Draft Recommendation Statement
Chronic Obstructive Pulmonary Disease: Screening
This opportunity for public comment expired on September 14, 2015 at 8:00 PM EST
Note: This is a Draft Recommendation Statement. This draft is distributed solely for the purpose of receiving public input. It has not been disseminated otherwise by the USPSTF. The final Recommendation Statement will be developed after careful consideration of the feedback received and will include both the Research Plan and Evidence Review as a basis.
Recommendations made by the USPSTF are independent of the U.S. government. They should not be construed as an official position of the Agency for Healthcare Research and Quality or the U.S. Department of Health and Human Services.
About 14 percent of U.S. adults ages 40 to 79 years have COPD, and it is the third leading cause of death in the United States.1, 2 Persons with severe COPD are often unable to participate in normal physical activity due to deterioration of lung function.
COPD is defined as airflow limitation that is not fully reversible and is related to the abnormal inflammatory response of the lung to harmful particles or gases. Diagnosis is based on post-bronchodilator spirometry, which tests for fixed airway obstruction; a forced expiratory volume in 1 second to forced vital capacity (FEV1/FVC) ratio of less than 0.70 is the threshold for diagnosis. Persons with COPD often, but not always, have symptoms such as dyspnea, chronic cough, and chronic sputum production. Patients often have a history of exposure to risk factors such as cigarette smoke or heating fuels or occupational exposure to dusts or chemicals. Although post-bronchodilator spirometry is required to make a definitive diagnosis, prescreening questionnaires can elicit current symptoms and previous exposures to harmful particles or gases.
Benefits of Detection and Early Treatment
The USPSTF found no evidence that screening for COPD in asymptomatic persons with questionnaires or spirometry improves health outcomes. There are no data to suggest that screening for COPD before the development of symptoms affects treatment decisions, alters the course of the disease, or improves patient outcomes.
Harms of Detection and Early Treatment
The USPSTF found inadequate evidence on the harms of screening. However, given the lack of benefit of early detection and treatment, the opportunity cost associated with screening asymptomatic persons may be large. The amount of time and effort required to screen for COPD in asymptomatic persons (using screening spirometry with or without prescreening questionnaires) are not trivial.
The USPSTF concludes with moderate certainty that screening for COPD in asymptomatic persons has no net benefit. Thus, screening is not recommended in persons who do not have symptoms suggestive of COPD.
Draft: Clinical Considerations
Patient Population Under Consideration
This recommendation statement applies to asymptomatic adults who do not recognize or report respiratory symptoms. It does not apply to at-risk persons who present to clinicians with symptoms such as chronic cough, sputum production, dyspnea, or wheezing. It also does not apply to persons with a family history of alpha-1 antitrypsin deficiency.
Exposure to cigarette smoke or toxic fumes increases the risk for COPD. Epidemiological studies have found that 15 to 50 percent of smokers develop COPD.3 More than 70 percent of COPD cases occur in current or former smokers. Occupational exposure to toxins, dusts, or industrial chemicals contributes an estimated 15 percent of COPD cases. Environmental pollution, including wood smoke and traffic pollutants, is also associated with increased risk for COPD. Nonmodifiable risk factors for COPD include history of asthma or childhood respiratory infections and alpha-1 antitrypsin deficiency.
Screening adults in primary care involves either risk assessment via a formal prescreening questionnaire and, if positive, followup with diagnostic spirometry testing, or screening spirometry administered without a bronchodilator and, if positive, followup with diagnostic spirometry testing. Patients identified as high risk by a prescreening questionnaire or by screening spirometry are referred for diagnostic spirometry testing. Diagnostic spirometry requires persistent airway obstruction after administration of an inhaled bronchodilator, such as albuterol (i.e., post-bronchodilator spirometry). COPD is diagnosed when the post-bronchodilator FEV1/FVC ratio is less than 0.7. Severity is defined by the percentage of predicted post-bronchodilator FEV1; 80 percent or more is mild, 50 to 79 percent is moderate, 30 to 49 percent is severe, and less than 30 percent is very severe.
Other Approaches to Prevention
Prevention of exposure to cigarette smoke and other toxic fumes is the best way to prevent COPD. Current smokers should receive smoking cessation counseling and be offered behavioral and pharmacological therapies to stop smoking.
The USPSTF recommends that clinicians ask all adults about tobacco use and provide tobacco cessation interventions for those who use tobacco products, including pregnant women. The USPSTF also recommends that clinicians provide interventions, including education or brief counseling, to prevent initiation of tobacco use in school-age children and adolescents. These recommendations and their supporting evidence are available on the USPSTF Web site (www.uspreventiveservicestaskforce.org).
Draft: Other Considerations
Research Needs and Gaps
Trials of screening current and previous smokers for COPD in primary care with long-term outcome data are needed. Additionally, long-term treatment trials of screen-detected patients are also needed. Better treatment options for COPD and long-term epidemiological studies of the natural history and heterogeneity of COPD progression would also help identify patients who are at greatest risk for clinical deterioration.
Burden of Disease
About 13.7 million persons in the United States are affected annually by COPD.4 As lung function deteriorates over time, patients with COPD experience significant restrictions in their ability to work and participate in other activities of daily living. In 2013, COPD was responsible for about 10.3 million physician visits and 1.5 million emergency department visits.4 Health care costs associated with COPD are estimated at $32 billion per year.3 The prevalence of COPD and its associated mortality have been rising among women, possibly due to increasing smoking rates, environmental exposures, or biological mechanisms that increase susceptibility to COPD. Among different racial/ethnic groups, the prevalence of COPD is highest among non-Hispanic white adults (14.9%) and non-Hispanic black adults (12.8%).2, 5
Scope of Review
Since the 2008 USPSTF recommendation, there is still no evidence that screening for COPD in asymptomatic persons improves health-related quality of life, morbidity, or mortality. The USPSTF commissioned a systematic review to examine whether screening for COPD improves the delivery and uptake of targeted preventive services, such as smoking cessation or relevant immunizations. In addition to the potential benefits of screening, the USPSTF also examined the possible harms of screening for and treatment of mild to moderate COPD. The diagnostic accuracy of screening tools (including prescreening questionnaires and spirometry) was not part of the previous systematic review, but was evaluated in the current review.3
Accuracy of Prescreening and Screening Tests
The USPSTF identified three externally-validated risk factor- and/or symptom-based questionnaires—the COPD Diagnostic Questionnaire,6, 7 the Lung Function Questionnaire,8 and the COPD Population Screener.9 In addition, three other questionnaires are currently in development and have not yet been externally validated.3 The COPD Diagnostic Questionnaire is an eight-item questionnaire with sensitivity of about 90 percent and specificity of about 40 percent for identifying persons with COPD in primary care populations at a cutpoint of greater than 16.5.3 The Lung Function Questionnaire is a five-item questionnaire with sensitivity of about 88 percent and specificity of about 25 percent in primary care populations of current and former smokers at a cutpoint of 18 or greater.3 The COPD Population Screener is a five-item questionnaire with sensitivity of 67 percent and specificity of 73 percent in a general population in Japan at a cutpoint of 4 or greater.3
The USPSTF found two heterogeneous international studies of screening with handheld peak flow meters that were considered not applicable to U.S. primary care populations.3 Screening with pulmonary function tests (without bronchodilators) was studied in primary care populations in Australia and Sweden3 and yielded sensitivity of about 50 percent and specificity of 90 percent for a cutpoint of less than 0.7. Another screening study conducted in Greece evaluated post-bronchodilator spirometry and yielded sensitivity of 80 percent and specificity of 95 percent for the same cutpoint.3 The USPSTF found no pulmonary function screening studies conducted in the United States.3
Effectiveness of Early Detection and Treatment
The USPSTF found no studies that directly assessed the effects of screening for COPD in asymptomatic adults on morbidity, mortality, or health-related quality of life. The USPSTF also found no studies that examined the effectiveness of screening on relevant immunization rates. The USPSTF identified five studies that assessed the effects of screening on smoking cessation.10-14 These studies primarily examined the incremental value of adding spirometry testing to existing smoking cessation programs. One trial showed a statistically significant difference in smoking cessation rates between participants who received explanations of their spirometry results using “lung age” and those who did not.10 The other four trials did not report any significant differences in smoking abstinence rates.
The USPSTF examined the treatment efficacy of four classes of medications used in the treatment of COPD—long-acting beta-agonists (LABAs), inhaled corticosteroids, long-acting anticholinergics (tiotropium), and combination therapy with corticosteroids and LABAs.3 None of the treatment trials were conducted in asymptomatic or screen-detected populations; all were conducted in populations with moderate COPD. Two studies of LABAs found no difference in all-cause mortality, but decreased COPD exacerbation in the treatment group compared with the control group in post hoc subanalyses. Six trials of inhaled corticosteroids found decreased COPD exacerbation but no difference in all-cause mortality, dyspnea, or quality of life. One trial of combination therapy with corticosteroids and LABAs showed decreased COPD exacerbation but no differences in mortality or quality of life. Five trials of anticholinergics found decreased COPD exacerbation but insufficient evidence on other outcomes. For all classes of medications, the one consistent finding was that treatment decreases COPD exacerbation in persons with moderate COPD, without consistent effects on all-cause mortality, dyspnea, or quality of life. For all classes of medications, there was insufficient evidence on the effects of treatment on exercise capacity.
Estimate of Magnitude of Net Benefit
The harms of prescreening questionnaires and screening spirometry are false-positive and false-negative results. The USPSTF found no evidence to estimate the long-term harms of these screening tests. Potential harms of treatment may include pneumonia with use of LABAs and inhaled corticosteroids and decreased bone density and increased fractures with use of inhaled corticosteroids. However, data were sparse, with few adverse events, and there were no differences between the intervention and control groups.3
Since all of the treatment trials were conducted in persons with mild to moderate COPD, it is unclear how these results would apply to asymptomatic populations. The potential treatment benefit of decreased exacerbation of symptoms may not apply to patients who report no symptoms to begin with. Given the lack of potential benefits of treatment in asymptomatic persons and the not trivial efforts of screening, the USPSTF determined that there is no net benefit of screening.
How Does Evidence Fit With Biological Understanding?
To date, treatment trials of COPD have found modest treatment benefits in patients with mild to moderate COPD. Since the majority of COPD cases results from exposure to cigarette smoke and other noxious fumes, the most effective way to prevent COPD is to limit such exposure. Persons with a history of exposure and symptoms such as dyspnea, chronic cough, or sputum production should be evaluated for the diagnosis of COPD.
Draft: Recommendations of Others
In 2011, the American College of Physicians, American College of Chest Physicians, American Thoracic Society, and the European Respiratory Society issued joint guidelines recommending that spirometry be used to diagnose airflow obstruction in patients with respiratory symptoms.15 The panel recommends against screening for COPD with spirometry in asymptomatic patients, citing the lack of benefit. Similarly, in 2010, the National Institute for Health and Clinical Excellence recommended against screening for COPD in asymptomatic patients.16 Recent guidelines from the Global Initiative for Chronic Obstructive Lung Disease recommend case finding in symptomatic patients but not screening in asymptomatic populations.17
1. Kochanek KD, Murphy SL, Xu J, Arias E. Mortality in the United States, 2013. NCHS Data Brief. 2014;(178):1-8.
2. Tilert T, Dillon C, Paulose-Ram R, et al. Estimating the U.S. prevalence of chronic obstructive pulmonary disease using pre- and post-bronchodilator spirometry: the National Health and Nutrition Examination Survey (NHANES) 2007-2010. Respir Res. 2013;14:103.
3. Guirguis-Blake JM, Senger CA, Webber EM, et al. Screening for Chronic Obstructive Pulmonary Disease: A Systematic Evidence Review for the U.S. Preventive Services Task Force. Evidence Synthesis No. 130. AHRQ Publication No. 14-05205-EF-1. Rockville, MD: Agency for Healthcare Research and Quality; 2015.
4. Ford ES, Croft JB, Mannino DM, et al. COPD surveillance—United States, 1999-2011. Chest. 2013;144(1):284-305.
5. Centers for Disease Control and Prevention. Chronic obstructive pulmonary disease among adults—United States, 2011. MMWR Morb Mortal Wkly Rep. 2012;61(46):938-43.
6. Price DB, Tinkelman DG, Halbert RJ, et al. Symptom-based questionnaire for identifying COPD in smokers. Respiration. 2006;73(3):285-95.
7. Price DB, Tinkelman DG, Nordyke RJ, et al; COPD Questionnaire Study Group. Scoring system and clinical application of COPD diagnostic questionnaires. Chest. 2006;129(6):1531-9.
8. Yawn BP, Mapel DW, Mannino DM, et al; Lung Function Questionnaire Working Group. Development of the Lung Function Questionnaire (LFQ) to identify airflow obstruction. Int J Chron Obstruct Pulmon Dis. 2010;5:1-10.
9. Martinez FJ, Raczek AE, Seifer FD, et al; COPD-PS Clinician Working Group. Development and initial validation of a self-scored COPD Population Screener Questionnaire (COPD-PS). COPD. 2008;5(2):85-95.
10. Parkes G, Greenhalgh T, Griffin M, Dent R. Effect on smoking quit rate of telling patients their lung age: the Step2quit randomised controlled trial. BMJ. 2008;336(7644):598-600.
11. Risser NL, Belcher DW. Adding spirometry, carbon monoxide, and pulmonary symptom results to smoking cessation counseling: a randomized trial. J Gen Intern Med. 1990;5(1):16-22.
12. Kotz D, Wesseling G, Huibers MJ, van Schayck OC. Efficacy of confronting smokers with airflow limitation for smoking cessation. Eur Respir J. 2009;33(4):754-62.
13.Sippel JM, Osborne ML, Bjornson W, et al. Smoking cessation in primary care clinics. J Gen Intern Med. 1999;14(11):670-6.
14. McClure JB, Ludman EJ, Grothaus L, et al. Impact of a brief motivational smoking cessation intervention: the Get PHIT randomized controlled trial. Am J Prev Med. 2009;37(2):116-23.
15. Qaseem A, Wilt TJ, Weinberger SE, et al. Diagnosis and management of stable chronic obstructive pulmonary disease: a clinical practice guideline update from the American College of Physicians, American College of Chest Physicians, American Thoracic Society, and European Respiratory Society. Ann Intern Med. 2011;155(3):179-91.
16. National Institute for Health and Clinical Excellence. Chronic Obstructive Pulmonary Disease: Management of Chronic Obstructive Pulmonary Disease in Adults in Primary and Secondary Care (Partial Update). London: National Institute for Health and Clinical Excellence; 2010. https://www.nice.org.uk/guidance/cg101. Accessed July 22, 2015.
17. Global Initiative for Chronic Obstructive Lung Disease. Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease. 2015. http://www.goldcopd.org/guidelines-global-strategy-for-diagnosis-management.html. Accessed July 22, 2015.
Internet Citation: Draft Recommendation Statement: Chronic Obstructive Pulmonary Disease: Screening. U.S. Preventive Services Task Force. March 2016.