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Jan Sieluk, MPharm, PhD1,2 Joseph Levy, PhD1 Robert A. Sandhaus, MD, PhD3 Henry Silverman, MD, PhD4 Kristen E. Holm, PhD5 C. Daniel Mullins, PhD1
Author Affiliations
- Pharmaceutical Health Services Research Department, School of Pharmacy, University of Maryland, Baltimore
- OptumLabs, Cambridge, Massachusetts
- Division of Pulmonary, Critical Care and Sleep Medicine, National Jewish Health, Denver, Colorado
- School of Medicine, University of Maryland, Baltimore
- Division of Medical, Behavioral, and Community Health, National Jewish Health, Denver, Colorado
Address correspondence to:
C. Daniel Mullins, PhD
Pharmaceutical Health Services Research Department
University of Maryland School of Pharmacy
220 N Arch St, 12th Floor
Baltimore, MD 21201-1531 Email: Daniel.Mullins@rx.umaryland.edu
Abstract
Background: This study is the first to utilize a large claims database to estimate medical costs of patients with alpha-1 antitrypsin deficiency (AATD) in the United States.
Methods: Adult AATD patients were identified from the OptumLabs™ Data Warehouse. Insurer and patient out-of-pocket costs were categorized into the following cost buckets, stratified by augmentation therapy use: physician visits (PV), emergency department visits (ED), inpatient stays (IP), augmentation therapy (AUG), other prescription drug costs (RX), and other costs (OTH). Costs were weighted and adjusted to 2017 U.S. dollars using the medical care component of the consumer price index.
Results: The study cohort consisted of9117 AATD patients followed for 53,872 person years observed between 1993 and 2015. The annual costs among AATD patients totaled $127,537 among augmentation therapy users and $15,874 among non-users. The major drivers of annual costs to the insurer among the 7975 patients not on augmentation therapy were: PV: $5352 (37.7%) and IP: $4506 (31.8%). Among the 1142 augmentation users, major annual cost drivers to the insurer were PV: $15,064 (12.3%) and AUG: $82,002 (66.7%). Annual patient out-of-pocket costs were $4601 (AUG: $2084 [45.3%]; RX: $940 [20.4%]) and $1689 (PV: $727 [43.0%]; RX: $589 [34.9%]) among augmentation therapy users and non-users, respectively. Averaged across the entire cohort, the average annual costs per AATD patient were $22,975, paid by insurers ($21,100) and patients ($1875).
Conclusions: Annual medical costs among patients with AATD are $127,537 and $15,874 among augmentation therapy users and non-users, respectively, with 75.3% of the cost difference attributable to AUG.
Citation
Citation: Sieluk J, Levy J, Sandhaus RA, Silverman H, Holm KE, Mullins CD. Costs of medical care among augmentation therapy users and non-users with alpha-1 antitrypsin deficiency in the United States. Chronic Obstr Pulm Dis. 2019; 6(1): 6-16. doi: http://dx.doi.org/10.15326/jcopdf.6.1.2017.0187
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Nicole M. Robertson1 Emily M. Nagourney, MSPH2 Suzanne L. Pollard, PhD, MSPH1,2 Trishul Siddharthan, MD1 Robert Kalyesubula, MBChB, MMed3 Pamela J. Surkan, PhD, ScD2 John R. Hurst, PhD, FRCP4 William Checkley, MD, PhD1,2 Bruce J. Kirenga, MBChB, MMed5
Author Affiliations
- Division of Pulmonary and Critical Care, School of Medicine, Johns Hopkins University, Baltimore, Maryland
- Department of International Health, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland
- Department of Physiology, College of Health Sciences, Makerere University, Kampala, Uganda
- UCL Respiratory, University College London, United Kingdom
- Department of Medicine and Lung Institute, College of Health Sciences, Makerere University, Kampala, Uganda
Abstract
Introduction: Almost 90% of chronic obstructive pulmonary disease (COPD) deaths occur in low- and middle-income countries (LMICs), where there are large rural populations and access to health care for COPD is poor. The purpose of this study was to compare urban-rural provider experiences regarding systemic facilitators and barriers to COPD management and treatment access.
Methods: We conducted a qualitative study using direct observations and in-depth semi-structured interviews with 16 and 10 health care providers in urban Kampala and rural Nakaseke, Uganda, respectively. We analyzed interviews by performing inductive coding using generated topical codes.
Results: In both urban and rural districts, exposure to evidence-based practices for COPD diagnosis and treatment was limited. The biomedical definition of COPD is not well distinguished in rural communities and was commonly confused with asthma and other respiratory diseases. Urban and rural participants alike described low availability of medications, limited access to diagnostic tools, poor awareness of the disease, and lack of financial means for medical care as common barriers to seeking and receiving care for COPD. While there was greater access to COPD treatment in urban areas, rural populations faced more pronounced barriers in access to diagnostic equipment, following standard treatment guidelines, and training medical personnel in non-communicable disease (NCD) management and treatment.
Conclusion: Our results suggest that health system challenges for the treatment of COPD may disproportionately affect rural areas in Uganda. Implementation of diagnostic and treatment guidelines and training health professionals in COPD, with a special emphasis on rural communities, will assist in addressing these barriers.
Citation
Citation: Robertson NM, Nagourney EM, Pollard SL, et al. Urban-rural disparities in chronic obstructive pulmonary disease management and access in Uganda. Chronic Obstr Pulm Dis. 2019; 6(1): 17-28. doi: http://dx.doi.org/10.15326/jcopdf.6.1.2018.0143
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Radmila Choate, MPH1 David M. Mannino, MD1 Kristen E. Holm, PhD, MPH2 Robert A. Sandhaus, MD, PhD3
Author Affiliations
- Department of Preventive Medicine and Environmental Health, University of Kentucky College of Public Health, Lexington
- Division of Medical, Behavioral, and Community Health, National Jewish Health; Department of Community and Behavioral Health, University of Colorado Denver School of Public Health, Denver
- Division of Pulmonary Sciences and Critical Care Medicine, National Jewish Health, University of Colorado Denver School of Medicine, Denver
Address correspondence to:
Radmila Choate, MPH
Department of Preventive Medicine and Environmental Health
University of Kentucky College of Public Health
111 Washington Avenue
Lexington, KY 40536
Phone: 859-218-2237
E-mail: radmila.choate@uky.edu
Abstract
Background: The aim of this study was to examine differences in demographic, health, and behavioral characteristics in individuals with ZZ and SZ genotypes of alpha-1 antitrypsin deficiency (AATD) within AlphaNet’s Disease Management and Prevention Program (ADMAPP).
Methods: Self-reported data from 3535 patients with AATD, including 3031 (85.7%) patients with ZZ, ZNull, and NullNull genotypes (referred to here as ZZ), and 504 (14.3%) with the SZ genotype were analyzed using t-tests, ANOVAs, and Chi-squared tests.
Results: The average age of the cohort was 56.3±10.6 years. The majority of respondents were male (51.2%), white (98.2%) and married (65.2%). SZs reported having more frequent exacerbations (p<0.001) and hospitalizations (p=0.012) than ZZs. A higher proportion of SZs than ZZs had been diagnosed with high blood pressure, diabetes, congestive heart failure, and other comorbid conditions. SZs were more likely than ZZs to report “poor” health (p=0.005). Over a third (38.4%) of SZs do not exercise compared to 27.1% of ZZs (p<0.001). A greater proportion of SZs compared to ZZs view themselves as being overweight (p<0.001) or “out of shape” (p=0.001). A higher proportion of SZs than ZZs reported any history of smoking and current smoking (p<0.001).
Conclusions: In patients with AATD and lung disease participating in a disease management program, a higher proportion of SZs than ZZs report exacerbations, comorbidities, and overall poor health, as well as unhealthy behaviors such as lack of exercise and current smoking. Future work should consider the extent to which genotype-specific health promotion interventions would be useful.
Citation
Citation: Choate R, Mannino DM, Holm KE, Sandhaus RA. Comparing patients with ZZ versus SZ alpha-1 antitrypsin deficiency: findings from AlphaNet’s disease management program. Chronic Obstr Pulm Dis. 2019; 6(1): 29-39. doi: http://dx.doi.org/10.15326/jcopdf.6.1.2018.0134
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Rachel N. Criner, MD1 Daohai Yu, PhD2 Michael R. Jacobs, PharmD3 Gerard J. Criner, MD3
Author Affiliations
- Department of Internal Medicine, University of Michigan, Ann Arbor
- Department of Clinical Sciences, Lewis Katz School of Medicine, Temple University, Philadelphia, Pennsylvania
- Department of Thoracic Medicine and Surgery, Lewis Katz School of Medicine, Temple University, Philadelphia, Pennsylvania
Address correspondence to:
Rachel N. Criner, MD
Department of Internal Medicine
University of Michigan Health Systems
UH Internal Medicine – Core 3116 TC
1500 E. Medical Center Drive
Ann Arbor, MI 48109
rcriner@med.umich.edu
734-936-4385
Abstract
Abstract
Background: Long-term effects of lung volume reduction surgery (LVRS) on respiratory muscle strength and effects of age, sex, and emphysema pattern on these changes are unknown. Therefore, we aimed to determine the long-term effect of LVRS on respiratory muscle strength changes in severe emphysema.
Methods: The National Emphysema Treatment Trial was a prospective controlled multicentered trial, comparing LVRS to optimal medical treatment on survival and maximal exercise capacity. We examined percentage change in maximum inspiratory pressure (MIP) from baseline to 36 months follow-up to determine impact of LVRS as well as age, sex, emphysema pattern and exercise capacity on changes in MIP compared to medical treatment.
Results: LVRS individuals had significantly greater increases in MIP from baseline compared to medical individuals at all follow-ups (LVRS 19.8 ± 42.3%, medical 3.2 ± 29.3%, p<0.0001, 12 months). The LVRS group had significant decreases in total lung capacity (TLC), residual volume (RV), functional residual capacity (FRC) and RV/TLC compared to the medical arm at all follow-up periods. Males and individuals 65-70 years of age had significantly greater increases in MIP following LVRS compared to the medical arm at all follow-ups; this same relationship was seen at up to 24 months for low exercise capacity, upper lobe predominant emphysema.
Conclusions: LVRS significantly increases inspiratory muscle strength up to 3 years post-operatively, with male sex, age 65-70 years and low exercise capacity, upper lobe predominant emphysema especially associated with increased MIP. Inspiratory muscle strength increases were associated with decreases in non-invasive markers of dynamic hyperinflation, suggesting that LVRS allows inspiratory muscles to return to their optimal length-tension relationship.
Citation
Citation: Criner RN, Yu D, Jacobs MR, Criner GJ. Effect of lung volume reduction surgery on respiratory muscle strength in advanced emphysema. Chronic Obstr Pulm Dis. 2019; 6(1): 40-50. doi: http://dx.doi.org/10.15326/jcopdf.6.1.2018.0188
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Carol Mansfield, PhD1 Jessie Sutphin, MA1 Kelly Shriner, BS2 Gerard J. Criner, MD3 Bartolome R. Celli, MD4
Author Affiliations
- RTI Health Solutions, Research Triangle Park, North Carolina
- Pulmonx Corporation, Redwood City, California
- Department of Thoracic Medicine and Surgery, Lewis Katz School of Medicine, Temple University, Philadelphia, Pennsylvania
- Division of Pulmonary and Critical Care Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, Massachusetts
Address correspondence to:
Carol Mansfield
RTI Health Solutions
200 Park Offices Drive
Research Triangle Park, NC, 27709
Email:carolm@rti.org
Phone: 919.541.8053
Abstract
Background: Patients with severe emphysema have limited treatment options. Little is known about patients’ willingness to accept risks for new treatments that offer meaningful benefits.
Methods: We determined treatment preferences of patients with severe emphysema using a web-based discrete-choice experiment survey. Respondents answered 9 questions that offered choices between 2 hypothetical interventional treatments or continuing current medical management. Variations in 5 attributes defined the 2 interventional treatments: improvement in ability to breathe and carry out day-to-day activities, frequency of hospitalized exacerbations, treatment type, risk of pneumothorax within 30 days of procedure, and risk of death within 3 months. Respondents were recruited through the COPD Foundation’s COPD Patient-Powered Research Network and had a self-reported emphysema diagnosis and 2+ score on the modified Medical Research Council Dyspnea Scale. The relative importance of the attributes and the percentage of respondents who would select different treatment options was modeled using random-parameters logit.
Results: Among 294 respondents, 51% always chose an interventional treatment option, while 19% always selected continued medical management. The most important change on average was moving from continued medical management (with no improvement in breathlessness) to an interventional treatment with improvement in breathlessness. The model predicted 71% of respondents would select a treatment option similar to removable endobronchial valve implants, 6% would select lung volume reduction surgery (LVRS), and 23% continued medical management.
Conclusion: Patients with severe emphysema perceive that a procedure with risks and benefits similar to the Zephyr® endobronchial valve implants is desirable over continued medical management or LVRS.
Citation
Citation: Mansfield C, Sutphin J, Shriner K, Criner GJ, Celli BR. Patient preferences for endobronchial valve treatment of severe emphysema. Chronic Obstr Pulm Dis. 2019; 6(1): 51-63. doi: http://dx.doi.org/10.15326/jcopdf.6.1.2018.0147
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Rachel N. Criner, MD1 Wassim W. Labaki, MD2 Elizabeth A. Regan, MD, PhD3 Jessica M. Bon, MD, MS4 Xavier Soler, MD, PhD5 Surya P. Bhatt, MD6 Susan Murray, ScD7 John E. Hokanson, PhD8 Edwin K. Silverman, MD, PhD9 James D. Crapo, MD3 Jeffrey L. Curtis, MD2,10 Fernando J. Martinez, MD, MS2 Barry J. Make, MD3 MeiLan K. Han MD, MS2 Carlos H. Martinez, MD, MPH;2 for the COPDGene® Investigators
Author Affiliations
- Department of Internal Medicine, University of Michigan, Ann Arbor
- Division of Pulmonary and Critical Care Medicine, University of Michigan, Ann Arbor
- Division of Pulmonary Medicine, National Jewish Health, Denver, Colorado
- Division of Pulmonary and Critical Care Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania
- Division of Pulmonary, Critical Care and Sleep Medicine, University of California, San Diego
- Division of Pulmonary, Allergy and Critical Care Medicine, University of Alabama, Birmingham
- School of Public Health, University of Michigan, Ann Arbor
- School of Public Health, University of Colorado, Aurora
- Channing Division of Network Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts
- Veterans’ Administration Ann Arbor Healthcare System, Ann Arbor, Michigan
Address correspondence to:
MeiLan Han, MD, MS
Division of Pulmonary and Critical Care Medicine
3916 Taubman Center
1500 E. Medical Center Drive
University of Michigan Medical Center
Ann Arbor, MI 48109-0360
Phone: 734-763-2540
Email: Mrking@med.umich.edu
Abstract
Background: The Global initiative for chronic Obstructive Lung Disease (GOLD) ABCD groupings were recently modified. The GOLD 2011 guidelines defined increased risk as forced expiratory volume in 1 second (FEV1) < 50% predicted or ≥ 2 outpatient or ≥ 1 hospitalized exacerbation in the prior year, whereas the GOLD 2017 guidelines use only exacerbation history. We compared mortality and exacerbation rates in the Genetic Epidemiology of COPD Study cohort (COPDGene®) by 2011 (exacerbation history/FEV1 and dyspnea) versus 2017 (exacerbations and dyspnea) classifications.
Methods: Using data from COPDGene®, we tested associations of ABCD groups with all-cause mortality (Cox models, adjusted for age, sex, race and comorbidities) and longitudinal exacerbations (zero-inflated Poisson models).
Results: In 4469 individuals (mean age 63.1 years, 44% female), individual distributions in 2011 versus 2017 systems were: A, 32.0% versus 37.0%; B, 17.6% versus 36.3%; C, 9.4% versus 4.4%; D, 41.0% versus 22.3%; (observed agreement 76% [expected 27.8%], Kappa 0.67, p<0.001). Individuals in group D-2011 had 1.1 ± 1.6 exacerbations/year (mean ± standard deviation [SD]) versus 1.4 ± 1.8 for D-2017 (median follow-up 3.7 years). Using group A as reference, for both systems, mortality (median follow-up 6.8 years) was highest in group D (D-2011, [hazard ratio] HR 5.2 [95% confidence interval (CI) 4.2, 6.4]; D-2017, HR 5.5 [4.5, 6.8]), lowest for group C (HR 1.9 [1.4, 2.6] versus HR 1.9 [1.3, 2.8]) and intermediate for group B (HR 2.6 [2.0, 3.4] versus HR 3.4 [2.8, 4.1]). GOLD 2011 had better mortality discrimination (area under the curve [AUC] 0.68) than GOLD 2017 (AUC 0.66, p<0.001 for comparison) but similar exacerbation rate prediction.
Conclusions: Relative to the GOLD 2011 consensus statement, discriminate predictive power of the 2017 ABCD classification is similar for exacerbations but lower for survival.
Citation
Citation: Criner RN, Labaki WW, Regan EA, et al; for the COPDGene Investigators. Mortality and exacerbations by Global Initiative for Chronic Obstructive Lung Disease Groups ABCD: 2011 versus 2017 in the COPDGene® Cohort. Chronic Obstr Pulm Dis. 2019; 6(1): 64-73. doi: http://dx.doi.org/10.15326/jcopdf.6.1.2018.0130
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Gerard J. Criner, MD1 Michael R. Jacobs, Pharm D2 Huaqing Zhao, PhD3 Nathaniel Marchetti, DO1
Author Affiliations
- Department of Thoracic Medicine and Surgery, Lewis Katz School of Medicine, Temple University, Philadelphia, Pennsylvania
- Department of Thoracic Medicine and Surgery, Lewis Katz School of Medicine and Temple School of Pharmacy, Temple University, Philadelphia, Pennsylvania
- Department of Clinical Sciences, Lewis Katz School of Medicine at Temple University, Philadelphia, Pennsylvania
Address correspondence to:
Gerard J. Criner, MD
Department of Thoracic Medicine and Surgery
Lewis Katz School of Medicine at Temple University
745 Parkinson Pavilion
3401 North Broad Street
Philadelphia Pa 19140
Phone: 215 707-8113
Email: gerard.criner@tuhs.temple.edu
Abstract
Introduction: Hospitalization for chronic obstructive pulmonary disease (COPD) exacerbation portends the greatest risk of rehospitalization and mortality. Treatments that prevent hospitalizations could significantly lessen COPD morbidity and mortality.
Methods: We performed a prospective, randomized, double-blind, placebo-controlled study of roflumilast 500 ug daily versus placebo in patients hospitalized for acute COPD exacerbation. Primary outcome was time to all-cause mortality or non-elective rehospitalization at 180 days post-randomization. Secondary outcomes were death or hospitalization from a respiratory cause, quality of life, change in health status, forced expiratory volume in 1 second (FEV1) and roflumilast tolerance.
Results: A total of 64 patients with moderate to severe COPD (FEV1, 37.6 ± 16.4% predicted; 61% female, 61.6 ± 7.9 years old) were assigned to roflumilast or placebo. No deaths occurred in the follow-up period. There was no difference in the time to first readmission between the roflumilast and placebo groups (46.1 days versus 47.3 days respectively, p=0.93). There were 29 and 30 readmissions in the roflumilast and placebo groups, respectively (p=0.47). The St George’s Respiratory Questionnaire (SGRQ) decreased 10.8 points and 7.8 points in the roflumilast and placebo groups, respectively and were not different. EuroQuality of Life Five Dimension scale (EQ5D) scores improved, but not significantly in either group. Weight loss and nausea were more common with roflumilast but not different from placebo. Change in glycosylated hemoglobin percentage (HgbA1C%) was not different between groups. Sub-analysis for the impact of chronic bronchitis did not affect outcomes.
Conclusion: In this pilot study conducted in patients hospitalized with an exacerbation of COPD, roflumilast did not affect time to all-cause rehospitalization, quality of life, FEV1 or any other measured parameter.
Citation
Citation: Criner GJ, Jacobs MR, Zhao H, Marchetti N.Effects ofroflumilast on rehospitalization and mortality in patients hospitalized with a COPD exacerbation. Chronic Obstr Pulm Dis. 2019; 6(1): 74-85. doi: http://dx.doi.org/10.15326/jcopdf.6.1.2018.0139
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Gary T. Ferguson, MD1 Robert Tosiello, MS2 Shahin Sanjar, PhD2 Thomas Goodin, PhD2
Author Affiliations
- Pulmonary Research Institute of Southeast Michigan, Farmington Hills
- Sunovion Pharmaceuticals Inc., Marlborough, Massachusetts
Address correspondence to:
Gary T. Ferguson, MD,
Pulmonary Research Institute of Southeast Michigan
29255 West 10 Mile Road, Suite A
Farmington Hills, MI 48336
Phone: 248-478-6561
E-mail: garytferguson@msn.com
Abstract
Purpose: The purpose of this study was to assess the effect of pre-existing cardiovascular (CV) risk factors on the efficacy and safety of nebulized glycopyrrolate (GLY) in patients with chronic obstructive pulmonary disease (COPD).
Methods: A total of 2379 patients from 3 phase III studies (12-week, placebo-controlled Glycopyrrolate for Obstructive Lung Disease via Electronic Nebulizer [GOLDEN] -3 and -4, and 48-week, active-controlled GOLDEN-5) stratified by high (n=1526) or low (n=853) CV risk were randomized to placebo, GLY 25 mcg or 50 mcg twice daily, or tiotropium (TIO; 18 mcg once daily). Safety, lung function, patient-reported outcomes (PROs), and exacerbations were assessed by CV risk.
Results: Treatment-emergent adverse events (TEAEs) were similar across CV risk subgroups, with serious TEAEs higher in the high CV risk subgroup. In the 12-week studies, discontinuation due to TEAEs with GLY 25 mcg and 50 mcg was similar between CV risk subgroups, and lower than placebo (high risk: 6.2%, 3.6%, 9.0%; low risk: 3.2%, 4.5%, 9.9%, respectively). In the 48-week, open-label study, discontinuation rates were higher with GLY versus TIO (high risk: 10.7%, 3.7%; low risk: 8.7%, 1.2%, respectively). Rates of CV events of special interest were similar across CV risk subgroups. Regardless of CV risk, GLY led to significant improvements in efficacy and PRO assessments at 12 weeks versus placebo, whereas changes were similar between GLY and TIO at 48 weeks, except for PROs in the low risk subgroup. Exacerbation rates were similar across all treatment groups.
Conclusions: Nebulized GLY had an acceptable safety profile and improved lung function and PROs in COPD patients, irrespective of CV risk status.
Citation
Citation: Ferguson GT, Tosiello R, Sanjar S, Goodin T. Efficacy and safety of nebulized glycopyrrolate/eflow® closed system in patients with moderate-to-very-severe chronic obstructive pulmonary disease with pre-existing cardiovascular risk factors. Chronic Obstr Pulm Dis. 2019; 6(1): 86-99. doi: http://dx.doi.org/10.15326/jcopdf.6.1.2018.0146
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