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        Jacob S. Warner, DO1 Jane M. Bryan2 Laura M. Paulin, MD, MHS3 
        
        
            Author Affiliations
 Department of Internal Medicine, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, United StatesDartmouth College, Hanover, New Hampshire, United StatesDepartment of Pulmonary and Critical Care, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, United States 
            Address correspondence to:Jacob S. Warner, DODepartment of Internal Medicine
 Dartmouth-Hitchcock Medical Center
 1 Medical Center Drive
 Lebanon, NH, 03756
 Phone: (805) 674-1168
 Email: Jacob.s.warner@outlook.com
 
            AbstractPurpose: Individuals in rural areas of the United States have a greater risk of chronic obstructive pulmonary disease (COPD) and have worse COPD outcomes. New Hampshire (NH) is split between non-rural and rural counties. Methods: We examined differences in COPD exacerbation rates ([encounters per county/county population of 35 years of age and older] × 100), length of stay (LOS), and total charges by rurality, determined by the 2013 National Center for Health Statistics rural-urban classification. Linear regression analysis determined the association of rural status on COPD outcomes, adjusting for age, gender, insurance status, and county-level smoking prevalence. Findings: A total of 15,916 encounters were analyzed, of which 5805 were inpatient and 10,111 were from the emergency department, 7058 (44%) were male, and the mean age was 65.6. A total of 31% were from large, fringe metro counties, 25.9% were from medium metro counties, 37.6% were from micropolitan counties, and 5.5% were from non-core counties. In multivariable regression, rural counties had higher COPD exacerbation rates compared to urban counties (non-core beta=0.18, [confidence interval (CI) 0.16, 0.20]; micropolitan beta=0.02, CI [0.01, 0.03]); medium metro counties (beta=-0.07, Cl [-0.09, -0.06]) had lower rates of COPD exacerbations (P < 0.001 for all). Compared to urban counties, encounters from rural counties had lower total charges (medium metro beta=-1695 [-2410, -980]; micropolitan beta=-2701 [-3315, -2088]; non-core beta=-4453 [-5646, -3260], all p<0.001). LOS did not differ by rurality. Conclusions: Accounting for poverty and other sociodemographic factors, the rates of COPD exacerbation encounters were higher in rural versus non-rural NH counties. Additionally, non-rural areas carried higher total charges, potentially due to more resource availability. These results support the need for future interventions to improve outcomes in rural COPD patients. 
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                Citation: Warner JS, Bryan JM, Paulin LM. The effect of rurality and poverty on COPD outcomes in New Hampshire: an analysis of statewide hospital discharge data. Chronic Obstr Pulm Dis. 2022; 9(4): 500-509. doi: http://dx.doi.org/10.15326/jcopdf.2022.0299
                
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        William Z. Zhang, MD1* Stephanie L. LaBedz, MD2* Janet T. Holbrook, PhD3 Andrew Gangemi, MD4 Ramasubramanian Baalachandran, MBBS5 Michelle N. Eakin, PhD, MD6 Robert A. Wise, MD6 Kaharu Sumino, MD, MPH7 for the American Lung Association Airways Clinical Research Centers. 
        
        
            Author Affiliations
 *Contributed equally as first authorDivision of Pulmonary and Critical Care Medicine, Joan and Sanford I. Weill Department of Medicine, Weill Cornell Medicine, New York, New York, United StatesDivision of Pulmonary, Critical Care, Sleep, and Allergy, University of Illinois at Chicago, Chicago, Illinois, United StatesCenter for Clinical Trials and Evidence Synthesis, Department of Epidemiology, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland, United StatesDepartment of Thoracic Medicine and Surgery, Lewis Katz School of Medicine at Temple University, Philadelphia, Pennsylvania, United StatesPulmonary and Critical Care Medicine, University of Vermont, Burlington, Vermont, United StatesDivision of Pulmonary and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, United StatesDivision of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Washington University School of Medicine, St. Louis, Missouri, United States 
            Address correspondence to:Janet T. Holbrook, PhD415 N. Washington Street
 Baltimore, MD 21231
 Phone: 443-287-5791
 Email: janet.holbrook@jhu.edu
 
            AbstractBackground: Patients with chronic obstructive pulmonary disease (COPD) are at higher risk for severe coronavirus disease 2019 (COVID-19). From the pandemic’s onset there has been concern regarding effects on health and well-being of high-risk patients. Methods: This was an ancillary study to the Losartan Effects on Emphysema Progression (LEEP) Trial and was designed to collect descriptive information longitudinally about the health and wellbeing of COPD patients who were enrolled in a clinical trial. Participants were interviewed by telephone about their health status every 2 weeks and their mental health, knowledge, and behaviors every 8 weeks from June 2020 to April 2021. There were no pre-specified hypotheses. Results: We enrolled 157 of the 220 participants from the parent LEEP trial. Their median age was 69 years, 55% were male, and 82% were White; median forced expiratory volume in 1 second (FEV1)% predicted was 48%. Nine confirmed COVID-19 infections were reported, 2 resulting in hospitalization. Rates of elevated anxiety or depressive symptoms were 8% and 19% respectively in June 2020 and remained relatively stable during follow-up. By April 2021, 85% of participants said they were “very likely” to receive a vaccine; 91% were vaccinated (≥1 dose) by the end of December 2021. Conclusion: Our select cohort of moderate to severe COPD patients who were well integrated into a health care network coped well with the COVID-19 pandemic. Few participants were diagnosed with COVID-19, levels of depression and anxiety were stable, most adopted accepted risk reduction behaviors, and did not become socially isolated; most were vaccinated by the end of 2021. 
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                Citation: Zhang WZ, LaBedz SL, Holbrook JT, et al; the American Lung Association Airways Clinical Research Centers. Impact of the coronavirus disease 2019 pandemic on physical and mental health of patients with COPD: results from a longitudinal cohort study conducted in the United States (2020-2021). Chronic Obstr Pulm Dis. 2022; 9(4): 510-519. doi: http://dx.doi.org/10.15326/jcopdf.2022.0287
                
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        Richard Casaburi, PhD, MD1 Debora Merrill, MBA2 Thomas E. Dolmage, MSc3 Judith Garcia-Aymerich, MD, PhD4,5,6 Malin Fageras, PhD7 Roger Goldstein, MD8 Gale Harding, MS9 Nancy Kline Leidy, PhD9 François Maltais, MD10 Denis O’Donnell, MD11 Janos Porszasz, MD, PhD1 Luis Puente-Maestu, PhD, MD12,13 Stephen Rennard, MD14 Frank Sciurba, MD15 Martijn A. Spruit, PhD, PT16 Ruth Tal-Singer, PhD2 Kay Tetzlaff, MD17,18 Alex van ’t Hul, PhD19 Ren Yu, MA9 Alan Hamilton, PhD2 
        
        
            Author Affiliations
 Rehabilitation Clinical Trials Center, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Torrance, California, United StatesCOPD Foundation, Miami, Florida, United StatesRespiratory Diagnostic and Evaluation Services and Respiratory Medicine, West Park Healthcare Centre, Toronto, CanadaISGlobal, Barcelona, SpainUniversitat Pompeu Fabra, Barcelona, SpainConsorcio de Investigación Biomédica en Red Epidemiología y Salud Pública, Madrid, SpainBiopharmaceuticals, Respiratory and Immunology, AstraZeneca, Gothenburg SwedenDepartment of Medicine and Rehabilitation Science, University of Toronto, Toronto, CanadaEvidera, Bethesda, Maryland, United StatesUniversité Laval, Quebec, CanadaRespiratory Investigation Unit, Department of Medicine, Queen's University and Kingston Health Sciences Centre, Kingston, Ontario, CanadaHospital General Universitario Gregorio Marañón Universidad, Madrid, SpainComplutense de Madrid-Medical School, Madrid, SpainDivision of Pulmonary, Critical Care and Sleep Medicine, Department of Internal Medicine, University of Nebraska Medical Center, Omaha, Nebraska, United StatesDivision of Pulmonary, Allergy and Critical Care Medicine, Department of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, United StatesDepartment of Research and Development, Ciro, Horn and Department of Respiratory Medicine, Maastricht University Medical Centre, Maastricht, NetherlandsBoehringer Ingelheim International GmbH, Ingelheim am Rhein, GermanyDepartment of Sports Medicine, University of Tübingen, Tübingen, GermanyDepartment of Respiratory Diseases, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, The Netherlands 
            Address correspondence to:Richard Casaburi, PhD, MDRehabilitation Clinical Trials Center
 The Lundquist Institute at Harbor UCLA Medical Center
 CDCRC Building
 1124 W. Carson St.
 Torrance, CA 90502
 Email: casaburi@ucla.edu
 Phone: (310) 222-8200
 
            AbstractIntroduction: The COPD Biomarkers Qualification Consortium (CBQC) was formed under COPD Foundation management, with the goal of qualifying biomarkers and clinical outcome assessments through established regulatory processes for chronic obstructive pulmonary disease (COPD). Within CBQC, a working group evaluated opportunities for qualification of an exercise endurance measure. In a recent publication (Chronic Obstr Pulm Dis. 2022; 9[2]:252-265), we described a conceptual framework establishing exercise endurance’s direct relationship to an individual with COPD’s experience of physical functioning in daily life, and that increase in exercise endurance is a patient-centered, meaningful treatment benefit. We further proposed endurance time during constant work rate cycle ergometery (CWRCE) as a useful efficacy endpoint in clinical therapeutic intervention trials. In this current publication, we describe the process of assembling an integrated database of endurance time responses to interventions in COPD. Methods: We sought participant-level data from published studies incorporating CWRCE as an outcome measure. A literature search screened 2993 publications and identified 553 studies for assessment. Two interventions had sufficient data across studies to warrant data extraction: bronchodilators and rehabilitative exercise training. Investigators were contacted and requested to provide participant-by-participant data from their published studies. Results: The final dataset included data from 8 bronchodilator studies (2166) participants and 15 exercise training studies (3488 participants). The database includes 71 variables per participant, comprising demographic, pulmonary function, and detailed physiologic response data. This paper provides a detailed description of the analysis population, while analysis supporting the validation/qualification process and addressing other scientific questions will be described in subsequent publications. 
            Citation
                
                
                Citation: Casaburi R, Merrill D, Dolmage T, et al. Endurance time during constant work rate cycle ergometry in COPD: development of an integrated database from interventional studies. Chronic Obstr Pulm Dis. 2022; 9(4): 520-537. doi: http://dx.doi.org/10.15326/jcopdf.2022.0331
                
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        Arianne K. Baldomero, MD, MS1,2,3 Ken M. Kunisaki, MD, MS1,2 Ann Bangerter, BS3 David B. Nelson, PhD3 Chris H. Wendt, MD1,2 Spyridon Fortis, MD4,5 Hildi Hagedorn, PhD3 R. Adams Dudley, MD, MBA1,2,3 
        
        
            Author Affiliations
 Pulmonary, Allergy, Critical Care, and Sleep Medicine, Minneapolis VA Health Care System, Minneapolis, Minnesota, United StatesPulmonary, Allergy, Critical Care, and Sleep Medicine, University of Minnesota, Minneapolis, Minnesota, United StatesCenter for Care Delivery and Outcomes Research, Minneapolis VA Health Care System, Minneapolis, Minnesota, United StatesPulmonary, Critical Care, and Occupational Medicine, University of Iowa Hospital and Clinics, Iowa City, Iowa, United StatesCenter for Access and Delivery Research and Evaluation, Iowa City VA Health Care System, Iowa City, Iowa, United States 
            Address correspondence to:Arianne K. Baldomero, MD, MSAssistant Professor of Medicine
 Minneapolis VA Health Care System
 Pulmonary, Critical Care, and Sleep (111N)
 One Veterans Drive, Minneapolis, MN, 55417
 Email: baldo004@umn.edu
 
            AbstractRationale: Many patients with suspected chronic obstructive pulmonary disease (COPD) do not undergo spirometry to confirm the diagnosis. Underutilization is often attributed to barriers to accessing spirometry. Objective: Our objective wasto identify factors associated with spirometry underutilization for patients who are less likely to face access barriers related to travel, insurance, and availability of spirometry. Methods: A retrospective analysis was conducted of patients enrolled in the Veterans Health Administration and living in urban areas with a new diagnosis of COPD between 2012 to 2015, reducing out-of-pocket cost and travel barriers, respectively. We included only patients whose primary care clinic was located in an academically affiliated tertiary level facility with spirometry available. We used logistic regression to estimate associations between patient characteristics and receipt of spirometry within 2 years before or after COPD diagnosis. Results: Of 24,300 patients, 59.7% had spirometry. Compared to patients <55 years, patients 75–84 years had an adjusted odds ratio (aOR) of undergoing spirometry of 0.80 (95% confidence interval [CI]:0.72–0.90), while patients ≥85 years had an aOR of 0.47 (95%CI: 0.40–0.54). Compared to patients with a Charlson Comorbidity Index (CCI) ≥3, patients with a CCI of 0 had an aOR of 0.60 (95%CI:0.54–0.67). Patients who had not seen a pulmonary specialist had lower odds of receiving spirometry (aOR 0.38 [95%CI:0.35–0.41]). Conclusion: Spirometry underutilization persists among patients who are less likely to have access barriers related to travel, insurance, and availability of spirometry. Spirometry underutilization is associated with older age, not having received pulmonary care, and having fewer comorbidities. COPD care quality initiatives will need to address these factors. 
            Citation
                
                
                Citation: Baldomero AK, Kunisaki KM, Bangerter A, et al. Beyond access: factors associated with spirometry underutilization among patients with a diagnosis of COPD in urban tertiary care centers. Chronic Obstr Pulm Dis. 2022; 9(4): 538-548. doi: http://dx.doi.org/10.15326/jcopdf.2022.0303
                
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        Radmila Choate, PhD, MPH1 Robert A. Sandhaus, MD, PhD2,3 Kristen E. Holm, PhD, MPH2,3 David M. Mannino, MD4 Charlie Strange, MD3,5 
        
        
            Author Affiliations
 College of Public Health, University of Kentucky, Lexington, Kentucky, United StatesDepartment of Medicine, National Jewish Health, Denver, Colorado, United StatesAlphaNet, Inc., Coral Gables, Florida, United StatesCollege of Medicine, University of Kentucky, Lexington, Kentucky, United StatesDivision of Pulmonary, Critical Care, Allergy and Sleep Medicine, Medical University of SouthCarolina, Charleston, South Carolina, United States
 
            Address correspondence to:Radmila Choate, PhD, MPHCollege of Public Health
 University of Kentucky
 Lexington, KY
 Phone: (859)218-2237
 E-mail: radmila.choate@uky.edu
 
            AbstractRationale: Identifying pulmonary exacerbations in patients with alpha-1 antitrypsin deficiency (AATD) is critical as they are associated with disease progression and poor health-related quality of life. Not all changes in usual respiratory symptoms will be identified as exacerbations by patients with AATD. Methods: Data collected via regular monthly telephone calls during the first year of the AlphaNet Step Forward Study were analyzed. AlphaNet subscribers were asked about changes in their usual respiratory symptoms, whether they considered changes in symptoms to be pulmonary exacerbations, and their management. Participants who reported changes in their usual respiratory symptoms throughout the year were included in the study. Per-patient and per-event analyses were performed. Results: Participants (n=316, age 58±10 years, 53% female) reported 797 events of changes in their usual respiratory symptoms in 1 year. Almost half (48%) of these symptom events were identified as pulmonary exacerbations by the study participants. The average number of symptoms was higher in events recognized by participants as exacerbations than those not identified as exacerbations (3.3±1.5 versus 1.8±1.1, respectively). A greater proportion of the exacerbation events were managed by taking antibiotics or corticosteroids or both (81%, 53%, and 41% of the events, respectively). With exacerbations, participants mainly spoke to the pulmonary specialist (39%) or went to the doctor's office (37%). Symptom events not recognized as exacerbations were mostly self-treated (56%). Conclusions: Changes in usual pulmonary symptoms are not universally recognized as exacerbations. Patients' perspectives in recognizing changes in pulmonary symptoms as exacerbation events are critical. 
            Citation
                
                
                Citation: Choate R, Sandhaus RA, Holm KE, Mannino DM, Strange C. Patient-reported pulmonary symptoms, exacerbations, and management in a cohort of patients with alpha-1 antitrypsin deficiency. Chronic Obstr Pulm Dis. 2022; 9(4): 549-561. doi: http://dx.doi.org/10.15326/jcopdf.2022.0317
                
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        Barbara P. Yawn, MD, MSc, MSPH1,2* Natalia Y. Loskutova, MD, PhD3* Debora D. Merrill, MBA2 Sergio Martinez2 Elisabeth Callen, PhD3 Janice Cotton, MA2 Jennifer K. Carroll, MD, MPH3,4 Dennis Williams, PharmD5 
        
        
            Author Affiliations
 *Affiliation at the time the study was conducted.Department of Family and Community Health, University of Minnesota, Minneapolis, Minnesota, United StatesCOPD Foundation, Miami, Florida, United StatesAmerican Academy of Family Physicians National Research Network, Leawood, Kansas, United StatesDepartment of Family Medicine, University of Colorado, Aurora, Colorado, United StatesDivision of Pharmacotherapy and Experimental Therapeutics, Eshelman School of Pharmacy, University of North Carolina, Chapel Hill, North Carolina, United States 
            Address correspondence to:Barbara P. Yawn, MD, MSc, MSPH1963 112th Circle NE
 Blaine, MN 55449
 Phone: (507) 261-3096
 Email: byawn47@gmail.com
 
            AbstractObjectives: The objective of this study was to assess health care professionals’ (HCPs) knowledge of an increased herpes zoster (HZ) risk and burden for patients with chronic obstructive pulmonary disease (COPD), HCPs’ familiarity with the Advisory Committee on Immunization Practices’ (ACIP) HZ vaccine recommendations, and the HCPs’ current adult vaccine practices. Another objective was to evaluate the impact of a short educational video on knowledge and future vaccine intent. Participants and Methods: An online survey of family physicians (FPs), pulmonologists, nurse practitioners (NPs), and physician assistants (PAs) querying demographics, awareness of ACIP HZ vaccine recommendations, and HZ burdens and risks in patients with COPD and their current recommendations for HZ, influenza, and pneumococcal vaccines was conducted. For those not strongly recommending HZ vaccines concordant with ACIP recommendations, a 5-minute educational video was presented, and post video questions assessed future intended HZ vaccine recommendations. Results: Among 1020 HCP responders, awareness and ACIP concordant HZ vaccine recommendations ranged from 59.0% to 95.2% across HCPs. Lowest recommendation rates were consistently reported by pulmonologists for the 2-dose HZ vaccine beginning at age 50; for the 2-dose vaccine use in those with prior 1-dose HZ vaccinations, and for those with prior HZ. Among all HCPs, HZ vaccine recommendations were lower than for pneumococcal and influenza vaccines. After viewing the educational video, reported vaccine recommendation intent increased significantly in all groups of HCPs, as did awareness of increased HZ risk among patients with COPD. Conclusions: Significant educational opportunities exist for HCPs related to HZ and its vaccine prevention among patients with COPD which may be responsive to brief, targeted interventions. 
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                Citation: Yawn BP, Loskutova NY, Merrill DD, et al. Health care professionals’ herpes zoster awareness and vaccine recommendations for patients with COPD. Chronic Obstr Pulm Dis. 2022; 9(4): 562-575. doi: http://dx.doi.org/10.15326/jcopdf.2022.0322
                
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        Abraham Bohadana, MD1 Ariel Rokach, MD1 Pascal Wild, PhD2 Bela Peker1 Yossi-Freier Dror, PhD3 Polina Babai3 Nissim Arish, MD1 Gabriel Izbicki, MD1 
        
        
            Author Affiliations
 Respiratory Research Unit, Pulmonary Institute, Department of Medicine, Shaare Zedek Medical Center and Faculty of Medicine, Hebrew University of Jerusalem, Jerusalem, IsraelPW Statistical Consulting, Laxou, FranceMashav Applied Research, Jerusalem, Israel 
            Address correspondence to:Abraham B. Bohadana, MDPulmonary Institute, Shaare Zedek Medical Center
 12 Bayit Street
 Jerusalem, Israel
 Phone: (972) (0) 58-437-8069
 Fax: (972) 02 6555686
 Email: abraham.bohadana@gmail.com
 
            AbstractBackground: Although smoking is the leading cause of chronic obstructive pulmonary disease (COPD), many patients with COPD smoke, highlighting the need for effective smoking cessation interventions in this population. This study examined the efficacy and safety of varenicline in increasing smoking cessation rates through "gradual" versus "abrupt" cessation in COPD patients with low motivation to quit smoking. Methods: A randomized, open label, 30-week, controlled trial (ClinicalTrials.gov identifier: NCT02894957) was conducted between January 2019 and October 2020 at a center in Israel. Smokers with COPD, poorly motivated to quit, were randomized to 6 weeks of varenicline for smoking reduction and a target quit day (TQD) at the end of week 6 (gradual cessation group) or ad libitum smoking for 5 weeks, 1 week of varenicline, and a TQD at the end of week 6 (abrupt cessation group). After the pre-quit phase, both groups received 12-week regular varenicline treatment and 12-week follow-up. Primary outcome was biochemically-validated continuous abstinence for weeks 6–30. Secondary outcomes were: (1) biochemically-confirmed7-day point prevalence abstinence for weeks 4–30, (2) efficient smoking reduction (≥50% in number of cigarettes/day) in the pre-quit phase; and (3) number of cigarettes/day, motivation to quit, and changes in respiratory symptoms and spirometry from baseline through week 30. Results: A drug recall issued by the study sponsor stopped the study after 70/242 (28.9%) patients had been enrolled. The gradual cessation group (n=29) had significantly higher continuous abstinence rates from TQD through week 30 versus the abrupt cessation group (n=41): 20.7% versus 4.9% (odds ratio [OR]=5.09; 95% confidence interval [CI] 0.89-29.17; p=0.048) and higher 7-day point prevalence abstinence levels at all time points but week 18 (p=0.027 at week 6, 0.056 at week 7, and 0.096 at week 9). Motivation to quit increased (p=0.002) and the number of cigarettes/day decreased (p=0.002) over time in both groups. Respiratory symptoms, but not spirometry, improved in both groups at week 30. Treatment was safe and well tolerated. Conclusions: In poorly motivated smokers with COPD, using varenicline for a 6-week gradual smoking cessation before TQD, compared with abrupt cessation, significantly increased quit rates up to 6 months. Results were not affected by the smaller-than-expected sample size. Further studies are needed to confirm these data. 
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                Citation: Bohadana A, Rokach A, Wild P, et al. Varenicline for gradual versus abrupt smoking cessation in poorly motivated smokers with COPD: a prematurely terminated randomized controlled trial. Chronic Obstr Pulm Dis. 2022; 9(4): 486-499. doi: http://dx.doi.org/10.15326/jcopdf.2022.0305
                
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