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Folarin Sogbetun, MD1 William L. Eschenbacher, MD1,2 Jeffrey A. Welge, PhD3 Ralph J. Panos, MD1,2
Author Affiliations
- Division of Pulmonary, Critical Care, and Sleep Medicine, Cincinnati, Veterans Affairs Medical Center Cincinnati, Ohio
- Division of Pulmonary, Critical Care, and Sleep Medicine, Cincinnati, University of Cincinnati College of Medicine, Cincinnati, Ohio
- Department of Psychiatry & Behavioral Neuroscience, Department of Environmental Health (Division of Biostatistics and Bioinformatics), University of Cincinnati College of Medicine, Cincinnati, Ohio
Address correspondence to:
Ralph J. Panos, MD
Department of Medicine
Division of Pulmonary, Critical Care and Sleep Medicine,
Cincinnati Veteran Affairs Medical Center
3200 Vine Street,
Cincinnati, OH 45220
Phone: (513)475-6317
Email: ralph.panos@va.gov
Abstract
Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity and mortality within the Veterans Healthcare Administration (VHA) and is frequently under-diagnosed. We developed the Veterans Airflow Screening Questionnaire (VAFOSQ) to improve the identification of Veterans with airflow obstruction (AFO), the most commonly used criterion for the diagnosis of COPD.We created an initial survey with 78 variables that have been associated with AFO. A total of 825 patients in 3 primary care clinics performed spirometry after bronchodilator administration and completed the initial survey. Best sets regression was used to build a model that predicted AFO optimally. A total of 195 of 825 (23.3%) patients had AFO and 7 items positively predicted AFO. When the questionnaire score was greater than 25, the VAFOSQ accurately identified AFO with an area under the receiver operating curve of 0.72. In a prospective validation cohort of 376 participants, the positive predictive value was 32% and negative predictive value 81%. The VAFOSQ is a reliable and valid instrument for the identification of veterans at risk for AFO who would benefit from further evaluation with spirometry and assessment for COPD. The VAFOSQ is straightforward to use and can be easily self-administered and self-scored enabling widespread application within the VHA.
Citation
Citation: Sogbetun F, Eschenbacher WL, Welge JA, Panos RJ. Veterans airflow obstruction screening questionnaire: A survey to identify veterans with airflow obstruction. Chronic Obstr Pulm Dis (Miami). 2016; 3(4): 705-715. doi: http://dx.doi.org/10.15326/jcopdf.3.4.2016.0128
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Gary T. Ferguson, MD1 Angel Fowler Taylor, BSc, Pharm2 Chau Thach, PhD2 Qian Wang, PhD3 Agnes A. Schubert-Tennigkeit, MD4 Francesco Patalano, MD4 and Donald Banerji, MD2
Author Affiliations
- Pulmonary Research Institute of Southeast Michigan-Farmington Hills
- Novartis Pharmaceuticals Corporation, East Hanover, New Jersey
- Beijing Novartis Pharma Co. Ltd., Shanghai, China
- Novartis Pharma AG, Basel, Switzerland
Address correspondence to:
Gary T. Ferguson, MD
Pulmonary Research Institute of Southeast Michigan
29255 West 10 Mile Road, Suite A
Farmington Hills, Michigan 48336
E-mail: garytferguson@msn.com
Phone: (248) 350-2722
Abstract
Background: The objective of the FLIGHT3 study was to evaluate the long-term safety and efficacy of indacaterol/glycopyrrolate* (IND/GLY) versus an active comparator, IND, in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD) over 52 weeks.
Method: FLIGHT3 was a multicenter, randomized, double-blind, parallel-group, 52-week study. Patients were randomized (1:1:1) to IND/GLY (27.5/15.6 or 27.5/31.2 µg twice daily [b.i.d.]) or IND (75 µg once daily [o.d.]), delivered via the Neohaler® device. The primary objective was to evaluate the long-term safety and tolerability of IND/GLY versus IND in terms of adverse event (AE)-reporting rates in patients with moderate-to-severe COPD over 52 weeks. The secondary objective was to evaluate the long-term efficacy of IND/GLY versus IND in terms of pre-dose trough forced expiratory volume in 1 second (FEV1) and post-dose 1-h FEV1 over 52 weeks.
Results: A total of 85.2% patients completed the study treatment. The overall incidence of AEs (and SAEs) was similar between treatments. Major adverse cardiovascular events (MACE) and/or cardiovascular (CV) events were comparable between treatment groups. The rate of discontinuation of the study treatment due to AEs was lower for IND/GLY than IND. Improvements in pre-dose trough FEV1 and post-dose 1-h FEV1 were consistently superior with IND/GLY than with IND over 52 weeks, demonstrating long-term maintenance of lung function.
Conclusions: IND/GLY demonstrated a favorable long-term safety and tolerability profile and provided effective bronchodilation, with maintenance of lung function over 52 weeks in patients with moderate-to-severe COPD. These data support the safety and efficacy of IND/GLY as a treatment option for COPD.
Trial registration: ClinTrials.gov identifier NCT01682863
*Glycopyrrolate 15.6 µg (excluding the bromide salt) is equivalent to 12.5 µg glycopyrronium
Citation
Citation: Ferguson GT, Taylor AF, Thach C, et al. Long-term maintenance bronchodilation with indacaterol/glycopyrrolate versus indacterol in modertate-to-severe COPD patients: The Flight3 study. Chronic Obstr Pulm Dis (Miami). 2016; 3(4): 716-728. doi: http://dx.doi.org/10.15326/jcopdf.3.4.2016.0131
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Gregory L. Kinney, MPH, PhD1 Emma H. Baker, MRCP, PhD2 Oana L. Klein, MD, MS3 Jennifer L. Black-Shinn, MPH, PhD1 Emily S. Wan, MD4 Barry Make, MD5 Elizabeth Regan, MD, PhD5 Russell P. Bowler, MD, PhD5 Sharon M. Lutz, PhD6 Kendra A. Young, PhD1 Lindsey M. Duca, MS1 George R. Washko, MD7 Edwin K. Silverman, MD, PhD4 James D. Crapo, MD5 John E. Hokanson, MD, PhD1 and the COPDGene Investigators
Author Affiliations
- Department of Epidemiology, Colorado School of Public Health, University of Colorado Anschutz Medical Campus
- St. George’s, University of London, United Kingdom
- Department of Medicine, University of California-San Francisco
- Channing Division of Network Medicine, Brigham and Women’s Hospital, Boston, Massachusetts
- National Jewish Health and University of Colorado-Denver
- Department of Biostatistics, Colorado School of Public Health, University of Colorado Anschutz Medical Campus
- Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts
Address correspondence to:
Gregory L Kinney, MPH, PhD
Department of Epidemiology
Colorado School of Public Health
University of Colorado Denver
13001 East 17th Avenue
Room W3141A, Campus Box B-119
Aurora, CO 80045
Telephone: 303-724-4437
Email: Greg.Kinney@UCDenver.edu
Abstract
Background: Diabetes mellitus and its complications are a large and increasing burden for health care worldwide. Reduced pulmonary function has been observed in diabetes (both type 1 and type 2), and this reduction is thought to occur prior to diagnosis. Other measures of pulmonary health are associated with diabetes, including lower exercise tolerance, greater dyspnea, lower quality of life (as measured by the St. George’s Respiratory Questionaire [SGRQ]) and susceptibility to lung infection and these measures may also predate diabetes diagnosis.
Methods: We examined 7080 participants in the COPD Genetic Epidemiology (COPDGene) study who did not report diabetes at their baseline visit and who provided health status updates during 4.2 years of longitudinal follow-up (LFU). We used Cox proportional hazards modeling, censoring participants at final LFU contact, reported mortality or report of incident diabetes to model predictors of diabetes. These models were constructed using known risk factors as well as proposed markers related to pulmonary health, forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), FEV1/FVC, respiratory exacerbations (RE), 6-minute walk distance (6MWD), pulmonary associated quality of life (as measured by the SGRQ), corticosteroid use, chronic bronchitis and dyspnea.
Results: Over 21,519 person years of follow-up, 392 of 7080 participants reported incident diabetes which was associated with expected predictors; increased body mass index (BMI), high blood pressure, high cholesterol and current smoking status. Age, gender and accumulated smoking exposure were not associated with incident diabetes. Additionally, preserved ratio with impaired spirometry (PRISm) pattern pulmonary function, reduced 6MWD and any report of serious pulmonary events were associated with incident diabetes.
Conclusions: This cluster of pulmonary indicators may aid clinicians in identifying and treating patients with pre- or undiagnosed diabetes.
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Marie Topp, PhD1 Jørgen Vestbo, DMSc2 Erik Lykke Mortensen, MS3
Author Affiliations
- Department of Respiratory Medicine, Hvidovre Hospital, Denmark
- Respiratory and Allergy Research Group, Manchester Academic Health Science Centre, University Hospital South Manchester, NHS Foundation Trust, Manchester, United Kingdom
- Department of Public Health and Center for Healthy Aging, University of Copenhagen, Denmark
Address correspondence to:
Marie Topp, PhD
Kettegaard Alle 30
2650 Hvidovre, Denmark
E-mail: marie_topp@hotmail.com
Phone: +45 61463089
Abstract
Background: Understanding non-adherence in patients with chronic obstructive pulmonary disease (COPD) remains challenging. The necessity and the concerns scales of the Beliefs about Medicines Questionnaire (BMQ) are known to correlate with adherence behavior in several chronic diseases including asthma but less is known about COPD. In the present study a COPD-specific BMQ (BMQ-COPD) was translated and administered to Danish COPD outpatients. Our aim was to derive high-quality measures of the 2 dimensions included in the BMQ-COPD.
Methods: A total of 168 patients with COPD were included from a Danish respiratory outpatient clinic. The Rasch model was used to evaluate psychometric characteristics of the BMQ-COPD and to obtain necessity and concerns scales fulfilling criteria of unidimensionality and overall fit, and with all items showing individual item fit with no local dependencies, and no differential item functioning. Further, we explored the association with disease-related variables and subsequent adherence behavior.
Results: Shortened versions of the original necessity and concerns scales fitted the Rasch model and were at least as good as the original scales as predictors of adherence, although only the necessity scale was significantly associated with adherence.
Conclusion: In a Danish COPD setting high-quality measures of necessity and concerns could be derived from the BMQ-COPD. The excluded items appear to reflect other dimensions.
Citation
Citation: Topp M, Vestbo J, Mortensen EL. Psychometric properties of the COPD-specific Beliefs about Medicine Questionnaire in an outpatient population: A Rasch-analysis. Chronic Obstr Pulm Dis (Miami). 2016; 3(4): 748-757. doi: http://dx.doi.org/10.15326/jcopdf.3.4.2016.0134
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Donald A. Mahler, MD1 Dorothy L. Keininger, MSc2 Karen Mezzi, MD2 Robert Fogel, MD3 Donald Banerji, MD3
Author Affiliations
- Professor Emeritus, Geisel School of Medicine at Dartmouth, Hanover, New Hampshire
- Novartis Pharma AG, Basel, Switzerland
- Novartis Pharmaceuticals Corporation, East Hanover, New Jersey
Address correspondence to:
Donald A. Mahler, MD
Valley Regional Hospital
243 Elm Street
Claremont, NH 03743
Tel: (603) 277-0383
Fax: (603) 542-6731
Email: mahlerdonald@gmail.com
Abstract
Introduction: The Global initiative for chronic Obstructive Lung Disease (GOLD) recommends treating patients with chronic obstructive pulmonary disease (COPD) based on a combined assessment of symptom severity and airflow limitation and/or exacerbation risk. According to GOLD, patients with mild-to-moderate airflow limitation and distressing symptoms such as dyspnea should be treated with a long-acting beta2-agonist (LABA) or a long-acting muscarinic antagonist (LAMA). If symptoms persist on monotherapy, GOLD recommends a combination of bronchodilators (LABA/LAMA).
Methods: We performed a post-hoc analysis of data from two 26-week, prospective clinical trials to investigate the effect of treating patients with moderate-to-severe dyspnea with the once-daily LABA/LAMA combination indacaterol/glycopyrronium (IND/GLY) 110/50 µg compared with placebo, once-daily tiotropium 18 µg, and twice-daily salmeterol/fluticasone propionate (SFC) 50/500 µg. In this analysis, a Baseline Dyspnea Index (BDI) score ≤7 was used to identify dyspneic patients.
Results: In dyspneic patients, IND/GLY significantly improved Transition Dyspnea Index (TDI) total scores compared with tiotropium (0.59 units; p<0.05) and SFC (0.97 units; p<0.05), and significantly increased the likelihood of a patient achieving a 1-unit improvement in TDI compared with tiotropium (odds ratio [OR] 1.87; p<0.05). IND/GLY also significantly improved trough forced expiratory volume in 1 second (FEV1) compared with tiotropium and SFC (p<0.001 and p<0.0001, respectively), and significantly reduced rescue medication use compared with tiotropium (p<0.001).
Conclusions: Our analysis indicates that IND/GLY provides additional improvements in dyspnea and lung function compared with tiotropium and SFC in dyspneic patients.
Citation
Citation: Mahler DA, Keininger DL, Mezzi K, Fogel R, Banerji D. Efficacy of indacaterol/glycopyrronium in patients with COPD who have increased dyspnea with daily activities. Chronic Obstr Pulm Dis (Miami). 2016; 3(4): 758-768. doi: http://dx.doi.org/10.15326/jcopdf.3.4.2016.0138
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Bruce G. Bender, PhD1 Ann Depew, MA2 Amanda Emmett4 Kelly Goelz, MA2 Barry Make, MD2 Sanjay Sharma, Bsc4 Jennifer Underwood2 David Stempel, MD3
Author Affiliations
- Departments of Pediatrics, National Jewish Health, Denver, Colorado
- Department of Medicine, National Jewish Health, Denver, Colorado
- GlaxoSmithKline, Research Triangle Park, North Carolina
- Former employee, GlaxoSmithKline
Address correspondence to:
Bruce G. Bender, Ph.D.
National Jewish Health
1400 Jackson Street
Denver, Colorado 80206
303-398-1697
Email: BenderB@njhealth.org
Abstract
Background: Pulmonary rehabilitation programs improve dyspnea and health status associated with chronic obstructive pulmonary disease (COPD), but benefits wane when patients return to a sedentary lifestyle. This study tested a simple, low-resource, low-cost home walking program.
Methods: In this single center, 3-month study, 115 COPD patients were randomized to a control cohort or a goal setting cohort. Each patient met with study staff and received 5 telephone calls at 2-week intervals. During these contacts, the Goal group was assisted by a wellness coach who helped them set personal activity goals. All patients wore a pedometer to record daily steps, the primary study outcome.
Results: Over the 12-week interval, the average step-per-days was 36% higher for the Goal cohort patients (Week 12 mean = 4390) than for Control patients (mean = 3790). No group differences emerged on the modified Medical Research Council (mMRC) dyspnea scale, the COPD Assessment Test, or the St. George’s Respiratory Questionnaire. Secondary analyses indicated that even patients with greater disease severity, including those with an mMRC score >2 or forced expiratory volume in 1 second (FEV1) % predicted below 50%, increased their walking relative to Control patients. Almost half (48%) of Goal patients successfully reached at least one personal goal such as increasing stamina and activity, or decreasing shortness of breath or weight.
Conclusions: A relatively low-resource wellness coaching, goal-setting intervention resulted in a small improvement in the activity level of COPD patients over a 12-week period including those with marked pulmonary impairment. Further investigation should be directed at understanding the optimal blend of in person and remote coaching needed to produce the greatest cost-to-benefit ratio.
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Jacob E. Simmering, MS1 Linnea A. Polgreen, PhD1 Alejandro P. Comellas, MD2 Joseph E. Cavanaugh, PhD3 Philip M. Polgreen, MD, MPH2
Author Affiliations
- University of Iowa, Department of Pharmacy Practice and Science, Iowa City
- University of Iowa, Department of Internal Medicine, Iowa City
- University of Iowa, Department of Biostatistics, Iowa City
Abstract
Background: Readmission within 30 days of a COPD hospitalization is a common measure of performance for COPD care. However, most studies of COPD readmission risk have been constrained to a single data source, private payer claims, or Medicare claims data, making it difficult to generalize results from these studies to other populations. The purpose of this study was to examine the risk for readmission within 30 days from time of discharge in patients with COPD using the Healthcare Cost and Utilization Project (HCUP) State Inpatient Database for California for the years 2005-2011. This statewide dataset allows us to consider all readmissions for COPD regardless of age or payer status.
Methods: The total dataset included 28,265,070 visits among 17,918,374 patients over 480 hospitals. We identified patients with a hospitalization, a primary diagnosis related to COPD, age 40 or older, and discharged alive. We found 286,313 hospitalizations that matched this definition and included information on covariates such as comorbidities, age, and insurance status. To characterize the joint associations of these covariates with readmission within 30 days, we used a generalized linear model.
Results: Patients aged 40-64 are more likely to be readmitted to the hospital within 30 days of a COPD-related hospitalization than patients 65 and older. This effect persists after adjustment for patient severity, comorbidities, payer, and demographics.
Our model featured an interaction of age with insurance type. We found that younger patients (aged 40-64) on public insurance have the highest readmission rates: 14.77% for Medicare and 16.27% for Medicaid. However, younger patients with private insurance have the lowest readmission rates at 8.25%. Additional significant covariates included whether or not the patient left against medical advice, and diagnoses of congestive heart failure and diabetes.
In addition, we found that although admissions for COPD were highest in the winter, this is not true for COPD readmissions, which peak in summer. Also, inpatient mortality for patients admitted for COPD decreased from approximately 3% to 1.25% over the study period.
Conclusion: Our results demonstrate that many of the risk factors for readmission may be dependent on the data source used. Furthermore, many of the strongest predictors are clearly related to the patients themselves. This observation may help explain why prior programs to reduce readmissions have had limited success.
Citation
Citation: Simmering JE, Polgreen LA, Comellas AP, Cavanaugh JE, Polgreen PM. Identifying patients with COPD at high risk of readmission. Chronic Obstr Pulm Dis (Miami). 2016; 3(4): 729-738. doi: http://dx.doi.org/10.15326/jcopdf.3.4.2016.0136
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