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* From Galt Associates (Dr. Stang), Sterling, VA; SmithKline Beecham Pharmaceuticals (Drs. Lydick and Silberman and Ms. Keating), Collegeville, PA; and Pharmametrics GmbH (Dr. Kempel), Freiburg, Germany.
Correspondence to: Paul Stang, PhD, 1744 Dekalb Pike, Suite 175, Blue Bell, PA 19422; e-mail: pstang{at}galt-assoc.com
| Abstract |
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Design: Model based on literature review. Age- and gender-specific rates of lung impairment by smoking status were applied to US smoking data. Resultant estimates were compared to the actual prevalence of obstructive airway disease as estimated by US national surveys. The model then was applied to estimate the prevalence of COPD in several European countries, where national data on undiagnosed lung disease do not exist.
Setting: The model was adapted from both a literature review and health-care data, and the analysis was applied to the United States and Europe.
Results: Using smoking rates, we estimate from our model that 15.3 million people who are > 40 years of age in the United States have COPD. The prevalence estimate, based on spirometric definitions for COPD in the same age group using the Third National Health and Nutrition Examination Survey (NHANES III), is 17.1 million people. NHANES III and other US national health-care surveys further suggest that only between 2.4 and 7 million people actually have COPD diagnosed; thus, the proportion of COPD that is currently being diagnosed in the United States is between 14% and 46% of all cases. Using smoking rates and our model, which was developed and validated for the United States, we calculated the prevalence of COPD for Germany (2.7 million people), the United Kingdom (3.0 million people), Spain (1.5 million people), Italy (2.6 million people), and France (2.6 million people) in those people > 45 years of age.
Conclusions: Smoking rates appear to provide a useful method of estimating current COPD prevalence in those countries where more objective data are unavailable. These results are important because recognition of the true burden of disease and corresponding efforts to increase early identification of COPD can help to reduce the morbidity and mortality associated with COPD in populations at risk.
Key Words: COPD prevalence smoking
| Introduction |
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COPD is very difficult to diagnose and detect clinically in its milder forms without the use of spirometry. Unfortunately, spirometry is not routinely employed in patients at risk for developing COPD (ie, smokers), and spirometric test results are not routinely recorded or consistently interpreted. This is due, in part, to the gradual and insidious development of airflow obstruction in COPD and, in part, to absent or nonspecific symptoms that may occur in patients with mild forms of the disease.3 4 5 Along with the difficulty of early detection, the clinician is challenged by the need to distinguish COPD from the persistent airflow limitation of chronic asthma in older subjects. Recent studies appear to indicate that most older adults with asthma have a chronic irreversible component to their disease.6 The following factors favor the diagnosis of COPD and may help clinicians distinguish between these two conditions: a history of smoking of > 10 pack-years; evidence of emphysema on imaging; decreased diffusing capacity; and chronic hypoxemia.
The terminology in the field of obstructive lung diseases is also complex and often confusing, despite several attempts during the last 30 years to define asthma, chronic bronchitis, and emphysema. Diagnostic labels vary by individual physician, by country, and by time period.7 8 9 This makes estimation of the incidence and prevalence of COPD through a review of the biomedical literature extremely difficult, if not impossible, as a number of reports in the literature cite their own definitions of COPD that vary across time and investigation.
There are several possible ways to estimate the prevalence and, consequently, the burden of COPD. Health-care resource use attributed to COPD diagnoses, ie, outpatient visits or hospital discharges, may provide some estimate of the prevalence of COPD. An estimate based on resource utilization will underestimate true prevalence, however, as only those patients seeking medical attention or recognized by the clinician are captured. Most commonly, patients seeking medical attention have acute exacerbations and, in most cases, present with later stage disease.10 Thus, estimates of the prevalence of COPD are probably biased toward the more severe and symptomatic cases. Furthermore, those with comorbid conditions may elude detection as treatment focuses on the more immediate and visible chronic diseases, leaving COPD relatively undetected for some period of time. COPD estimates also are hindered by inaccuracies in coding as well as inconsistent physician recognition of early disease. Additionally, health-care resource utilization data can be difficult to obtain or may be unavailable in some countries. Therefore, some more reliable means is needed to estimate the true prevalence of COPD in the general population.
Studies have repeatedly found that cigarette smoking is the most important and consistent determinant of the development and progression of COPD.3 11 12 13 14 15 16 Most publications cite that 10 to 15% of smokers are expected to develop COPD; however, this figure appears to have been derived from the report of the Surgeon General11 and the occupational cohort work by Fletcher et al3 and has not been supported consistently across ages or cohorts. The work described in this article pursues an alternative, albeit simplified, approach with a goal of estimating true COPD prevalence based on smoking rates. We sought to provide more precise estimates by including in our analysis only those studies that report rates of COPD based on systematic spirometric examination of a general population. This increases the validity of our model in more precisely estimating the extent of COPD in the general population.
There are several diagnostic schemes accepted in various parts of the world relating COPD diagnosis to spirometric test values. However, as we were undertaking the initial development and validation effort using data from the United States, we used the American Thoracic Society guidelines.17 This approach, if successful, could simplify the estimation of actual COPD prevalence and could facilitate estimates of the social and economic costs of COPD in the near term, despite the absence of high-quality longitudinal or cross-sectional assessments of pulmonary function and smoking status.
| Materials and Methods |
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Estimates of Total COPD Prevalence
Using a computerized MEDLINE search, we identified studies in
the biomedical literature that met the following criteria:
population-based; presented information about smoking status (never,
current, and former smokers), age, and race (analyses were confined to
whites to facilitate extrapolation to European countries); and used a
spirometric definition of COPD. We also restricted our estimates in the
United States to those persons aged
40 years to reduce the
likelihood of including cases of asthma. We thought that these criteria
would provide us with the best estimates of the true rate of COPD by
age, gender, and smoking status. Estimates from the literature were
then smoothed using a simple linear regression to facilitate
extrapolation with available country-specific smoking data.
The proportion of individuals in each smoking category (never, current, or former) within specific age groups was multiplied by the proportion of individuals with COPD as estimated by regression lines. Age groups were estimated by their midpoint values.
Last, we adapted our approach to use available data (including information obtained through government surveys and information in the biomedical literature) on smoking rates in Germany, the United Kingdom, Spain, and Italy to derive estimates of COPD prevalence in those countries. In adapting our approach for France, smoking rates were obtained from a population-based study.18
Validation of Model Estimates
We validated our estimates by comparing them with estimates
calculated using NHANES III data, which includes self-reported
diagnosis, the results of pulmonary function tests, and smoking
status.19
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An estimate of the number of persons
diagnosed with COPD was determined from NHANES III based on
the number of individuals who reported having been told by a physician
that they had either chronic bronchitis or emphysema.19
An
estimate of all cases of obstructive lung disease was based on
spirometry using American Thoracic Society criteria. These estimates
from NHANES III for the total number of cases of COPD then were
compared to estimates obtained from our regression model based on
reports in the literature.
| Results |
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Total COPD Prevalence in Europe
Smoking rates for the five European countries that were studied
are presented in Table 5
, and the corresponding estimates of COPD prevalence based on our model
are presented in Table 6
. Our estimates of COPD prevalence in these countries range from 1.5
million people with COPD in Spain to 3.0 million people in the United
Kingdom, with estimates of 2.7 million people with COPD in Germany, 2.6
million people in Italy, and 2.6 million people in France. In
comparison with the number of hospitalizations in these same countries
(Table 7 , which does not include France), a striking difference in frequency can
be seen even without adjusting the number of hospitalizations to
represent the actual numbers of patients.
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| Discussion |
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40 years, we found that the rate of COPD increased from 2 to
10% among never-smokers and from 17 to 43% among current smokers as
the age range increased. The results obtained using a smoking-rates
model for estimating COPD prevalence are similar to those obtained
directly from the NHANES III "gold standard" (15.3 people with COPD
vs 17.1 million people with COPD, respectively). Both the model and the
rates from NHANES III were estimates of COPD based on the prevalence of
obstructive lung disease as assessed by spirometry rather than by a
clinical diagnosis, which may have been overinclusive. However, because
of the close agreement of the results from the two methods and the need
for better data in other countries, we believe that there is value in
our application of the regression model to smoking data from European
countries. Since smoking prevalence data are readily available in most
countries, our model can provide a practical means of estimating more
accurately the true burden of COPD in a population. Although it is
based on a spirometric definition of COPD and is anchored to the
principal etiologic factor for the disease, the limitations of taking a
simplified approach to a very complex physiologic process should be
borne in mind. The key data informing our model were taken from a handful of population-based studies that had complete spirometry data and smoking status information. Although we have no reason to believe that these data are misleading, even minor variations could lead to overestimation or underestimation. Furthermore, we limited our US analysis to those people > 40 years of age, as there are very limited data available on COPD rates in younger populations and the data that do exist are probably contaminated by poorly differentiated asthma cases. However, the bulk of the disease occurs in the sector of the population aged > 40 years of age,3 15 17 and it is unlikely that we are losing a large fraction of the population with even mild cases of COPD.
Tobacco exposure continues to change, especially with the introduction of new therapies and public health measures to curb tobacco use. Our implicit assumption is that age and smoking status (current, former, or never) serve as surrogates for total exposure to cigarette smoke (for example, pack-years). Other countries could have shorter or longer tobacco exposure times than are currently applicable in the United States. Additionally, the spirometry definitions used in our analysis are not equivalent to clinical COPD definitions, and the definitions are not identical within the four studies. Given the difficulty of accurately diagnosing COPD, particularly in its early stages, this is clearly a study limitation. In addition, the precision of estimates from the model will vary with the quality of available smoking data. Last, the estimates make no adjustment for secular trends in smoking rates, competing causes of morbidity and mortality in a given population, or ethnic differences in smoking rates, which may influence the generalized estimates of COPD prevalence in some European communities.
Despite its prominent impact on the health of a nation, COPD receives disproportionately less funding from the National Institutes of Health when compared with other illnesses based on mortality, disability, and years of life lost.25 Only recognition of the true size of the population affected by COPD is likely to lead to efforts to increase diagnosis and to improve treatment, including greater efforts for smoking cessation. When compared to several measures of clinically recognized COPD, it is clear that people with diagnosed COPD make up only a small proportion of the number of people with COPD who actually are present in the community.
| Conclusion |
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| Acknowledgements |
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| Footnotes |
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This study was supported by SmithKline Beecham Pharmaceuticals.
| References |
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