Author Affiliations

1. Strategic Consulting, AESARA, Inc., Chapel Hill, North Carolina
2. Department of Pharmaceutical Outcomes and Policy, University of North Carolina, Chapel Hill
3. Health Economics and Outcomes Research, Optum Inc., Eden Prairie, Minnesota

Address correspondence to:

Richard H. Stanford, PharmD, MS
Strategic Consulting
AESARA, Inc.
Chapel Hill, NC
Email: richard@aesara.com
Phone: (919) 602-0283

Abstract

Background: Population-based risk assessments are needed to identify individuals who may benefit from chronic obstructive pulmonary disease (COPD) management programs for preventing exacerbations. This study compared the validated COPD treatment ratio (CTR) versus other COPD exacerbation predictors: prior exacerbation and rescue and maintenance medication use.

Methods: A retrospective observational study using medical and pharmacy claims data among Medicare Advantage with Part D beneficiaries with COPD (January 2011–August 2016). Unadjusted and adjusted logistic regression models tested the predictive performance (C-statistic) of potential exacerbation predictors for future severe exacerbations.

Results: The unadjusted association between exacerbation predictors and severe exacerbation was examined in 60,776 patients: baseline severe exacerbation had the highest C-statistic (0.668), then number of rescue units dispensed (0.651), CTR (0.619), and number of controller units dispensed (0.562). During the at-risk period, baseline CTR was inversely associated with severe exacerbation (odds ratio, <1.0); other predictors were positively associated with a severe exacerbation (odds ratio, >1.0). Adjusting for age, geographic region, chronic oxygen, and nebulizer use, the severe exacerbation odds were 0.90 (95% confidence interval [CI], 0.89–0.91) lower per 0.10 change in CTR (C-statistic, 0.710). The C-statistic was 0.734 when baseline exacerbation was added to the model.

Conclusions: The CTR is an effective tool for identifying patients diagnosed with COPD who are at increased risk of severe exacerbation. Although CTR does not predict future exacerbation as well as prior severe exacerbation history, it has the advantage of being applicable in predicting future exacerbations in patients without an exacerbation history, or in databases limited to pharmacy claims only. In addition, the significant reduction in risk has been observed with incremental increases in the ratio: the ratio can be monitored to assess COPD health improvements over time.

Citation

Citation: Stanford RH, Korrer S, Brekke L, Reinsch T, Bengston LGS. Validation and assessment of the COPD treatment ratio as a predictor of severe exacerbations.

Keywords

copd, chronic obstructive pulmonary disease, COPD exacerbation, COPD treatment ratio, CTR, maintenance medication, rescue inhaler

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Author Affiliations

1. Research, COPD Foundation, Inc., Washington, DC
2. University of Kentucky College of Public Health, Lexington
3. Tulane University School of Medicine, New Orleans, Louisiana
4. University of Illinois at Chicago
5. Kaiser Permanente Center for Health Research, Portland, Oregon

Address correspondence to:

Radmila Choate, PhD, MPH
University of Kentucky College of Public Health
111 Washington Avenue, Room 215B
Lexington, KY 40536
Phone: 859-218-2237
Email: Radmila.choate@uky.edu

Abstract

Rationale: Cough and phlegm are common symptoms of chronic obstructive pulmonary disease (COPD) and may significantly affect quality of life. This study assessed the burden of cough and phlegm on clinical outcomes and quality of life among people with a self-reported physician diagnosis of COPD.

Methods: Patient-reported data from the COPD Foundation’s Patient-Powered Research Network (COPD PPRN) were utilized. Cough and phlegm severity and frequency were assessed by responses to questions on the COPD Assessment Test (CAT) and categorized into none/low, moderate and severe. Quality of life domains were evaluated using the Patient-Reported Outcome Measurement Information System (PROMIS-29). Associations between cough and phlegm levels and PROMIS-29 domains were examined using multivariate analysis of variance (MANOVA).

Results: The 5286 participants were average age 64.4 years (SD=11.4), 87.9% white, 60.4% female, 51.2% married, and 42.2% with caregivers. Approximately three-fourths of the participants had moderate or severe cough or phlegm levels. Respondents with moderate and high cough or phlegm had significantly worse dyspnea (p<0.0001), more exacerbations in the previous one year (p<0.0001), worse physical and social functioning, and more symptoms of anxiety and depression on PROMIS-29 compared to those with no/low cough and phlegm.

Conclusions: In this group of people with COPD, higher levels of cough and phlegm are associated with worse clinical and quality of life outcomes.

Citation

Citation: Choate R, Pasquale CB, Parada NA, Prieto-Centurion V, Mularski RA, Yawn BR.The burden of cough and phlegm in people with COPD: a COPD Patient-Powered Research Network study.

Keywords

chronic obstructive pulmonary disease, patient-reported outcomes, symptom burden, COPD, cough, phlegm, PROMIS-29

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Author Affiliations

1. U.S. Value Evidence and Outcomes, GlaxoSmithKline plc., Research Triangle Park, North Carolina
2. Value Evidence and Outcomes, GlaxoSmithKline plc., Uxbridge, United Kingdom
3. Optum, Eden Prairie, Minnesota

Address correspondence to:

Maggie Tabberer, MSc
Value Evidence and Outcomes
GlaxoSmithKline
R&D Stockley Park
Uxbridge, UB11 1BT, United Kingdom
Email: margaret.x.tabberer@gsk.com
Tel: +44 208 990 2041

Abstract

Rationale: Uptake of the COPD Assessment Test (CAT^TM) is not yet widespread in patients with chronic obstructive pulmonary disease (COPD) within U.S. primary care and its alignment with other assessments has not been evaluated in U.S. clinical practice.

Objectives: To assess the alignment of the CAT with other standard measures of COPD severity and its usability in a U.S. primary care population.

Methods: This was a multicenter, prospective, observational, longitudinal study of patients with COPD and their primary care physicians. Patients with spirometry-confirmed airflow restriction completed a daily electronic diary (eDiary) over 12 weeks; surveys were also administered at baseline and at 6- and 12-week follow-up.

Measurements and Main Results: In the study population (n=178), statistically significant differences (P&lt;0.05) were found across 4 CAT impact score groups where at all time points patients in the Low Impact CAT score group had superior lung function and physical/mental health status than patients in the Medium, High, and Very High Impact groups. Numerical, though lesser, differences were also found across these latter 3 groups. Furthermore, the average total EXAcerbations of COPD Tool (EXACT®) score was significantly worse in patients in the highest CAT score group over the first 7 days.

Conclusions: COPD severity; respiratory symptoms; frequency, severity, and duration of pulmonary exacerbations; and overall physical and mental health status are linked concurrently and prospectively to CAT impact score categories. The stratification of patients according to CAT impact scores, and application of clinical and functional health status information to these categories, enhances the usability of the CAT in practice settings for COPD management.

Citation

Citation: Stanford RH, Tabberer M, Kosinski MA, et al. Assessment of the COPD Assessment test within U.S. primary care.

Keywords

chronic obstructive pulmonary disease, COPD Assessment Test, EXACT, primary health care, communication, EXacerbations of COPD Tool

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Author Affiliations

1. Channing Division of Network Medicine, Brigham and Women’s Hospital, Boston, Massachusetts
2. Arasila Biotech, San Diego, California
3. Division of Pulmonary and Critical Care Medicine, Johns Hopkins University, Baltimore, Maryland

Address correspondence to:

Craig P. Hersh, MD, MPH
Channing Division of Network Medicine
Brigham and Women’s Hospital
181 Longwood Ave
Boston, MA 02115
Phone: 617-525-0729
Email: craig.hersh@channing.harvard.edu

Abstract

Asthma-COPD overlap (ACO) is a common clinical syndrome, yet there is no single objective definition. We hypothesized that immunoglobulin E (IgE) measurements could be used to refine the definition of ACO. In baseline plasma samples from 2870 participants in the COPD Genetic Epidemiology (COPDGene^®) study, we measured total IgE levels and specific IgE levels to 6 common allergens. Compared to usual chronic obstructive pulmonary disease (COPD), participants with ACO (based on self-report of asthma) had higher total IgE levels (median 67.0 versus 42.2 IU/ml) and more frequently had at least one positive specific IgE (43.5% versus 24.5%). We previously used a strict definition of ACO in participants with COPD, based on self-report of a doctor’s diagnosis of asthma before age 40. This strict ACO definition was refined by the presence of atopy, determined by total IgE > 100 IU/ml or at least one positive specific IgE, as was the broader definition of ACO based on self-reported asthma history. Participants with all 3 ACO definitions were younger (mean age 60.0–61.3 years), were more commonly African American (36.8%–44.2%), had a higher exacerbation frequency (1.0–1.2 in the past year), and had more airway wall thickening on quantitative analysis of chest computed tomography (CT) scans. Among participants with ACO, 37%–46% did not have atopy; these individuals had more emphysema on chest CT scan. Based on associations with exacerbations and CT airway disease, IgE did not clearly improve the clinical definition of ACO. However, IgE measurements could be used to subdivide individuals with atopic and non-atopic ACO, who might have different biologic mechanisms and potential treatments.

Citation

Citation: Hersh CP, Zacharia S, Prakash R, et al and the COPDGene Investigators. Immunoglobulin E as a biomarker for the overlap of atopic asthma and chronic obstructive pulmonary disease.

Keywords

chronic obstructive pulmonary disease, asthma, atopy, chest CT scan, immunoglobulin E

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Author Affiliations

1. Medical Innovation, Value Evidence and Outcomes, GlaxoSmithKline, Collegeville, Pennsylvania
2. Epidemiology, Value Evidence and Outcomes, GlaxoSmithKline, Middlesex, United Kingdom
3. Quantitative Sciences and Statistics, GlaxoSmithKline, Collegeville, Pennsylvania
4. Quantitative Sciences and Statistics, GlaxoSmithKline, Stevenage, United Kingdom
5. National Institute for Health Research, Nottingham Biomedical Research Centre, Respiratory Theme and Department of Respiratory Medicine, University of Nottingham, School of Medicine, City Hospital, Nottingham University Hospitals National Health Service Trust Campus, Nottingham, United Kingdom
6. Department of Cardiology, Wales Heart Research Institute, Cardiff University, Cardiff, United Kingdom
7. Medical Research Council Centre for Inflammation Research, University of Edinburgh, Edinburgh, United Kingdom
8. University of Cambridge, Division of Experimental Medicine and Immunotherapeutics, Addenbrooke’s Hospital, Cambridge, United Kingdom
9. National Institute for Health Research, Respiratory Biomedical Research Unit, Royal Brompton & Harefield National Health Service Foundation Trust and Imperial College, London, United Kingdom

*These authors contributed equally to this manuscript as joint first authors.
**These authors contributed equally to this manuscript as joint last authors.

Address correspondence to:

Victoria S. Benson, PhD
Phone: 020 89903306
Email: victoria.x.tribble@gsk.com

Abstract

Objective: To identify phenotypic factors associated with the Short Physical Performance Battery (SPPB) and its individual sub-tests: standing balance, 4‑meter gait speed (4mGS) and 5-repetition sit-to-stand (5STS).

Methods: The Evaluation of the Role of Inflammation in non-pulmonary disease manifestations in Chronic Airways disease (ERICA) study recruited adult participants with stable chronic obstructive pulmonary disease (COPD). Proportional odds models identified factors associated with the SPPB, and a principal component analysis (PCA) evaluated how much SPPB variance was explainable by each of its 3 sub-tests.

Results: Of 729 enrolled participants, 717 (60% male, mean age 67 years) had full SPPB data. Overall, 76% of patients had some evidence of functional limitations (SPPB total score < 12). Scores < 4 were observed in 71%, 31%, and 22% of participants for the 5STS, 4mGS, and balance sub-tests, respectively. A longer 6-minute walk test and greater quadriceps maximal voluntary contraction decreased the odds of being in a lower score category for SPPB total score and for all 3 sub-tests. Aging, self-reported hypertension and higher dyspnea increased the odds, and being married decreased the odds of being in a lower category for total score. All sub-tests contributed equally to total score.

Conclusion: Each of the 3 sub-tests contributed independent information to the SPPB, demonstrating their usefulness for assessing COPD when considered together rather than individually. The 5STS sub-test had the greatest variation in scores and may thus have the best discriminatory power for clinical COPD studies of lower limb performance where only one SPPB test is feasible.

Citation

Citation: Mohan D, Benson VS, Allinder M, et al. Short physical performance battery: what does each sub-test measure in patients with chronic obstructive pulmonary disease? Chronic Obstr Pulm Dis. 2020; 7(1):In press. doi: http://dx.doi.org/10.15326/jcopdf.7.1.2019.0144

Keywords

copd, chronic obstructive pulmonary disease, cross-sectional study, Short Physical Performance Battery test, 4-meter gait speed, 5-repetition sit-to-stand

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