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Radmila Choate, PhD, MPH1 David M. Mannino, MD2 Kristen E. Holm, PhD, MPH3,4 Tatsiana Beiko, MD, MSCR5 Bonnie Boyd, BSN4†† Robert A. Sandhaus, MD, PhD3,4
Author Affiliations
- College of Public Health, University of Kentucky, Lexington, Kentucky, United States
- College of Medicine, University of Kentucky, Lexington, Kentucky, United States
- Department of Medicine, National Jewish Health, Denver, Colorado, United States
- AlphaNet, Inc., Coral Gables, Florida, United States
- Division of Pulmonary, Critical Care, Allergy and Sleep Medicine, Medical University of South Carolina, Charleston, South Carolina, United States
†deceased
Address correspondence to:
Radmila Choate, PhD, MPH
Department of Epidemiology
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 Step Forward Study (SFS) was designed to increase exercise activity and improve body mass index (BMI) among individuals with alpha-1 antitrypsin deficiency (AATD)-associated lung disease.
Methods: The SFS is a randomized trial of an intensive distance intervention that was delivered via a series of mailings and teleconferences versus no additional intervention. All participants (n=500) were also enrolled in a disease management program designed for individuals with AATD-associated lung disease who have been prescribed augmentation therapy. The primary outcome was self-reported number of exercise minutes per week. The secondary outcome was BMI. Linear mixed model analyses were used to assess the difference in average weekly exercise minutes between the intervention arms over time. T-tests, signed rank and Wilcoxon rank-sum tests were used to evaluate changes in BMI between the intervention arms and within each BMI category.
Results: The study included 429 individuals with evaluable primary outcome data.There was a significant effect of intervention on exercise minutes over time (p=0.018). Participants in the intervention group reported an average of 167.14 minutes (standard deviation [SD]=10.68) of weekly exercise and those in the standard care group reported 148.31 minutes (SD=10.96). There was a significant difference in BMI change between the intervention (mean BMI decrease 0.74, SD=2.16) and the standard care group (mean BMI decrease 0.27, SD=1.63); p=0.0122.
Conclusions: Individuals who were randomly assigned to the intervention group reported more exercise activity and improvements in BMI over the course of this multicomponent intervention compared to individuals assigned to standard care.
Citation
Citation: Choate R, Mannino DM, Holm KE, Beiko T, Boyd B, Sandhaus RA. Home-based multicomponent intervention increases exercise activity and improves body mass index: results of a 5-year randomized trial among individuals with alpha-1 antitrypsin deficiency-associated lung disease. Chronic Obstr Pulm Dis. 2021; 8(1): 7-18. doi: http://dx.doi.org/10.15326/jcopdf.8.1.2020.0183
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Melanie Schroeder, MSc1 Katie Hall, MPH2 Lina Eliasson, PhD, CPsychol2 Sophia Bracey, MSc3 Necdet B. Gunsoy, PhD4 Jake Macey, MSc3 Paul W. Jones, PhD5 Afisi S. Ismaila, PhD6,7
Author Affiliations
- Value Evidence and Outcomes, GlaxoSmithKline plc., Brentford, United Kingdom
- Patient Centred Outcomes, ICON plc., London, United Kingdom
- Patient Centred Outcomes, ICON plc., Abingdon, United Kingdom
- Value Evidence and Outcomes, GlaxoSmithKline plc., Uxbridge, United Kingdom
- Global Respiratory Therapy Area, GlaxoSmithKline plc., Brentford, United Kingdom
- Value Evidence and Outcomes, GlaxoSmithKline plc., Collegeville, Pennsylvania, United States
- Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada
Address correspondence to:
Afisi S. Ismaila, PhD
Value Evidence and Outcomes
GlaxoSmithKline plc.
1250 South Collegeville Road
Collegeville, PA, USA 19426-0989
Phone: (919) 315 8229
E-mail: afisi.s.ismaila@gsk.com
Abstract
Background: A wide range of therapeutic regimens, including single-inhaler triple therapies (SITTs), are now available for the maintenance treatment of chronic obstructive pulmonary disease (COPD). Thus, an improved understanding of patient preferences may be valuable to inform physician prescribing decisions. This study was performed to assess the factors considered by patients when making decisions about their COPD treatments using qualitative techniques.
Methods: In the United Kingdom, United States and Germany, individual qualitative interviews (n=10 per country) and focus groups (1 per country; [United Kingdom, n=4; United States, n=6; Germany, n=6 participants]) were conducted. Interviews and focus groups were semi‑structured, lasting approximately 60 minutes, and focused on treatment preferences. Data were analyzed according to emerging themes identified from the interviews; qualitative thematic analysis of the data was performed using specialist software.
Results: In interviews and focus groups, efficacy, ease of use, and lower frequency of use were favored attributes for current treatment, while side effects, medication taste, and more complex administration techniques were key dislikes. In interviews, most participants would consider a switch in medication, mainly for improved efficacy, but also to reduce medication frequency or following physician advice. Overall, efficacy and ease of use were the 2 most important attributes reported in interviews in all 3 countries.
Conclusion: Patientswith COPD have preferences for certain attributes of medication, highlighting the multi-faceted nature of treatment effectiveness and the importance of the delivery device.These results were subsequently used to inform the design of a discrete choice experiment.
Citation
Citation: Schroeder M, Hall K, Eliasson L, et al. Treatment preferences of patients with chronic obstructive pulmonary disease: results from qualitative interviews and focus groups in the United Kingdom, United States, and Germany. Chronic Obstr Pulm Dis. 2021; 8(1): 19-30. doi: http://dx.doi.org/10.15326/jcopdf.8.1.2020.0131
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Judith Bellemare, PhD, MD1 Nathalie Gaudreault, BSc1 Kim Valette, MD1 Irene Belmonte, PhD2 Alexa Nuñez, MD2 Marc Miravitlles, MD2,3 François Maltais, MD1 Yohan Bossé, PhD1,4
Author Affiliations
- Institut universitaire de cardiologie et de pneumologie de Québec – Université Laval, Québec, QC, Canada
- Pneumology Department, Hospital Universitari Vall d´Hebron, Vall d´Hebron Institut de Recerca (VHIR), Vall d’Hebron Barcelona Hospital Campus, Barcelona, Spain
- CIBER de Enfermedades Respiratorias (CIBERES), Madrid, Spain
- Department of Molecular Medicine, Laval University, Quebec City, Canada
Address correspondence to:
Yohan Bossé, PhD
Professor, Université Laval
Department of Molecular Medicine
Canada Research Chair in Genomics of Heart and Lung Diseases
Institut universitaire de cardiologie et de pneumologie de Québec
Pavillon Marguerite-d'Youville, Y2106
2725, chemin Ste-Foy
Québec (Québec), Canada, G1V 4G5
Phone: 418-656-8711 ext. 3725
Email: yohan.bosse@criucpq.ulaval.ca
Abstract
Background: Alpha-1 antitrypsin deficiency (AATD) is caused by genetic variants in the SERPINA1 gene conferring risk of developing emphysema. The clinical expression of AATD-related emphysema mostly occurs in carriers of 2 deficient alleles. By DNA sequencing of SERPINA1, numerous rare variants have been identified. Clarifying whether 2 mutations observed in 1 patient are on the same or distinct alleles has obvious clinical implications.
Methods: We studied 7 carriers of a rare variant, Leu353Phe_fsTer24, known to lead to undetectable serum levels of AAT. Two of them were also carriers of the S or Z allele. We developed an allele-specific DNA sequencing method to characterize the allelic background of the Leu353Phe_fsTer24 variant.
Results: The Leu353Phe_fsTer24 variant was transmitted on the same allele as the M3 variant (E376D) in all patients. This mutation is thus named Q0Ourém on the conventional PI system. We demonstrated that individuals harboring the E264V (S) and E342K (Z) mutations had them on distinct alleles from Q0Ourém and are, thus, compound heterozygotes. The 7 Q0Ourém carriers had AAT levels ranging from 0.18g/l to 0.82g/l. The lowest AAT serum levels were observed in compound heterozygotes (S/Q0Ourém and Z/Q0Ourém) suggesting higher risk of developing emphysema.
Conclusion: For the 7 patients, Leu353Phe_fsTer24 is transmitted on the M3 background and they are, thus, carriers of the Q0Ourém allele. Allele-specific DNA sequencing was useful to distinguish 1 or 2 deficient alleles in carriers of 2 mutations. In rare cases, this method is important to understand the clinical significance of genetic variants found in SERPINA1.
Citation
Citation: Bellemare J, Gaudreault N, Valette K, et al. The clinical utility of determining the allelic background of mutations causing alpha-1 antitrypsin deficiency: the case with the null variant Q0(Mattawa)/Q0(Ourém). Chronic Obstr Pulm Dis. 2021; 8(1): 31-40. doi: http://dx.doi.org/10.15326/jcopdf.8.1.2020.0168
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John S. Kim, MD, MS1,2* Michael A. Thomashow, MD1,3* Natalie H. Yip, MD1 Kristin M. Burkart, MD, MSc1 Christian M. Lo Cascio, MD1 Daichi Shimbo, MD1 R. Graham Barr, MD, DrPH1,4
Author Affiliations
- Department of Medicine, Columbia University Irving Medical Center, New York, New York, United States
- Department of Medicine, University of Virginia School of Medicine, Charlottesville, Virginia, United States
- Kaiser Permanante San Francisco Medical Center, San Francisco, California, United States
- Department of Epidemiology, Mailman School of Public Health, Columbia University Irving Medical Center, New York, New York, United States
*Both authors contributed equally to the manuscript.
Address correspondence to:
R. Graham Barr, MD, DrPH
Columbia University Irving Medical Center
Presbyterian Hospital 9 East 105
630 West 168th Street, New York, NY 10032
rgb9@columbia.edu
Abstract
Rationale: Studies suggest a pathogenic role of endothelial dysfunction in chronic obstructive lung disease (COPD). Omega-3 (n-3) polyunsaturated fatty acid (PUFA) supplementation improves endothelial function in other diseases but has not been examined in COPD.
Objective: We hypothesized that n-3 PUFA supplementation would improve systemic endothelial function in COPD. We performed a pilot randomized, placebo-controlled, double-blind, phase 2 superiority trial (NCT00835289).
Methods: Adults with moderate and severe stable COPD (79% with emphysema on computed tomography [CT]) were randomized to high-dose fish oil capsules or placebo daily for 6 months. The primary endpoint was percentage change in brachial artery flow-mediated dilation (FMD) from baseline to 6 months. Secondary endpoints included peripheral arterial tonometry, endothelial microparticles (EMPs), 6-minute walk distance, respiratory symptoms, and pulmonary function.
Results: Thirty-three of 40 randomized participants completed all measurements. Change in FMD after 6 months did not differ between the fish oil and placebo arms (-1.1%, 95% CI -5.0—2.9, p=0.59). CD31+ EMPs increased in the fish oil arm (0.9%, 95% CI 0.1—1.7, p=0.04). More participants in the fish oil arm reported at least a 4-point improvement in the St George’s Respiratory Questionnaire (SGRQ) compared to placebo (8 versus 1; p=0.01). There were no significant changes in other secondary endpoints. There were 4 serious adverse events determined to be unrelated to the study (3 in the fish oil arm and 1 in the placebo arm).
Conclusion: Randomization to n-3 PUFAs for 6 months did not change systemic endothelial function in COPD. Changes in EMPs and SGRQ suggest n-3 PUFAs might have biologic and clinical effects that warrant further investigation.
Citation
Citation: Kim JS, Thomashow MA, Yip NH, et al. Randomization to omega-3 fatty acid supplementation and endothelial function in COPD: the COD-FISH randomized controlled trial. Chronic Obstr Pulm Dis. 2021; 8(1): 41-53. doi: http://dx.doi.org/10.15326/jcopdf.8.1.2020.0132
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Laura C. Myers, MD, MPH1,2 Carlos Camargo, DrPH, MD3 Gabriel Escobar, MD1,2 Vincent X. Liu, MD1,2
Author Affiliations
- Division of Research, Kaiser Permanente Northern California, Oakland, California, United States
- The Permanente Medical Group, Oakland, California, United States
- Department of Emergency Medicine, Massachusetts General Hospital, Boston, Massachusetts, United States
Address correspondence to:
Laura Myers, MD, MPH
Division of Research
Kaiser Permanente Northern California
2000 Broadway
Oakland, CA 94612
Email: laura.c.myers@kp.org
Telephone: (925) 433-3491
Abstract
Background: Chronic obstructive pulmonary disease (COPD) is a common and costly reason for hospitalization and rehospitalization. The Hospital Readmissions Reduction Program penalizes hospitals for excess, non-elective, all-cause 30-day, inpatient rehospitalizations for COPD. We sought to determine how broadening the outcome definition would alter the numbers of patients being counted, specifically if observation stays and patients who died in the post-discharge period were included.
Methods: We performed a retrospective cohort study of patients hospitalized for COPD between July 1, 2010 and December 31, 2017 in 21 hospitals in the Kaiser Permanente Northern California health care system. We classified encounters into 3 outcomes groups based on a 30-day post-discharge observation period: Group (1) non-elective, all-cause, inpatient rehospitalizations, which is the current metric; Group (2) composite outcome of Group 1 or all-cause mortality; and Group (3) composite outcome of Group 1 or non-elective, all-cause, observation rehospitalization. We used the Box-Cox method to find the transformation of the cumulative curves that resulted in the smallest mean standard error. We used the slope of the transformed curve against days to test for significant differences between pairs of cumulative density curves.
Results: Of 1,384,025 hospitalizations, 11,304 encounters from 8097 patients met criteria to be index hospitalizations. The event rate for non-elective, all-cause, inpatient rehospitalizations was 17.1% (95% CI 10.4–26.5). The event rate for all-cause mortality was 4.7% (95% CI 3.1–7.7). The event rate for non-elective observation rehospitalizations was 3.9% (95% CI 1.7–7.0). The slope and standard error for Group 1 were 1.17 and 0.01, respectively, while the slope and standard error for Group 2 were 1.62 and 0.01, respectively (P=0.02 comparing Groups 1 and 2). The slope and standard error for Group 3 were 1.45 and 0.01, respectively (P=0.02 comparing Groups 1 and 3).
Conclusion: We show that adding outcomes such as mortality and observation rehospitalizations would change the counts of patients contributing to the Hospital Readmission Reduction Program penalty for COPD if the outcome were broadened. Including mortality or observation stays in the quality incentive program might incentivize hospitals and providers to prevent these events in addition to inpatient rehospitalizations.
Citation
Citation: Myers LC, Camargo C, Escobar G, Liu VX. Expanding post-discharge readmission metrics in patients with chronic obstructive pulmonary disease. Chronic Obstr Pulm Dis. 2021; 8(1): 54-59. doi: http://dx.doi.org/10.15326/jcopdf.2020.0160
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Barbara P. Yawn, MD, MSc1,2 Meilan Han, MD, MPH3 Barry M. Make, MD4 David Mannino, MD5 Randall W. Brown, MD6 Catherine Meldrum, PhD, RN3 Susan Murray, ScD7 Cathie Spino, ScD7 Jacqueline S. Bronicki, MLIS, CCRA7 Nancy Leidy, PhD8 Hazel Tapp, PhD9 Rowena J. Dolor, MD10 Min Joo, MD, MPH11 Lyndee Knox, PhD12 Linda Zittleman, MPH, MSPH13 Byron M. Thomashow, MD14 Fernando J. Martinez, MD15
Author Affiliations
- Department of Family and Community Health, University of Minnesota, Minneapolis, Minnesota, United States
- COPD Foundation, Miami, Florida, United States
- Department of Internal Medicine, University of Michigan Health System, Ann Arbor, Michigan, United States
- Pulmonary Sciences and Critical Care Medicine, National Jewish Health, Denver, Colorado, United States
- College of Public Health, Department of Preventive Medicine and Environmental Health, University of Kentucky, Lexington, Kentucky, United States
- School of Public Health, University of Michigan, Ann Arbor, Michigan, United States
- Department of Biostatistics, School of Public Health, University of Michigan, Ann Arbor, Michigan, United States
- Evidera, Bethesda, Maryland, United States
- Department of Family Medicine, Atrium Health, Charlotte, North Carolina, United States
- Division of General Internal Medicine, Duke University Medical Center, Durham, North Carolina, United States
- Medicine and Pulmonary and Critical Care, University of Illinois, Chicago, Illinois, United States
- L.A. Net Community Health Center, Los Angeles, California, United States
- Department of Family Medicine, University of Colorado, High Plains Research Network, Aurora, Colorado, United States
- Division of Pulmonary and Critical Care Medicine, Columbia University, New York, New York, United States
- Division of Pulmonary and Critical Care Medicine, Weill Cornell Medicine, New York-Presbyterian Hospital, New York, New York, United States
Address correspondence to:
Barbara Yawn
Email: yawnx002@umn.edu
Phone: (507) 261-3096
Abstract
Chronic obstructive pulmonary disease (COPD) often remains undiagnosed and untreated. To date, COPD screening/case finding has not been designed to identify clinically significant COPD, disease ready for therapies beyond smoking cessation. Herein, we describe the ongoing prospective, pragmatic cluster-randomized controlled trial to assess specificity and sensitivity of the COPD Assessment in Primary Care To Identify Undiagnosed Respiratory Disease and Exacerbation Risk (CAPTURE) tool consisting of 5 questions and peak expiratory flow. The tool is designed to identify clinically significant COPD (forced expiratory volume in 1 second [FEV1] to forced vital capacity [FVC] ratio <.70 plus FEV1% predicted <60% or increased risk for exacerbation) and the trial will explore the impact of CAPTURE-based screening on COPD diagnosis and treatment rates in primary care patients.
Of a total planned enrollment of 5000 English- or Spanish-speaking patients 45 to 80 years of age without a prior COPD diagnosis from 100 primary care practices, a total of 68 practices and 3064 patients have been enrolled in the study. Practices are centrally randomized to either usual care or clinician receipt of patient-level CAPTURE results. All clinicians receive basic COPD education with those in intervention practices also receiving CAPTURE interpretation education. In a single visit, patient participants complete a CAPTURE screening, pre- and post-bronchodilator spirometry and baseline demographic and health questionnaires to validate CAPTURE sensitivity, specificity, and predictive value of identifying undiagnosed, clinically significant COPD. One-year follow-up chart reviews and participant surveys assess the impact of sharing versus not sharing CAPTURE results with clinicians on clinical outcomes including level of respiratory symptoms and events and clinicians’ initiation of recommendation-concordant COPD care. This is one of the first U.S. studies to validate and assess impact of a simple COPD screening tool in primary care.
Citation
Citation: Yawn BP, Han M, Make BM, et al. Protocol summary of the COPD Assessment in Primary Care To Identify Undiagnosed Respiratory Disease and Exacerbation Risk (CAPTURE) validation in primary care study. Chronic Obstr Pulm Dis. 2021; 8(1): 60-75. doi: http://dx.doi.org/10.15326/jcopdf.2020.0155
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Arnaud Bourdin, MD, PhD1 Gerard Criner, MD2 Gilles Devouassoux, MD, PhD3,4 Mark Dransfield, MD5 David M.G. Halpin, MD6 MeiLan K. Han, MD7 C. Elaine Jones, PhD8 Ravi Kalhan, MD9 Peter Lange, MD10,11 Sally Lettis, PhD12 David A. Lipson, MD13, 14 David A. Lomas, MD15 José M. Echave-Sustaeta María-Tomé, MD16 Neil Martin, MD17,18 Fernando J. Martinez, MD19 Holly Quasny, PharmD8 Lynda Sail, MD20 Thomas M. Siler, MD21 Dave Singh, MD22 Byron Thomashow, MD23 Henrik Watz, MD24 Robert Wise, MD25 Nicola A. Hanania, MD, MS26
Author Affiliations
- Department of Pneumology and Addictology, University of Montpellier, CHU Montpellier, Montpellier, France
- Lewis Katz School of Medicine at Temple University, Philadelphia, Pennsylvania, United States
- Univ. Lyon, Université Claude-Bernard Lyon 1, Lyon, France
- Hôpital de la Croix-Rousse, Service de Pneumologie, Hospices Civils de Lyon, Lyon, France
- Division of Pulmonary, Allergy, and Critical Care Medicine, Lung Health Center, University of Alabama at Birmingham, Alabama, United States
- College of Medicine and Health, University of Exeter Medical School, Exeter, United Kingdom
- Pulmonary and Critical Care, University of Michigan, Ann Arbor, Michigan, United States
- GlaxoSmithKline, Research Triangle Park, North Carolina, United States
- Division of Pulmonary and Critical Care Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois, United States
- Department of Public Health, University of Copenhagen, Copenhagen, Denmark
- Medical Department, Herlev University Hospital, Herlev, Denmark
- GlaxoSmithKline, Stockley Park West, Uxbridge, Middlesex, United Kingdom
- GlaxoSmithKline, Collegeville, Pennsylvania, United States
- Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, United States
- UCL Respiratory, University College London, London, United Kingdom
- Respiratory Department, Hospital Universitario Quirónsalud Madrid, Universidad Europea de Madrid, Madrid, Spain
- GlaxoSmithKline, Brentford, Middlesex, United Kingdom
- University of Leicester, Leicester, United Kingdom
- Weill Cornell Medicine, New York, New York, United States
- GlaxoSmithKline, Paris, France
- Midwest Chest Consultants, PC, St. Charles, Missouri, United States
- The University of Manchester, Manchester University National Health Service Foundation Trust, United Kingdom
- Division of Pulmonary, Allergy, and Critical Care, Columbia University Medical Center, New York, New York, United States
- Pulmonary Research Institute at Lungen Clinic Grosshansdorf, Airway Research Center North, German Center for Lung Research, Grosshansdorf, Germany
- Division of Pulmonary and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, United States
- Section of Pulmonary and Critical Care Medicine, Airways Clinical Research Center, Baylor College of Medicine, Houston, Texas, United States
Address correspondence to:
Nicola A. Hanania, MD, MS
Airways Clinical Research Center Section of Pulmonary and Critical Care Medicine
Baylor College of Medicine
1504 Taub Loop, Houston, TX
Email: hanania@bcm.edu
Telephone: +1 713 873 3454
Abstract
Background: The InforMing the Pathway of COPD Treatment (IMPACT) trial demonstrated lower moderate/severe exacerbation rates with fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) versus FF/VI or UMEC/VI in patients with chronic obstructive pulmonary disease (COPD) and a history of exacerbations. Since IMPACT was a global study, post-hoc analyses were conducted by geographic region to investigate potential differences in overall findings.
Methods: IMPACT was a 52-week, randomized, double-blind trial. Patients with symptomatic COPD and ≥1 moderate/severe exacerbation in the prior year were randomized 2:2:1 to once-daily FF/UMEC/VI 100/62.5/25µg, FF/VI 100/25µg, or UMEC/VI 62.5/25µg. Endpoints assessed in the overall, Western Europe and North America populations included on-treatment moderate/severe exacerbation (rates and time-to-first), trough forced expiratory volume in 1 second and St George’s Respiratory Questionnaire (SGRQ) total score. Safety was assessed.
Results: Overall, 10,355 patients were enrolled, 3164 from Western Europe, 2639 from North America. FF/UMEC/VI significantly reduced on-treatment moderate/severe exacerbation rates versus FF/VI and UMEC/VI in Western Europe (rate ratios 0.82 [95%CI 0.74-0.91], P<.001 and 0.76 [0.67-0.87], P<.001) and in North America (0.87 [0.77-0.97], P=.014 and 0.69 [0.60-0.80], P<.001). FF/UMEC/VI reduced time-to-first moderate/severe exacerbation and improved lung function versus FF/VI and UMEC/VI in both regions, and improved SGRQ total score in Western Europe, but not North America. Safety profiles were generally similar between treatment groups/regions; the inhaled corticosteroid class effect of increased pneumonia incidence was seen in North America but not Western Europe.
Conclusions: Consistent with intent-to-treat results, FF/UMEC/VI reduced moderate/severe exacerbation rate and risk and improved lung function in Western Europe and North America; however, between-regions differences were seen for SGRQ total score and pneumonia incidence.
Clinical Trial Registration: NCT02164513.
Citation
Citation: Bourdin A, Criner G, Devouassoux G, et al. Informing the pathway of COPD treatment (IMPACT) single-inhaler triple therapy (fluticasone furoate/umeclidinium/vilanterol) versus fluticasone furoate/vilanterol and umeclidinium/vilanterol in patients with COPD: analysis of the Western Europe and North America regions. Chronic Obstr Pulm Dis. 2021; 8(1): 76-90. doi: http://dx.doi.org/10.15326/jcopdf.2020.0158
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Vickram Tejwani, MD1 Eric Moughames, MD2 Karthik Suresh, MD1 Shih-En Tang, MD, PhD3 Laura G. Mair, MS2 Karina Romero, MD, MSc2 Nirupama Putcha, MD, MHS1 Neil E. Alexis, PhD4 Han Woo, PhD1 Franco R. D’Alessio, MD1** Nadia N. Hansel, MD, MPH1**
Author Affiliations
- Division of Pulmonary and Critical Care Medicine, Johns Hopkins University, Baltimore, Maryland, United States
- Johns Hopkins Bayview Medical Center, Baltimore, Maryland, United States
- Division of Pulmonary and Critical Care Medicine, Tri-Service General Hospital, Taipei, Taiwan
- Department of Pediatrics, University of North Carolina, Chapel Hill, North Carolina, United States
**These authors share senior authorship
Address correspondence to:
Vickram Tejwani, MD
Email: tejwani@jhmi.edu
Phone: (443)287-3345
Abstract
Background: Chronic obstructive pulmonary disease (COPD) is characterized by recurrent exacerbations. Macrophages play a critical role in immune response and tissue repair in COPD. Airway macrophages (AM) are exposed to environmental exposures which are retained in the cytoplasmic material. Both biomass and particulate matter have been linked to higher AM black carbon. It is unknown if AM black carbon is associated with COPD morbidity and macrophage phenotype.
Methods: Former smokers with COPD were enrolled and sputum induction was performed to obtain airway macrophages. Macrophages underwent black carbon quantification and flow cytometry phenotyping. Health information was obtained the same day as sputum induction and prospective exacerbations were assessed by monthly telephone calls.
Results: We studied 30 former smokers with COPD who had a mean age of 67 years and mean forced expiratory volume in 1 second (FEV1)% predicted of 60.8%. Higher AM black carbon content was associated with increased total exacerbations and severe exacerbations and reduced CD80 expression.
Conclusion: AM black carbon association with respiratory morbidity is largely unexplored and this is the first study to identify association with prospective exacerbations. Macrophages expressed reduced CD80, a surface marker providing costimulatory signals required for development of antigen-specific immune responses. Our findings suggest that reduced CD80 expression is the pathophysiologic mechanism for the association of AM black carbon content and increased exacerbations. Therefore, beyond solely serving as a marker for increased exposures, AM black carbon content may be a predictor of future exacerbations given a macrophage less equipped to respond to an acute infectious exposure.
Citation
Citation: Tejwani V, Moughames E, Suresh K, et al. Black carbon content in airway macrophages is associated with reduced CD80 expression and increased exacerbations in former smokers with COPD. Chronic Obstr Pulm Dis. 2021; 8(1): 91-99. doi: http://dx.doi.org/10.15326/jcopdf.2020.0170
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Patricia B. Koff, RRT, MEd1* Sung-joon Min, PhD2* Tammie J. Freitag, RN, BSN1 Debora L. P. Diaz1 Shannon S. James, RN, BSN1 Norbert F. Voelkel, MD1 Derek J. Linderman, MD1 Fernando Diaz del Valle, MD1 Jonathan K. Zakrajsek, MS1 Richard K. Albert, MD1 Todd M. Bull, MD1 Arne Beck, PhD3 Thomas J. Stelzner, MD3 Debra P. Ritzwoller, PhD3 Christine M. Kveton, RRT3 Stephanie Carwin, RRT3 Moumita Ghosh, PhD4 Robert L. Keith, MD1,5 John M. Westfall, MD6 R. William Vandivier, MD1
Author Affiliations
- Division of Pulmonary Sciences and Critical Care Medicine, Colorado Pulmonary Outcomes Research Group, Aurora, Colorado, United States
- Division of Health Care Policy and Research, Department of Medicine, University of Colorado Denver, Anschutz Medical Campus, Aurora, Colorado, United States
- Institute for Health Research, Kaiser Permanente Colorado, Denver, Colorado, United States
- National Jewish Health, Denver, Colorado, United States
- Denver Veterans Administration Medical Center, Denver, Colorado, United States
- Department of Family Medicine, High Plains Research Network, University of Colorado Denver, Anschutz Medical Campus, United States
*Authors contributed equally to the study
Address correspondence to:
R. William Vandivier, MD
Professor of Medicine
Department of Medicine
Division of Pulmonary Sciences and Critical Care Medicine
University of Colorado-Denver
Aurora, CO 80045
Phone: (303)724-6068
Email: Bill.Vandivier@cuanschutz.edu
Abstract
Background: Up to 50% of chronic obstructive pulmonary disease (COPD) patients do not receive recommended care for COPD. To address this issue, we developed Proactive Integrated Care (Proactive iCare), a health care delivery model that couples integrated care with remote monitoring.
Methods: We conducted a prospective, quasi-randomized clinical trial in 511 patients with advanced COPD or a recent COPD exacerbation, to test whether Proactive iCare impacts patient-centered outcomes and health care utilization. Patients were allocated to Proactive iCare (n=352) or Usual Care ( =159) and were examined for changes in quality of life using the St George’s Respiratory Questionnaire (SGRQ), symptoms, guideline-based care, and health care utilization.
Findings: Proactive iCare improved total SGRQ by 7–9 units (p < 0.0001), symptom SGRQ by 9 units (p<0.0001), activity SGRQ by 6–7 units (p<0.001) and impact SGRQ by 7–11 units (p<0.0001) at 3, 6 and 9 months compared with Usual Care. Proactive iCare increased the 6-minute walk distance by 40 m (p<0.001), reduced annual COPD-related urgent office visits by 76 visits per 100 participants (p<0.0001), identified unreported exacerbations, and decreased smoking (p=0.01). Proactive iCare also improved symptoms, the body mass index-airway obstruction-dyspnea-exercise tolerance (BODE) index and oxygen titration (p<0.05). Mortality in the Proactive iCare group (1.1%) was not significantly different than mortality in the Usual Care group (3.8%; p=0.08).
Interpretation: Linking integrated care with remote monitoring improves the lives of people with advanced COPD, findings that may have been made more relevant by the coronavirus 2019 (COVID-19) pandemic.
Citation
Citation: Koff KB, Min S, Diaz DLP, et al. Impact of Proactive Integrated Care on chronic obstructive pulmonary disease. Chronic Obstr Pulm Dis. 2021; 8(1): 100-116. doi: http://dx.doi.org/10.15326/jcopdf.2020.0139
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Meghan McGraw, MD1 Heath D. White, DO, MS1 Kiumars Zolfaghari, MS1 Angela Hochhalter, PhD1 Alejandro Arroliga, MD1 Carl Boethel, MD1
Author Affiliations
- Division of Pulmonary, Critical Care and Sleep Medicine, Baylor Scott and White Health, Temple, Texas, United States
Address correspondence to:
Carl Boethal, MD
Department of Internal Medicine
Division of Pulmonary, Critical Care & Sleep Medicine
Scott & White Medical Center
Texas A & M University
2401 S. 31st Street
Temple, TX 76508
Phone: 254-724-9887
Email: Carl.Boethel@BSWHealth.org
Abstract
Introduction: Hospital admissions and readmissions for chronic obstructive pulmonary disease (COPD) exacerbations are associated with increased mortality and higher cost. The management of exacerbations with a shortened course of systemic corticosteroids has similar efficacy as compared to longer steroid courses, but actual overall steroid dose given is still variable. The outcomes associated with steroid side effects, such as hyperglycemia, need further evaluation. We hypothesized that the use of higher doses of corticosteroids, and the subsequent hyperglycemia, contributes to readmission.
Methods: This is a retrospective study at a tertiary care referral center in central Texas between February 2014 and July 2016. Daily corticosteroid dose, blood glucose levels, and readmission rates at 30 and 31-90 days were recorded. Sample characteristics are described using descriptive statistics. A chi-square test or student’s t-test were used to test for associations in bivariate comparisons. Multivariable logistic regression assessed the association between readmission rate and demographic and clinical characteristics.
Results: There were 1120 patients admitted for COPD exacerbation between February 2014 and July 2016. A total of 57% were female, mean age was 69 years (standard deviation [SD] 12), and average body mass index (BMI) was 29.4 (SD 9.8). Of the total, 349 (31%) had diabetes prior to admission. The 30-day readmission rate was 16%, and the readmission rate from 31-90 days was 14%. The average prednisone equivalent dose per day during hospitalization was 86 mg (SD 52). A multivariable logistic regression model did not show any significant association between readmission and average daily glucose, high maximum glucose (>180 mg/dL on any reading), or prednisone equivalent administered per day.
Conclusion: Corticosteroid dose and hyperglycemia were not associated with an increased 30-day or 31-90-day readmission rate after COPD exacerbation discharge. In addition, using higher doses of corticosteroids instead of standard-of-care (prednisone 40 mg per day for a 5-day period) did not appear to affect the readmission rate in this cohort.
Citation
Citation: McGraw M, White HD, Boethel C, Zolfaghari K, Hochhalter A, Arroliga A.Corticosteroid dosing and glucose levels in COPD patients are not associated with increased readmissions. Chronic Obstr Pulm Dis. 2021; 8(1): 117-123. doi: http://dx.doi.org/10.15326/jcopdf.2020.0172
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Arthur F. Gelb, MD1 Alfred Yamamoto, MD2 Eric K. Verbeken, MD3 James C. Hogg, MD, PhD4 Donald P. Tashkin, MD5 Diem N. T. Tran, BA6 Roxanna M. Moridzadeh, BA, PA-C6 Christine Fraser, CPFT, RT6 Mark J. Schein, MD7 Marc Decramer, MD, PhD8 Eric F. Glassy, MD9 Jay A. Nadel, MD10
Author Affiliations
- Pulmonary Division, Department of Medicine, Lakewood Regional Medical Center, Lakewood, California, United States and David Geffen School of Medicine at University of California-Los Angeles Health Sciences, Los Angeles, California, United States
- Department of Pathology, Lakewood Regional Medical Center, Lakewood, California, United States
- Department of Pathology, Katholieke Univeritair Ziekenhuis Gasthuisberg, Leuven, Belgium
- University of British Columbia James Hogg Research Centre, St. Paul`s Hospital Vancouver, British Columbia, Canada
- Division of Pulmonary and Critical Care Medicine, David Geffen School of Medicine at University of California-Los Angeles Health Sciences, Los Angeles, California, United States
- Independent pulmonary function investigator, Lakewood, California, United States
- Department of Radiology, Lakewood Regional Medical Center, Lakewood, California, United States
- Department of Clinical and Experimental Medicine, Katholieke Univeritair Leuven-University of Leuven and University Hospitals Leuven, Leuven, Belgium
- Affiliated Pathologists Medical Group, Rancho Dominguez, California, United States
- Cardiovascular Research Institute and Departments of Medicine, Physiology, and Radiology, School of Medicine, University of California San Francisco, San Francisco, California, United States
Address correspondence to:
Arthur F. Gelb MD
3650 E. South St., Suite 308
Lakewood, Calif. 90712
Phone: (562)565-5333
Email: afgelb@msn.com
Abstract
Background: Recent studies have emphasized the difficulty of early detection of chronic obstructive pulmonary disease (COPD) in symptomatic smokers with normal routine spirometry. This includes post-bronchodilator normal forced expiratory volume in 1 second (FEV1)(L)≥80% predicted, forced vital capacity (FVC)(L)≥80% predicted, and FEV1/FVC ≥70% or greater than age corrected lower limit of normal (LLN). However, in COPD the pathologic site of small airway obstruction and emphysema begins in the small peripheral airways ≤2 mm id which normally contribute <20% of total airway resistance.
Methods: Expiratory airflow at high and low lung volumes post-bronchodilator were measured and correlated with lung computed tomography (CT) and lung pathology (6 patients) in 16 symptomatic, treated smokers, and all with normal routine spirometry.
Results: Despite normal routine spirometry, all16 patients had isolated, abnormal forced expiratory flow at 75% of FVC (FEF75) using data from Knudson et al, Hankinson et al NHAMES III, and Quanjer et al and the Global Lung Function Initiative. This reflects isolated detection of small airways obstruction and/or emphysema. Measuring airflow at FEF50 detected only 8 of 16 patients, maximal expiratory flow at 25%-75% of FVC (MEF25-75) only 4 of 16, residual volume (RV) 4 of 16, and RV to total lung capacity ratio only 2 of 16. There was excellent correlation between limited lung pathology and lung CT for absence of emphysema.
Conclusions: This study confirms our earlier observations that detection of small airways obstruction and/or emphysema, in symptomatic smokers with normal routine spirometry, requires analysis of expiratory airflow at low lung volumes, including FEF75. Dependence upon normal routine spirometry may result in clinical and physiologic delay in the diagnosis and treatment in symptomatic smokers with emphysema and small airways obstruction.
Citation
Citation: Gelb AF, Yamamoto A, Verbeken EK, et al. Normal routine spirometry can mask COPD and emphysema in symptomatic smokers. Chronic Obstr Pulm Dis. 2021; 8(1): 124-134. doi: http://dx.doi.org/10.15326/jcopdf.2020.0176
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Chelsea L. Edwards, PhD1 Alan G. Kaplan, MD, CCFP(EM)2,3,4 Barbara P. Yawn, MD, MSc5,6 Janwillem W. H. Kocks, MD, PhD1,7,8 Lakmini Bulathsinhala, MPH1 Victoria A. Carter, BSc1 Ku-Lang Chang, MD9 Chester Fox, MD10,11 Gokul Gopalan, MD12 MeiLan K. Han, MD13 Maja Kruszyk, BEng1 Chantal E. Le Lievre, BPH1 Cathy Mahle, PhD, MBA12 Barry Make, MD14 Wilson D. Pace, MD10,15 Chris Price, LLB1 Asif Shaikh, MD, MPH12 Neil Skolnik, MD16,17 David B. Price, FRCGP1,7,18
Author Affiliations
- Optimum Patient Care, Cambridge, United Kingdom
- Observational and Pragmatic Research Institute, Singapore
- Family Physician Airways Group of Canada, Stouffville, Ontario
- University of Toronto, Toronto, Canada
- University of Minnesota, Minneapolis, Minnesota, United States
- COPD Foundation, Washington, DC, United States
- Observational Pragmatic Research Institute, Singapore
- General Practitioners Research Institute, Groningen, Netherlands
- College of Medicine, University of Florida, Gainesville, Florida, United States
- DARTNet Institute, Aurora, Colorado, United States
- University at Buffalo, Buffalo, New York, United States
- Boehringer Ingelheim, Ridgefield, Connecticut, United States
- University of Michigan, Ann Arbor, Michigan, United States
- Department of Medicine, National Jewish Health, Denver, Colorado, United States
- University of Colorado, Denver, Colorado, United States
- Thomas Jefferson University, Jenkintown, Pennsylvania, United States
- Abington Jefferson Health, Jenkintown, Pennsylvania, United States
- Centre of Academic Primary Care, Division of Applied Health Sciences, University of Aberdeen, Aberdeen, United Kingdom
Address correspondence to:
Professor David B. Price
Academic Primary Care
Division of Applied Health Sciences
University of Aberdeen, Polwarth Building
Foresterhill, Aberdeen
AB25 2ZD, UK
Phone: +65 6962 3627
E-mail: dprice@opri.sg
Abstract
Background: Chronic obstructive pulmonary disease (COPD) is commonly managed by family physicians, but little is known about specifics of management and how this may be improved. The Advancing the Patient Experience in COPD (APEX COPD) registry will be the first U.S. primary care, health system-based registry following patients diagnosed with COPD longitudinally, using a standardized set of variables to investigate how patients are managed in real life and assess outcomes of various management strategies.
Objective: Gaining expert consensus on a standardized list of variables to capture in the APEX COPD registry.
Methods: A modified, Delphi process was used to reach consensus on which data to collect in the registry from electronic health records (EHRs), patient-reported information (PRI) and patient-reported outcomes (PRO), and by physicians during subsequent office visits. The Delphi panel comprised 14 primary care and specialty COPD experts from the United States and internationally. The process consisted of 3 iterative rounds. Responses were collected electronically.
Results: Of the initial 195 variables considered, consensus was reached to include up to 115 EHR variables, 34 PRI/PRO variables and 5 office-visit variables in the APEX COPD registry. These should include information on symptom burden, diagnosis, COPD exacerbations, lung function, quality of life, comorbidities, smoking status/history, treatment specifics (including side effects), inhaler management, and patient education/self-management.
Conclusions: COPD experts agreed upon the core variables to collect from EHR data and from patients to populate the APEX COPD registry. Data will eventually be integrated, standardized and stored in the APEX COPD database and used for approved COPD-related research.
Citation
Citation: Edwards CL, Kaplan AG, Yawn BP, et al. Development of the Advancing the Patient Experience in COPD registry: a modified Delphi study. Chronic Obstr Pulm Dis. 2021; 8(1): 135-151. doi: http://dx.doi.org/10.15326/jcopdf.2020.0154
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Jennifer Kim, PharmD, BCPS, BCACP1-3 Amy Lin, PharmD4 Randy Absher, PharmD, BCPS1 Tanya Makhlouf, PharmD1 Casey Wells, PharmD3
Author Affiliations
- Cone Health, Greensboro, North Carolina, United States
- Area Health Education Center, Greensboro, North Carolina, United States
- Eshelman School of Pharmacy, Chapel Hill, University of North Carolina, North Carolina, United States
- Nebraska Medicine, Omaha, Nebraska, United States
Address correspondence to:
Jennifer Kim, PharmD
Email: jen.kim@conehealth.com
Phone: (336)832-7885
Abstract
Background: Mortality risk from chronic obstructive pulmonary disease (COPD) increases significantly in the first year after a 30-day hospital readmission.
Objective: To evaluate a comprehensive and collaborative pharmacist transitions of care service for patients hospitalized with COPD compared to usual care.
Methods: In this within-site, retrospective study, discharge counseling, medication reconciliation, medication access assistance, therapy changes, and post-discharge long-term follow-up were provided to underserved adult patients with a primary care provider at the study clinic and admitted to the affiliated hospital with a primary diagnosis of COPD exacerbation. Primary outcome was a 180-day composite of COPD-related hospitalizations and emergency department (ED) visits. Secondary outcomes were 30-, 60-, 90-, and 180-day events, costs, pharmacist interventions, time to follow-up, and pneumonia.
Results: Sixty-five patients were identified with a total of 101 index admissions. The mean age was 62.5 years, approximately 55.3% were female, and 67.7% were black or African American. The primary composite was significantly lower in the pharmacist intervention group compared to usual care (mean difference 0.82, P=0.0364, 95% confidence interval [CI] 0.05–1.60), driven by lower 30-day hospitalizations in the intervention group (mean difference 0.15, P=0.0099, 95% CI 0.04–0.27). Cost associated with COPD-related hospitalizations was significantly lower in the pharmacist intervention group compared to usual care ($173,808, P = 0.0330) as well as before intervention ($79,662, P=0.0233). There was no significant difference in time to follow-up or pneumonia.
Conclusions: A comprehensive, collaborative pharmacist transitions of care service significantly reduced 30-day COPD-related hospital readmissions, ED re-visits, and associated costs in an underserved population.
Citation
Citation: Kim J, Lin A, Absher R, Makhlouf T, Wells C. Comprehensive and collaborative pharmacist transitions of care service for underserved patients with chronic obstructive pulmonary disease. Chronic Obstr Pulm Dis. 2021; 8(1): 152-161. doi: http://dx.doi.org/10.15326/jcopdf.2019.0175
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