Abstract
Background
This study tested the properties of a Spanish translation of CAPTURE (COPD Assessment in Primary Care To Identify Undiagnosed Respiratory Disease and Exacerbation Risk) with selective use of peak expiratory flow (PEF).
Methods
: This study comprised analyses of data from the Spanish-speaking cohort of the cross-sectional, case-control study used to develop CAPTURE. Translation procedures included forward and backward translation, reconciliation, and cognitive interviewing to assure linguistic and cultural equivalence, yielding CAPTURE-S. Spanish-speaking participants were recruited through one center and designated as case subjects (clinically significant COPD: FEV1 ≤ 60% predicted and/or at risk of COPD exacerbation) or control subjects (no or mild COPD). Subjects completed a questionnaire booklet that included 44 candidate items, the COPD Assessment Test (CAT), and the modified Medical Research Council (mMRC) dyspnea question. PEF and spirometry were also performed.
Results
The study included 30 participants (17 case subjects and 13 control subjects). Their mean (± SD) age was 62.6 (11.49) years, and 33% were male. CAPTURE-S scores were significantly correlated with PEF (r = –0.78), the FEV1/FVC ratio (r = –0.74), FEV1 (r = –0.69), FEV1 % predicted (r = –0.69), the CAT score (r = 0.70), and the mMRC dyspnea question (r = 0.59) (P < .0001), with significantly higher scores in case subjects than in control subjects (t = 6.16; P < .0001). PEF significantly correlated with FEV1 (r = 0.89), FEV1 % predicted (r = 0.79), and the FEV1/FVC ratio (r = 0.75) (P < .0001), with significantly lower PEF in case subjects than in control subjects (t = 5.08; P < .0001). CAPTURE-S score + PEF differentiated case subjects and control subjects with a sensitivity of 88.2% and a specificity of 92.3%.
Conclusions
CAPTURE-S with selective use of PEF seems to be useful for identifying Spanish-speaking patients in need of diagnostic evaluation for clinically significant COPD who may benefit from initiation of COPD treatment.
Trial Registry
ClinicalTrials.gov; No.: NCT01880177; URL: www.clinicaltrials.gov.
Key Words: case-finding, COPD, diagnosis, lung function
Abbreviations: CAPTURE, COPD Assessment in Primary Care to Identify Undiagnosed Respiratory Disease and Exacerbation Risk; CAT, COPD Assessment Test; IRB, institutional review board; mMRC, modified Medical Research Council; PEF, peak expiratory flow; ROC, receiver-operating characteristic
COPD is a major public health problem in the United States. Despite increasing prevalence and morbidity, COPD is underdiagnosed in primary care settings.1, 2 Many patients are first diagnosed when they present with an exacerbation,3 placing them at risk for future events,4 and/or after significant loss of lung function with unrecognized COPD symptoms. These individuals would benefit from therapies to improve lung function, reduce symptoms and exacerbations, and improve health status.5, 6
The Hispanic population is the fastest growing minority group in the United States,7 and COPD has been historically understudied in this population.8, 9 The overall incidence of COPD among Hispanic subjects is estimated at 8.2% (95% CI: 7.1-9.5).10 Although the rate of COPD is less among Hispanic subjects compared to whites and other minority groups, COPD-related hospitalization rates are higher among Hispanic men of all ages and Hispanic women aged > 65 years compared with non-Hispanic whites.11, 12 Inadequate access to health-care services, underdiagnosis, and poor health literacy (secondary to language and socioeconomic factors) may be contributing factors. Furthermore, the prevalence of undiagnosed COPD among Hispanic subjects is unknown, with language differences complicating recognition.
A simple method for identifying Hispanic patients who may have clinically significant disease would facilitate diagnosis and treatment. Although spirometry is essential for diagnosis, it is not practical or recommended for routine screening in primary care.13 Questionnaires can be useful for initial evaluation; however, they can uncover mild cases rather than more severe cases who would benefit most from treatment.14, 15, 16 Only a limited number of questionnaires have been tested for use in the US Hispanic population.
The COPD Assessment in Primary Care to Identify Undiagnosed Respiratory Disease and Exacerbation Risk (CAPTURE) questionnaire was developed to identify patients with undiagnosed, clinically significant COPD (FEV1 ≤ 60% and/or at risk for exacerbation) who would benefit from diagnosis and treatment.17 This five-item self-administered questionnaire asks patients about symptoms, impact, and acute respiratory illness (e-Fig 1). Through simple summation, scores range from 0 to 6; higher scores are associated with a stronger likelihood of COPD. With selective use of peak expiratory flow (PEF), sensitivity and specificity of the English version for differentiating case subjects (ie, those with clinically significant COPD) and control subjects (ie, those with mild or no COPD) was 89.7% and 78.1%, respectively, with values of 89.7% and 93.1% for case subjects vs no COPD. The goal of the present article was to examine the properties of a Spanish translation of CAPTURE (CAPTURE-S) and PEF as a case-finding approach for Spanish-speaking patients.
Methods
Design
Data from Spanish-speaking patients were gathered during the prospective, cross-sectional, multicenter, case-control study used to develop CAPTURE. Development procedures in English-speaking patients are described elsewhere.17 The protocol was approved by a central institutional review board (IRB) (Ethical and Independent Review Services IRB-14025-01) and IRBs at each participating site, including Columbia University (IRB-AAAK8511).
Participants
The Spanish cohort was recruited from primary care and pulmonary clinics at New York-Presbyterian Hospital, Columbia University Medical Center, where the surrounding neighborhood is 71% Hispanic18 (e-Appendix 1), using physician referrals and brochures placed in patient care areas.
Spanish-speaking subjects were enrolled concurrently with the larger cohort used for development and validation of the CAPTURE instrument. All subjects met the primary study criteria and considered Spanish their primary language, including reading, speaking, and writing. After obtaining informed consent, subjects completed a questionnaire including sociodemographic and health-related questions (including comorbidities), as well as 44 candidate items (described later). Subjects were not excluded on the basis of self-reported comorbidities. COPD was defined according to a medical diagnosis with prescribed pharmacologic therapy and an FEV1/FVC ratio < 0.70. Case subjects (target population) included subjects with COPD and exacerbation risk (group 1: ≥ 1 exacerbation in the prior 12 months) or moderate to severe airway obstruction (group 2: FEV1 ≤ 60% predicted and exacerbation free ≥ 12 months). Control subjects had no known diagnosis of or treatment for COPD (group 3) or had mild COPD (group 4: FEV1 > 60% predicted and exacerbation free ≥ 12 months). The mild group was included to optimize the identification of items most sensitive to the detection of individuals in the target population, as distinct from milder asymptomatic patients.
Procedures
To ascertain eligibility, a brief screening questionnaire was administered to potential participants in Spanish by clinical staff via telephone or in person. The questionnaire included questions about COPD and exacerbation history. Those subjects who were qualified and interested were consented in Spanish by a Spanish-speaking clinician. All procedures were performed in a single study-related visit scheduled outside of routine physician appointments.
Each participant completed a 44-item questionnaire in Spanish (described later). Time to complete the booklet was not measured. Participants were allowed to receive assistance from accompanying family members and ask clinical staff for clarification. Subjects also underwent PEF testing (Vitalograph AsmaPLAN mechanical PEF meter), performing three maneuvers, with the highest value (L/min) used for analysis. For patients without a recent spirometry (past 5 years), pre-bronchodilator spirometry (FVC, FEV1, and FEV1/FVC ratio) was obtained.
Measures
Candidate Item Pool
The pool of 44 candidate items for CAPTURE was developed by using a multi-method approach. This approach included a comprehensive literature review,19 qualitative interviews with English-speaking patients from the target population,20 and analyses of existing datasets.21
All candidate items and instructions were translated into Spanish with the use of an established process designed to assure linguistic and cultural equivalence across translations.22 This process included independent translation by two native Spanish speakers originating from different countries, reconciled by a third native speaker, and translated back into English by two independent native English speakers fluent in Spanish. The back translations were reviewed for linguistic and conceptual equivalence with adjustments as needed. The translated questionnaire (instructions and candidate items) was completed by 12 Spanish-speaking adults > 40 years of age from Cuba, the Dominican Republic, Guatemala, Ecuador, Mexico, and Puerto Rico, each residing in the United States. Semi-structured cognitive interviews were conducted by trained interviewers to evaluate the extent to which respondents understood and interpreted items as intended. Comments generated during these interviews were used to adjust the translation to yield a final translation of the item pool that was conceptually equivalent to the English version and culturally and linguistically appropriate for use across different Spanish-speaking nationalities. A language coordinator conducted reviews and quality checks throughout the translation process.
CAPTURE-S
Random forest methods was used in the larger (English) analytical dataset (N = 346) to develop the final five-item CAPTURE instrument (e-Fig 1).17 This final five-item instrument was not available for testing in the Spanish cohort because both studies occurred concurrently. Because small sample size precluded use of random forest methods in the Spanish cohort, translations of each item comprising the English version of CAPTURE were used to derive the Spanish version (Fig 1). The English and Spanish versions are identical, with performance properties of CAPTURE-S tested in the present study.
Figure 1.
CAPTURE-S questionnaire. CAPTURE-S = Spanish translation of the COPD Assessment in Primary Care to Identify Undiagnosed Respiratory Disease and Exacerbation Risk.
Criterion Variables
The modified Medical Research Council dyspnea scale (mMRC), translated into Spanish using procedures outlined earlier, and the published Spanish translation of the COPD Assessment Test (CAT) (http://www.catestonline.org/english/index_SpainUS.htm) were used to assess respiratory symptoms and test the performance properties of CAPTURE-S.6, 23, 24, 25
Statistical Analyses
Sensitivity, specificity, misclassification error, area under the curve, and receiver-operating characteristic (ROC) curves for differentiating case subjects and control subjects were estimated and examined, with exploratory analyses of case subjects vs no COPD (group 3). Pearson product-moment correlations between CAPTURE-S scores and PEF, spirometry, CAT, and mMRC scores were examined and the mean score difference between case subjects and control subjects were tested by using Student’s t test.
Assessments of PEF performance properties included sensitivity, specificity, overall error, area under the curve, and ROC curves using the sex-specific PEF thresholds derived previously (male subjects: < 350 L/min; female subjects: < 250 L/min).17 We also examined correlations between PEF and spirometry (Pearson product-moment), and mean score difference between case subjects and control subjects (Student’s t test), with descriptive statistics used to assess values across Global Initiative for Chronic Obstructive Lung Disease (GOLD) and COPD Foundation (COPDF) airflow limitation categories. Because of the small sample size, the latter were not tested statistically.
Finally, sensitivity, specificity, error, area under the curve, and ROC were examined for CAPTURE-S + PEF in this sample, using the scoring system derived in the larger study17 (e-Appendix 1).
Results
Sample
Thirty-one Spanish-speaking participants were enrolled, with spirometric data on all participants. One subject with a self-diagnosis of COPD did not meet spirometric criteria and was excluded from analysis. The final analytical sample included 17 case subjects and 13 control subjects (group 1: n = 10; group 2: n = 7; group 3: n = 10; and group 4: n = 3).
Sample demographic and clinical characteristics are shown in Table 1. Characteristics according to groups 1 through 4 are provided in e-Table 1. The sample was similar to the English-speaking sample, with the exception of educational status. A higher proportion of the Spanish-speaking subjects reported less than a high school education (e-Table 2).
Table 1.
Sample Demographic and Clinical Characteristics
Characteristic | Analytic Sample (N = 30) |
Case Subjectsa (n = 17) |
Control Subjectsb (n = 13) |
---|---|---|---|
Age, mean ± SD, y | 62.6 ± 11.49 | 68.2 ± 7.41 | 55.2 ± 11.86 |
Male sex | 10 (33) | 6 (35) | 4 (31) |
Employment | |||
Employed (full- or part-time) | 11 (37) | 1 (6) | 10 (77) |
Retired | 10 (33) | 9 (53) | 1 (8) |
Disabled | 6 (20) | 5 (29) | 1 (8) |
Homemaker | 3 (10) | 2 (12) | 1 (8) |
Education status | |||
Less than high school | 10 (33) | 9 (53) | 1 (8) |
High school | 7 (23) | 4 (24) | 3 (23) |
Associate, technical, or trade school | 5 (17) | 1 (6) | 4 (31) |
College degree or more | 7 (23) | 2 (12) | 5 (39) |
Smoking history | |||
Ever smoked (≥ 100 cigarettes) | 22 (73) | 17 (100.0) | 5 (39) |
Current smoker | 6 (20) | 6 (35) | 0 |
Spirometry, mean ± SD | |||
FEV1, L | 1.7 ± 0.95 | 1.1 ± 0.51 | 2.5 ± 0.86 |
FEV1 % predicted | 68.2 ± 30.30 | 48.4 ± 19.98 | 94.2 ± 19.84 |
FEV1/FVC ratio | 0.6 ± 0.21 | 0.5 ± 0.15 | 0.8 ± 0.13 |
GOLD classification, airflow limitation | |||
No COPD | 10 (33) | 0 | 10 (77) |
GOLD 1/2, mild/moderate | 9 (30) | 6 (35) | 3 (23) |
GOLD 3/4, severe/very severe | 11 (37) | 11 (65) | 0 |
COPD Foundation classification | |||
SG0, normal | 9 (30) | 0 | 9 (69) |
SG1, mild | 6 (20) | 3 (18) | 3 (23) |
SG2/3, moderate/severe | 14 (47) | 14 (82) | 0 |
SGU, undefined | 1 (3) | 0 | 1 (8) |
COPD Assessment Test, mean ± SD | 16.6 ± 11.53 | 21.8 ± 10.1 | 8.5 ± 8.23 |
mMRC | |||
0 | 7 (23) | 1 (6) | 6 (46) |
1 | 11 (37) | 6 (35) | 5 (39) |
>2 | 11 (37) | 10 (59) | 1 (8) |
Comorbid health conditions (any) | 28 (93) | 17 (100) | 11 (85) |
Data are presented as No. (%) unless otherwise indicated. GOLD = Global Initiative for Chronic Obstructive Lung Disease; mMRC = modified Medical Research Council; SG = spirometric grade.
Clinically significant COPD (FEV1 < 60% predicted or exacerbation risk).
COPD with FEV1 > 60% and exacerbation free > 12 months; or no known diagnosis or treatment for COPD and an FEV1/FVC ratio > 0.70.
CAPTURE and PEF Properties
Sensitivity, specificity, and overall error for differentiating case subjects and control subjects and case subjects vs no COPD using CAPTURE-S alone, PEF alone, and CAPURE-S + PEF are shown in Table 2. ROC curves for differentiating case subjects and control subjects are shown in Figures 2A, 2B, and 2C. It is noteworthy that the PEF curve for male subjects shows a perfect correspondence between the PEF threshold and case/control designation.
Table 2.
Predictive Performance of PEF Alone, CAPTURE Alone, and CAPTURE Plus Selective Use of PEF
Score Cutoff (Performance Indicator) | Case Subjectsa Vs Control Subjectsb (N = 30) |
Case Subjectsa Vs No COPDc (n = 27) |
---|---|---|
PEF alone; threshold (male subjects < 350; female subjects < 250) | ||
Sensitivity | 88.2% | 88.2% |
Specificity | 84.6% | 100% |
Overall error | 13.3% | 7.4% |
CAPTURE alone; scores ≥ 2 | ||
Sensitivity | 100% | 100% |
Specificity | 61.5% | 70.0% |
Overall error | 16.7% | 11.1% |
CAPTURE + PEF 0–1 = control; score 5–6 = case Score 2, 3, 4 = PEF used for group assignment |
||
Sensitivity | 88.2% | 88.2% |
Specificity | 92.3% | 100% |
Overall error | 10.0% | 7.4% |
CAPTURE = COPD Assessment in Primary Care to Identify Undiagnosed Respiratory Disease and Exacerbation Risk; PEF = peak expiratory flow.
Clinically significant COPD (FEV1 < 60% predicted or exacerbation risk).
COPD with FEV1 > 60% and exacerbation free > 12 months; or no known diagnosis or treatment for COPD and an EV1/FVC ratio > 0.70.
No known diagnosis or treatment for COPD and an FEV1/FVC ratio > 0.70.
Figure 2.
A-C, ROC for distinguishing case subjects and control subjects according to method. A, CAPTURE-S alone. B, Peak expiratory flow alone according to sex. C, CAPTURE-S with peak expiratory flow. ROC = receiver-operating characteristic. See Figure 1 legend for expansion of other abbreviation.
CAPTURE-S scores were significantly correlated with PEF (–0.78), the FEV1/FVC ratio (r = –0.74), FEV1 (r = –0.69), FEV1 % predicted (r = –0.69) (P < .0001), CAT score (r = 0.70), and the mMRC score (r = 0.59). The mean ± SD scores were significantly higher in case subjects (3.9 ± 0.97) than in control subjects (1.3 ± 1.38; t = 6.16; P < .0001).
PEF was significantly correlated with FEV1 (r = 0.89), FEV1 % predicted (r = 0.79), and the FEV1/FVC ratio (r = 0.75) (P < .0001). The mean ± SD PEF for case subjects (190.6 ± 57.82 L/min) was significantly lower than for control subjects (421.2 ± 155.50 L/min) (t = 5.08; P = .0001). Table 3 presents mean PEF data stratified according to GOLD and COPD Foundation classifications; participants with more severe disease had lower PEF rates. Group 1 (COPD with recent exacerbation) had the lowest PEF values compared with groups 2 (moderate/severe COPD without exacerbation) and 4 (mild COPD) (Fig 3).
Table 3.
PEF Rates According to COPD Classification
COPD Classification | PEF (L/min) |
---|---|
No COPD (n = 10) | 475.5 ± 129.86 |
GOLD Classification | |
GOLD 1 (n = 3) | 240.0 ± 72.11 |
GOLD 2 (n = 6) | 201.7 ± 74.68 |
GOLD 3 (n = 10) | 189.0 ± 49.77 |
GOLD 4 (n = 1) | 140.0 |
COPD Foundation Classification | |
SG0 (n = 9) | 500.6 ± 109.13 |
SG1 (n = 6) | 211.7 ± 59.47 |
SG2 (n = 13) | 196.2 ± 63.18 |
SG3 (n = 1) | 140.0 |
SGU (n = 1) | 250.0 |
Figure 3.
Mean peak expiratory flow for case subjects (clinically significant COPD [FEV1 < 60% predicted or exacerbation risk]) and control subjects (COPD with FEV1 > 60% and exacerbation free > 12 months; or no known diagnosis or treatment for COPD and an FEV1/FVC ratio > 0.70) and according to group.
Although time to complete the questionnaire booklet was not recorded, study staff noted that Spanish-speaking participants more frequently asked for clarification and took longer to complete the booklet than English-speaking subjects. They also seemed to be unfamiliar with medical terms, such as COPD (EPOC- “Enfermedad Pulmonar Obstructiva Crónica”). Subjects were diligent, with little to no missing data.
Discussion
COPD is often underdiagnosed or misdiagnosed. Most screening methods to date have uncovered patients with mild disease who may not benefit from treatment; the US Preventive Services Task Force recommends against widespread screening.26 CAPTURE and CAPTURE-S with PEF were designed to meet the need for a simple, clinically feasible method to identify patients with undiagnosed clinically significant disease who should be evaluated further.17 Having the same instrument in English and Spanish would facilitate its use in a wider range of primary care settings.
Our results show that a carefully developed Spanish translation of CAPTURE (CAPTURE-S) with selective use of PEF measurement may be useful for Spanish-speaking patients. To our knowledge, this study is the first to develop such a tool for use in the growing Hispanic population. The translation process assured us that CAPTURE-S is equivalent to the English version and is linguistically and culturally appropriate for Spanish-speaking patients from various countries of origin.
Sensitivity, specificity, and error were not unlike those observed in the English-speaking sample. In that study, values for CAPTURE alone (score ≥ 2 cutoff) were 95.7%, 44.4%, and 28.0%, respectively, for predicting case subjects vs control subjects and 95.7%, 67.8%, and 13.2% for case subjects vs no COPD. For PEF alone, values were 88.0%, 77.5%, and 16.9% for case subjects vs control subjects, and 88.0%, 90.8%, and 11.1% for case subjects vs no COPD. For CAPTURE + PEF, values were 89.7, 78.1, and 15.7 for case subjects vs control subjects and 89.7, 93.1, and 9.2 for case subjects vs no COPD17 (e-Appendix 1). Our results suggest that CAPTURE-S is as precise as the English version for differentiating case subjects and control subjects and case subjects vs no COPD. It should be noted that CAPTURE (and CAPTURE-S) is a case-finding tool to identify patients who should undergo further evaluation (ie, spirometry, chest imaging) and not a diagnostic tool.
The validity estimates for the CAPTURE-S were consistent and in some cases better than those observed in the English-speaking sample, where correlations were as follows: FEV1: r = 0.47; FEV1 % predicted: r = 0.53; FEV1/FVC ratio: r = 0.50 (all P < 0.0001; N = 344); CAT: r = 0.74; and mMRC rating: r = 0.58.17 Mean differences in CAPTURE score and PEF between case subjects and control subjects were also similar.
To effectively identify case subjects in routine clinical settings, the method should be of low cost, easy to administer, and take into consideration the characteristics of the patient population, including language and education. During the process of screening potential subjects and the administration of the questionnaire booklet, the site investigator and clinical coordinators observed a qualitative difference between Spanish- and English-speaking participants. As noted previously, Spanish-speaking participants took more time to complete the questionnaire booklet, required more clarification from staff, and seemed to have less knowledge of COPD compared with the English-speaking participants at this site. These differences may be related to educational level, health literacy, and/or the lengthy questionnaire booklet used in the instrument development study. The Spanish-speaking subjects were mostly residents of the Washington Heights community, and we do not know if disparities observed in this study are generalizable to the broader US Hispanic population. The final five-item questionnaire is intended to be simple and easy to complete with an estimated sixth grade (US) reading level,17 suggesting it is suitable for use across a broad range of educational backgrounds.
The sensitivity and specificity of CAPTURE + PEF compared with those of PEF alone may suggest that PEF may suffice in identifying English-speaking patients or Spanish-speaking patients with airflow obstruction.17 PEF does not assess impact or exacerbation risk, however. Furthermore, performing PEF maneuvers in all primary care patients for case-finding purposes is likely to be impractical. In fact, data from the Burden of Lung Disease study shows that despite the availability of inexpensive and easy-to-use spirometers, increased utilization of these instruments in routine primary care has not occurred.27 CAPTURE is an attempt to balance efficiency and precision, with the questionnaire used as an initial screen and PEF administered to a subset of patients to assure fewer false-positive findings and lower overall screening costs (e-Appendix 1).
The present study was limited by small sample size, with all subjects recruited through one center in an underserved urban community comprised primarily of immigrants from the Dominican Republic. Although recent data suggest that there is no major difference in COPD prevalence among various Hispanic groups, adjusting for smoking and asthma history,9 further study in a larger sample and varied Hispanic groups is needed. The translation process purposefully included individuals from different Spanish-speaking countries so that CAPTURE-S could be used in various Spanish-speaking populations. Finally, we noted the limited knowledge of COPD in this study cohort. Health literacy among the different Hispanic groups is poorly understood, and the applicability of our results to the larger US Hispanic population is unknown.
Conclusions
CAPTURE-S + PEF may be useful as a case-finding method for Spanish-speaking patients with undiagnosed, clinically significant COPD in need of further testing (eg, spirometry, chest imaging). Future research in a larger, diverse cohort of Spanish-speaking individuals is warranted.
Acknowledgments
Author contributions: W. A. Q. takes responsibility for the content of the manuscript, including data and analysis. W. A. Q., B. A. W., P. A. J., and B. M. T. directed and gathered data from the Spanish-speaking cohort described in this article, participated in the interpretation of study results, and drafted the manuscript. F. J. M., N. K. L., and D. M. M. were principal investigators of the multi-method CAPTURE project, including the design and interpretation of these analyses. N. K. L. directed these statistical analyses and interpretation of results and manuscript preparation. K. G. M. participated in the analytical design, programming/analyses, and interpretation. K. J. K. directed the translation process. M. K. H., J. F. H., B. M., C. A. M., S. I. R., and B. P. Y. participated in the study design, analytical plan, data collection, and interpretation. Members of the study group participated in the study design, implementation, data collection and/or interpretation of the CAPTURE project. All authors reviewed and approved the manuscript prior to submission.
Financial/nonfinancial disclosures: The authors have reported to CHEST the following: N. K. L. and K. K. are employees of Evidera, a health-care research firm that provides consulting and other research services to pharmaceutical, device, government, and nongovernment organizations. In this salaried position, they work with a variety of companies and receive no direct payment or honoraria from these companies for services rendered. Over the past 3 years, F. J. M. has participated in COPD studies sponsored by the NHLBI, GlaxoSmithKline, Takeda, AstraZeneca, Boehringer Ingelheim, and Forest. He has participated in advisory boards for Janssen, GlaxoSmithKline, AstraZeneca, Boehringer Ingelheim, Bellerophon, ConCert, Genentech, Novartis, Pearl, Roche, Sunovion, and Theravance. He has presented disease state or CME presentations for AstraZeneca, Boehringer Ingelheim, Novartis, CME Incite, Annenberg Center for Health Sciences at Eisenhower, Integritas, National Association for Continuing Education, Paradigm Medical Communications, PeerVoice, UpToDate, Haymarket, Western Society of Allergy and Immunology, Methodist Hospital Brooklyn, Columbia University, Takeda, Prime Healthcare, WebMD, California Society of Allergy and Immunology, Chiesi, and the Puerto Rican Thoracic Society. He has consulted with InThought, Unity Biotechnology, ProterrixBio and Lucid. He has participated on a DSMB for GlaxoSmithKline. D. M. M. has received honoraria/consulting fees and served on speaker bureaus for GlaxoSmithKline, Novartis Pharmaceuticals, Pfizer Inc, Boehringer Ingelheim, AstraZeneca, Forest Laboratories Inc, Merck, Amgen, and Sunovion. D. M. M. has also received royalties from UptoDate, is on the Board of Directors of the COPD Foundation, and has been compensated as a medical expert in legal cases. M. K. H. has consulted for GlaxoSmithKline, Boehringer Ingelheim, AstraZeneca, Sunovion, and Novartis. B. M. has served on medical advisory boards for Aerocrine, AstraZeneca, Boehringer Ingelheim, CSL Bering, GlaxoSmithKline, Forest, Novartis, Spiration, Theravance, and Sunovion and has participated in research studies funded by AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Pfizer, Forest, Sunovion, and Pearl. B. M. has also conducted continuing medical education for the American Thoracic Society, the American College of Chest Physicians, the Academy for Continued Healthcare Learning, Medscape, Projects in Knowledge, Catamount, Carden Jennings, the Cleveland Clinic, the Eastern Virginia Medical Center, Hybrid Communications, SPIRE, the Foundation for Improving Patient Outcomes, Consensus, WebMD, National Jewish Health, and the National Medical Association; has received royalties from UpToDate; has served on Data Monitoring Boards for Spiration and Baxalta; and has provided unbranded education talks for GlaxoSmithKline. K. G. M. is an hourly employee of Evidera and a salaried employee of Malley Research Programming, Inc; in the latter capacity, she provides custom computer programming services to clinical research organizations. S. I. R. was employed by the University of Nebraska Medical Center during the conduct of this study and remains the Richard and Margaret Larson Professor of Pulmonary Research at the University of Nebraska Medical Center and had a number of relationships with companies who provide products and/or services relevant to outpatient management of COPD, including A2B Bio, Almirall, APT, AstraZeneca, Boehringer Ingelheim, Chiesi, CME Incite, CSL Behring, Daiichi Sankyo, Decision Resources, Dunn Group, Easton Associates, Forest, Gerson, GlaxoSmithKline, Johnson & Johnson, MedImmune, Novartis, Novis, Nycomed, Otsuka, Pearl, Pfizer, PriMed, Pulmatrix, Roche, Takeda, and Theravance; these relationships include serving as a consultant, advising regarding clinical trials, speaking at continuing medical education programs, and performing funded research both at basic and clinical levels. S. I. R. is currently employed by AstraZeneca, in which he owns shares; he does not own any stock in any other pharmaceutical companies. B. P. Y. has received research funding from the National Institutes of Health, the Agency for Healthcare Research and Quality, the Centers for Disease Control and Prevention, and from Boehringer Ingelheim for research on COPD. B. P. Y. has received compensation from Merck, Novartis, AstraZeneca, and Forest for COPD advisory boards on COPD, and Grifols for advisory boards on α1-antitrypsin deficiency states. B. T. has consulted for Boehringer Ingelheim and has been on advisory boards for GlaxoSmithKline, Novartis, AstraZeneca, and Forest. None declared (W. Q., B. W., P. J., J. F. H., C. A. M.).
Role of the sponsor: The sponsor had no role in the design of the study, the collection and analysis of the data, or the preparation of the manuscript.
*Members of the High-Risk-COPD Screening Study Group: R. Graham Barr, MD, Columbia University; Russ P. Bowler, MD, National Jewish Health; Rebecca Copeland, BS, University of Kentucky; Tim Dorius, MD, University of Nebraska Medical Center; Karen Ishitani, RN, MSN, Olmsted Medical Center; Marge Kurland, RN, Olmsted Medical Center; James Melson, RN, BSN, University of Nebraska Medical Center; Randel Plant, BA, COPD Foundation; Christina Schnell, BA, CCRC, National Jewish Health; Jason Shiffermiller, MD, MPH, University of Nebraska Medical Center; Sonja Stringer, MPH, Evidera; Deb Sumnick, PBT, University of Nebraska; Kyle Textor, BA, Olmsted Medical Center; Jennifer Underwood, CCRC, National Jewish Health; and John Walsh, COPD Foundation. The study group also includes all authors listed on page 1.
Other contributions: The COPD Foundation contributed PEF meters for this study, Christine Thompson assisted with statistical programming, and Kathryn Miller performed manuscript text editing and formatting. FACIT (http://www.facit.org/FACITOrg) performed the translations.
Additional information: The e-Appendix, e-Figure, and e-Tables can be found in the Supplemental Materials section of the online article.
Footnotes
Portions of this research were presented at the COPD9 Conference, June 5-6, 2015, Chicago, IL (Quezada WA, Whippo BA, Jellen PA, Martinez F, Leidy NK, Kim K, Mannino D, Thomashow BM for the High-Risk-COPD Screening Study Group [June 2015]. Development of a New COPD Case-Finding Method for Use in Spanish-Speaking Patients: Challenges and Future Directions).
FUNDING/SUPPORT: This study was funded by the National Heart, Lung, and Blood Institute [NIH/NHLBI grant 1R01 HL1144055].
Contributor Information
Fernando J. Martinez, Email: fjm2003@med.cornell.edu.
High-Risk-COPD Screening Study Group∗:
R. Graham Barr, Russ P. Bowler, Rebecca Copeland, Tim Dorius, Karen Ishitani, Marge Kurland, James Melson, Randel Plant, Christina Schnell, Jason Shiffermiller, Sonja Stringer, Deb Sumnick, Kyle Textor, Jennifer Underwood, and John Walsh
Supplementary Data
References
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