPD. 2015;12(4):355-365.
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17. American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR). Online searchable program directory. https://www.aacvpr.org/Resources/Program-Directory Accessed July 19, 2018.
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24. Spitzer RL, Kroenke K, Williams JBW, Löwe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006;166(10):1092-1097.
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27. Holland AE, Spruit MA, Troosters T, et al. An official European Respiratory Society/American Thoracic Society technical standard: field walking tests in chronic respiratory disease. Eur Respir J. 2014;44(6):1428-1446.
28. Mahler DA, Horowitz MB. Perception of breathlessness during exercise in patients with respiratory disease. Med Sci Sports Exerc. 1994;26(9):1078-1081.
29. Liao WC, Wang CH, Yu SY, Chen LY, Wang CY. Grip strength measurement in older adults in Taiwan: a comparison of three testing positions. Australas J Ageing. 2014;33(4):278-282.
30. Buatois S, Miljkovic D, Manckoundia P, et al. Five times sit to stand test is a predictor of recurrent falls in healthy community-living subjects aged 65 and older. J Am Geriatr Soc. 2008;56(8):1575-1577.
31. Bryant MS, Workman CD, Jackson GR. Multidirectional walk test in persons with Parkinson’s disease: a validity study. Int J Rehabil Res. 2015;38(1):88-91.
32. Podsiadlo D, Richardson S. The timed “Up & Go”: a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991;39(2):142-148.
33. University of Nebraska Medical Center. Timed Up and Go (TUG) Test. https://www.unmc.edu/media/intmed/geriatrics/nebgec/pdf/frailelderlyjuly09/toolkits/timedupandgo_w_norms.pdf. Accessed August 13, 2019.
34. Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-381.
35. Mahler DA, Horowitz MB. Clinical evaluation of exertional dyspnea. Clin Chest Med. 1994;15(2):259-269.
36. Dudgeon D, Baracos VE. Physiological and functional failure in chronic obstructive pulmonary disease, congestive heart failure and cancer: a debilitating intersection of sarcopenia, cachexia and breathlessness. Curr Opin Support Palliat Care. 2016;10(3):236-241.
37. Lee AL, Holland AE. Time to adapt exercise training regimens in pulmonary rehabilitation—a review of the literature. Int J Chron Obstruct Pulmon Dis. 2014;9:1275-1288.
38. Qiu S, Cai X, Wang X, et al. Using step counters to promote physical activity and exercise capacity in patients with chronic obstructive pulmonary disease: a meta-analysis. Ther Adv Respir Dis. 2018;12:1753466618787386.
39. Donaire-Gonzalez D, Gimeno-Santos E, Balcells E, et al; PAC-COPD Study Group. Benefits of physical activity on COPD hospitalization depend on intensity. Eur Respir J. 2015;46(5):1281-1289.
40. Bravata DM, Smith-Spangler C, Sundaram V, et al. Using pedometers to increase physical activity and improve health: a systematic review. JAMA. 2007;298(19):2296-2304.
41. Zwerink M, Brusse-Keizer M, van der Valk PD, et al. Self-management for patients with chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2014;19(3):CD002990.
42. Wilson JS, O’Neill B, Reilly J, MacMahon J, Bradley JM. Education in pulmonary rehabilitation: the patient’s perspective. Arch Phys Med Rehabil. 2007;88(12):1704-1709.
43. Bourbeau J, Nault D, Dang-Tan T. Self-management and behaviour modification in COPD. Patient Educ Couns. 2004;52(3):271-277.
According to World Health Organization estimates, 65 million people have moderate-to-severe chronic obstructive pulmonary disease (COPD) globally, and > 20 million patients with COPD are living in the US.1 COPD is a progressive respiratory disease with a poor prognosis and a significant cause of morbidity and mortality in the US, especially within the Veterans Health Administration (VHA).2 The prevalence of COPD is higher in veterans than it is in the general population. COPD prevalence in the adult US population has been estimated to be between 5% and 15%, whereas in veterans, prevalence estimates have ranged from about 5% to 43%.3-5
COPD is associated with disabling dyspnea, muscle weakness, exercise intolerance, morbidity, and mortality. These symptoms and complications gradually and progressively compromise mobility, ability to perform daily functions, and decrease quality of life (QOL). Dyspnea, fatigue, and discomfort are the principal symptoms that negatively impact exercise tolerance.6,7 Therefore, patients often intentionally limit their activities to avoid these uncomfortable feelings and adopt a more sedentary behavior. As the disease progresses, individuals with COPD will gradually need assistance in performing activities of daily living, which eventually leads to functional dependence.
Pulmonary rehabilitation (PR) is an essential component of the management of symptomatic patients with COPD. PR is an evidence-based, multidisciplinary, comprehensive intervention that includes exercise and education for patients with chronic respiratory disease.8 The key benefits of PR are clinical improvements in dyspnea, physical capacity, QOL, and reduced disability in patients with COPD and other respiratory diseases.9-11 PR was found to improve respiratory health in veterans with COPD and decrease respiratory-related health care utilization.12
Despite the known benefits of PR, many patients with chronic respiratory diseases are not referred or do not have access to rehabilitation. Also, uptake of PR is low due to patient frailty, transportation issues, and other health care access problems.13-15 Unfortunately, in the US health care system, access to PR and other nonpharmacologic treatments can be challenging due to a shortage of available PR programs, limited physician referral to existing programs, and lack of family and social support.16
There are only a few accredited PR programs in VHA facilities, and they tend to be located in urban areas.12,17 Many patients have limited access to the PR programs due to geographic distance to the programs and transportation challenges (eg, limited ability to drive, cost of transportation). Moreover, veterans with COPD are likely to have limited mobility or are homebound due to experiencing shortness of breath with minimal exertion. Given the clear benefits of PR and the increasing impact of COPD on morbidity and mortality of the patients with COPD, strategies to improve the access and capacity of PR are needed. VA telehealth services allow for distribution of health care services in different geographic locations by providing access for the veterans who live in rural and highly rural areas. The most recent implementation of VA Video Connect (VVC) by the VHA provides a new avenue for clinicians to deliver much needed medical care into the veterans’ home.
COPD Telehealth Program
In this article, we describe the processes for developing and delivering an in-home, interactive, supervised PR program for veterans with severe COPD through VA telehealth service. The program consists of 18 sessions delivered over 6 weeks by a licensed physical therapist (PT) and a respiratory therapist (RT). The aims of the telehealth PR are to improve exercise tolerance, reduce dyspnea and fatigue, improve QOL, improve accessibility, and decrease costs and transportation burdens for patients with COPD. The program was developed, implemented and delivered by an interdisciplinary team, including a pulmonologist, PT, RT, physiatrist, and nonclinical supporting staff.
Patient Assessment
To be eligible to participate in the program the patient must: (1) have a forced expiratory volume (FEV1) < 60%; ( 2) be medically stable and be receiving optimal medical management; (3) have no severe cognitive impairments; (4) be able to use a computer and e-mail; (5) be able to ambulate with or without a walking device; (6) be willing to enroll in a smoking cessation program or to stop smoking; (7) be willing to participate without prolonged interruption; and (8) have all visual and auditory impairments corrected with medical devices.
After referral and enrollment, patients receive medical and physical examinations by the PR team, including a pulmonologist, a PT, and a RT, to ensure that the patients are medically stable to undergo rehabilitation and to develop a tailored exercise program while being mindful of the comorbidities, limitations, and precautions, (eg, loss of balance, risk of fall, limited range of motion). The preprogram assessment includes a pulmonary function test, arterial blood gas test, Montreal Cognitive Assessment, Modified Medical Research Council Scale, St. George Respiratory Questionnaire, the COPD Assessment Test, Patient Health Questionnaire-9,Generalized Anxiety Disorder Assessment-7, Epworth Sleepiness Scale, Katz Index of Independence of Activities of Daily Living, medications and inhaler use, oxygen use, breathing pattern, coughing, 6-minute walk test, Modified Borg Dyspnea Scale, grip strength, 5 Times Sit to Stand Test, manual muscle test, gait measure, Timed Up & Go test, clinical balance tests, range of motion, flexibility, sensation, pain, and fall history.18-32 Educational needs (eg, respiratory hygiene, nutrition, infection control, sleep, disease/symptom management) also are evaluated.
This thorough assessment is performed in a face-to-face outpatient visit. During the program participation, a physiatrist may be consulted for additional needs (eg, wheelchair assessment, home safety evaluation/ modifications, and mobility/disability issues). After completing the 6-week program, patients are scheduled for the postprogram evaluation in a face-to-face outpatient visit with the clinicians.
Equipment
Both clinician and the patient are equipped with a computer with Wi-Fi connectivity, a webcam, and a microphone. Patients are provided an exercise pictorial booklet, an exercise compact disk (audio and video), small exercise apparatuses (eg, assorted colors of resistance bands, hand grip exerciser, hand putty, ergometer, harmonica, and pedometer), incentive spirometer, pulse oximeter, cough assistive device (as needed), blood pressure monitor, COPD information booklets, and a diary to use at home during the program.33
Technology Preparation
Prior to starting the telehealth program, the patient is contacted 1 or 2 days before the first session for technical preparation and familiarization of the VA telehealth connection process. Either the PT or RT provides step-by-step instructions for the patient to practice connecting through VVC during this preparatory phone call. The patient also practices using the computer webcam, speaker, and microphone; checks the telehealth scheduling e-mail; and learns how to solve possible common technical issues (eg, adjusting volume and position of webcam). The patient is asked to set up a table close to the computer and to place all exercise apparatuses and respiratory devices on the table surface.
Program Delivery
A secure online VVC is used for connection during the telehealth session. The patient received an e-mail from the telehealth scheduling system with a link for VVC before each session. During the 6-week program, each telehealth session is conducted by a PT and a RT concurrently for 120 minutes, 3 days per week. The PT provides exercises for the patient to attempt, and the RT provides breathing training and monitoring during the session. After a successful connection to VVC, the therapist verifies the patient’s identity and confirms patient consent for the telehealth session.
After this check-in process, the patient performs a self-measure of resting blood pressure (BP), heart rate, respiratory rate, and blood oxygen saturation and reports to the therapists. During the exercise session, fatigue/exertion, dyspnea (Modified Borg Dyspnea Scale; Borg CR10 Scale), BP, heart rate, oxygen saturation, and other clinical symptoms and responses to exercise are monitored by the therapists, using both patient-reported measures and clinical observation by the therapists.34,35 Any medical emergency during the session is reported immediately to the pulmonologist for further management.
Structure
Prior to each exercise session, exercise precautions, fall prevention, good posture, pursed-lip breathing, pacing, and coordinated breathing are discussed with the patient. The PT demonstrates stretching and warm-up exercises in front of the webcam for the patient to follow. Then the patient performs all exercises in view of the webcam during the session (Figure 1). A RT monitors breathing patterns and corrects with verbal instructions if not properly performed.
Loss of skeletal muscle mass and cachexia are highly prevalent comorbidities of COPD and have been associated with breathlessness, functional limitation, and poor prognosis.36 To address these comorbidities, our program consists of progressive strengthening, aerobic, balance, and flexibility exercises. Resistance bands and tubes are used for strengthening exercises. Callisthenic exercises (eg, chair squat, chair stand, knee marching, bridging, single limb stances, and lunge) are used for progressive strengthening and balance exercises. Progression of strengthening and balance exercises are done through increasing the volume of exercise (ie, numbers of sets and repetitions) and increased load and level of difficulty based on the patient’s progress and comorbidity. The exercise program focuses on strengthening muscles, especially large muscle groups, to improve overall muscle strength and performance of functional activities.37
Arm/pedal ergometer and daily walking are used for daily aerobic exercise. In a study of patients with COPD by the PAC-COPD Study Group, step counter use was found to increase physical activity and improve exercise capacity, which supports its use in COPD management.38 During program participation, the patient is asked to wear a pedometer to monitor the number of steps taken per day and to report step data to the therapists during the telehealth session. The pedometer stores the previous 41 calendar days of data and displays the most recent 7 calendar days of data.
The patient is encouraged to set a realistic daily step goal. The general program goal is to increase at least 1000 steps per day. However, this goal can be adjusted depending on the patient’s health status and comorbid conditions. The PAC-COPD Study Group found that for every additional 1000 daily steps at low intensity, COPD hospitalization risk decreased by 20%.39 A magnitude of 2000 steps or about 1 mile of walking per day was found to be associated with increased physical activity and health benefits in the general population.40
Respiratory muscle training and breathing exercise are provided by the RT, using breathing and incentive spirometer techniques (Figure 2). Huff coughing, diaphragmatic deep breathing, and pursed-lip breathing are instructed by the RT during the session. Effective coughing technique with a cough assistive device is also provided during breathing training if needed.
Patient Education
In patients with COPD, there are numerous positive health benefits associated with education, including assisting the patients to become active participants in the PR program leading to satisfying outcomes; assisting the patients to better understand the lung health, disease processes, physical and psychological changes that occur with COPD; assisting the patients to explore coping strategies for those changes; building lifelong behavioral changes; and developing the self-management skills for sustainability. Through the educational process, patients with COPD can become more skilled at collaborative self-management and improve adherence to their treatment plan, which in turn can result in a reduction in hospital admissions and reduced health care costs.8,41
Education is provided with every session after the patient completes the exercise. Patients are required to record their COPD symptoms, daily activity, home exercise program, sleep, food intake, and additional physical or social activity in their COPD diary and to report during the session (Figure 3). A COPD diary assists patients in self-monitoring their COPD symptoms and provides the therapists with information about clinical changes, behavioral changes, and/or specific unmet needs for education. Several topics related to COPD are included in the education session: lung or respiratory disease/condition and self-management; smoking cessation; physical activity; energy-conserving techniques; breathing and coughing techniques; smoking cessation; nutrition/healthy eating and weight counseling; sex and intimacy; psychological counseling and/or group support; emergency planning (eg, medical, travel, and inclement weather); correct use of inhaler and medications; home oxygen; sleep and sleep hygiene; palliative care and advanced directive; infection control; and sputum clearance.42,43
Program Maintenance
After successfully completing the 6-week program, patients are referred to the VA TeleMOVE! Program or MOVE! Weight Management Program for continuous, long-term management of weight, nutrition, physical activity/exercise, and social activity needs or goals. The patients are scheduled for monthly follow-up phone visits for 6 months with the telerehabilitation team for enforcing sustainability. The phone call visit consists of reviewing breathing techniques, exercise program, physical activity, education, encouragement, and addressing any issues that arise during the self-maintained period.
Limitations
There are several issues of concern and precautions when delivering PR through telehealth into the home. First, the patient performs exercises independently without being manually guarded by the therapists. Risk of falls are a major concern due to impaired balance, poor vision, and other possible unusual physiologic responses to exercise (eg, drop in BP, dizziness, loss of balance). The area in front of the computer needs to be cleared of fall hazards (ie, area rug, wires, objects on the floor). The patient also needs to be educated on self-measurements of BP and oxygen saturation and reports to the therapists. The therapists provide detailed instructions on how to obtain these measures correctly; otherwise, the values may not be valid for a clinical judgment during the exercise session or for other clinical management. In a home environment, there is a limited use of exercise apparatuses. For this program, we only used resistance bands/tubes, small arm/leg ergometer, hand grip, and hand putty for the exercise program. We feel that dumbbell and weight plates are not suitable due to a possible risk of injury if the patient accidently drops them.
Advanced balance training is not suitable due to an increased risk for falls. Without the presence of the PT, level of challenge/difficulty is somewhat limited for this telehealth supervision exercise program. In addition, visual and audio quality are necessary for the session. The patient and the therapists need to see each other clearly to ensure correct methods and forms of each exercise. Furthermore, rehearsal of technical skills with the therapists is very important because this population is older and often has limited computer skills. Any technical difficulty or failure can lead to undesirable situations (eg, anxiety episodes, worries, shortness of breath, upset), which compromise exercise performance during the session. Finally, a phone is needed as an alternative in case of a poor VVC connection.
Conclusion
COPD symptoms and complications greatly affect patients’ ability to perform daily activities, decrease QOL and functional ability, and result in extensive use of health services. Many patients have limited access to a PR program at hospitals or rehabilitation centers due to health conditions, lack of transportation, and/or family support. This home-based, interactive telehealth PR program can break down the geographic barriers, solve poor program accessibility, potentially increase the utilization of PR, and reduce the cost and travel required by the patients.
Acknowledgments
The Telehealth Pulmonary Rehabilitation Program was originally funded by the Veterans Health Administration VA ACCESS Program (AS, CL, HKH). We thank all the veterans for their time and effort in participating in this newly developed rehabilitation program.
According to World Health Organization estimates, 65 million people have moderate-to-severe chronic obstructive pulmonary disease (COPD) globally, and > 20 million patients with COPD are living in the US.1 COPD is a progressive respiratory disease with a poor prognosis and a significant cause of morbidity and mortality in the US, especially within the Veterans Health Administration (VHA).2 The prevalence of COPD is higher in veterans than it is in the general population. COPD prevalence in the adult US population has been estimated to be between 5% and 15%, whereas in veterans, prevalence estimates have ranged from about 5% to 43%.3-5
COPD is associated with disabling dyspnea, muscle weakness, exercise intolerance, morbidity, and mortality. These symptoms and complications gradually and progressively compromise mobility, ability to perform daily functions, and decrease quality of life (QOL). Dyspnea, fatigue, and discomfort are the principal symptoms that negatively impact exercise tolerance.6,7 Therefore, patients often intentionally limit their activities to avoid these uncomfortable feelings and adopt a more sedentary behavior. As the disease progresses, individuals with COPD will gradually need assistance in performing activities of daily living, which eventually leads to functional dependence.
Pulmonary rehabilitation (PR) is an essential component of the management of symptomatic patients with COPD. PR is an evidence-based, multidisciplinary, comprehensive intervention that includes exercise and education for patients with chronic respiratory disease.8 The key benefits of PR are clinical improvements in dyspnea, physical capacity, QOL, and reduced disability in patients with COPD and other respiratory diseases.9-11 PR was found to improve respiratory health in veterans with COPD and decrease respiratory-related health care utilization.12
Despite the known benefits of PR, many patients with chronic respiratory diseases are not referred or do not have access to rehabilitation. Also, uptake of PR is low due to patient frailty, transportation issues, and other health care access problems.13-15 Unfortunately, in the US health care system, access to PR and other nonpharmacologic treatments can be challenging due to a shortage of available PR programs, limited physician referral to existing programs, and lack of family and social support.16
There are only a few accredited PR programs in VHA facilities, and they tend to be located in urban areas.12,17 Many patients have limited access to the PR programs due to geographic distance to the programs and transportation challenges (eg, limited ability to drive, cost of transportation). Moreover, veterans with COPD are likely to have limited mobility or are homebound due to experiencing shortness of breath with minimal exertion. Given the clear benefits of PR and the increasing impact of COPD on morbidity and mortality of the patients with COPD, strategies to improve the access and capacity of PR are needed. VA telehealth services allow for distribution of health care services in different geographic locations by providing access for the veterans who live in rural and highly rural areas. The most recent implementation of VA Video Connect (VVC) by the VHA provides a new avenue for clinicians to deliver much needed medical care into the veterans’ home.
COPD Telehealth Program
In this article, we describe the processes for developing and delivering an in-home, interactive, supervised PR program for veterans with severe COPD through VA telehealth service. The program consists of 18 sessions delivered over 6 weeks by a licensed physical therapist (PT) and a respiratory therapist (RT). The aims of the telehealth PR are to improve exercise tolerance, reduce dyspnea and fatigue, improve QOL, improve accessibility, and decrease costs and transportation burdens for patients with COPD. The program was developed, implemented and delivered by an interdisciplinary team, including a pulmonologist, PT, RT, physiatrist, and nonclinical supporting staff.
Patient Assessment
To be eligible to participate in the program the patient must: (1) have a forced expiratory volume (FEV1) < 60%; ( 2) be medically stable and be receiving optimal medical management; (3) have no severe cognitive impairments; (4) be able to use a computer and e-mail; (5) be able to ambulate with or without a walking device; (6) be willing to enroll in a smoking cessation program or to stop smoking; (7) be willing to participate without prolonged interruption; and (8) have all visual and auditory impairments corrected with medical devices.
After referral and enrollment, patients receive medical and physical examinations by the PR team, including a pulmonologist, a PT, and a RT, to ensure that the patients are medically stable to undergo rehabilitation and to develop a tailored exercise program while being mindful of the comorbidities, limitations, and precautions, (eg, loss of balance, risk of fall, limited range of motion). The preprogram assessment includes a pulmonary function test, arterial blood gas test, Montreal Cognitive Assessment, Modified Medical Research Council Scale, St. George Respiratory Questionnaire, the COPD Assessment Test, Patient Health Questionnaire-9,Generalized Anxiety Disorder Assessment-7, Epworth Sleepiness Scale, Katz Index of Independence of Activities of Daily Living, medications and inhaler use, oxygen use, breathing pattern, coughing, 6-minute walk test, Modified Borg Dyspnea Scale, grip strength, 5 Times Sit to Stand Test, manual muscle test, gait measure, Timed Up & Go test, clinical balance tests, range of motion, flexibility, sensation, pain, and fall history.18-32 Educational needs (eg, respiratory hygiene, nutrition, infection control, sleep, disease/symptom management) also are evaluated.
This thorough assessment is performed in a face-to-face outpatient visit. During the program participation, a physiatrist may be consulted for additional needs (eg, wheelchair assessment, home safety evaluation/ modifications, and mobility/disability issues). After completing the 6-week program, patients are scheduled for the postprogram evaluation in a face-to-face outpatient visit with the clinicians.
Equipment
Both clinician and the patient are equipped with a computer with Wi-Fi connectivity, a webcam, and a microphone. Patients are provided an exercise pictorial booklet, an exercise compact disk (audio and video), small exercise apparatuses (eg, assorted colors of resistance bands, hand grip exerciser, hand putty, ergometer, harmonica, and pedometer), incentive spirometer, pulse oximeter, cough assistive device (as needed), blood pressure monitor, COPD information booklets, and a diary to use at home during the program.33
Technology Preparation
Prior to starting the telehealth program, the patient is contacted 1 or 2 days before the first session for technical preparation and familiarization of the VA telehealth connection process. Either the PT or RT provides step-by-step instructions for the patient to practice connecting through VVC during this preparatory phone call. The patient also practices using the computer webcam, speaker, and microphone; checks the telehealth scheduling e-mail; and learns how to solve possible common technical issues (eg, adjusting volume and position of webcam). The patient is asked to set up a table close to the computer and to place all exercise apparatuses and respiratory devices on the table surface.
Program Delivery
A secure online VVC is used for connection during the telehealth session. The patient received an e-mail from the telehealth scheduling system with a link for VVC before each session. During the 6-week program, each telehealth session is conducted by a PT and a RT concurrently for 120 minutes, 3 days per week. The PT provides exercises for the patient to attempt, and the RT provides breathing training and monitoring during the session. After a successful connection to VVC, the therapist verifies the patient’s identity and confirms patient consent for the telehealth session.
After this check-in process, the patient performs a self-measure of resting blood pressure (BP), heart rate, respiratory rate, and blood oxygen saturation and reports to the therapists. During the exercise session, fatigue/exertion, dyspnea (Modified Borg Dyspnea Scale; Borg CR10 Scale), BP, heart rate, oxygen saturation, and other clinical symptoms and responses to exercise are monitored by the therapists, using both patient-reported measures and clinical observation by the therapists.34,35 Any medical emergency during the session is reported immediately to the pulmonologist for further management.
Structure
Prior to each exercise session, exercise precautions, fall prevention, good posture, pursed-lip breathing, pacing, and coordinated breathing are discussed with the patient. The PT demonstrates stretching and warm-up exercises in front of the webcam for the patient to follow. Then the patient performs all exercises in view of the webcam during the session (Figure 1). A RT monitors breathing patterns and corrects with verbal instructions if not properly performed.
Loss of skeletal muscle mass and cachexia are highly prevalent comorbidities of COPD and have been associated with breathlessness, functional limitation, and poor prognosis.36 To address these comorbidities, our program consists of progressive strengthening, aerobic, balance, and flexibility exercises. Resistance bands and tubes are used for strengthening exercises. Callisthenic exercises (eg, chair squat, chair stand, knee marching, bridging, single limb stances, and lunge) are used for progressive strengthening and balance exercises. Progression of strengthening and balance exercises are done through increasing the volume of exercise (ie, numbers of sets and repetitions) and increased load and level of difficulty based on the patient’s progress and comorbidity. The exercise program focuses on strengthening muscles, especially large muscle groups, to improve overall muscle strength and performance of functional activities.37
Arm/pedal ergometer and daily walking are used for daily aerobic exercise. In a study of patients with COPD by the PAC-COPD Study Group, step counter use was found to increase physical activity and improve exercise capacity, which supports its use in COPD management.38 During program participation, the patient is asked to wear a pedometer to monitor the number of steps taken per day and to report step data to the therapists during the telehealth session. The pedometer stores the previous 41 calendar days of data and displays the most recent 7 calendar days of data.
The patient is encouraged to set a realistic daily step goal. The general program goal is to increase at least 1000 steps per day. However, this goal can be adjusted depending on the patient’s health status and comorbid conditions. The PAC-COPD Study Group found that for every additional 1000 daily steps at low intensity, COPD hospitalization risk decreased by 20%.39 A magnitude of 2000 steps or about 1 mile of walking per day was found to be associated with increased physical activity and health benefits in the general population.40
Respiratory muscle training and breathing exercise are provided by the RT, using breathing and incentive spirometer techniques (Figure 2). Huff coughing, diaphragmatic deep breathing, and pursed-lip breathing are instructed by the RT during the session. Effective coughing technique with a cough assistive device is also provided during breathing training if needed.
Patient Education
In patients with COPD, there are numerous positive health benefits associated with education, including assisting the patients to become active participants in the PR program leading to satisfying outcomes; assisting the patients to better understand the lung health, disease processes, physical and psychological changes that occur with COPD; assisting the patients to explore coping strategies for those changes; building lifelong behavioral changes; and developing the self-management skills for sustainability. Through the educational process, patients with COPD can become more skilled at collaborative self-management and improve adherence to their treatment plan, which in turn can result in a reduction in hospital admissions and reduced health care costs.8,41
Education is provided with every session after the patient completes the exercise. Patients are required to record their COPD symptoms, daily activity, home exercise program, sleep, food intake, and additional physical or social activity in their COPD diary and to report during the session (Figure 3). A COPD diary assists patients in self-monitoring their COPD symptoms and provides the therapists with information about clinical changes, behavioral changes, and/or specific unmet needs for education. Several topics related to COPD are included in the education session: lung or respiratory disease/condition and self-management; smoking cessation; physical activity; energy-conserving techniques; breathing and coughing techniques; smoking cessation; nutrition/healthy eating and weight counseling; sex and intimacy; psychological counseling and/or group support; emergency planning (eg, medical, travel, and inclement weather); correct use of inhaler and medications; home oxygen; sleep and sleep hygiene; palliative care and advanced directive; infection control; and sputum clearance.42,43
Program Maintenance
After successfully completing the 6-week program, patients are referred to the VA TeleMOVE! Program or MOVE! Weight Management Program for continuous, long-term management of weight, nutrition, physical activity/exercise, and social activity needs or goals. The patients are scheduled for monthly follow-up phone visits for 6 months with the telerehabilitation team for enforcing sustainability. The phone call visit consists of reviewing breathing techniques, exercise program, physical activity, education, encouragement, and addressing any issues that arise during the self-maintained period.
Limitations
There are several issues of concern and precautions when delivering PR through telehealth into the home. First, the patient performs exercises independently without being manually guarded by the therapists. Risk of falls are a major concern due to impaired balance, poor vision, and other possible unusual physiologic responses to exercise (eg, drop in BP, dizziness, loss of balance). The area in front of the computer needs to be cleared of fall hazards (ie, area rug, wires, objects on the floor). The patient also needs to be educated on self-measurements of BP and oxygen saturation and reports to the therapists. The therapists provide detailed instructions on how to obtain these measures correctly; otherwise, the values may not be valid for a clinical judgment during the exercise session or for other clinical management. In a home environment, there is a limited use of exercise apparatuses. For this program, we only used resistance bands/tubes, small arm/leg ergometer, hand grip, and hand putty for the exercise program. We feel that dumbbell and weight plates are not suitable due to a possible risk of injury if the patient accidently drops them.
Advanced balance training is not suitable due to an increased risk for falls. Without the presence of the PT, level of challenge/difficulty is somewhat limited for this telehealth supervision exercise program. In addition, visual and audio quality are necessary for the session. The patient and the therapists need to see each other clearly to ensure correct methods and forms of each exercise. Furthermore, rehearsal of technical skills with the therapists is very important because this population is older and often has limited computer skills. Any technical difficulty or failure can lead to undesirable situations (eg, anxiety episodes, worries, shortness of breath, upset), which compromise exercise performance during the session. Finally, a phone is needed as an alternative in case of a poor VVC connection.
Conclusion
COPD symptoms and complications greatly affect patients’ ability to perform daily activities, decrease QOL and functional ability, and result in extensive use of health services. Many patients have limited access to a PR program at hospitals or rehabilitation centers due to health conditions, lack of transportation, and/or family support. This home-based, interactive telehealth PR program can break down the geographic barriers, solve poor program accessibility, potentially increase the utilization of PR, and reduce the cost and travel required by the patients.
Acknowledgments
The Telehealth Pulmonary Rehabilitation Program was originally funded by the Veterans Health Administration VA ACCESS Program (AS, CL, HKH). We thank all the veterans for their time and effort in participating in this newly developed rehabilitation program.
1. World Health Organization. Chronic obstructive pulmonary disease (COPD). http://www.who.int/news-room/fact-sheets/detail/chronic-obstructive-pulmonary-disease-(copd). Published December 1, 2017. Accessed August 7, 2019.
2. Yu W, Ravelo A, Wagner TH, et al. Prevalence and costs of chronic conditions in the VA health care system. Med Care Res Rev. 2003;60(suppl 3):146S-167S.
3. Doney B, Hnizdo E, Dillon CF, et al. Prevalence of airflow obstruction in U.S. adults aged 40-79 years: NHANES data 1988-1994 and 2007-2010. COPD. 2015;12(4):355-365.
4. Murphy DE, Chaudhry Z, Almoosa KF, Panos RJ. High prevalence of chronic obstructive pulmonary disease among veterans in the urban midwest. Mil Med. 2011;176(5):552-560.
5. Cypel YS, Hines SE, Davey VJ, Eber SM, Schneiderman AI. Self-reported physician-diagnosed chronic obstructive pulmonary disease and spirometry patterns in Vietnam Era US Army Chemical Corps veterans: a retrospective cohort study. Am J Ind Med. 2018;61(10):802-814.
6. Rochester CL. Exercise training in chronic obstructive pulmonary disease. J Rehabil Res Dev. 2003;40(5)(suppl 2):59-80.
7. Cortopassi F, Gurung P, Pinto-Plata V. Chronic obstructive pulmonary disease in elderly patients. Clin Geriatr Med. 2017;33(4):539-552.
8. Spruit MA, Singh SJ, Garvey C, et al; ATS/ERS Task Force on Pulmonary Rehabilitation. An official American Thoracic Society/European Respiratory Society statement: key concepts and advances in pulmonary rehabilitation. Am J Respir Crit Care Med. 2013;188(8):e13-e64.
9. Robinson H, Williams V, Curtis F, Bridle C, Jones AW. Facilitators and barriers to physical activity following pulmonary rehabilitation in COPD: a systematic review of qualitative studies. NPJ Prim Care Respir Med. 2018;28(1):19.
10. McCarthy B, Casey D, Devane D, Murphy K, Murphy E, Lacasse Y. Pulmonary rehabilitation for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2015;(2):CD003793.
11. Ries AL, Bauldoff GS, Carlin BW, et al. Pulmonary rehabilitation: joint AACP/AACVPR evidence-based clinical practice guidelines. Chest. 2007;131(suppl 5):4S-42S.
12. Major S, Moreno M, Shelton J, Panos RJ. Veterans with chronic obstructive pulmonary disease achieve clinically relevant improvements in respiratory health after pulmonary rehabilitation. J Cardiopulm Rehabil Prev. 2014;34(6):420-429.
13. Liu Y, Dickerson T, Early F, Fuld J, Clarkson PJ. Understanding influences on the uptake of pulmonary rehabilitation in the East of England: an inclusive design/mixed methods study protocol. BMJ Open. 2018;8(4):e020750.
14. Harris D, Hayter M, Allender S. Factors affecting the offer of pulmonary rehabilitation to patients with chronic obstructive pulmonary disease by primary care professionals: a qualitative study. Prim Health Care Res Dev. 2008;9(4):280-290.
15. Mathar H, Fastholm P, Hansen IR, Larsen NS. Why do patients with COPD decline rehabilitation. Scand J Caring Sci. 2016;30(3):432-441.
16. Han MK, Martinez CH, Au DH, et al. Meeting the challenge of COPD care delivery in the USA: a multiprovider perspective. Lancet Respir Med. 2016;4(6):473-526.
17. American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR). Online searchable program directory. https://www.aacvpr.org/Resources/Program-Directory Accessed July 19, 2018.
18. Nasreddine ZS, Phillips NA, Bédirian V, et al. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005;53(4):695-699.
19. Fletcher CM, Elmes PC, Fairbairn AS, Wood CH. The significance of respiratory symptoms and the diagnosis of chronic bronchitis in a working population. Br Med J. 1959;2(5147):257-266.
20. O’Donnell DE, Aaron S, Bourbeau J, et al. Canadian Thoracic Society recommendations for management of chronic obstructive pulmonary disease—2007 update. Can Respir J. 2007;14(suppl B):5B-32B.
21. Jones PW, Quirk FH, Baveystock CM. The St George’s Respiratory Questionnaire. Respir Med. 1991;85(suppl B):25-31.
22. Jones PW, Harding G, Berry P, Wiklund I, Chen WH, Kline Leidy N. Development and first validation of the COPD Assessment Test. Eur Respir J. 2009;34(3):648-654.
23. Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001;16(9):606-613.
24. Spitzer RL, Kroenke K, Williams JBW, Löwe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006;166(10):1092-1097.
25. Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep. 1991;14(6):540-545.
26. Katz S. Assessing self-maintenance: activities of daily living, mobility and instrumental activities of daily living. J Am Geriatr Soc. 1983;31(12):721-727.
27. Holland AE, Spruit MA, Troosters T, et al. An official European Respiratory Society/American Thoracic Society technical standard: field walking tests in chronic respiratory disease. Eur Respir J. 2014;44(6):1428-1446.
28. Mahler DA, Horowitz MB. Perception of breathlessness during exercise in patients with respiratory disease. Med Sci Sports Exerc. 1994;26(9):1078-1081.
29. Liao WC, Wang CH, Yu SY, Chen LY, Wang CY. Grip strength measurement in older adults in Taiwan: a comparison of three testing positions. Australas J Ageing. 2014;33(4):278-282.
30. Buatois S, Miljkovic D, Manckoundia P, et al. Five times sit to stand test is a predictor of recurrent falls in healthy community-living subjects aged 65 and older. J Am Geriatr Soc. 2008;56(8):1575-1577.
31. Bryant MS, Workman CD, Jackson GR. Multidirectional walk test in persons with Parkinson’s disease: a validity study. Int J Rehabil Res. 2015;38(1):88-91.
32. Podsiadlo D, Richardson S. The timed “Up & Go”: a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991;39(2):142-148.
33. University of Nebraska Medical Center. Timed Up and Go (TUG) Test. https://www.unmc.edu/media/intmed/geriatrics/nebgec/pdf/frailelderlyjuly09/toolkits/timedupandgo_w_norms.pdf. Accessed August 13, 2019.
34. Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-381.
35. Mahler DA, Horowitz MB. Clinical evaluation of exertional dyspnea. Clin Chest Med. 1994;15(2):259-269.
36. Dudgeon D, Baracos VE. Physiological and functional failure in chronic obstructive pulmonary disease, congestive heart failure and cancer: a debilitating intersection of sarcopenia, cachexia and breathlessness. Curr Opin Support Palliat Care. 2016;10(3):236-241.
37. Lee AL, Holland AE. Time to adapt exercise training regimens in pulmonary rehabilitation—a review of the literature. Int J Chron Obstruct Pulmon Dis. 2014;9:1275-1288.
38. Qiu S, Cai X, Wang X, et al. Using step counters to promote physical activity and exercise capacity in patients with chronic obstructive pulmonary disease: a meta-analysis. Ther Adv Respir Dis. 2018;12:1753466618787386.
39. Donaire-Gonzalez D, Gimeno-Santos E, Balcells E, et al; PAC-COPD Study Group. Benefits of physical activity on COPD hospitalization depend on intensity. Eur Respir J. 2015;46(5):1281-1289.
40. Bravata DM, Smith-Spangler C, Sundaram V, et al. Using pedometers to increase physical activity and improve health: a systematic review. JAMA. 2007;298(19):2296-2304.
41. Zwerink M, Brusse-Keizer M, van der Valk PD, et al. Self-management for patients with chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2014;19(3):CD002990.
42. Wilson JS, O’Neill B, Reilly J, MacMahon J, Bradley JM. Education in pulmonary rehabilitation: the patient’s perspective. Arch Phys Med Rehabil. 2007;88(12):1704-1709.
43. Bourbeau J, Nault D, Dang-Tan T. Self-management and behaviour modification in COPD. Patient Educ Couns. 2004;52(3):271-277.
1. World Health Organization. Chronic obstructive pulmonary disease (COPD). http://www.who.int/news-room/fact-sheets/detail/chronic-obstructive-pulmonary-disease-(copd). Published December 1, 2017. Accessed August 7, 2019.
2. Yu W, Ravelo A, Wagner TH, et al. Prevalence and costs of chronic conditions in the VA health care system. Med Care Res Rev. 2003;60(suppl 3):146S-167S.
3. Doney B, Hnizdo E, Dillon CF, et al. Prevalence of airflow obstruction in U.S. adults aged 40-79 years: NHANES data 1988-1994 and 2007-2010. COPD. 2015;12(4):355-365.
4. Murphy DE, Chaudhry Z, Almoosa KF, Panos RJ. High prevalence of chronic obstructive pulmonary disease among veterans in the urban midwest. Mil Med. 2011;176(5):552-560.
5. Cypel YS, Hines SE, Davey VJ, Eber SM, Schneiderman AI. Self-reported physician-diagnosed chronic obstructive pulmonary disease and spirometry patterns in Vietnam Era US Army Chemical Corps veterans: a retrospective cohort study. Am J Ind Med. 2018;61(10):802-814.
6. Rochester CL. Exercise training in chronic obstructive pulmonary disease. J Rehabil Res Dev. 2003;40(5)(suppl 2):59-80.
7. Cortopassi F, Gurung P, Pinto-Plata V. Chronic obstructive pulmonary disease in elderly patients. Clin Geriatr Med. 2017;33(4):539-552.
8. Spruit MA, Singh SJ, Garvey C, et al; ATS/ERS Task Force on Pulmonary Rehabilitation. An official American Thoracic Society/European Respiratory Society statement: key concepts and advances in pulmonary rehabilitation. Am J Respir Crit Care Med. 2013;188(8):e13-e64.
9. Robinson H, Williams V, Curtis F, Bridle C, Jones AW. Facilitators and barriers to physical activity following pulmonary rehabilitation in COPD: a systematic review of qualitative studies. NPJ Prim Care Respir Med. 2018;28(1):19.
10. McCarthy B, Casey D, Devane D, Murphy K, Murphy E, Lacasse Y. Pulmonary rehabilitation for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2015;(2):CD003793.
11. Ries AL, Bauldoff GS, Carlin BW, et al. Pulmonary rehabilitation: joint AACP/AACVPR evidence-based clinical practice guidelines. Chest. 2007;131(suppl 5):4S-42S.
12. Major S, Moreno M, Shelton J, Panos RJ. Veterans with chronic obstructive pulmonary disease achieve clinically relevant improvements in respiratory health after pulmonary rehabilitation. J Cardiopulm Rehabil Prev. 2014;34(6):420-429.
13. Liu Y, Dickerson T, Early F, Fuld J, Clarkson PJ. Understanding influences on the uptake of pulmonary rehabilitation in the East of England: an inclusive design/mixed methods study protocol. BMJ Open. 2018;8(4):e020750.
14. Harris D, Hayter M, Allender S. Factors affecting the offer of pulmonary rehabilitation to patients with chronic obstructive pulmonary disease by primary care professionals: a qualitative study. Prim Health Care Res Dev. 2008;9(4):280-290.
15. Mathar H, Fastholm P, Hansen IR, Larsen NS. Why do patients with COPD decline rehabilitation. Scand J Caring Sci. 2016;30(3):432-441.
16. Han MK, Martinez CH, Au DH, et al. Meeting the challenge of COPD care delivery in the USA: a multiprovider perspective. Lancet Respir Med. 2016;4(6):473-526.
17. American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR). Online searchable program directory. https://www.aacvpr.org/Resources/Program-Directory Accessed July 19, 2018.
18. Nasreddine ZS, Phillips NA, Bédirian V, et al. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005;53(4):695-699.
19. Fletcher CM, Elmes PC, Fairbairn AS, Wood CH. The significance of respiratory symptoms and the diagnosis of chronic bronchitis in a working population. Br Med J. 1959;2(5147):257-266.
20. O’Donnell DE, Aaron S, Bourbeau J, et al. Canadian Thoracic Society recommendations for management of chronic obstructive pulmonary disease—2007 update. Can Respir J. 2007;14(suppl B):5B-32B.
21. Jones PW, Quirk FH, Baveystock CM. The St George’s Respiratory Questionnaire. Respir Med. 1991;85(suppl B):25-31.
22. Jones PW, Harding G, Berry P, Wiklund I, Chen WH, Kline Leidy N. Development and first validation of the COPD Assessment Test. Eur Respir J. 2009;34(3):648-654.
23. Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001;16(9):606-613.
24. Spitzer RL, Kroenke K, Williams JBW, Löwe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006;166(10):1092-1097.
25. Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep. 1991;14(6):540-545.
26. Katz S. Assessing self-maintenance: activities of daily living, mobility and instrumental activities of daily living. J Am Geriatr Soc. 1983;31(12):721-727.
27. Holland AE, Spruit MA, Troosters T, et al. An official European Respiratory Society/American Thoracic Society technical standard: field walking tests in chronic respiratory disease. Eur Respir J. 2014;44(6):1428-1446.
28. Mahler DA, Horowitz MB. Perception of breathlessness during exercise in patients with respiratory disease. Med Sci Sports Exerc. 1994;26(9):1078-1081.
29. Liao WC, Wang CH, Yu SY, Chen LY, Wang CY. Grip strength measurement in older adults in Taiwan: a comparison of three testing positions. Australas J Ageing. 2014;33(4):278-282.
30. Buatois S, Miljkovic D, Manckoundia P, et al. Five times sit to stand test is a predictor of recurrent falls in healthy community-living subjects aged 65 and older. J Am Geriatr Soc. 2008;56(8):1575-1577.
31. Bryant MS, Workman CD, Jackson GR. Multidirectional walk test in persons with Parkinson’s disease: a validity study. Int J Rehabil Res. 2015;38(1):88-91.
32. Podsiadlo D, Richardson S. The timed “Up & Go”: a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991;39(2):142-148.
33. University of Nebraska Medical Center. Timed Up and Go (TUG) Test. https://www.unmc.edu/media/intmed/geriatrics/nebgec/pdf/frailelderlyjuly09/toolkits/timedupandgo_w_norms.pdf. Accessed August 13, 2019.
34. Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-381.
35. Mahler DA, Horowitz MB. Clinical evaluation of exertional dyspnea. Clin Chest Med. 1994;15(2):259-269.
36. Dudgeon D, Baracos VE. Physiological and functional failure in chronic obstructive pulmonary disease, congestive heart failure and cancer: a debilitating intersection of sarcopenia, cachexia and breathlessness. Curr Opin Support Palliat Care. 2016;10(3):236-241.
37. Lee AL, Holland AE. Time to adapt exercise training regimens in pulmonary rehabilitation—a review of the literature. Int J Chron Obstruct Pulmon Dis. 2014;9:1275-1288.
38. Qiu S, Cai X, Wang X, et al. Using step counters to promote physical activity and exercise capacity in patients with chronic obstructive pulmonary disease: a meta-analysis. Ther Adv Respir Dis. 2018;12:1753466618787386.
39. Donaire-Gonzalez D, Gimeno-Santos E, Balcells E, et al; PAC-COPD Study Group. Benefits of physical activity on COPD hospitalization depend on intensity. Eur Respir J. 2015;46(5):1281-1289.
40. Bravata DM, Smith-Spangler C, Sundaram V, et al. Using pedometers to increase physical activity and improve health: a systematic review. JAMA. 2007;298(19):2296-2304.
41. Zwerink M, Brusse-Keizer M, van der Valk PD, et al. Self-management for patients with chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2014;19(3):CD002990.
42. Wilson JS, O’Neill B, Reilly J, MacMahon J, Bradley JM. Education in pulmonary rehabilitation: the patient’s perspective. Arch Phys Med Rehabil. 2007;88(12):1704-1709.
43. Bourbeau J, Nault D, Dang-Tan T. Self-management and behaviour modification in COPD. Patient Educ Couns. 2004;52(3):271-277.